December 2013
Vol. 12
Issue 5
Mumbai
Price ` 150
www.pharmabioworld.com PHARMA BIO WORLD DECEMBER 2013 VOL. 12 ISSUE 5 MUMBAI ` 150 B & R COVER PAGE .indd 1
07-01-2014 11:17:46
The Economical Choice!
Fast, Accurate Viscosity Readings Advanced features such as user-enabled calibration and motor-auto test make viscometer operation easy. Includes Two-Year Warranty!
Find Solutions from Lab to Process in the 2013/14 Cole-Parmer速 India Catalog
304 pages featuring dual pricing, duty paid and duty exempt
Request your FREE copy today! 3746
3746_Pharma Bio World India SpAd_1213.indd 1
december ads.indd 2
022-6716-2222 response@coleparmer.in
ColeParmer.in/3125 12/4/2013 3:26:05 PM
06-01-2014 15:45:45
december ads.indd 4
06-01-2014 19:29:14
december ads.indd 5
06-01-2014 15:34:52
PHARMA BIO WORLD R.N.I. No.: MAHENG/2002/8502 Chairman
Jasu Shah
Publisher & Printer
Maulik Jasubhai Shah
Chief Executive Officer
Hemant Shetty
EDITORIAL Editor
Mittravinda Ranjan (mittra_ranjan@jasubhai.com)
Editorial Advisory Board
Ajit Singh, Jai Shankar, Dr Narges Mahaluxmivala, Dr Prabuddha Ganguly, Dr Satish Ravetkar, Utkarsh Palnitkar
Sub-Editor
Ananya Sen (ananya_sen@jasubhai.com)
Feature Writer
Mahesh Kallayil (mahesh_kallayil@jasubhai.com)
Design Team
Arun Parab, Umesh Chougule, Amol Patkar
Events Management Team
Abhijeet Mirashi
Marketing Co-ordinator
Brenda Fernandes
Subscription Team
Dilip Parab, Girish Kamble
Production Team
V Raj Misquitta (Head), Arun Madye
Vol. 12 | No. 5 | DECEMBER 2013 | MUMBAI | ` 150
PLACE OF PUBLICATION
Jasubhai Media Pvt Ltd 210, Taj Building, 3 rd Floor, Dr. D. N. Road, Fort, Mumbai 400 001, Tel: +91-22-4037 3636, Fax: +91-22-4037 3635
SALES General Manager, Sales : Amit Bhalerao (amit_bhalerao@jasubhai.com) Prashant Koshti (prashant_koshti@jasubhai.com) MARKETING TEAM & REGIONAL OFFICES Mumbai
Godfrey Lobo / V Ramdas 210, Taj Building, 3rd Floor, Dr. D. N. Road, Fort, Mumbai 400 001 Tel: +91-22-4037 3636 Fax: +91-22-4037 3635 E-mail: godfrey_lobo@jasubhai.com, v_ramdas@jasubhai.com
Ahmedabad
Vikas Kumar 64/A, Phase 1, GIDC Indl Estate, Vatva, Ahmedabad 382 445 Tel: 91-079-49003636 / Ext:627, Fax: 91-079-25831825 Mobile: 09712148258 E-mail: vikas_kumar@jasubhai.com
Vadodara
Pervindersingh Rawat 202 Concorde Bldg, Above Times of India Office, R C Dutt Road, Alkapuri, Baroda 390 007 Telefax: 91-0265-2337189, Mobile: 09737114204 E-mail: pervinder_rawat@jasubhai.com
Bengaluru
Princebel M / Huliraj. E.N Mobile: 09444728035, 09481888718 E-mail: princebel_m@jasubhai.com, huliraj_mba@jasubhai.com
Chennai / Coimbatore
Princebel M / Yonack Pradeep 1-A, Jhaver Plaza, 1 st floor, Nungambakkam High Road, Chennai 600 034 Tel: 91-044-43123936 Mobile: 09444728035, 09176963737 E-mail: princebel_m@jasubhai.com, yonack_pradeep@jasubhai.com
Delhi
Priyaranjan Singh / Suman Kumar 803, Chiranjeev Tower, No 43, Nehru Place, New Delhi – 110 019 Tel: 011-2629 3174, 011-4674 5513; Fax: 011-2642 7404 E-mail: pr_singh@jasubhai.com, suman_kumar@jasubhai.com
Hyderabad
Princebel M / Sunil Kulkarni Mobile: 09444728035, 09823410712 E-mail: princebel_m@jasubhai.com, sunil_kulkarni@jasubhai.com
Kolkata
E-mail: industrialmags@jasubhai.com
Pune
Sunil Kulkarni Suite 201, White House, 1482, Sadashiv Peth, Tilak Road, Pune 411 030 Tel: 020-24494572, Telefax: 020-24482059 Mobile: 09823410712 E-mail: sunil_kulkarni@jasubhai.com
Single Copy Price: ` 150/-, Annual Subscription: ` 1530/-, Foreign: US$ 180
Jasubhai Media Pvt Ltd Registered Office: 26, Maker Chambers VI, 2 nd Floor, Nariman Point, Mumbai 400 021, INDIA. Tel.: 022-4037 3737 Fax: 022-2287 0502 E-mail: sales@jasubhai.com Printed and published by Mr Maulik Jasubhai Shah on behalf of Jasubhai Media Private Limited, 26, Maker Chamber VI, Nariman Point, Mumbai 400 021 and printed at Varma Print, Pragati Industrial Estate, N M Joshi Marg, Lower Parel, Mumbai 400 011 and published from Mumbai. Editor: Ms Mittravinda Ranjan, 26, Maker Chamber VI, Nariman Point, Mumbai 400 021.
6 ď‚ƒ December 2013
Contents.indd 6
Pharma Bio World
06-01-2014 13:54:00
december ads.indd 7
06-01-2014 15:37:08
INTERVIEW 12
“Our mission has been to offer even our innovative molecules at an affordable price.” – Rajiv Modi, CMD, Cadila Pharmaceuticals
FEATURES 16
Are Labeling Complexities Destroying Your Drug Pipeline? – Stephen Birtsas & Hans van Zoonen, Kalypso
12 20
Complex Solutions in Modular Design – Dr Thomas Brinz, Bosch Packaging Technology
28
Optical Character Recognition & Optical Character Verification in Pharma Industry – Didier Lacroix, Cognex Corporation
32
RFID - Potential Technology to Prevent Drug Counterfeiting – Rani Ratna, Beroe Consulting
37 28
Cold Chain Management in Pharma Logistics - A Case Study on Transport Corporation of India Ltd – Jasjit Sethi, TCI Supply Chain Solutions
MARKET RESEARCH 40
Healthcare Industry – An Indian Perspective – Subroto Ghoshal
NEWS FEATURE 44
Survival Strategies – Ananya Sen
37
NEWS UPDATE 51 58
Pharma News Biotech News
CORPORATE AFFAIRS 61 64
Product Trends Events
BACKYARD 44
65 66
Bookshelf AD Index Next Issue Focus: Drug Development & Delivery
8 December 2013
Contents.indd 8
Pharma Bio World
06-01-2014 13:55:52
Safety technology from Schmersal. Safety from a single source. World’s leading supplier to the pharmaceutical industry Offers extensive product portfolio and customized solutions in your production lines Your partner for faster, efďŹ cient and safer operations Safety Products manufactured at Pune.
Safety by professionals. Ph.: +91-2138614756
december ads.indd 9
E-mail: siplmarketing@schmersal.com
www.schmersal.in
06-01-2014 15:52:19
India Amrish Shah.pdf
december ads.indd 10
2
2/05/11
12:25 PM
06-01-2014 15:57:09
Chemical Engineering World
december ads.indd 11 Final Ad template.indd 7
October 2013 • 7
06-01-2014 29-10-201318:59:42 10:48:09
interview
12 December 2013
final interview.indd 12
“
“
DR RAJIV MODI
“Our mission has been to offer even our innovative molecules at an affordable price.” Mycidac-C is priced at about a tenth of the cost of those made by multinational competitors.
DR RAJIV MODI Dr Rajiv Modi, CMD, Cadila Pharmaceuticals in an interview with Ananya Sen discusses Cadila’s innovation Mycidiac-C and their new research partnership. What prompted Cadila Pharmaceuticals Ltd to e nte r i nto a n R & D a greement w ith Helperby specifically to work out antibiotic resistance?
This need prompted us to look for solution and the science pursued by Helperby made us enter into the agreement with them.
Cadila Pharmaceuticals Ltd as one of the leading R&D companies in India is focusing on providing innovative solutions for human health care by indigenous efforts as well as collaborative research. We have already successfully addressed some of the areas like cardiovascular diseases (Polycap), TB (Risorine) and cancer (Mycidac-C).
Please elaborate on the concept of Antibiotic Resistance Breakers (ARB). How will this prove beneficial?
Antibiotic Resistance has emerged as a major public health problem globally. The world has run out of the pipeline of new antibiotics and we run the risk of returning to pre-antibiotic era if no solution is found very soon. The world used to make new antibiotics to cope with resistance, but this lifeline has now almost dried up. Like tuberculosis, antibiotic resistance, though a major public health problem, is now a neglected area of research. Recognising the need and practically dry pipeline of new antibiotics, we are looking at providing solutions.
Our partner, Helperby Therapeutics has developed a new way to tackle the problem of antibiotic resistance. The idea is to rescue old antibiotics and Helperby does this by discovering new compounds using novel cutting edge technology which it has developed. These new compounds are called Antibiotic Resistance Breakers. When an Antibiotic Resistance Breaker is combined with an old obsolete antibiotic, it can rejuvenate it and make it active against highly resistant bacteria. Helperby has Antibiotic Resistance Breakers which can potentially rescue several different classes of antibiotics. It is shown that it is feasible, at least in early stage preclinical and clinical development. Furthermore, this approach requires the development Pharma Bio World
04-01-2014 12:38:30
december ads.indd 13
06-01-2014 16:02:01
of fewer novel compounds, is less risky and less costly than the traditional ‘one antibiotic’ route. The other perceived added advantage of this approach is the least chance of developing future resistance. If this comes out true in real life then patients with recurrent infections may not need to change antibiotics. They may be treated using same antibiotic for subsequent episodes. To what extent will this help to solve the problem of antibiotic resistance? The laboratory findings are promising indeed. We will confirm this through our clinical development programme at Cadila Pharmaceuticals. If the approach meets expectations, problem of antibiotic resistance will be significantly reduced. We believe that this approach can bring in a paradigm shift in the way we fight antibiotic resistance. There will be significant savings due to decrease in morbidity and mortality due to antibiotic resistance. This will also result in significant savings in health care costs related to prevention and treatment infections with resistant organisms. The novel products are likely to be effective against the bacteria for much longer. We believe that our research on ARB will address the antibiotic resistance developed by number of bacteria including multi-drug resistance gram negative strains including NDM1. How affordable will this newly developed treatment be? Cadila Pharmaceuticals has always believed in ‘affordable’ medication. Our mission, as established by our Founder Chairman I A Modi is to offer our innovative and even ‘world’s first’ molecules at an affordable price. Polycap (for secondary prevention of cardio vascular disease), Risorine (a novel Anti TB medicine) are such examples. This demonstrates our commitment to the cause of affordable 14 December 2013
final interview.indd 14
medicines. Very recently, we launched Mycidac-C for lung cancer management. This is also first-in-class therapy for lung cancer (NSCLC) in the world – however we priced it at a fraction of the cost compared to similar drugs sold by multinational companies in India. So going by this track record, our future pricing strategy for the molecules with ARB can be anticipated. I remain quite optimistic that Cadila would be able to continue to maintain the tradition of affordable pricing for our innovative products.
How do you plan to price Mycidac-C in India?
Is the lung cancer drug Mycidiac-C launched by Cadila a result of the organisation’s indigenous research?
Mycidac-C has already been made available in Indian market since the beginning of December 2013 and has been used in NSCLC patients in India.
Definitely. The entire basic and clinical development leading to its approval is an indigenous effort. Our scientists at Cadila were successful in finding a novel target Desmocollin-3 for this drug and have worked for over a decade to come out with this first-in-class active immunotherapy for lung cancer. The entire innovation is hundred per cent indigenous. Why do you call it unique/ innovative? Mycidac C is unique in several ways. This is ‘world’s first’ Active Immunotherapy for management of any cancer. The target Desmocollin 3 is a novel target. The drug offers novel treatment for squamous non small cell lung cancer (NSCLC). This was an unmet medical need as there has been no advancement in squamous NSCLS since 1983. Mycidac-C offers survival benefit of over 43 per cent which is significantly higher when compared to benefit offered by recently introduced similar molecules. Yet it is priced at a fraction of the cost to identical novel therapies marketed by MNCs in India. Mycidac C is the world’s first ever innovative drug in cancer therapy from an Indian company and that underlines our R&D strength.
Have you obtained a patent for this product? Yes, we have obtained patent for Mycidac-C.
Mycidac-C is priced at about a tenth of the cost of those made by multinational competitors. The cost of Mycidac-C therapy to Indian patients will be just ` 40,000 for a 10-course injection - compare it against ` 37,000 per vial cost of recently introduced innovative MNC products for Lung cancer. When does it hit the Indian market?
Has it been tried on subjects in India? Yes. The pivotal trial of Mycidac-C was conducted at about 17 leading cancer hospitals spread across India and that showed over 43 per cent survival benefit to NSCLC lung cancer patients. This is indeed remarkable for a new drug in lung cancer. Do you intend to launch it in other countries as well? Do you have plans of partnering with other companies to market the product outside India? We have plans to launch Mycidac-C in several countries across the world in a time bound manner. We have an active IND with USFDA for this product. We have also received an ‘Orphan Drug’ status for Mycidac-C from USFDA for treatment of Desmocollin-3 expressing lung cancers. Could you brief us on the product pipeline of CPL Biologics? We have a very exciting range of biologicals at CPLB. We have several prophylactic and therapeutic vaccines at different stages of development. We expect our Influenza vaccine to be the first one, out of our basket, to hit the market. Pharma Bio World
04-01-2014 12:38:56
december ads.indd 15
06-01-2014 18:46:34
Are Labeling Complexities Destroying Your Drug Pipeline? This article will outline labeling complexities biopharmaceutical companies come across and the steps that can be taken to overcome them, increase labeling productivity, and maintain a strong drug development and commercialisation pipeline.
Hans van Zoonen Partner Kalypso
Stephen Birtsas Senior Manager Kalypso
16 December 2013
Labeling Complexities.indd 16
B
iopharmaceutical companies face an increasing number of challenges to create, deliver and maintain a strong product development pipeline, and their package label and insert development process can have significant impact on productivity, profitability and compliance. The Challenges As an industry used to working against very detailed specifications in a well-defined highly regulated environment, several trends are emerging that challenge the biopharmaceutical packaging status quo. First, ongoing globalisation puts pressure on companies to harmonise product packaging and labeling information. Second, patent expiry and lengthening product development cycles force companies to continue to develop existing products and expand into new geographical markets, multiplying regulatory complexity and the number of product changes. Third, environmental concern focusing on sustainability drives companies to rethink traditional manufacturing processes and materials, which in turn impact manufacturing cost and productivity. Central amongst these trends is that most biopharmaceutical packaging operations need to manage an ever increasing amount of data across geographically dispersed sites and competitive pressure forces them to do so in less time. Regulatory pressure and severe penalties for compliance violations encourage companies to take a conservative — and time consuming — approach. In the end, productivity suffers and costs increase at the expense of competitive advantage, as the following examples show: 1. Disparate Data: biopharmaceutical industry
is
The highly
regulated and companies have large amounts of product-related data that serve as the foundation for drug labeling. The data typically reside in unstructured document files or file formats that cannot be easily searched or re-used. In addition, data is stored in multiple locations throughout the organisation, often as duplicated copies that become out of sync. With no single source of the truth, companies have to collect, compile, organise, restructure or re-write the information to be used for product labeling and submission. This process usually involves manual compilation and cross-checking of labeling data which is error-prone and results in inefficiencies at best and drug labeling mistakes at worst. 2. Label Labour: Traditional label development processes are inefficient and prone to costly errors. The unstructured, disparate product data mentioned in the first example makes the drug labeling process a manual and tedious process for labeling departments. Labeling departments must collect product information from multiple sources, re-write labeling copy and re-validate the information before developing labeling artwork files. 3. Regulatory Realities: Structured Product Labeling (SPL) standards require biopharmaceutical companies to provide XML-based submissions via SPL standards. To meet these standards, companies have to answer the question, “where does the truth lie?” Unstructured data, authored by different people and stored in different locations often result in re-writes and copy-and-pasting between disparate systems. The consequence is that regulatory submitters may be working from incorrect or outdated information that later has to be corrected or requires a labeling change to match the submission information. Pharma Bio World
04-01-2014 12:48:47
december ads.indd 17
06-01-2014 16:18:55
What to Do? Start with Product Lifecycle Management to Fix Your Disparate Data: When we look for examples of how companies overcame their disparate data challenges, we find industries such as aerospace, defence, automotive, high tech, medical device, food and beverage, and consumer packaged goods have all solved the issue with Product Lifecycle Management (PLM). PLM provides companies with the ability to define a globally centralised product record that contains all product, package, processing and registration information in a single location. A robust and accurate product record enables global collaboration, visibility to product and registration information with a complete history of changes, and validation and approval history. Implementing PLM is the first step in solving disparate data challenges and the foundation for building efficient and accurate package label and insert development capabilities. Add Artwork Management to Complement PLM and Solve Label Labour and Regulatory Realities: The biopharmaceutical industry’s complex copy development processes demand that the package artwork, inserts, promotional materials and regulatory submissions stay in sync and meet multiple global market requirements. PLM systems do a great job enabling the product development process and storing the product record from concept to end of life but they have a capability gap when it comes to managing the complex and specialised artwork associated with label and insert development. This gap is often reflected in label and insert development teams that struggle to keep pace with tight product launch and commercialisation timelines. A late market entry can cost a company valuable patent life and lost opportunity costs of over USD 1 million a day, while inaccurate product labeling can rack up compliance fines or product recalls. Artwork Management (AM) solutions fill PLM’s labeling capability gap with 18 December 2013
Labeling Complexities.indd 18
the following functionality and help biopharmaceutical companies develop accurate labeling faster and with fewer errors: 1. Artwork annotation and markup: Having a system that allows multiple designers to collaborate on a labeling project simultaneously greatly reduces artwork review time and eliminates laborious phone and email communications when developing and approving labels and inserts. Artwork annotation and markup systems provide virtual spaces where Labeling Specialists, Brand Owners, R&D, Quality, Regulatory and Legal can all electronically review, mark-up and approve labels and inserts throughout the label development process. 2. Digital asset management (DAM): One of the biggest “time wasters” in label development occurs when a labeling specialist spends time working on a digital asset (eg, design file, production artwork file, image, chart or logo) that is not up to date. Maintaining control of digital assets within a globally centralised DAM eliminates de-synchronisation of digital assets by allowing collaboration and sharing of digital assets from a single location thus minimsing labeling errors and speeding up the label development process. 3. Copy Management and Translation: Copy management and translation functionality is arguably one of the most important features of AM systems. Copy management allows biopharmaceutical companies to create a master label manuscript that contains all approved label and insert copy in a centralised database. Labeling copy stored as data rather than as individual documents allows AM systems to implement a robust change control process for all labeling changes and the stored master version of that labeling copy can then be reused for international market launches and translations. Leading companies even integrate parts of their labeling content into their product record stored in PLM so they can automatically flag the need for a label or insert change when critical
product information changes. This tight integration of labeling content stored in AM with the product record stored in PLM provides biopharmaceutical companies with world class labeling practices that eliminate the complexities often associated with labeling changes. A second advantage to using AM software to centralise labeling content in a database is that it allows companies to syndicate label data to multiple locations such as websites and regulatory submissions via XML. Translation, historically a common cause of delays, is also handled by AM software. Copy management gives package label designers an automated workflow combined with stored common phrases. These tools help reduce copy development time associated with translations. 4. Automatic Artwork Generation: In situations where packaging artwork teams are forced to produce a final product very quickly, they can turn to artwork generation tools that can produce error-free artwork through standardised label and insert design templates that are populated with copy stored in the AM systems copy management module. While automatic artwork generation is not easy to implement or appropriate in all cases, companies can significantly reduce time and costs by eliminating variation seen in a manual label development process. The Roadmap to a Strong Pipeline Biopharmaceutical companies seeking to thrive in a competitive market must align all stakeholders involved in product development, regulatory and labeling so that their product information is structured and stored within a centralised location, such as PLM, integrated with an AM solution. Once a company is able to maximise the re-use of labeling content, improve labeling efficiency and reduce the likelihood of labeling and submission errors they will be well-positioned to maintain a strong drug development and commercialisation pipeline. Contact:stephen.birtsas@kalypso.com Pharma Bio World
04-01-2014 12:49:24
Complex Solutions in Modular Design
M
ixing, stirring, dosing, applying regardless of the outcome, a machine maps certain processes. These may lead to the production of varnishes, pesticides, glues, or pharmaceutical formulations. The pharmaceutical industry can learn and benefit from these kinds of procedures and systems, which have already been successful in chemistry for some time. As pharmaceutical laboratories continuously automate their processes, the need for individual solutions and complex special-purpose machinery is also on the rise. The aim is to transfer customised development processes into industry-standard, highly flexible and modular automation solutions for the pharmaceutical market – from fundamental research to product and quality control. Higher Throughput, Development
Faster
Product
Over many decades, chemical and pharmaceutical laboratory technicians have developed samples in numerous manual trials. Methods from combinatorial chemistry triggered major changes, which are especially important for the development of new medicines. Automation has simplified processing operations and significantly increased the reproducibility of trial results. Automated processes and experiments can now be carried out simultaneously. They can also be repeated as often as required with comparatively small effort. This leads to a significant improvement of results.
Dr Thomas Brinz
Director Lab Systems and Custom Solutions Bosch Packaging Technology 20 December 2013
Art_e_Bosch_Lab_Systems_Pharma Bio World_2013_11_26.indd 20
“
Automated laboratory procedures give users access to a wide spectrum of processes and analytical opportunities. Thanks to the large amount of available samples, automated processes now lead to the final product much quicker. Moreover they considerably reduce the use of raw material. Solutions for lab automation such as Bosch’s system for “high-throughput synthesis and screening” quickly lead to higher performance. In the chemical industry, automation increases lab efficiency by a factor of approximately 2.5. This corresponds to a reduction of 60 per cent in terms of time and costs. The automated lab offers a further important advantage: Useful reactions and process parameters are often not found by manual formulation tests. The manual lab classifies some additives as ‘not exploitable’ and eliminates them. However, automated test series reveal how useful these additives are in combination with other compounds, for example when testing the solubility of active substances. New Patented Formulation Technology The patented BLS (Bosch Lab Systems) syringe was originally developed by Bosch for the chemical industry. But it also promises great improvements to pharmaceutical labs: Together with the powder formulation, also patented by Bosch, it forms the basis for the formulation technology. In both chemistry and pharmacy, liquids with different viscosities, pigments and additives serve as raw materials for the mixture.
“
Laboratory automation has significantly changed chemical and pharmaceutical research since the 1980s. Complex automation and handling solutions have proven successful in chemical laboratories for a long time. This concept of lab automation and handling is now being transferred to the pharmaceutical market.
Automation has simplified processing operations and significantly increased the reproducibility of trial results. Automated processes and experiments can now be carried out simultaneously. Pharma Bio World
04-01-2014 12:53:44
Traditional dosing technologies apply these liquids by sucking in the material. However, they do not process media with high viscosity. The patented BLS syringe greatly facilitates this procedure, because its cylinder can absorb media with different textures. By using a piston with separate outflow, the syringe becomes a very precise dosing device.
Modules Flexibly Combined Larger machines make handling a lot easier. By moving along the linear axis, handling robots carry out highly complex actions. The robots are adapted to customers’ needs with a combination of standardised and flexible modules. The technological foundation of these modular combinations is key for their flexibility: based on a modular construction system, the required components are connected with each other to form customised solutions. This modular concept enables to offer complex special constructions, combining different assembly groups along the value chain. They range from fundamental research to quality control, and include the integration of external customer-owned processes. Focusing on the Pharmaceutical Industry Over the last years, this lab automation concept has been successfully implemented in the chemical industry many times. For example, Bosch cooperated with BASF in the development 24 December 2013
Art_e_Bosch_Lab_Systems_Pharma Bio World_2013_11_26.indd 24
“
Bosch Compact Lab Station
“
Raw material container and reaction process vessel are both integrated in the airlessly filled syringe. The same syringe can be used for developing and applying formulations in order to test the properties under realistic conditions. This enables the production of highly complex formulations such as oil/water emulsions. The disposable syringe not only eliminates cleaning efforts. It also significantly reduces the amount of liquid waste.
The manual lab classifies some additives as ‘not exploitable’ and eliminates them. However, automated test series reveal how useful these additives are in combination with other compounds.
of high-throughput screening equipment for varnish. Up to 100 different types of varnish systems can be processed within a very short time. Considering the broad range of varnish systems that needed to be examined, Bosch’s BLS syringe dosing system was the key to success. The system was awarded the ‘Farbe und Lack Preis’ for its environmental friendliness in 2005. These achievements have now also entered the pharmaceutical market: “The pharmaceutical industry focuses on the medicinal and chemical design of small molecules and their biological testing for active ingredient research.
We use automated systems to replace the traditional manual and repetitive tasks in chemical synthesis, filtration or analytics by new processes and innovative technologies,” said Stefan Oberbörsch, Head of Medicinal Chemistry Technologies at Grünenthal GmbH in Aachen, Germany. Another user of these specific solutions from Bosch is Eurofins MWG Operon, headquartered in Ebersberg near Munich, provider of services for DNA, RNA and gen syntheses as well as sequencing, applied genetics and forensics. The company uses a robot for storing and sending DNA samples. Contact: thomas.brinz@bosch.com Pharma Bio World
04-01-2014 12:54:07
citizen
december ads.indd 20
06-01-2014 15:05:06
INDONESIA. Japanese encephalitis affects thousands of people each year causing death or disability. Especially among children.
NOIDA NNE Pharmaplan B-15, Sector 2 Noida – 201301 T: +91 120 4775100 F: +91 120 4775200
december ads.indd 21
BANGALORE NNE Pharmaplan #12, Achiah Shetty Layout RMV Extension, Sadashivnagar Bangalore – 560080 T: +91 80 49056300 F: +91 80 23617240
MUMBAI NNE Pharmaplan 703-704, Sagar Tech Plaza, A-Wing, Andheri Kurla Road, Sakinaka, Andheri (East) Mumbai – 400 072 T: +91 22 40647000 F: +91 22 40647099
SALES CONTACT Sanjay Gupta General Manager Business Development T: +91 9818900253 E: sgpt@nnepharmaplan.com
06-01-2014 14:58:31
WHO WE ARE NNE Pharmaplan is one of the world’s leading engineering and consulting companies in the complex field of pharma and biotech. We cover all segments from biopharmaceuticals and vaccines to medical devices and help our customers develop, establish and improve their product manufacturing. NNE Pharmaplan employs 1,700 people at more than 30 locations around the world. NNE PHARMAPLAN IN INDIA NNE Pharmaplan started operations India in 1996 and today, we have three offices in Bangalore, Mumbai and Noida. During our 17 year presence in India we have executed more than100 projects within active pharmaceutical ingredients, herbal products, oral solid dosage, liquids, sterile production, biopharmaceuticals and vaccines. WHY WE DO IT Engineering for a healthier world – our role in an industry that improves people’s lives worldwide. To learn more about our company, please visit nnepharmaplan.com
INDIA. HLL Lifecare is building a world class vaccine production facility to combat world health issues including Japanese encephalitis.
december ads.indd 22
06-01-2014 14:59:02
Optical Character Recognition & Optical Character Verification in Pharma Industry The pharmaceutical industry has been compelled by government regulations to adhere to standardised solutions across all production and packaging operations. As the challenges become greater and the stakes higher, pharmaceutical product manufacturers need even more sophisticated machine vision hardware and tools to stay compliant with regulations, ensure customer confidence and mitigate risks. At the same time, these tools need to be easy to use and deliver even more reliable and repeatable results.
Didier Lacroix
Senior Vice President Cognex Corporation 28 December 2013
Cognex Article - OCR OCV for Pharma Industry (2).indd 28
T
he Optical Character’s powerful algorithm prevents misreads, handles process variations and provides easy font management. It’s fast, easy to set up and simple to use across all platforms with minimal training being required. Regulations Worldwide Drive the Need for OCR Barcodes are a traditional solution, but consumers cannot read. Hence manufacturers are turning to optical character recognition (OCR) technology using vision systems that can read alphanumeric text. Machine vision systems with OCR tools provide four functions for pharma operations processing and packaging operations: 1. Presence/Absence: To check that product descriptions and tracking text have been printed on the product. 2. Track and trace: Reading of every alphanumeric text written in the content, based on the data which is placed in the system 3. Verification: Verifies each and every alphanumeric text, and identifies the mismatch. eg, It verifies whether alpha numeric print is done or not on the product While the pharmaceutical industry has deep experience with OCR/OCV applications driven by government regulations that require standardised solutions across all production and packaging, most customers do not use standardised fonts, software or hardware. Seeing the growth in number sorting and tracking applications, Cognex engineers realised that they needed to redesign their existing OCR/OCV tools to: • Learn and read any printed font; • Read text even when there is
little contrast between type and background; • Read text even when there is significant variation in width and height; • Read text when letters are touching, skewed, and distorted; and • Differentiate between similar shapes, such as the letter “O” and the number “0” OCRMax Achieves Automated Character Reading Accuracy Rates Above 99 per cent The exceptional performance of OCRMax in comparison to other OCR/OCV tools is based on several factors, most notably better approaches to image preprocessing, segmentation, classification, a dual-verification process, fielding and font training and management. When combined together, these features give users the chance to optimise the OCR/OCV for millisecond character reads, 99.99 per cent read rates, or anywhere in between. According to the above images, OCRMax easily handles a wide variation of character appearances some doubt whether the character is a letter B or number eight (8). Fielding rules programmed by the user give OCRMax another way to determine the proper character value. Fielding functionality featured in OCRMax allows wildcards, and works with defined variable length strings (this serial number should be between three and five characters, for example) as well as fixed length strings. While many OCR/OCV tools have fielding capabilities, OCRMax is the only tool that can use fielded strings in both fixed and variable length character sets. As an example, a variable length character string may have the year embedded in it, but the location varies depending on the product and lot number. Using the Fielding tool, Pharma Bio World
04-01-2014 13:02:41
Who’s Who th 14 Edition
Who’s Who is an exhaustive listing & fact book on CHEMICAL PROCESS, PHARMA BIOTECH, HYDROCARBON INDUSTRY & INDUSTRIAL SAFETY
AN ISO 9001:2008 CERTIFIED COMPANY
Ad Template 01.indd 39
25-11-2013 11:54:22
often used to verify that the printed codes will be of sufficiently high quality to be legible throughout the supply chain in the event of a product recall – of particular concern in the pharmaceutical industry.
OCRMax will read the character string and then search for the expected year code within that string, regardless of the overall length. If the year is not located, OCRMax will “fail” the character string based on the customer’s preset Fielding rules. Usage of OCR in Pharma Industry: 1. OCR ensures code presence and readability before products exit the factory: Machine Vision helps to verify that required text strings make it onto the product or packaging. For instance, inkjet printers are commonly used for marking date codes, batch codes and expiration dates in many packaging applications, due to their ability to print variable information at very high speed. However, print quality can degrade over the course of process runs, resulting in inconsistent codes or no code at all. Without a system in place to confirm the presence of the code, a printing fault - such as a clogged nozzle, interference from debris, or depleted ink - may affect print quality, and this error could go unnoticed until later in the process. This result to increased downtime, costly re-runs or worse: if the product makes it out of the factory without a required code, it will need to be scrapped or recalled. OCR reads a code to determine its presence, whereas OCV (Optical Character Verification) recommends for confirmation that a code will be readable after it leaves the plant. OCV-based inspection is most 30 December 2013
Cognex Article - OCR OCV for Pharma Industry (2).indd 30
Absent or unreadable codes are unacceptable in this highly regulated i n d u s t r y. M a c h i n e v i s i o n p r o v i d e s manufacturers with the peace of mind that their products are properly marked before they make their way into the supply chain. 2. OCR tracks products throughout the Supply Chain: The traceability through every step of the manufacturing process is critical across all industries where manufacturers are required to comply with safety and anticounterfeiting regulations. OCR reads barcoding, lot coding, batch codes, expiration dates and serialisation numbers. An OCR application can be programmed to compare the actual text with an expected string, as defined in the database, and flag any missing or outof-sequence serial numbers. Barcodes and OCR are frequently used together to achieve maximum reliability of the data collection process. Reliable product tracking and data management is essential for this industry. It also helps in preventing diversion of goods to so-called “gray market” vendors. 3. OCR Matches Labels to Products: Mislabeling has severe implications to both manufacturer and consumers. OCR helps to ensure accurate labeling to all the products. Manufacturers must accurately state the contents of an item on its label or packaging, or face severe consequences, such as governmentimposed penalties, costly recalls, and diminished brand perception. One of the most common reasons for product recalls - mislabeling - has serious implications for both manufacturers and consumers, ranging from customer dissatisfaction to
safety risks. OCR is highly effective in applications where multiple character strings, such as sequential numbers are presented to the system. In applications where all the contents are expected to be the same, OCV may be recommended; in these cases, the vision system does not read the characters, but instead verifies that they match an expected string. Machine vision automation eliminates human error due to fatigue and distraction, resulting in improved accuracy and increased throughput. How to evaluate OCR technology in a vision system Questions in consumers’ minds while evaluating OCR software: ✓ Can the OCR software read any printed font? ✓ Can it read text when there is little contrast between the text and background (colored text or background noise), with a lot of letter-to-letter variation, skewed letters, or touching letters? ✓ Can it read text strings that are poorly printed, scratched, or with washed-out characters? ✓ Can it read text regardless of surface type, including glass, metal, cardboard, ceramic, and plastic? The future of OCR-enabled vision systems in the pharma industry The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. With the strict rules and regulations that are being adopted and implemented in the industry to stop drug counterfeiting, it is seen that the drug manufacturers are taking effective measures in their production line to bar the same. Contact: mails@mindmatterscorp.com Pharma Bio World
04-01-2014 13:03:07
DK ET
SDK Engineers & Traders
Working towards sustainability
Pioneers in Clean room Creation
in Pharma , Food & Electronics Industry
Contact us@
No:10-b,Venkateshwara Nagar,Bethel Nagar Main Road, Perungudi, Chennai – 600096.
Tel: +91 44 24960605 Mob: +91 9566004581 Mail: info@sdkengineers.com Web: www.sdkengineers.com
“Wish you a Very Happy New Year 2014â€? When The Others Are Stopped‌ SAURUS Vacuum Pump Continues! Main featu features
EM JAY ENGINEERS Mr. Jayant Joshi 5GNO -NXM@ %*5 5G@MSHU@M $NQHU@KH '@RS /TLA@H 6DK /NAHKD DKDBSQNLDBG DMFF DMSO"FL@HK BNL
december ads.indd 24
 #ARNKTSD  #ARNKTSD R@EDSX ENQ SGD SGD OQNBDRR @MC SGD NODQ@SNQR R@EDS  NHK BNMS@LH  0N 0N NHK BNMS@LHM@SHNM ENQ SGD OQNCTBS
@R BDQSHEHDC AX
@R BDQSHEHDC AX SGD @M@KXRHR NE 6TQHM¢R 2NKHSDBGMHB  VHSGNTS KHL  7RD 7RD VHSGNTS KHLHSR HM @KK U@BTTL Q@MFD  QDB  %NMSHMTNTR %NMSHMTNTR QDBNUDQX NE DWSQ@BSDC RNKUDMSR  DMCTQ@MB  *HFG *HFG DMCTQ@MBD @F@HMRS ONVCDQR @MC BNMCDMR@SD RNKUDMSR  QDRHRS@MB  *HFG *HFG QDRHRS@MBD @F@HMRS BNQQNRHNM  VNQJHMF SD  .NV .NV VNQJHMF SDLODQ@STQD @MC KNV MNHRD CA  QDKH@A  #ARNKTSD #ARNKTSD QDKH@AHKHSX TMCDQ BNMSHMTNTR NODQ@SHNM BNMCHSHNMR  EKNV Q G  0NLHM@K 0NLHM@K EKNV Q@SD EQNL SN L   8@BTTL EQNL SN LA@Q 8@BTTL EQNL  8DQX KNV NODQ@SHMF BNRSR 8DQX KNV NODQ@  @ KNV BNMRTL @ KNV BNMRTLOSHNM DMFHMD A MDV .TAQH<D Ž KTAQHB@SHNM RXRSDL SG@S QDCTBDC A MDV .TAQH<DQN MD@QKX SN YD MD@QKX SN YDQN SGD NHK BNMRTLOSHNM B KNMF KHED @MC D@RD NE L@HMSDM@MBD KNMF KHED @MC  +MRS@KK@SHNM HM C@MFDQNTR DMUHQNMLDMS + S KK SHN H   #6': BDQSHEHB@SD TMSHK YNMD
(NQ ETQSGDQ CDS@HKR VVV HS@KU@BTTL BNL VVV R@TQTR HS
07-01-2014 11:31:10
RFID - Potential Technology to Prevent Drug Counterfeiting This article delves into the threat posed by counterfeit drugs and uses of RFID technology in controlling drug counterfeiting. The counterfeit drug market is growing at a rapid rate and developed, developing or under developed â&#x20AC;&#x201C; all countries have been more or less affected by it. The hazards posed by this menace needs to be countered through effective use of latest technology like RFID.
Rani Ratna
Senior Research Analyst Capex & MRO Beroe Consulting 32 ď&#x201A;&#x192;December 2013
RFID.indd 32
Drug Counterfeiting: the Society
An
Evil
to
What if we take a prescribed drug to get relief from pain, but despite the problem getting solved we get other health related issues. As per WHO (World Health Organisation), more than 700,000 people die every year due to fake medicine of malaria and tuberculosis itself. Size of the fake drug market is estimated to be aroungd USD 75 â&#x20AC;&#x201C; 200 billion. The year 2012 witnessed the death of more than hundred heart patients in Pakistan due to adulterated drugs which came from Punjab Institute of Cardiology. In the same year, the United States reported the death of 11 and hospitalisation of 100 people due to the use of tainted steroids. During the year 2007-08, a contaminated blood thinner killed around 149 Americans. As per the research done by Pharmaceutical Security Institute there was a decrease in the arrest cases of Phrama fraud by 6 per cent in 2012, but it still holds a good number. The chart below depicts the geographical distribution of counterfeit incidents that occurred in 2012. As per the report by National Crime Prevention Council, almost 10 per cent of the entire pharmaceutical drug into the market is counterfeit and it is worse in developing countries where it is estimated that 70 per cent of the drugs are substandard or counterfeit. One of the biggest pharmaceutical frauds took place in 2005, when FDA had to recall around 18 million Lipitor tablets during Albers Medical Investigation. USD 42 million was involved in this case when the owner and distributors of Kansas City Pharmaceuticals tried to smuggle foreign version of popular tablet Lipitor
and Celebrex. These tablets were brought into South America illegally then re-packaged to hide the true origin of the medicine and sold in the market.
Counterfeit Drug Incidents 2012
Arrest cases against Pharma fraud 2012
These incidences give empirical evidences of the role of licensed distributors in marketing counterfeit drugs. They exploit the supply chain regulatory norms to their effect. Vulnerabilities in the supply chain have given a continuation to such incidences which does not bode well for the public. Therefore in spite of relying upon the regulatory reforms we must adopt new approaches and dissolute leadership to counter these loopholes in the system. One such approach can be implying RFID technology which gives automatic tracking of any object attached to it associated with a unique serial number. Pharma Bio World
04-01-2014 13:09:13
1 1 1 1 1 1
DMF NO. 26710
US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine Highly advanced auto-curing system
ified Cert m nroo Clea
ADVERTISE TO EXPAND YOUR REACH THROUGH
C HEMICAL
ENGINEERING WORLD
ERRATIC READINGS ?
These could be due to microscopic corrosion of lab equipment caused by excess moisture
OffshoreWorld INSIGHT INTO UPSTREAM & DOWNSTREAM HYDROCARBON INDUSTRY
®
DEHUMIDIFIERS
The Journal of Materials & Equipment for the Process Industries www.cpfndia.com Vol. 30 No. 3 August 2011 ISSN 0971-5274 ` 50/-
Chemical Products Finder
remove moisture most efficiently
Chemicals, Petrochemicals
& Agrochemicals
August 2011 Vol.10 l Issue 1
l
Price `100
l
www.pharmabioworld.com
es
Backed by
actic
g Pr
turin
ufac
Good
Man
Service
www.smpworld.com
Your Radar to Shipping, Marine & Ports World
Vol - 3 Issue - 6 • JUNE - JULY 2011 • ` 100
South Special
Port Sector in South India
For Details Contact:
Jasubhai Media Pvt. Ltd. Taj Building, 3rd Floor, 210 Dr D N Road, Fort, Mumbai - 400 001 Tel: 022-4037 3636, Fax: 022-4037 3635 Email: industrialmags@jasubhai.com
december ads.indd 33
Write to us today for cost effective solutions ISO 9001:2008 & 14001:2004 CERTIFIED
Phone: +91 11 23906777 • E-Mail: bryairmarketing@pahwa.com
www.bryair.com
RB/BA/1314HVCA3
Interview of Y S Prasad, Kakinada Seaport
07-01-2014 10:52:58
How Counterfeit Drugs Enter into Supply Chain Most of the counterfeit and substandard drugs are manufactured in developing countries like India, China, Latin America, Nigeria and Southeast Asia. Surprisingly, these counterfeits drugs are supplied and delivered by infiltrating the legitimate distribution channel. For instance, drugs moves sideways from authorised distributor to middlemen or secondary wholesalers who sell drugs to one another. It is at this point that counterfeit are mixed and enter into the market. Again many countries do not have effective regulated and monitored distribution channel which provides opportunity for drug mafia to exploit the loopholes to import, repackage and sell the drugs. As per OECD organisation the people involved in such crimes include medical professionals, pharmaceutical companies and few terrorist organisations. Asia has the largest share in pushing counterfeit drugs into the market. Counterfeit products are mixed in the supply chain with the help of freight carriers, shipping companies, wholesaler, importers, distributors and the retailers. Online shopping has given another easy way to sell and purchase drugs. As creating a website is an easy task, there are thousands of illegal sites which sell medicines online. We can buy medicine from these websites without any prescription. Recently the National Association Board of Pharmacy audited around 10,000 sites and found that only 3 per cent of these sites are in compliance with pharmacy laws and following standard practices. 50 per cent of the drugs purchased online from illegal sites, that hide their physical address, are found to be counterfeit. Patients might buy these products unknowingly through legitimates sources or knowingly from the black market. Current Methodology Avoid Counterfeiting
Adopted
to
An entrepreneur in Ghana has developed an innovative solution to avoid counterfeiting with the help of mobile 34 ď&#x201A;&#x192;December 2013
RFID.indd 34
Figure 1: Counterfeit products getting mixed mostly at transit stage
messaging application. A scratch-off label is placed on the product packaging, which contains a unique code. When the consumer receives the product, he/she will send this unique number via SMS to the manufacturer. Manufacturer then confirms the authenticity of the product. Holley Cotec, an antimalarial drug manufacturer puts a unique 3D hologram seal on the packaging of drugs. Raman Spectroscopy and the X-ray techniques can also be used to find whether the drug possess all the ingredients mentioned over the packaging. But such systems require a lot of manual work and can be bypassed. An RFID tag which helps in tracking the product right from its origin, can help us in tracking the product on a real time basis. US FDA is also encouraging pharma manufacturers to make use of RFID technology throughout their supply chain until it reaches the consumer. RFID in Pharma Supply Chain RFID is a technology that enables automatic identification and data collection of the products in movement through electromagnetic exchange. This incredible feature provides an opportunity to reconceptualise the notion of collecting valuable and authentic information. The success of RFID implementation depends upon forward and backward integration in the supply chain. It depends upon the user industry in the backward side of supply chain where it wants to access the data of the raw material from tierâ&#x20AC;&#x201C;I, II, III suppliers. Similarly in the forward side they can track it upto distributors, retailers or may be upto the consumers.
The deeper it is the better accountability can be done. Making smart use of such data will can help in proactive decision making and will ensure a safe supply chain. Some of the information which can be tracked with the help of RFID is; 1. Counterfeit/diversion prevention. 2. Electronic pedigree compliance. 3. Reduced medication errors. 4. Patient identification. 5. Continuity of care. 6. Provider, drug, dosage and patient validation. 7. Automatic identification and tracking. 8. Recalls/withdrawals management. 9. Inventory management. 10.Contract administration. Products are tagged at the supplier stage itself. The readers are installed at various stages in the supply chain wherever the product information is required to be traced. In the above example the product is tracked from the supplier to the consumer level. All the drug related information like chemical constituents, manufacturing and expiry date, the suppliers, manufacturers, retailer, distributor are updated throughout the journey in the supply chain. Each tag is given a unique serial number. All the information against that serial number is authenticated by scanning the tag attached to the drug. The RFID tag can store upto 64 KB of information. The reader will transmit the signal to the local server via internet. The observer connected with internet will be able to access the data at any stage automatically and identify the counterfeit product. Illegal activities, if any, can Pharma Bio World
04-01-2014 13:09:48
ADVERTISE TO EXPAND your reach through INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
For Details Contact
Jasubhai Media Pvt. Ltd. Taj Building, 3rd Floor, 210 Dr D N Road, Fort, Mumbai - 400 001 Tel: 022-4037 3636, Fax: 022-4037 3635 Email: industrialmags@jasubhai.com
december ads.indd 66
07-01-2014 10:16:05
Companies along with controlling authorities including FDA, British Medicines and Healthcare products Regulatory Agency (MHRA) are working on setting standards, KPI’s and working protocol that will enable a safe supply chain and patient’s safety. Conclusion
Figure 2: RFID enabled Supply Chain
be traced and stopped immediately. In such case product recall will be easy and specific. RFID tags are unique and hard to copy. It allows product tracking at an individual basis. The tags can even give an alert if a drug is expired. Tagging drugs with RFID will ensure a safe supply chain and patient safety. RFID tags are adjoined with sensors that can detect real time temperature, light, PH-level around the product to provide safety and maintain required temperature. Obstacles to RFID Implementation 1. Lack of RFID knowledge: Not many people are acquainted with RF (Radio- frequency), UHF (Ultra High Frequency) technology, RFID standard, RFID middleware, software and the whole application side of technology. 2. Implementation cost: A fully functional RFID system incurs multiple costs, including tags, readers, printers, middleware, infrastructure, consulting, R&D, system changes, implementation, training, change management, and service provider fees etc. Spend on RFID implementation varies from USD 9-25 Million depending upon the size of application and integration level. 3. Fragmented market: The supplier market for RFID is highly fragmented. 36 December 2013
RFID.indd 36
Also for the project implementation we need to bring together various people such as RFID tag manufacturer, middleware and software provider and the system integrator. 4. No top players: As said above the market is highly fragmented with no top player with this as a core competency. 5. Need for certified talent: Not much information is available about the certifications required for this technology. Hence very few people are certified in RFID technology. 6. Immediate ROI not visible: One of the biggest concerns of all the companies is that there is not much justifiable information on cost and ROI. 7. Patient’s privacy issue Few Pharmacies Investing in RFID Pilot Projects Many big Pharma companies like GlaxoSmithKline, Johnson and Johnson and Purdue Pharma have invested in RFID Pilot projects. Pfizer is using this technology to track few highly counterfeited products in US, especially Sildenafil (Viagra). Purdue Pharma also has started tracking OxyContin (Oxycodone), used for pain relief.
As drug mafia continue to search and exploit vulnerable gaps in the distribution system the companies should adopt and standardise a regulatory framework to ensure safety of the supply chain and further protect patients. For this one corrective measure is track and trace. RFID is such technology which links the product identity with the digital world which further can be tracked with the help of GPS/GPRS. It, therefore, has the potential to enrich and shield the supply chain from the intrusion of counterfeit drugs. These monumental benefits would do away the cost of implementation of RFID. As per HDMA (The Healthcare Distribution Management Association), pharmaceutical industries can gain up to 250-300 per cent of return on investment annually. The distributor can achieve an ROI of 300-600 per cent annually. Moreover, the cost can be transferred to the consumer. Apart from this, increased competition in the field of RFID has eventually lowered the price of RFID tags. All of these will provide safety and integrity to the supply chain and keep a check on wholesale distributor, which ultimately will benefit the patient. References 1. www.psi-inc.org 2. http://www.fda.gov/Drugs/DrugSafety/ DrugIntegrityandSupplyChainSecurity/ default.htm 3. BRIDGE (Building Radio frequency IDentification solutions for the Global Environment), IP Nr. IST-FP6-033546, and SToP (Stop Tampering of Products), Nr. IST-FP6-034144. 4. http://rfidarena.com/2013/2/7/preventingcounterfeit-drugs-with-rfid.aspx 5. http://www.impinj.com/hanmipharmaceutical/ Contact: rani.ratna@beroe-inc.com Pharma Bio World
04-01-2014 13:09:48
Cold Chain Management in Pharma Logistics - A Case Study on Transport Corporation of India Ltd
T
he Indian Pharmaceutical industry is highly fragmented with about 24,000 players (with only approximately 330 in the organised sector). The top ten companies make up for more than a third of the market. It accounts for about 1.4 per cent of the world's pharma industry in value terms and 10 per cent in volume terms. As per a McKinsey report, the Indian pharmaceuticals market is expected to grow to USD 55 billion in 2020 and has a potential to reach USD 70 billion by 2020.
The total turnover of the Indian Pharma sector is estimated to be close to USD 21 billion of which around USd 9 billion comes from exports while the rest comes from domestic sales. Currently, India is the 4 th largest market in the world in terms of volume and 13 th in terms of value and around eight percent of the world's drugs are manufactured in India. Besides the domestic market, Indian pharma companies also have a large chunk of their revenues coming from exports. While some are focusing on the generics market in the US, Europe and semi-regulated markets, others are focusing on custom manufacturing for innovator companies. Companies from developed countries spend a large amount on R&D and are responsible for discovering and
Jasjit Sethi
CEO TCI Supply Chain Solutions Pharma Bio World
Pharma Logistics.indd 37
“
launching a number of innovative drugs/formulations. Compared to this, Indian companies have established their presence in the generics segment. Generics are low-cost versions of branded drugs and have the same medicinal effect as the branded or original drug. Once the patent period for a drug expires, companies can come in with generic versions of a drug which provides affordable medicines for consumers. Rising household income and improvements in health infrastructure and delivery systems will continue to support long-term growth in the pharmaceutical market. Driven by numerous factors including increasing health care expenditure, large population base, patient demographics, and rising life expectancy, India’s pharma industry is expected to touch the pinnacle of success in near future. Logistics in Pharmaceutical Industry Pharma logistics is one of the most important stages of the operations for any pharmaceutical business as the activities are highly time sensitive. It is very critical for providing the right medicine to the right patient at the right time, place and dosage and most importantly at the right price. Since business is highly competitive today, success largely depends upon the efficiency of supply
“
Global pharmaceutical markets are in the midst of major discontinuities. While growth in developed markets will slow down, emerging markets will become increasingly important in the coming decade. The Indian pharmaceuticals market, along with the markets of China, Brazil and Russia, will spearhead growth within these markets.
A well designed supply chain with robust planning cycles that takes care of the various lead times in the end-to-end supply chain can help achieve speed to market as well as an agile supply chain.
December 2013 37
06-01-2014 18:18:38
chain. Supply chain is very critical as it maintains the complex network relationship between the organisations (drug manufacturers), trading partners to source raw materials, delivery products, retailers and hospitals. The Indian logistics and transport industry has huge growth prospects for local and foreign operators alike. The lifeline of the pharmaceutical industry is new product innovation and delivery. Pharmaceutical products need temperature-controlled storage and distribution. The industry has given importance to logistics by focusing on supply chain and logistic level activities such as delivering the product to the end-customer at the right time, right place, in a secure mode and at a competitive operational cost. As international and domestic firms are increasing their presence with new pharma products having new characteristics, they have started raising the bar for Logistics Service Providers (LSPs). Practices such as handling products without touching them and temperature monitoring are becoming common. In-house training programmes on product handling are being conducted to educate the front level people who handle these products. Issues and Challenges The most important supply chain factors in pharmaceutical industry are Inventory Reduction and Reduction of Order cycle time. This is because, operational performance is directly linked to logistics costs, while inventory reduction and the demand to decrease order cycle time are related to just-in-time deliveries and supply chain speed. Since pharma products are sensitive to external environmental factors such as heat, light, etc, any sort of deficiency in the pharma transport/storage system 38 December 2013
Pharma Logistics.indd 38
could damage them. So starting from collection to delivery/distribution of pharma products, logistics service providers need to arrange for maximum safety of the consignment. The major problem is transportation and infrastructure, in terms of roads, rail, ports, warehouses, and others are woefully inadequate to support the country's manufacturing growth. The important considerations pharma SCM are:
for
• • • • • • • • •
Protection from contamination, etc. Managing perishable products. Maintaining temperature control. Exceptionally long cycle times. Maintaining Inventory. Specialised packaging. Barcode scanners. Data loggers for temperature control To maintain delivery schedules and meet deadlines. • Relative humidity indicators (RH) Temperature Mapping for the storage area before storing critical and temperature sensitive products (vaccines). Opportunities The opportunities from the logistics perspective are very high as most of the pharmacy retail players are approaching the third party logistics service providers to provide them with effective logistics solutions for the smooth functioning of the back-end operations. Logistics is regarded as a crucial part of the pharmaceutical industry since the activities are highly time sensitive. In addition, pharma products need temperature-controlled storage and distribution. From the cost composition point of view, the major logistics costs in the pharmaceutical industry
include packaging, distribution, etc. Transportation of goods and inventory management are concerned areas. SCM has helped pharma companies to enhance their efficiency in managing resources and improving relationships. With the growing competition among major pharmaceutical players in the industry, inventory control plays a significant role in pharma value chain as lots of inventory exists in the supply chain. For instance, out of stock situation in existing business environment is unacceptable and research and development requires huge investment to bring products to market, when it finally arrives. Outlook The Indian pharmaceutical industry has grown well at over 10 per cent in the last few years, and is expected to maintain the growth rate for the next few years too. The pharma retail segment is a very promising and upcoming segment and since pharma logistics is a very important part of the operation for any pharmaceutical business, pharma companies are ready to spend to improve efficiency of supply chain; therefore logistics providers have a great opportunity to cater to this market. A well designed supply chain with robust planning cycles that takes care of the various lead times in the end-to-end supply chain can help achieve speed to market as well as an agile supply chain. Thus, logistics and SCM are expected to play a significant role in Indian pharma industry and could contribute towards the enhancement of productivity as well as growth of the industry. India's pharmaceuticals market is firmly moving on the growth path. The central issue now rests on the extent of the markets potential. With strong player intent, investments and conducive business environment will enable the sector to break into the top global markets. Pharma Bio World
06-01-2014 18:19:48
TCI – Providing Critical Service to the Pharma Sector TCI services a host of leading pharma companies and offers customized solutions to pharma companies to suit their requirements. TCI offers seamless solutions -from conventional to express on road services to air and express deliveries, storage and distribution and specialised temperature controlled movements through reefers for the time critical & speed dependent pharma sector. Some of the major services provided to the healthcare sector include: Inbound logistics: wherein bulk intermediates/Active Pharmaceutical Ingredients (APIs), chemicals are carried to the manufacturing plants. Warehousing/3PL: TCI can provide Distribution Centers, Carry Forward Agent (DC/CFA) management covering inventory, invoicing, distribution, end-toend forward supply chain, with reverse logistics. It will also cover working with a DL (Drug License) wherever/as required. Temperature Controlled movement: TCI offers time sensitive temperature controlled Express Logistics (Air and Road) for movement of high value & perishable cargos such as vaccines, vials, ampules, gelatin capsules besides regular medicines across India. Pharma Bio World
Pharma Logistics.indd 39
Outbound Logistics/Distribution (OBL): TCI caters to the OBL through full loads as well as part loads using containers to provide reliability and security. Inbound logistics: wherein bulk intermediates/Active Pharmaceutical Ingredients (APIs), chemicals are carried to the manufacturing plants. Express Delivery Solutions: TCI XPS Air and Surface provide express delivery services for the time sensitive and critical Pharma sector. The surface deliveries for regular consignments are sent through secure vehicles routed through the hub and spoke system. Time sensitive and critical consignments are dispatched via air mode after being packed with Cooling Agents, like Dry Ice and Ice Gel Packs and delivered within 24-48 hours. TCI Cold Chain: As a logistics service provider, TCI sees the importance of cold chain in coming years as it is very important to invest in the infrastructure for pharma logistics The company provides state-of-the-art vehicles with imported reefer units for temperature controlled pharma products. The vehicles are equipped with GPS base tracking system and temperature data loggers to log the temperature throughout the journey.
TCI has taken various steps to develop and upgrade cold chains such as: • Fully customised services as per the customer need. • Imported units with digital data logger • GPS tracking with central control room Temperature range from -25 to +25 with +/-0.5. • Project movement during harvesting season. • Distribution system in relation to pharmaceuticals is been organized and brought under a proper domain ‘cold chain’. • Multi-functional warehouse with temperature control. • Multi-chambered warehouse. • Proper infrastructure better cold chain vehicles is essential for the proper transportation and storage of the drugs. • WMS & inventory management for providing product integrity, and thus ensuring patient safety. • Careful climate control throughout the transit period. • Ensure fully integrated upgraded software such as track & trace system, bar coding/RFID to monitor the total visibility of the position of the product. Contact: pooja@image-publicrelations.com December 2013 39
06-01-2014 18:19:48
market research
Healthcare Industry – An Indian Perspective Indian healthcare industry is growing at a much rapid pace. However, Indian healthcare expenditure is still amongst the lowest globally and there are significant challenges to be addressed which comprises of the patient care quality and accessibility of healthcare service. Dr Subroto Ghoshal
H
ealthcare sector has witnessed a growth even during recession and it is being predicted that this sector will become a major sector that will add to the economic growth of the country along with information technology sector. The growing importance of India in the international arena has also contributed in the growth of this sector. In the past few years, healthcare industry witnessed huge expansion plan with many companies showing interest in investment in this sector. Healthcare in India Healthcare is one of the largest sectors, in terms of revenue and employment. During the 1990s, Indian healthcare grew at an annual rate of 16 per cent. Today, the total value of the sector is around USD 40 billion. There is significant growth opportunity for the private sector in the healthcare segment. The private sector accounts for more than 80 per cent of the total healthcare spending in India. Comparatively, the Government participation has been low to the private participation and can also play an important role in facilitating the revolution. One of the key factors for the growth in the healthcare sector is India’s 40 December 2013
MARKET RESEARCH.indd 40
increasing population, currently 1.1 billion and increasing at a 2 per cent annual rate. By 2030, India is expected to surpass China as the world’s most populous nation. It is being projected that by 2050, the population will reach 1.6 billion. This population increase is due to decline in infant mortality better healthcare facilities and Government’s initiative to eradicate diseases. The Indian healthcare sector currently represents a USD 40 billion industry. A break-up of the sector as on 2009 is shown.
Figure 1: Health industry break-up Source: IDFC securities hospital sector, November 2010
Globally compared, India’s healthcare spend is significantly low. When we compare the spending as a percentage of GDP of developed and emerging economies, we get to see a much lesser percentage. USA- 15.7 per cent, UK- 8.40 per cent, Brazil- 8.40 per cent, China- 4.30 per cent and India- 4.10 per cent. While comparing public and private contribution, there is a major variation when compared with global scenario. In India, private sector contribution to the healthcare sector is highest when compared with developed and emerging economies. The table below shows the percentage spending in some of the countries: The Indian healthcare industry is estimated at USD 40 billion and this industry is expected to grow to USD 79 billion by 2015 and USD 280 billion by 2020.
Countries
Public Spending (%)
Private Spending (%)
USA
45.50
54.50
UK
81.70
18.30
Brazil
41.60
58.40
China
44.70
55.30
India
26.20
73.80
Table 1: Percentage spending Source: KPMG report 2011
Pharma Bio World
04-01-2014 14:01:05
“
“
While India has several centers of excellence healthcare delivery, these facilities are limited in their ability to drive healthcare standards because of the poor condition of the infrastructure in the vast majority of the country.
Disease Pattern in India The factor which has contributed in the growth of India’s healthcare sector is a rise in both infectious and chronic diseases. Even though India is on the threshold of eliminating diseases like polio and leprosy, some communicable diseases are still on the forefront like dengue fever, viral hepatitis, tuberculosis and HIV to name a few. These diseases have returned in force and developed resistance to drugs. Urban India is now on the threshold of becoming the disease capital of the world and facing an increased incidence of lifestyle related diseases such as cardiovascular diseases, diabetes, cancer, COPD etc. Due to more affluent lifestyle and by adopting unhealthy western diet that are high in fat and sugar, the country is expecting a dramatic rise in lifestyle diseases. Over the next 5 to 10 years, lifestyle diseases are expected to grow at a faster rate than the infectious diseases. This has become a serious challenge that Indian healthcare system needs to address. The population of India has increased up to 3 times since 1951–2000. It is also estimated that the urban population has increased to almost 4.5 times during this period. This rise in urban population with change in the standard of living, the disease pattern has shifted to lifestyle related diseases. It is estimated that the spending on in-patient bed would be 50 per cent for lifestyle related diseases by year 2012. Pharma Bio World
MARKET RESEARCH.indd 41
Infrastructure Lack of infrastructure and manpower has also been seen as a hurdle in the quality of service required to meet the growth in the healthcare sector. Accessibility to healthcare service is extremely limited to many rural areas of the country. In addition, existing healthcare infrastructure in unplanned and is irregularly distributed. Further, there is a severe lack of trained doctors and nurses to serve the needs of the large Indian populous. While India has several centers of excellence healthcare delivery, these facilities are limited in their ability to drive healthcare standards because of the poor condition of the infrastructure in the vast majority of the country. In 2003, private companies accounted for 82 per cent of India’s USD 30.5 billion expenditure on healthcare. It is estimated that nearly 70 per cent of all hospitals in the country are in the private sector. The private sector has evolved a multi-pronged approach to increase accessibility and penetration. Today, both the sectors have also undertaken
initiatives to improve functional efficiencies in the form of accreditations, clinical research, outsourcing of non-core areas etc. The healthcare infrastructure in India is inadequate compared with the global standards. It is below the global average in terms of healthcare infrastructure and manpower. India has an average 0.6 doctors per 1000 population against global average of 1.23. In 2009, the number of beds available per 1000 people in India was only 1.27, which is less than half the global average of 2.6. There are 369,351 Government beds in urban areas and a mere 143,069 beds in rural areas. Moreover, the medical personnel are concentrated in urban areas. Around 74 per cent of the graduate doctors in India work in urban settlement, which accounts for only approximately 1/4 th of the population. While the rural poor are under served, at least they can access the limited number of Government support medical facilities that are available to them. The urban poor fare worse because they cannot afford to visit the private facilities which are very expensive. Health Insurance Health insurance though established in many countries still remains largely untapped in India. Less than 15 per cent of India’s 1.1 billion people are covered through health insurance. Over 80 per
Countries
No. of doctors per 1000 population (year 2009)
No of nurses per 1000 population (Year 2009)
USA
2.7
9.8
UK
2.1
0.6
Brazil
1.7
2.9
China
1.4
1
India
0.6
1.3
Table 2: Distribution of medical staff per 1000 population Source: whoIndia.org
December 2013 41
04-01-2014 14:03:03
cent of the health financing is private financing, much of which is out-of-pocket payments and not by any pre-payment scheme. India’s first medical insurance scheme was launched in the 1996–97 budget. The ‘Janarogya Yojana’ scheme is marketed by the four subsidiaries of GIC. While public sector health insurance has not fared well, the market for private health plan is expanding in India. In 2001–02, 7.5 million policies were sold. By 2003–04, the number of policies issued had increased by 37 per cent to 10.3 million. Government seems to be initiating the health insurance scheme like Rashtriya Swasthya Bima Yojana, Arogyashree and other schemes which aims to improve healthcare delivery through private player to cover the millions of BPL (Below Poverty Line) patients in the year to come. With opening of health insurance to private players, the insurance is booming. With the rise in disposable income for the population in the age group of 15–60 years, the insurance reach is expected to grow, as estimated by industry experts. Patients will have a choice to select between various providers and this will bring in better quality care and professionalism. Medical Tourism Medical tourism is one of the major external drivers of the growth of the Indian healthcare sector. According to a joint study by CII and Mckinsey, Indian medical tourism was estimated at USD 350 million in 2006 and has the potential to grow into USD 2 billion industry by 2012. An estimated 180,000 medical tourists were treated at Indian facilities in 2004. India’s private hospitals excel in fields such as cardiology, joint replacement, orthopedic surgery, gastroenterology, ophthalmology, transplant and urology. To encourage the growth of medical tourism, the Government is also providing a variety of 42 December 2013
MARKET RESEARCH.indd 42
Figure 2: Cost comparison in USD for treatment Source: Mediminds.com
incentives for overseas patients seeking medical care in India. Corporate hospitals have taken a major initiative in attracting foreigners for medical treatment to India. Some of the major players in this field are Apollo hospital, Fortis, Max, Escorts, Narayana Hridayalaya to name a few, by providing some of the best facilities compared with any good international facility. Indian doctors are considered among the best doctors in the world. India also has a major cost advantage over the developed countries with similar facilities. India is having a major edge over other countries because of English speaking manpower which provides better communication with the patients. Along with this, Indian hospitals extensively use computerised hospital information system added with 24 hours on ground support, air ambulance support and advanced diagnostic facilities. These are the factors which have put India on the global medical tourism destination. Pharmaceutical Industry Pharmaceutical industry is one of the leading industries in India and it represents 8 per cent of the global total
industry by volume. Pharmaceutical industry is split into organised as well as unorganised segment. In the organised segment of pharmaceutical industry, there are about 250–300 companies, which account for 70 per cent of the product in the market with top 10 firms representing 30 per cent. With huge manufacturing capacity and technical knowhow, India has become a major supplier to many multinational generic companies who are into contract manufacturing. It is estimated that generic market is worth USD 350 million and is expected to cross USD 1 billion by 2012. However, R&D does not feature majority in the domestic industry and the expenditure is much less when compared globally. The Department of Pharmaceuticals has estimated that the total revenue of pharmaceutical industry in India between 2008 and 2009 was USD 21.04 billion. The domestic market was estimated to be worth USD 12.65 billion. It is being anticipated that the Indian pharmaceutical market will reach USD 55 billion by 2020. The pharmaceutical industry is booming with specialties in manufacturing specialty drugs and advanced technology. The DoP has prepared “Pharma Vision 2020” with an objective to focus India as a leading destination for drug discovery Pharma Bio World
04-01-2014 14:03:03
Conclusion
and innovation and to provide support for scientific information, international infrastructure, venture fund for R&D and many other measures. The Indian market is skeptical about the possible recession but pharmaceutical industry is not concerned about the slow down and is expected to continue to grow with its good performance in the year to come.
has been expanding their operations.
Opportunities in Healthcare Industry
year 2020.
As per the report of investment commission of India, the healthcare sector in the last 4 years has experienced a growth of more than 12 per cent per annum. This growth has been experienced due to various factors like rising life expectancy, good health insurance plans, increase in the level of income and increase in the lifestyle related and infectious diseases. Around 40 million new jobs are expected by 2020.
It
The private healthcare has been growing even during the economic slow down and
have been contributing for the growth of
manpower in this industry. By bringing in foreign tourists to India for medical tourism, education and leisure tourism, it is expected that the industry can generate additional USD 6–50 billion in revenue and is capable of creating 10-40 million jobs directly or indirectly by the
was
highlighted
by
Mckinsey-CII
advisory that they estimate the number of insurance coverage of 315 million with a potential to generate ` 34,650 crore as premium by 2015. India is in advantage with the availability of good medical/ technical universities and 100 million plus English speaking professionals. India is one of the top 3 countries where companies plan to spend in R&D and also
“
“
There has also been an addition in the
has strong IT industry availability. These the country as well as the industry.
It is being anticipated that the Indian pharmaceutical market will reach USD 55 billion by 2020.
Pharma Bio World
MARKET RESEARCH.indd 43
Healthcare sector is at an influx of paradigm shift in terms of changing disease pattern, increasing dual disease burden for both rural and urban India. Private sector should work in tandem with the Government on initiatives to educate for developing more sustainable delivery models. Both, private and the Government should work together, to encourage better penetration and utilisation of health insurance schemes, encourage accreditions, making it mandatory for medical professionals, which will help ensure quality standards. Pharmaceutical research is also another area that is expected to achieve tremendous growth in the coming decade, due to India’s huge and growing population, low per capita drug usage and increasing incidence of diseases. Since the income has been increasing and personal disposable income rising more than 70 per cent, there is a demand to have better quality healthcare. The Government is also focusing on improving the quality of healthcare delivery system. In spite of immense opportunities, healthcare sector is faced with certain challenges to be addressed. There are no proper guidelines set by the Government for setting up of hospitals and nursing homes. It is felt that without uniform policy and sharing of information by the hospitals, a mature healthcare delivery system cannot materialise. The private health sector is also highly unregulated and there is a need for establishing an accreditation body which will ensure quality healthcare through assessing hospitals, for compliance to set standards and ensuring proper patient care. The Government has to explore the potential to have healthcare insurance which will support the poorer section of the population. There is a need to set up super specialty tertiary care hospitals across the country to cater to the weaker section of the society. Contact: subroto.ghoshal@mindteck.com December 2013 43
04-01-2014 14:03:03
news features
Survival Strategies With the drying drug pipelines and rise in R&D costs, dying patents, rigid regulatory structure, what are the strategies the pharma industry is considering ‘ to survive’? How smooth is the road ahead for the industry? Find out as Ananya Sen reviews some of the approaches adopted by big players to endure the longevity of their success in the years to come.
W
e are gradually drawing close to the end of an era as we bid adieu to the good old ‘Blockbuster Days’. The market today is flooded with generics than never before giving rise to cut throat competition. The expenditure incurred on research is not yielding satisfactory returns. A few months back, the American pharmaceutical giant, Merck made news soon after it announced to slash some 8,500 jobs to save USD 2.5 billion annually.
Pic courtesy: Chemistry World, RSC
On the regulatory front too things don’t look any better. Companies are striving to cope up as regulatory agencies worldwide are tightening their vigilance. Some of the markets are also witnessing an acute shortage of drug supply with the regulatory agencies forbidding facilities that fail to adhere to their standards. To add to this, there are patent related issues as well! A well-known multinational corporation having lost its patent in India is hesitant to get new drugs here. And there is much more! The road ahead as experts in the industry say doesn’t look rosy either. Hocus Focus
NOVARTIS INTRODUCED A CHANGE IN ITS BUSINESS APPROACH WHEN IT CHOSE TO DEVELOP DRUGS FOR RARE DISEASES. 44 December 2013
News feature.indd 44
Five years ago, Pfizer made a significant change in its growth strategy. The USbased drug maker decided to emphasise its research on developing drugs for diseases with a high potential for treatment improvements. With the fall in sale of its blockbuster lipid lowering
drug-Lipitor, Pfizer could forecast the profitability associated with markets such as oncology and immunology. Novartis introduced a change in its business approach when it chose to develop drugs for rare diseases. The tactic is to develop treatment of these diseases by tracking down their pathway and expanding it to ailments with the same genetic trigger. Francis Cuss, Executive Vice President and Chief Scientific Officer, BristolMyers Squibb in a statement released by the company said, “We are focusing our R&D organization on delivering the opportunities where the value is greatest to patients”. He added, “We have decided to shift R&D toward a more specialty BioPharma model that focuses on the areas of significant unmet medical need, driving near-term growth through our current late-stage portfolio and on ensuring the long-term growth of the company by evolving the disease areas and drug platforms on which we concentrate our research efforts.” A report by Evaluate Pharma (Figure.1) reveals that globally oncology will top the list of therapeutic segments in terms of sales with the major growth drivers being Revlimid from Celgene, Afinitor from Novartis and Perjeta from Roche, expecting Roche to lead the oncology market till 2018 with a worldwide sale of around thirty thousand million dollars. Pharma Bio World
04-01-2014 15:55:38
Joseph Jimenez, CEO, Novartis to an international publication, earlier this year stressed on the need to build the healthcare infrastructure in sub-Saharan African countries like Nigeria and Kenya. The ‘In’ Thing
Figure 1: Market Share & Sales Growth of Top 5 Therapy Areas in 2018
Moving on from this type of a business development model, a paper titled “Pharma 2020: Challenging Business Models” authored by Price Waterhouse Coopers proposes a collaborative modelthe fully diversified model. This model talks about expanding the business areas of an organisation from the core area to an area of related products and services. For a pharmaceutical firm it may mean expanding from drug manufacturing to healthcare, nutraceuticals, cosmetics, medical devices etc. One of the key advantages of adopting this kind of model is that it helps reduce and distribute the risk concentrated in one area. The paper cites Johnson & Johnson as the leading pharma company to have successfully embraced this strategy. Burgeoning Markets Players in the industry are gently moving to the emerging markets realizing the saturation in the developed world. Pharma giants have been eyeing the BRIC market for its promising growth. Brazil has witnessed the presence of a number of multinationals for quite some time now. Some of these big names are Sanofi-Aventis, Pfizer, Novartis, Astra Zeneca and Roche. Andrew Witty, Chief Pharma Bio World
News feature.indd 45
IN AN INTERVIEW TO A LEADING INDIAN BUSINESS DAILY KEVIN ALI, PRESIDENT, EMERGING MARKETS, MERCK SAID, “INDIA IS AMONG WHAT WE CALL ‘INVEST-TO-WIN’ COUNTRIES.” Executive Officer, GSK sees India and Brazil as potential markets for growth. GSK made headlines a few days ago as it offered to raise stake in its subsidiary in India by spending USD one billion. Making the announcement, David Redfern, Chief Strategy Officer, GSK said: “For GSK this transaction will increase exposure to a strategically important market“. In an interview to a leading Indian business daily Kevin Ali, President, Emerging Markets, Merck stated that their local unit in India is growing robustly at double digits and that they are ready to invest here. He said, “India is among what we call ‘invest-to-win’ countries. We must continue to invest in India and we must win in India.”
Even the big names in the industry are into in or out licensing realising the challenges arising due to patent cliffs and drying pipelines. From bridging portfolio gaps of big pharma to the need for a larger capital for funding research, licensing deals are increasingly being considered as a viable model for business development. Why is it favourable? It is obviously easier to develop a product further than do it from scratch. Working on a molecule from its discovery may not only prove costlier but also riskier with no guarantee for success. Add to that the time factor required from its inception to the many folds of regulatory approvals. Moreover licensing allows a much bigger window to innovation rather than restricting it within the walls of one company. Licensing deals aim at increasing productivity and curtailing the risk associated with R&D. The news of Pfizer collaborating with its long time rival Merck came as a big shock for all. Pfizer out-licensed its diabetes drug candidate ertugliflozin for its late stage clinical development and commercialization. Another recently signed licensing pact back home to watch out for is the BioconQuark deal. As per the agreement, Biocon will have access to Quark’s siRNA technology that will be leveraged to develop treatment for patients suffering from serious ophthalmic conditions and introduce other innovative therapeutics. Between the Lines The advent of the new pricing policyDrugs (Price Control) Order 2013, created a stir in the Indian pharma industry. Let December 2013 45
04-01-2014 15:55:53
us review the strategy innovated by GSK. Their formulation Crocin containing 500mg of Paracetamol came under the price control and so to escape it the drug maker introduced Crocin Advance which they claim is a product of their in house research. This ‘newly’ developed formulation per unit has been priced at more than double the cost of each conventional 500mg Paracetamol tablet. According to Section 32 of the Order, the price control will not be applicable to such indigenously developed novel delivery systems. Another loophole in the new DPCO has been exploited by many pharma companies. The DPCO 2013 does not cover Fixed Dose Combinations (FDCs) of most essential medicines other than very few included in the National List of Essential Medicines (NLEM). This gives companies the liberty to introduce varied drug combinations including irrational FDCs, a market trend that has been on the rise. Call for Co-creation Mithra Pharmaceuticals, a Belgiumbased pharmaceutical company specialised in women healthcare has an innovative concept for collaboration – the Mithra Campus. Mithra Pharmaceuticals has been synonymous with women healthcare in Belgium for quite some time now. A spin off of the University of Liege, this specialty pharma company became numero uno in Belgium with the launch of their full contraceptive range. Mithra's core focus areas have been contraception and fertility, menoupause and osteoporosis, the uterovaginal sphere and female cancers. It is an established name today in both generic and innovative drugs. An important turning point for Mithra was the European Registration of their generic contraceptive anti-acne product Cyproterone Acetate in 46 December 2013
News feature.indd 46
2003. The company with a current market share of 42 per cent has never had to look back since then. Today the company has distribution rights in 44 countries across the globe. Mithra as a part of the Belgian Economic Mission was in Mumbai recently to extend its proposal for partnering with Indian pharma companies. Francois Fornieri, CEO & Founder, Mithra Pharmaceuticals aims to make it big by forming synergies. Innovation, he believes should be cocreated together with the exchange of ideas. His brainchild, the Mithra Campus was born out of such thinking. The first phase of the fully equipped Campus will be operational from 2015 in Belgium, the heart of Europe. It has already partnered with a few international companies and looks forwardto partner with the remaining two companies perhaps from India. Fornieri says Mithra has already worked with a few Indian companies like Cipla in the past. This opportunity of partnering with Mithra can be viewed as a gateway to the whole of European pharmaceutical market besides Belgium. This surely according to many will be lucrative since the European market has not been explored much by the Indian pharma players. Mithra, says Fornieri has a basket full of offerings for its partners. This partnership they promise will provide regulatory, manufacturing, business development, marketing and legal assistance to the collaborating companies to help enter the European market. The Campus seeks to synergise with international organisations and universities to work together through co-development and exchange of technological knowhow. "Mithra Campus provides a great platform for pharmaceutical companies to come together and co-create and shape the future of pharmaceutcal advancements", said Fornieri urging drug makers to join hands and be a part of the Campus.
“MITHRA CAMPUS PROVIDES A GREAT PLATFORM FOR PHARMACEUTICAL COMPANIES TO COME TOGETHER AND CO-CREATE AND SHAPE THE FUTURE OF PHARMACEUTICAL ADVANCEMENTS”. - Francois Fornieri, CEO & Founder, Mithra Pharmaceuticals Ashish Sehgal, business consultant with Mithra says that the uniqueness of this model is that the collaborating companies actually don’t need to pay for infrastructure or people making it cost-effective. It serves to address the current challenges of the pharmaceutical industry. There are plans to launch another phase of the Campus as well soon after the closure of the first. Moving on Meanwhile as the industry walks the tight rope, business development strategists will gradually have to work out advanced models to survive the rat race. The emerging markets making it big, most major players shifting their focus to areas of unmet needs and licensing becoming the top choice, what more awaits pharma is to watch out for! Pharma Bio World
04-01-2014 15:55:54
Marketing Initiative
Multiple Code Reading Applications Made Easy For many manufacturing and material-handling engineers, it is difficult to read more than one barcode at a time. As also when it has to read multiple codes of the same symbology as well as mixed symbologies within one field of view (FOV). Even more difficult is reading one or more codes on multiple sides of a product to verify that codes match or to output both sides’ read results as one piece of data. Typical Multiple Code Reading Applications
•
1. Code Reading Algorithms : Multiple codes reading application must have the best algorithms to attain highest read rates. It should achieve a high percentage of successful code reads per attempt, with minimal no-reads and provide higher than 99 per cent read rates. 1DMax+™ and 2DMax+™ algorithms has a new standard to give highest read rates of challenging codes. When 1DMax+ algorithm is paired with Hotbars™ image analysis technology, 1-D barcode signals are extracted faster and more reliably for more decodes per second in a wider field of view.
Multiple codes of the same symbology within one field of view (FOV) • Multiple codes of mixed symbologies within one FOV 2. Simple Setup for One or More • One or more codes on multiple sides to Readers : System integrators should be set verify that codes match up for multiple-code reading application. It • One or more codes on multiple sides to should be as simple as answering the question, output both sides’ read results as one “How many codes are you looking for and of what types?” Image-based Reading Technology for Multiple Code Reading Applications 3. Data Output, Formatting and Validation : Once barcodes have been When it comes to multiple barcode reading decoded and data extracted, from a single or with laser scanners, what are the limitations? multiple reader, output has to be controlled and Why is image-based solution chosen reader should be able to do it. for reading multiple barcodes over laser scanning technology? DataMan readers feature various trigger modes during image acquisition. For example, For laser scanners, it is difficult to read codes a reader in burst mode can decode and output that are poorly printed, damaged or defective multiple codes from a sequence of images or and omnidirectional. They cannot manage in continuous mode can take many images when variations occurring part and package necessary to locate a specified number of positioning and cannot read 2-D codes and codes. Industrial ID readers should also offer cannot compete in two of the four types simple ways to help format and validate the of multiple code reading applications we data so that your PC or PLC (Programmable commonly see. Logic Controller) can use the data as intended. Match string validation or pattern matching Four Considerations for Barcode validation ensures that same barcode is read Reader Evaluation: each time. Sometimes the application includes both 1-D UPC and a 2-D Data Matrix code Advanced image-based industrial ID where the UPC code is the same part to part readers should adapt as per application even though Data Matrix code changes. With changes, especially when more match string validation, the UPC code is correct. than one code is present. It should read any code or set of codes, 4. Communication : With the data that every time, integrate into the processes and is available, how to send it to the control easy to maintain. center? Ethernet. Choose a solution that Pharma Bio World
Marketing initiative.indd 47
can communicate with PC or PLC without complexity such as Ethernet/IP Cognex. Multiple Code Reading Applications
PHARMACEUTICALS There are many types of applications in pharmaceuticals industry: multiple codes of the same symbology as well as multiple codes of mixed symbologies within a single view field. Regulations require unique identifiers to control traceability to combat counterfeiting from single unit, to package, to carton, shipping boxes and pallets. LOGISTICS During scanning of packages with multiple codes, reader should not re-read codes. If it looks and read two codes, output should be data of those two codes. High-speed material handling systems also move packages with multiple codes. Sometimes one or more codes are on multiple sides and read results must be outputted as one. FOOD AND BEVERAGE There many applications where we have multiple codes of mixed symbologies within a single view field for these industries. Often there is a need for more data than just UPC code so the addition of 2-D Data Matrix codes helps control traceability and aid in manufacturing process. In allergen applications, one or more codes on multiple sides must be verified to match. The code on the lid of a container must match the code on the container to ensure proper labeling. For further information, please contact: Sunil Vaggu Cognex Sensors India Pvt. Ltd Email: vaggu.sunil@cognex.com Mobile: +91-9881466003 OR Piya D Banerjee Mind Matters Email: mails@mindmatterscorp.com Mobile: +91-9096699998 December 2013 47
04-01-2014 14:07:03
Marketing Initiative
Peristaltic Pump Specialist Launches Fully Integrated Drive for OEM Pumps • • •
Single source solution for complete OEM drives with integrated controller. Highly adaptable with 51:1 control ratio and 408-8 rpm speed range. Ideal solution for biopharm, medical device and process analysis equipment. Watson-Marlow Pumps Group, the leader in peristaltic pump technology, introduces DriveSure™ its new panel-mount OEM brushless DC gear motor with fully integrated speed controller. DriveSure is highly adaptable, offering 24V and 48V dc options, a 51:1 control ratio between 408-8 rpm, and directly accepts market-standard analogue control signals. With DriveSure, OEM engineers can bring products to market faster and with less engineering cost by eliminating the time, design uncertainty and risks associated with the separate specification of pump motor, gearbox and drive. Driving down complexity
range that Watson-Marlow has offered to date, giving customers the peace of mind of a fully integrated pump solution from the marker leader. This assurance of pump performance is back up by a comprehensive two year warranty, and direct support in over 50 countries. The Watson-Marlow Pumps Group comprises of: • Watson-Marlow Pumps: peristaltic tube pumps for pharmaceuticals and industry. • Watson-Marlow Tubing: precision tubing for pumping and other purposes, in a range of materials. • Bredel Hose Pumps: heavy-duty hose pumps. • Watson-Marlow Alitea: unique peristaltic solutions for OEM customers. Flexicon Liquid Filling: aseptic filling and capping systems. MasoSine Process Pumps: sinusoidal pumps.
Building on Watson-Marlow’s extensive Easy set-up experience of providing peristaltic cased • pumps, DriveSure for the first time brings CE marked and manufactured in conformance a range of panel-mount brushless DC with IEC and EN 61010-1, the compact, • motor gearboxes and controllers as a lightweight and well-balanced design provides package. This innovative range offers market a ‘plug-in and forget’ solution. The use of leading speed control range and precision, Watson-Marlow’s own gearbox provides the Part of the Spirax-Sarco Engineering guaranteed torque and long service life ideal customer with excellent torque and silent Group, Watson-Marlow Pumps Group is an for OEMs wishing to panel-mount Watsonrunning. As a result, the solution is ideal for the international operation based in Falmouth, Marlow’s proven pumpheads, including the life science and Biopharm sectors where noise Cornwall, UK. Watson-Marlow Pumps has 102R, 114, 313D, 501RL and 520R series for offices in Argentina, Australia, Belgium, Brazil, can be a major issue. a flow range from 0.1 to 6100 ml/min. It also China, Denmark, France, Germany, India, Italy, interfaces with the market-standard analogue Typical life science applications might include Korea, Malaysia, Mexico, the Netherlands, control signals. dental, endoscopy, electro-medical and in-vitro New Zealand, Russia, Singapore, South Africa, DriveSure helps OEMs to reduce their diagnostics. The comprehensive control and Sweden, Switzerland and the USA. time-to-market significantly, so providing flow rate capability also meets the requirements valuable competitive gain. Furthermore, the of biopharmaceutical equipment such as For more details, contact: inherent risks of buying various system bioreactors, bench-top cross-flow filtration and Watson Marlow India Pvt Ltd components from different manufacturers chromatography equipment, while in terms of S .No 77/1, Opposite Malan Farm are eliminated, with the safety net of a single, analysers, process, toxicity and wet chemical Z.P.Road, Tathawade Pune -411 033 comprehensive two year warranty. analysis equipment is sure to benefit. Tel No: +91 20 6735 6200 Importantly, this includes a performance guarantee for the complete pump and full DriveSure technology enables the most Email: info@wmpg.in . integration support. competitively priced panel mount OEM pump Website: www.wmpg.co.uk 48 December 2013
Marketing initiative.indd 48
Pharma Bio World
04-01-2014 14:07:22
pharma news Anita Tripathy Named President of inVentiv Health India inVentiv Health has named a senior executive in India’s life sciences industry to lead its expanding operations in India. Anita Tripathy joins inVentiv Health from Capgemini, India, where she served on the leadership team of the global provider of consulting, technology and outsourcing services. At inVentiv Health, as President, India, she will be responsible for the management, development and growth of all business units in India across inVentiv’s Clinical and Commercial segments. India is a key market for inVentiv’s growth plans in Asia. With significant Indian operations already in place, the Company has an excellent platform for a new leader to expand both inVentiv’s customer base and the development of new services. She will be based in Mumbai and report to inVentiv Health Executive Vice President Ray Hill. At Capgemini, Anita Tripathy led a strategic cluster of IT products for the European market. While at Cognizant earlier in her career, she led the Strategic Business Unit for Life Sciences in India. She orchestrated teams based out of India, China and Argentina, delivering services across three continents, North America, Europe and Asia Pacific. Before transitioning to the life sciences industry, she worked in ERP applications for KPIT Cummins Infosystems Ltd, and at Satyam Computer Services Ltd. She also worked in Pune at Nestle India as a systems analyst, and at ICIM Ltd as a senior systems engineer. She holds a Bachelor’s degree in Chemistry from Berhampur University and a Master’s in Computer Applications from the Regional Engineering College, Rourkela, Orissa, India.
Cymbalta Patent Expiry Opens Floodgates to Generic Competition Indianapolis based Eli Lilly’s blockbuster antidepressant drug Cymbalta has lost it US patent exclusivity, clearing the way for the launch of cheaper versions of the drug from generic drug makers. Indian generic majors Sun Pharma, Dr Reddy’s Lab, Aurobindo Pharma, Lupin and Torrent have all secured US FDA approval, along with Israeli firm Teva Pharma to market generic versions of Cymbalta. Kathleen Uhl, acting director of the office of Generic Drugs in the FDA’s Centre for Drug evaluation and Research said consumers can be assured these approved generic drugs have met FDA’s rigorous standards. Pharma Bio World
Final Pharma News.indd 51
For Eli Lily, it will be tough to lose its top-selling drug. Cymbalta accounted for 22 per cent of the company’s USD 22.6 billion annual revenues in 2012. Earlier this year the company also lost US patent protection for its best-selling insulin injection for diabetics, Humalog, which had 2012 sales of USD 2.4 billion. Lilly has said it will counter the revenue loss from the patent expirations by developing new drugs, cutting costs and depending on sales in foreign markets and developing countries. Besides depression, Cymbalta is also prescribed to treat generalised anxiety disorder, diabetic nerve pain, fibromyalgia and forms of chronic pain. Cymbalta (Duloxetine) and other antidepressant drugs have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18 to 24. The warning also says data do not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.
Nuvo Research and NovaMedica Sign Deal to Market Pennsaid in Russia Nuvo Research Inc and NovaMedica LLC, a Russian pharmaceutical company, signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo’s Pennsaid 1.5% and Pennsaid 2% products in Russia and some of the Community of Independent States (CIS). Pennsaid 1.5% and Pennsaid 2% are used to treat the symptoms and pain of osteoarthritis of the knee. Pennsaid 1.5% is approved by the US Food and Drug Adminstration (FDA) and is currently being marketed in the US, Canada and certain European countries. A new drug application (NDA) for Pennsaid 2% is currently under review by the FDA which has indicated that it expects to respond to the NDA by Feburary 7, 2014. Under the terms of the agreement, NovaMedica is responsible for conducting required clinical studies and obtaining regulatory approval for the products in the licensed territories. Sales of Pennsaid 1.5% in Russia are projected to begin in 2015. “With an established sales force and excellent knowledge of the Russian pharmaceutical market, NovaMedica is the ideal commercial partner to obtain approval for and market Pennsaid 1.5% and Pennsaid 2% in Russia,” said Dan Chicoine, Chairman and Co-CEO of Nuvo. “Pennsaid 1.5% is currently marketed in five countries, and we will continue to expand its market potential by seeking marketing partners throughout the world.” December 2013 51
04-01-2014 14:09:28
Indegene Launches Complete Range of Brand-Focused MCM Solutions Indegene, a leading provider of R&D, commercial, and marketing solutions to top global pharmaceutical and healthcare organisations, has announced that its MultiChannel Marketing (MCM) division has launched a suite of Brand-Focused Solutions for the brand marketing teams. These solutions leverage Indegene’s robust and Rajesh Nair integrated Multi-Channel Marketing (iMCM) President framework to help the Sales and Marketing Indegene teams increase the outreach of their brands, while optimising the spend. Brand Promotion Solutions will help clients deploy successful MCM programmes with a ubiquitous, distributed, and integrated approach. Rajesh Nair, President, Indegene, said “We are excited to launch a complete suite of Brand-Focused MCM Solutions as a part of our MCM capabilities. These solutions are specifically focused at brand marketing teams to fill gaps in Sales Force coverage and increase Share of Voice. These solutions are intended to complement the Sales Force and drive prescriptions with targeted customers.” Brand teams across the industry are looking to increase their reach and frequency beyond the traditional Sales Force efforts by adding various digital and complementary tactics to their existing promotional mix. However, many such programs are fragmented and only reach a small audience, and engaging more targets via multiple tactics and channels become time consuming and impact budgets, as operations and content development quickly spiral out of control. In the past, such an approach required coordination with multiple vendor partners and a lengthy implementation of data and technology infrastructure.
OPPI Hosts HR Conclave
The pharmaceutical industry is a knowledge-based industry, which is growing steadily and plays a major role in the Indian economy. The country’s emergence as an important manufacturing base, as well as a market for the global pharmaceutical industry, makes this an attractive sector for young professionals in a wide range of specialties involving drug development, marketing, project management and technology. The pharmaceutical industry currently employs approximately 450,000 people and has contributed significantly in creating a rich talent pool of researchers, scientists, doctors and project managers. The key-note speaker, Dietmar Eidens, Executive Vice President, Human Resources, Merck Serono said, “Globally as well as in India, the pharmaceutical industry is rapidly undergoing changes. The pace of this transformation has made it important to invest in developing young talent and adapting to their needs. As Generation Y begins to play a more important role in the workforce, the pharmaceutical industry will also need to adjust to the changing workplace dynamic and cultivate a strong image as an ‘employer of choice’”. The pharmaceutical industry in India has clocked double digit growth rate in the last five years and this is expected to continue in 2014. With several multinational companies operating in this space, there are more jobs in the pharmaceutical sector and a great scope for hiring.
Meda to Acquire ZpearPoint
Jörg-Thomas Dierks CEO, Meda AB
Meda has signed an agreement to acquire ZpearPoint AS, including global rights to its main product, EB24, an OTC line for treating dental erosion. Dental erosion is a common, growing condition that impacts all ages and for which there is currently no effective treatment. The condition is estimated to affect 15-50 per cent of the population and it is sometimes referred to as the “new caries”.
The EB24 product is based on hydrogen fluoride highly diluted in water. In studies, the product has shown that it is able to penetrate enamel surfaces and form calcium fluoride resulting in an anti-erosive effect. As such, EB24 works as a protective agent against dental erosion.
The Organisation of Pharmaceutical Producers of India (OPPI) hosted an HR Conclave on “Talent Attraction – Engaging Gen Y” to address the Human Resources challenge in the pharmaceutical sector. The event brought together industry stalwarts, multinational pharmaceutical companies, distinguished academicians and HR Leaders from the pharmaceutical and allied sectors. 52 December 2013
Final Pharma News.indd 52
“EB24 will be an important addition to our OTC product portfolio and an excellent complement to CB12,” said Jörg-Thomas Dierks, CEO of Meda AB. “The acquisition enables us to continue to build on our OTC offering and adds to future growth.” The EB24 product is expected to be launched in first half of 2015 as a mouth rinse. Patents valid until 2025 have been approved in Europe and are pending in the US. The purchase price will amount up to 77 MSEK over time and is dependent on various milestones such as launch and approvals. Meda will also pay a low, single-digit percentage on sales. Pharma Bio World
04-01-2014 14:10:34
HRS Displays High Quality Heat Transfer Solutions at P-MEC 2013 HRS Process Systems Ltd (HRS), part of HRS Group, UK participated in the Pharma Machinery, Equipment & Technology (P-MEC) Expo 2013 which was held from 3 rd to 5 th December 2013 at Bombay Exhibition Centre, Mumbai. At the expo, HRS displayed specialised, high performance heat transfer solutions such as ECOFLUX Corrugated Tube Heat Exchangers, HRS Funke Plate Heat Exchangers and HRS Hot Water Systems, with an aim to focus on highlighting their products and expanding reach across the pharma industry. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the “must attended” event in the international pharmaceutical industry. P-MEC India and its co-located events are the largest and most comprehensive pharmaceutical industry events in South Asia. With focus areas on machinery & technology, ingredients, contract services and biopharmaceuticals, this event is the ultimate one-stop shop for pharmaceutical business needs. P-MEC India gave an unprecedented insight into the future of pharmaceutical equipment and machinery. The event highlighted latest knowledge and trends in the industry. The fifth P-Mec Expo 2013 exhibited the latest machinery & technology in Pharmaceutics at Mumbai. Pharma majors and HRS’ clients such as Cipla, Cadila, Glenmark, Ranbaxy, Lupin Ltd, Hetero Drugs, Ipca Laboratories, Sun Pharma to name a few, were some of the well-known companies that visited this exhibition. The Expo was a great opportunity for Machinery and Equipment suppliers to showcase their products.
CPhI & P-MEC India 2013 Woo Global Pharma Gaints If the success story of the CPhI & P-MEC India 2013 show is an indication of things to come, then the USD 30 billion Indian pharmaceutical industry is definitely poised to storm into the global pharma scene with its entire value chain. The industry exports have already surpassed USD 15 billion and it proposes to double it by 2020. CPhI & P-MEC India 2013, the three-day premier show of India’s strength in the pharma industry attracted countless visitors and over 1000 exhibitors from over 95 countries. From formulations, technology, machinery solutions, contract research, and process developments to packaging, Indian players in pharma and machinery manufacturing have successfully flexed their muscles in the global technology, ingredients, outsourcing and bio-pharma segments. With these plus points, the industry is now looking forward to opportunities in globalising their businesses through the much needed “Brand India Pharma” promotion. Organised by UBM India - a leading global business media company, the 2013 edition of CPhI & P-MEC India showcased pharmaceutical ingredients and related products such as Bulk Drugs, Excipients, Pharma Bio World
Final Pharma News.indd 53
biopharmaceuticals, APIs, intermediates and fine chemicals. The roster of participants reads like a ‘who’s who’ list of global pharma industry. While the global pharma giants like BASF, Capsugel Healthcare, Àurobindo Pharma, Merck Millipore, Indoco Remedies, ACG Worldwide, Bosch Ltd, Fette, IMA Industria Macchine Automatiche SPA, Marchesini Group, Truking Technology, Waters India, Agilent Technologies, Shimadzu, Thermo Fisher Scientific, Spinco Biotech, WALDNER Laboreinrichtungen GmbH & Co KG, Fabtech Technologies International Ltd, Mitsubishi Electric India, Cadmach Machinery Co Pvt Ltd, Thermolab Scientific Equipments Pvt Ltd, Hetero Drugs Ltd, UK Trade & Investment, DSM, Evonik Degussa India Pvt Ltd, etc are present in full strength, there was participation from drug manufacturers, machinery manufacturers and importers from countries such as Ghana, Latvia, Afganistan, Iraq, Burma, etc. One of the highlights of the show was that highlevel delegations from Nepal, Vietnam, Sri Lanka, Korea, Turkey and Egypt had discussed various issues related to the industry to find out how the two-way trade in pharma can be expanded. Some of the leaders in the industry attending the CPhI and P-MEC India 2013 show, were happy at the growth of the industry and emphasized the need for projecting the excellent quality standards equal to anywhere in the advanced countries, achieved by the industry.
Schmersal India’s Pune Factory to Build Industrial Safety Equipments In July 2013, the Schmersal Group started the production in its Indian factory in Ranjangaon near Pune, Maharashtra. Sagar Bhosale, Managing Director of Schmersal´s India Operations, explains the reasons why one of the leading manufacturers of safety switchgear and other devices for machine safety has established a production base in India. Schmersal India has now its manufacturing plant in Pune since July. The plant has been built with unique Precast Technology in a plot area of 20000 sqm. The first phase built up is around 9000 sqm and the products which will be produced in the first phase are Safety Position Switches (both metal and plastic versions), Safety Door Switches and Safety Pull cord/Emergency Trip wire Switches. Schmersal is serving the global players as well as native Indian companies eg, in the automotive and packaging industry, in material handling and textile industry, machine tool production, alternate energy sectors and the food processing industry with a variety of safety switchgear, safety controls and complete systems solutions. In the first step, the factory employs 35 people and manufactures safety switches, positioning switches with and without safety function and emergency pull wire switches exclusively for the Indian market. December 2013 53
04-01-2014 14:10:34
Torrent Acquires Elder Pharma Torrent Pharmaceuticals Limited has entered into a definitive binding agreement with Elder Pharmaceuticals to acquire its branded domestic formulations business in India and Nepal for a consideration of about ` 2000 crores. Elder ’s India Business comprises a portfolio of 30 brands including market leading brands in the Women’s Healthcare, Pain Management, Wound Care and Nutraceuticals therapeutic segments. The identified India Business is being sold as a going concern on a slump sale basis and the transaction will also involve the transfer of employees engaged in sales, marketing and operations of the India Business. Under the proposed transaction, Elder will continue to manufacture & supply the products at its existing manufacturing facilities for Torrent for a period of 3 years. Torrent would fund the acquisition through a mix of internal accruals and bank borrowings. Elder’s existing brand equity in the areas of women healthcare and pain management will help Torrent strengthen its position in the Indian market expanding into these fast growing areas. “The transaction is a strategic fit for Torrent and will strengthen its core prescription-based business. This acquisition strengthens our position in the Women Healthcare, Pain management & Vitamins/ Nutrition segments by enhancing & accelerating market access. It is also expected to enable cost & revenue synergies in Torrent’s domestic formulations business” said Sudhir Mehta, Chairman, Torrent Group. Thee transaction has been approved by the Boards of Directors of both companies. The transaction is subject to conditions precedent including shareholder approval and applicable regulatory approvals and is expected to close in the first half of 2014.
Endo to Acquire NuPathe Endo Health Solutions will acquire NuPathe Inc for USD 2.85 per share in cash, or approximately USD 105 million. In addition to the upfront cash payment, NuPathe shareholders will receive rights to receive additional cash payments of up to USD 3.15 per share if specified net sales of NuPathe’s migraine treatment ZECUITY are achieved Rajiv De Silva over time. Endo expects meaningful cost President & CEO synergies from the transaction, which is Endo expected to be accretive to Endo’s adjusted diluted earnings per share within the first 12 months of closing. ZECUITY, which was approved by the US Food and Drug Administration (FDA) in January 2013 for the acute treatment of migraine with or without aura in adults, is the first and only FDA54 December 2013
Final Pharma News.indd 54
approved prescription migraine patch. ZECUITY is a disposable, single-use, battery-powered transdermal patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. ZECUITY provides relief of both migraine headache pain and migraine-related nausea (MRN). ZECUITY was approved based upon an extensive development program with phase 3 trials that included 793 patients using nearly 10,000 ZECUITY patches. In these trials, ZECUITY demonstrated a favorable safety profile and was effective at relieving migraine headache pain and migraine-related nausea two hours after patch activation. “We’re excited about the opportunity to launch ZECUITY, a treatment that could be an option for millions of migraine patients, including those with migraine-related nausea. Following the close of the deal, we plan to launch ZECUITY in the first half of 2014 by leveraging our existing commercial expertise in pain and migraine management and the current infrastructure of our branded pharmaceuticals business overall,”said Rajiv De Silva, President and CEO of Endo. Under the terms of the merger agreement, an affiliate of Endo will promptly commence a tender offer to acquire all of the outstanding shares of NuPathe’s common stock for USD 2.85 per share in cash and the right to receive contingent cash consideration payments of up to USD 3.15 per share if specified net sales milestones for NuPathe’s migraine treatment ZECUITY are achieved.
Mylan Buys Rights of Novel LAMA Respiratory Compound from Pfizer Mylan Inc has received all regulatory approvals and has completed an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialise a novel long-acting muscarinic antagonist (LAMA) compound for various indications. Mylan expects that this product, which is ready to enter Phase IIb, will be submitted to the US FDA for approval as a new chemical entity, and expects the product to benefit from long-term patent protection in the US through 2029. Mylan CEO Heather Bresch commented, “This acquisition further expands Mylan’s growing respiratory franchise, building upon the products we already have in development, such as our generic Advair programme and our combination product for the treatment of chronic obstructive pulmonary disease (COPD). By adding a novel LAMA compound to our capabilities, we will have the opportunity to bring additional combination products to market, including triplecombination therapies, and further differentiate Mylan as a leader in this important therapeutic area.” Mylan will have exclusive commercialisation rights for this compound in the US, Canada, Australia, the EU and European Free Trade Association countries, India and Japan. In the rest of the world, Mylan and Pfizer will have co-promotion rights to the product. All other financial terms and product details remain confidential. Pharma Bio World
04-01-2014 14:10:34
Novogen, Cornell University to Jointly Develop Brain Cancer Drug Novogen Limited, an oncology drug development company, announced the signing of a Sponsored Research Agreement with Cornell University. The Weill Cornell Medical College (WCMC) in New York will become the cornerstone of a collaboration across Europe, US, Asia and Australia involving universities and biotechnology companies seeking a treatment capable of delivering long-term remission for the main form of primary brain cancer, glioblastoma multiforme (GBM). The research programme is focused on the super-benzopyran drug, Trilexium (Trx). The brain cancer programme parallels that of the Company’s efforts in the area of ovarian cancer through its joint venture, CanTx Inc, with Yale University. CanTx has identified a Trilexium derivative (Trx-1) as having equipotent killing ability of both ovarian cancer stem cells and ovarian cancer somatic cells, raising the prospect for the first time of being able with the one agent to kill the full hierarchy of cells within an ovarian cancer. The CanTx strategy is to bring Trx-1 into the clinic in the near-term as a generic treatment for late-stage ovarian cancer, but then to use the Trx pharmacophore to create a panel of drugs capable of killing ovarian cancer cells with specific genotypes, a further unique feature of this technology platform.The brain cancer programme has the same R&D and commercial objectives. The near-term goal is to bring Trilexium into the clinic as a generic treatment for GBM that has failed to respond to Temozolomide, the only drug approved for GBM. The longer-term goal is to identify a panel of drugs capable of providing a personalised approach to GBM chemotherapy.
The transaction will consolidate worldwide ownership of the diabetes business within AstraZeneca leveraging its primary and specialty care capabilities and its geographical reach, especially in emerging markets. The agreement reinforces AstraZeneca’s long-term commitment to patients with diabetes, a core strategic area and an important platform for returning AstraZeneca to growth. Based on the anticipated timing of the close, the transaction will have no impact on AstraZeneca’s guidance for Core EPS for 2013. The company expects the transaction when implemented to be neutral to Core EPS in 2014. AstraZeneca reaffirms its commitment to its progressive dividend policy. AstraZeneca intends to finance the transaction from existing cash resources and short-term credit facilities. AstraZeneca and Bristol-Myers Squibb anticipate that subject to local consultation and legislation, approximately 4,100 Bristol-Myers Squibb employees dedicated to the diabetes business, including those at Amylin, will eventually transition to AstraZeneca. Over time, AstraZeneca will also become responsible for the manufacturing and supply chain of the full portfolio of diabetes products. Bristol-Myers Squibb will continue to deliver specified clinical trials in line with the ongoing clinical trial plan. A number of R&D and manufacturing employees dedicated to diabetes will remain with Bristol-Myers Squibb to progress the diabetes portfolio and support the transition for these areas. The transaction is subject to customary terms and conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to become effective in January 2014.
Glenmark Launches Hydrocortisone Astrazeneca to Acquire Bristol-Myers in US Squibb’s Global Diabetes Business Glenmark Pharmaceuticals Ltd. said its US subsidiary Glenmark AstraZeneca announced an agreement under which AstraZeneca will acquire the entirety of Bristol-Myers Squibb’s interests in the companies’ diabetes alliance for an initial consideration of USD 2.7 billion on completion and up to USD 1.4 billion in regulatory, launch and sales-related payments. AstraZeneca has also agreed to pay various sales-related royalty payments up until 2025. In addition, AstraZeneca may make payments up to USD 225 million when certain assets are subsequently transferred.
Generics inc. had exclusively launched Hydrocortisone Butyrate cream USP, 0.1 percent in the United States. The company obtained the US FDA approval for Abbreviated New Drug Application (ANDA) for its generic version of Locoid Lipocream on September 27, 2013.
Upon completion of the transaction, AstraZeneca will own intellectual property and global rights for the development, manufacture and commercialisation of the diabetes business, which includes Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin HCl extended release), Komboglyze (saxagliptin and metformin HCl), dapagliflozin (marketed as Forxiga outside the US), Byetta (exenatide), Bydureon (exenatide extended-release for injectable suspension), metreleptin and Symlin (pramlintide acetate).
Hydrocortisone Butyrate cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age.
Pharma Bio World
Final Pharma News.indd 55
Glenmark is entitled to 180 days of exclusivity with respect to its Hydrocortisone Butyrate cream, as it is the first generic company to file an ANDA for the product.
According to IMS Health data, Hydrocortisone Butyrate cream generated annual sales of around USD 36.8 million for the twelve months ended September 2013. December 2013 55
04-01-2014 14:10:34
Lupin Introduces Generic Fenofi bric Acid Capsules Pharma Major Lupin Limited’s US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has launched its generic Fenofibric Acid DelayedRelease Capsules 45 mg and 135 mg. Lupin had earlier received final approval from the US FDA for the same. Lupin’s Fenofibric Acid DelayedRelease Capsules 45 mg and 135 mg are the generic equivalent of AbbVie Inc.’s Trilipix Delayed� Release Capsules 45 mg & 135 mg strengths are indicated as coadministration therapy with statins for the treatment of mixed dyslipidemia, treatment of severe hypertriglyceridemia and primary hypercholesterolemia or mixed dyslipidemia. Trilipix Delayed Release Capsules 45 mg & 135 mg strengths had annual US sales of approximately USD 449.5 million (IMS MAT Sep, 2013). Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, AntiInfective and NSAID space and holds global leadership positions in the AntiTB and Cephalosporin segment.
“Solta’s leading aesthetic devices are a natural fit with Valeant’s facial injectables, professional skin care products and physician dispensed products and will establish Valeant in a strong leadership position as we continue to build our presence in the aesthetic market. Moreover, this transaction will further enhance our ability to offer dermatologists and plastic surgeons the most comprehensive aesthetic product offering,” stated J Michael Pearson, Chairman and Chief Executive Officer of Valeant. Under the terms of the agreement, Valeant will commence a tender offer for all outstanding shares of Solta at a price of USD 2.92 per share in cash. The tender offer will be conditioned on the tender of a majority of Solta’s shares calculated on a diluted basis, as well as the receipt of regulatory approval and other customary closing conditions. Following the completion of the tender offer, a wholly owned subsidiary of Valeant will merge with Solta and the outstanding Solta shares not tendered in the tender offer will be converted into the right to receive the same USD 2.92 per share in cash paid in the tender offer. Solta’s Board has unanimously approved the transaction. Piper Jaffray & Co. acted as financial advisor to Solta and Fenwick & West LLP acted as legal advisor to Solta. Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Valeant.
Sandoz’s Airflusal Forspiro Gets Valeant Pharma to Buy Solta Medical Danish Marketing Nod
J Michael Pearson Chairman, CEO Valeant
Valeant Pharmaceuticals International, Inc has entered into a definitive agreement under which Valeant will acquire all of the outstanding common stock of Solta Medical, Inc for USD 2.92 per share in cash, which represents a 40 per cent premium to Solta’s closing share price on December 13, 2013, the last trading day prior to announcement, or a transaction value of approximately USD 250 million.
The transaction is expected to close in the first quarter of 2014 and Valeant expects the transaction, once completed, to be immediately accretive to Valeant’s cash earnings per share. Solta designs, develops, manufactures, and markets energy-based medical device systems for aesthetic applications. Solta’s products include the Thermage CPT system that provides non-invasive treatment options using radiofrequency energy for skin tightening, the Fraxel repair system for use in dermatological procedures requiring ablation, coagulation, and resurfacing of soft tissue, the Clear + Brilliant system to improve skin texture and help prevent the signs of aging skin, and the Liposonix system that destroys unwanted fat cells resulting in waist circumference reduction. Solta had total revenue of approximately USD 145 million in 2012. 56 December 2013
Final Pharma News.indd 56
Sandoz has received Danish marketing authorisation for AirFluSal Forspiro, an innovative new inhaler for patients with asthma and/ or chronic obstructive pulmonary disease (COPD). The Danish approval follows the completion of EU decentralised procedures (DCP) for eight EU countries, including Denmark. AirFluSal Forspiro offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative new inhalation device. The product’s safety, efficacy and equivalence have been proven in multiple clinical trials. Denmark has approved both mid and high-strength dosage forms (50-250μg and 50-500μg) for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. AirFluSal Forspiro was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz’ global respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura, a respiratory product development company, in the design and development of the product. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany. In order to improve patient experience with inhalation devices, Sandoz collaborated closely with patients during the development of AirFluSal Forspiro. Pharma Bio World
04-01-2014 14:10:35
AcelRx, Grunenthal Join Forces for EU Commercialisation of ZALVISO AcelRx Pharmaceuticals, Inc and Grunenthal GmbH have entered into a commercial collaboration, covering the territory of the European Union, certain other European countries and Australia for ZALVISO (previously known as ARX-01) for potential use in pain treatment within or dispensed by a hospital, hospice, nursing home or other medically supervised setting. ZALVISO, a drug-device combination product utilising the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device is AcelRx’s lead programme. AcelRx retains all rights in remaining countries, including the US and Asia.Under the terms of the agreement, AcelRx will receive an upfront cash payment of USD 30 million. AcelRx is eligible to receive approximately USD 220 million in additional milestone payments, based upon successful regulatory and product development efforts and net sales target achievements. Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-teens up to the mid-twenties per cent range, on net sales of ZALVISO in the Grunenthal territory. Grunenthal will be responsible for all commercial activities for ZALVISO, including obtaining and maintaining pharmaceutical product regulatory approval in the Grunenthal territory. AcelRx will be responsible for maintaining device regulatory approval in the Grunenthal territory and manufacturing and supply of ZALVISO to Grunenthal for commercial sales and clinical trials.
Sanner GmbH Presents New Pharma Packaging Design Concepts Sanner GmbH reinforces its expertise and market leadership in desiccants and gives an overview of its in-house engineering at Pharmapack Europe in Paris. Following a recent strategic repositioning, the packaging specialist now focuses on the pharmaceutical, medical technology and healthcare industries. This includes the expansion of the six product categories and the expertise for customised solutions. In the Effervescent Packaging category, Sanner presents new design concepts for tube packaging of effervescent tablets. The company further emphasizes its position as the Asian market leader in Test Strip Packaging. The Pharma & Medical Packaging section highlights options for packaging development which are made possible by Sanner’s structured in-house engineering process. Sanner also presents exemplary solutions for Eye Care and Ready-to-Fill Syringes at Pharmapack. The main focus of Sanner’s Pharma Bio World
Final Pharma News.indd 57
booth is on Pharma Desiccant Packaging. In this segment, Sanner introduces product solutions for capsules, sachets and tablet packaging. Pharma Desiccant Packaging, Test Strip Packaging and Effervescent Packaging all have one thing in common: Sanner’s industry-leading expertise in desiccant integration. The optimum coordination of closures and tubes or containers ensures that Sanner’s complete packaging solutions achieve an extremely high density. To maximize product shelf-life and enable usage in different climate zones, Sanner integrates the exact amount of required desiccant. This reduces weight and lowers costs and achieves positive results regarding sustainable material usage. The desiccant is either integrated into the closure or attached to the bottom of the package, thus meeting the key criteria of pharmaceutical manufacturers. Exemplary solutions demonstrate how modern and user-friendly packaging can be manufactured with fewer single components. At the same time, the packaging can easily be introduced into the filling process prior to closing, resealing and convenient repacking. Thus Sanner packaging solutions support simple and fast processes and reduce production costs.
Daiichi Sankyo Espha Introduces New Generic Drugs Daiichi Sankyo Espha, a Japanese generics subsidiary of Daiichi Sankyo Company, Limited, has launched two new generic drugs with two new active ingredients and two generic drugs with an additional standard. Valaciclovir tablets 500mg DSEP, an antiviral chemotherapeutic agent with the original brand name: Valtrex tablets 500; azithromycin tablets 250mg DSEP, a 15-membered-ring macrolide antibiotic with original brand name ZITHROMAC tablets 250mg. IT includes additional standard donepezil hydrochloride tablets 10mg DSEP and donepezil hydrochloride OD tablets 10mg DSEP, an anti-alzheimer’s agent with original brand names: Aricept tablets 10mg and Aricept D tablets 10mg. Daiichi Sankyo Espha has created innovative labeling on tablets and PTP sheets to prevent medical error and improve ease of use and hails these value added generics as “premium generics.” Tablets includes: printing on tablets (for valaciclovir tablets/ donepezil hydrochloride tablets, donepezil hydrochloride OD tablets). The product name, dosage per tablet and company name will be printed on both sides to be easily distinguishable, with a new inkjet printing method, it is now possible to print double-sided OD tablets as well. Daiichi Sankyo is working to improve medication adherence of OD tablets (oral dispersing tablets) through a dosage form design that reduces the bitter taste of the drug. December 2013 57
04-01-2014 14:10:35
biotech news DATRI Organises Blood Stem Cell Donor and Recipient Meeting
products in 2012 were pegged at ~USD 34 billion. The patent expiry of these products in regulated markets is expected from 2015 onwards.
Chennai-based NGO, DATRI Blood Stem Cell Donors Registry (DATRI), organised the meeting of the donor and recipient, of India’s first successful unrelated Blood Stem Cell transplant facilitated by an Indian registry. One year old Pranathi Gondu was diagnosed with Acute Lymphocytic Leukemia (ALL) in January 2011 and doctors treating her in CMC Vellore suggested that they go for a blood stem cell transplant. CMC approached DATRI to search for a donor in their registry. In one of the donor drives conducted by DATRI, Sadineni Venkateshwara Rao from Khammam had registered as a volunteer donor. He was found to be an uneralted genetic match for Pranathi. After the necessary medical tests, he donated blood stem cells in June 2011 during a 4 hour outpatient procedure in the blood bank at Apollo Specialty Hospitals, Chennai. CMC Vellore completed Blood Stem Cell transplant for Pranathi in July 2011. Pranathi started recovering and now has completed 2 years and 4 months after transplant. DATRI currently has more than 45,000 registered volunteer donors.
In another development, Biocon Ltd and Quark Pharmaceuticals, Inc have entered into a Licensing & Collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeutics.
PBSC transplant is successfully used the world over to cure cases of Leukemia, Aplastic Anemia, Thalassemia, bone marrow dysplasia and other such disorders. Blood Stem cells for the transplantation are obtained from the bone marrow or peripheral blood by apheresis, donated by Tissue (HLA) matched donors or Umbilical Cord Blood. The goal of the transplant is to rebuild the recipient’s blood cells and immune system and hopefully cure the underlying ailment. In case a patient needs a transplant, there is only 25 per cent chance of finding a match within his family. However, 75 per cent of patients do not find a suitable donor in their family. In such cases there is a need to find an unrelated donor or a cord blood unit through the donor registries. With very few registered donors available in India, the possibility of finding a match for an Indian anywhere in the world is low.
Biocon, Mylan Get DCGI Nod for Biosimilar Trastuzumab Biocon Ltd has received Marketing Authorisation from the Drugs Controller General of India (DCGI) for its biosimilar Trastuzumab being developed jointly with Mylan, for the treatment of Her 2+ metastatic breast cancer. The biosimilar Trastuzumab will be marketed in India under the brand name of CANMAb by Biocon and is expected to be available to Indian patients in Q4 FY14. The global sales for Trastuzumab stood at ~USD 6.4 billion in 2012, while in India it recorded sales of ~USD 21 million. Since 2009, Biocon and Mylan have been co-developing a high value portfolio of Biosimilar monoclonal antibodies and complex biologics, comprising Trastuzumab, Pegfilgrastim, Bevacizumab, Adalimumab and Etanercept. The Innovator product sales of these 58 December 2013
Biotech News.indd 58
This collaboration will enable Biocon to co-develop, manufacture & commercialise QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets. Biocon will have access to Quark’s innovative and proprietary siRNA technology platform that can be leveraged for the development of novel therapeutics for various unmet medical needs.
Omeros’ OMS721 Gets Orphan Drug Designation Omeros Corporation has announced that OMS721, the company’s lead human monoclonal antibody targeting mannan-binding lectinassociated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the US FDA for prevention of complementmediated thrombotic microangiopathies (TMAs). TMAs, including atypical hemolytic uremic syndrome and thrombotic thrombocytopenic purpura, are a family of rare, debilitating and life-threatening disorders characterised by multiple thrombi (clots) in the microcirculation of the body’s organs, most commonly the kidney and brain. The lectin pathway, one of the principal complement activation pathways in the immune system, is thought to play a central role in the development of TMAs. By targeting MASP-2, OMS721 specifically blocks the lectin pathway. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2. Omeros is completing a Phase 1 study to assess the safety and pharmacokinetics of OMS721. As previously announced, at the highest subcutaneous dose administered to date in this study, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase 1 subjects are similar to those associated with efficacy in animal models of diseases, including TMA, linked to the lectin pathway. Omeros expects to report additional Phase 1 clinical data in early 2014. The Phase 2 clinical program evaluating OMS721 for the prevention of complementmediated TMAs is expected to begin in the first quarter of 2014. “We are pleased that the FDA has granted orphan drug designation for OMS721. The designation should accelerate the development of OMS721 and, given the limitations of current treatments for TMAs, we look forward to initiating our Phase 2 clinical programme next quarter,” stated Gregory A Demopulos, MD, chairman and Chief Executive Officer of Omerosg. Pharma Bio World
04-01-2014 14:12:13
Sanofi, Regeneron Collaborate with Jazz Pharmaceuticals to Acquire American College of Cardiology Gentium for USD 57.00 Per Share Sanofi and leading science-based biopharmaceutical company, Regeneron Pharmaceuticals, Inc have collaborated with the American College of Cardiology (ACC) which will focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is known to contribute to circulating lowdensity lipoprotein cholesterol (LDL-C) levels. Alirocumab is being co-developed by Sanofi and Regeneron. Under the terms of the agreement, the ACC will apply its expertise in clinical research and utilise its extensive registries to identify patients who might be appropriate candidates for the phase III ODYSSEY OUTCOMES clinical trial. This Data Driven Trial Recruitment Programme is a new approach to identification and recruitment of patients for the clinical trial. Additional activities under the collaboration include a comprehensive educational program for both physicians and patients with the goal to broaden knowledge and understanding of the value of clinical trial research. “This project represents another example of how medical registries can help transform medicine,” said Ralph Brindis, pastpresident of the ACC and senior medical officer of External Affairs for the National Cardiovascular Data Registries (NCDR). “The ACC’s registries and related provider networks support quality improvement programs for practitioners. For the first time, through our PINNACLE ambulatory office-based registry of the NCDR, we will be helping to solve the difficult problem of identifying physicians with patients who may be eligible for a clinical trial.” “Through this collaboration, we hope to provide better access to our phase III ODYSSEY OUTCOMES Trial,” said Jay Edelberg, MD, Ph.D. vice president, PCSK9 Development and Launch Unit, Sanofi. This is the first time that ACC’s PINNACLE Registry will be used for clinical trial recruitment, and we believe this novel approach will help trial sites meet and hopefully exceed their recruitment goals.” ODYSSEY is the global phase III trial programme for investigational compound alirocumab. ODYSSEY currently comprises at least 12 clinical trials enrolling more than 23,000 patients with hypercholesterolemia in 2,000 study centers across North and South America, Europe, Australia, South Africa and Asia. The trials will evaluate alirocumab in combination with other lipid-lowering agents or as monotherapy across a broad patient population, including high cardiovascular risk patients with primary hypercholesterolemia, patients with primary hypercholesterolemia unable to tolerate statins, and patients with heterozygous familial hypercholesterolemia (HeFH) who are inadequately controlled by current lipid-modifying therapy. Pharma Bio World
Biotech News.indd 59
Bruce Cozadd Chairman, CEO Jazz Pharmaceuticals
Jazz Pharmaceuticals plc and Gentium SpA have entered into a definitive agreement pursuant to which a subsidiary of Jazz Pharmaceuticals will make a cash tender offer of USD 57.00 per share for all outstanding Gentium ordinary shares and American Depositary Shares, in a transaction that is valued at approximately USD 1 billion.
Gentium is a biopharmaceutical company focused on the development and manufacturing of therapies to treat and prevent a variety of rare diseases and conditions that currently have few or no treatment options, including orphan vascular diseases related to cancer treatments. In October 2013, the European Commission granted marketing authorisation for Defitelio (defibrotide), the company’s lead product, for the treatment of severe hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation.
Evotec, Yale University to Collaborate on Cancer Therapy Evotec AG has announced a research collaboration, TargetDBR (DNA Break Repair), with the laboratories of Prof Peter Glazer and Prof Ranjit Bindra at Yale School of Medicine. The objective of this collaboration is to identify novel mechanisms, targets and compounds that have the potential to interfere with DNA repair. DNA repair mechanisms allow cancer cells to cope with extensive genome rearrangements as well as to escape conventional radioand chemotherapy and thus have potential applications in many cancer indications. This is the first collaboration to be announced as part of Evotec’s open innovation alliance with Yale University. TargetDBR is based on systematic cell screens designed to identify DNA repair inhibitors and their mechanisms of action. The application of Evotec’s high-content cellular screening platforms allied to chemoproteomics-based target deconvolution will enable the identification not only of novel DNA repair inhibitors but also of novel tractable targets in DNA repair pathways. The initial focus will be on increasing the effectiveness of glioblastoma brain tumour treatments but it is expected that the DNA repair inhibitors will also find application in many other cancer types. Yale and Evotec will collaborate in a highly integrated fashion and share potential commercial rewards. December 2013 59
04-01-2014 14:13:00
ProBioGen Extends Deal with Emergent BioSolutions ProBioGen announced that it has signed an agreement with Emergent BioSolutions for a non-exclusive commercial multiproduct license and option agreement under which Emergent will be granted broad access to ProBioGen’s avian AGE1.CR cell line. Previously, ProBioGen had granted an exclusive license to Emergent for four indications and also conducted process development work for Emergent. As a result of the new agreement, ProBioGen’s relationship with Emergent is now extended to include additional infectious disease targets, with the option to expand to numerous further indications. The commercial licenses include milestones and royalty payments. Financial details were not disclosed. Volker Sandig, Chief Scientific Officer noted: “Innovative medicines against infectious diseases are urgently needed. We are convinced that the combination of ProBioGen’s AGE1.CR® cell line for production of MVA-based vaccines together with Emergent’s product development, manufacturing and marketing expertise will yield novel preventive and therapeutic products.” AGE1.CR is an immortalised cell line derived from primary cells of a Muscovy Duck. The cell line was created as a platform for replacing primary chicken cells for production of vaccines and hyper-attenuated viruses in chemically defined media and suspension cultures. In addition, AGE1.CR cells are also suitable for the generation of trans-complementing helper or packaging cell lines to support efficient production of replication-restricted viral vectorsg.
Biogen Idec, Samsung Bioepis Sign Marketing Deal Biogen Idec and Samsung Bioepis have announced that through their joint venture, Biogen Idec has exercised its right to enter into an agreement to commercialise anti-TNF biosimilar product candidates in Europe, including biosimilars for widely used therapies to treat conditions such as rheumatoid arthritis and Crohn’s disease. Under the agreement, Biogen Idec will be responsible for commercialisation of these product candidates across Europe, where there already exists a strong market for biosimilars and a defined regulatory pathway. The agreement with Samsung Bioepis aligns with Biogen Idec’s broader corporate objectives of remaining focused on its core business, while leveraging its expertise in manufacturing and specialty markets to meet the need for biosimilar therapies. 60 December 2013
Biotech News.indd 60
“This is a unique opportunity for us to leverage our experience in developing and manufacturing high-quality biologics in therapeutic areas where we are deeply focused, and provide medicines to patients where there is a significant societal need,” said Tony Kingsley, executive vice president of global commercial operations for Biogen Idec. “As a company that aims to make a difference in the lives of patients with serious diseases, we are excited by the potential to offer additional highly effective therapies in critical areas where there is growing demand.” “Biogen Idec has been an innovative joint venture partner in Samsung Bioepis and now with this agreement we are excited to extend our relationship into commercial operations,” said Christopher Hansung Ko, PhD, CEO of Samsung Bioepis. “Samsung Bioepis has established a global commercialisation plan for its antibody drugs currently under development, and we believe this agreement will further serve as a solid foundation for Samsung Bioepis to develop into a worldwide biosimilar leader.”
OPKO to Expand Latin American Presence OPKO Health, Inc has entered into an agreement to acquire Laboratorio Arama de Uruguay Limitada (Arama). Domiciled in Montevideo, Uruguay, Arama will add to OPKO’s growing South American presence in the important Mercosur economic region while further complementing our business activities in Chile, Mexico and Brazil. The transaction is expected to close in January 2014. This purchase is consistent with OPKO’s strategy of acquiring small, growing pharmaceutical companies which provide a platform to commercialise existing and future OPKO products while enhancing commercial synergies among our various units. “We continue to broaden our commercial prospects through investments that complement our existing businesses and bolster the global reach of our robust product pipeline,” said Phillip Frost, MD, Chairman and CEO of OPKO. “This acquisition will allow OPKO to establish a footprint in Uruguay and facilitate future sales and commercial expansion into neighboring Argentina. In the near term, Arama provides another platform for the commercialisation of our 4Kscore, a novel panel of biomarkers and associated algorithm to more accurately detects and grade possible prostate cancers.” OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialisation expertise and novel and proprietary technologies. Pharma Bio World
04-01-2014 14:13:22
Fluid Bed Dryers Aero Therm Systems Private Limited, Ahmedabad, Gujarat, offers fluid bed dryers with batch capacity of 15 kg to 500 kg. The digital temperature indicator controller will give accurate temperature control. Control action of this fluid bed dryer can be On-Off or PID. Construction of dryer can be made of MS/aluminium/SS-316/ SS-304 as per the requirement. Flame-proof and spark-proof versions is also available. Heating can be electrical/thermic fluid or steam radiator/oil fired hot air generator.
For more information, please contact: Aero Therm Systems Pvt Ltd Plot No: 1517, Phase III, GIDC Vatva, Ahmedabad Gujarat 382 445 Tel: 079-25890156, 25834987, Fax: 91-079-25834987 E-mail: contact@aerothermsystems.com
Gravity Feed Metal Detector Gravity feed metal detector - Model metaltrap03, from Technofour Electronics Private Limited, Pune, Maharashtra, is an eddy current based digital metal detection system designed for pharmaceutical, chemical and food industry for detecting metal contamination in powder and granules. The rejection mechanism used in this gravity feed metal detector of Technofour Electronics Private Limited, Pune, Maharashtra, is pneumatically operated cowbell type diverter as it is foolproof and allow product containing large lumps to be checked without danger of blockage.
For more information, please contact:
Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT), Kasurdi (Kheba), Khed ShivapurSaswad RoadOpp: Hotel Yogiraj Resort, Post: Khed Shivapur, Tal: Bhor, Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246, Fax: 91-02113-305250 E-mail: sales@tepl.co.in
Centrifugal Air Blower / Fan Vacunair Engg Co Pvt Ltd, Ahmedabad, Gujarat offers highly efficient centrifugal air blower/fan with new concept in fan engineering. Selection is from 9 types ranging from 14 to 40 and each type have sizes for specific requirement and different specific speed for best efficiency. It is possible to design the fan or synchronise the speed for direct drive arrangement with best efficiency. It can handle air/hot flow gases/corrosive gases/dust/fiber/powder material, etc. Blower/fan are available for impeller mounted on motor shaft/direct coupled/veebelt drive. Impeller has backward/back inclined/forward curve type design with construction welded/riveted selected base on required application. Impellers are balanced as per ISO 19401973 (E) Class G 6.3. Blower/fan can be designed in single stage/multi-stage/DWDI type depending upon required specification. Blower/fans are available in capacity ranging from 100 to 300,000 m3/hr and pressure up to 2,500 mm WG. For more information, please contact: Vacunair Engg Co Pvt Ltd Nr Gujarat Bottling, Rakhial Ahmedabad, Gujarat 360 023 Tel: 079-22910771, Fax: 91-079-22910770 E-mail: info@vacunair.com
Pharma Bio World
final product.indd 61
December 2013 ď&#x201A;&#x201E; 61
04-01-2014 14:17:16
Water Storage and Distribution Hydropure Systems, Mumbai offers water storage and distribution system. In order to meet the PW and WFI quality objectives, the US FDA recommends generation of PW and WFI where and when required. However, with growing demand, bigger plant sizes and layouts for pharmaceutical and biotech industries, it is increasingly becoming difficult to generate PW and WFI where and when required. Hydropure Systemâ&#x20AC;&#x2122;s high purity water storage and distribution systems are designed to store and distribute PW and WFI water to various user points maintaining the generated water quality.
Capsule Polishing & Dedusting Machine This machine is an advance dedusting and polishing tool in production of capsules. Combination of cGMP design and other engineering features for most efficient method of polishing makes it easier to clean and maintain. The flexibility innate in the machine results in high efficiency and cleanliness which can be incorporated into any existing production line. Features modest design and assembly for quick change of both separator net and polishing elements at the time of product changeover with minimum use of tools; variable frequency drive allows polishing time to be changed to match your production output requirements; and tilting assembly to match your various types of formulation.
For more information, please contact:
For more information, please contact:
Hydropure Systems 412 Diamond Estate Off WE Highway, Dahisar (E), Mumbai 400 068 Tel: 022-28978725, 28979097 E-mail: info@hydropure.in
Allegro Pharmachem Equipments Unit No: 18, Param Indl Estate, Naik Pada, Waliv, Vasai ( E), Dist: Thane, Maharashtra 401 208 Tel: 022-40146872, Fax: 91-022-40146874 E-mail: allegro@allegroindia.com
Steam-in-Place Connectors As part of a single use system, these disposable connectors enhance the sterility of your bioprocessing line. The innovative product design allows for a one-step process for sterilization and media transfer the need for a laminar flow hood. Terminations on these connectors are set to industry standards for bioreactors and are available in popular sizes of flexible tubing. All wetted surfaces meet requirements for USP Class VI, MEM elution, hemolysis in vitro and physicochemical tests. All units are made of animal-free medical grade polysulfone. Choose from two designs, the original Steam-Thru Connection and Steam-Thru II. The original Steam-Thru connectors feature a three-port design that allows steam to pass directly through the power ports to steam on to stainless equipment. Once the SIP cycle completed, remove the tear-away sleeve to actuate the valve and create a sterile flow path. Once actuated, the connection cannot be reversed because valve actuation punctures the internal membrane to allow flow of media. When the process is complete, the connector may be safely disposed. The Steam-Thru II connectors offer the additional benefit of both steam on and steam off functionality. The valve can return to the steam position to allow a second steam cycle after media transfer. For more information, please contact: Cole-Parmer India Pvt Ltd 403-404 B-Wing, Delphi Hiranandani Business Park, Powai, Mumbai 400 076 Tel: 022-67162222, Fax: 91-022-67162211 E-mail: info@coleparmer.in
62 ď&#x201A;&#x192; December 2013
final product.indd 62
Pharma Bio World
04-01-2014 14:17:48
Rotary Vane Vacuum Pump WOOVAC – WSVP 9000 Series double stage oil sealed rotary vane vacuum pumps are manufactured in collaboration with Woosung Vacuum Co Ltd of South Korea. The pumps are compact in design and offer consistent guaranteed high vacuum with very low input power and offer faster pump down time. The advanced pump design incorporating twin cylinders and components made of high quality specially graded raw materials ensure high thermal stability and superior performance. The pumps are manufactured to operate in the most stringent environment and do not require any external or forced cooling due to their low temperature use. WOOVAC pumps offer a higher degree of vacuum as compared to other pumps currently being manufactured in India. For more information, please contact: Indo Vacuum Technologies Pvt Ltd 20 Anupam Indl Estate No: 3 LBS Marg, Off Malviya Road Mulund (W), Mumbai 400 080 Tel: 022-25613336, 32923010, Fax: 91-022-25613335
Integrated Cleaning Solutions Clean-in-place is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly. The benefit to industries that use CIP is that the cleaning is faster, less labour intensive and more repeatable and poses less of a chemical exposure risk to people. CIP started as a manual practice involving a balance tank, centrifugal pump and connection to the system being cleaned. CIP has evolved to include fully automated systems with programmable logic controllers, multiple balance tanks, sensors, valves, heat exchangers, data acquisition and specially designed spray nozzle systems. The steam-in-place system responsible for repeatedly steaming areas of product contact including vessels, flow paths and sample parts. This may be done to reduce the bio burden on the system or to kill harmful materials at the end of a batch. Nilsan Nishotech Systems SIP system ensures and controls steam temperature, pressure and/or flow to ensure adequate steaming. For more information, please contact: Nilsan Nishotech Systems Pvt Ltd W-199 E, MIDC, Khairne Thane Belapur Road, Navi Mumbai 400 705 Tel: 022-41515151,Fax: 91-022-41515150 E-mail: info@nilsan-nishotech.com
Extruders STEER displays a versatile 40 mm Mega Special Plus extruder with new technology to utilize full motor power of 160 kW at screw speeds of 625, 750, 1,000 and 1,200 rpm. The Mega Special Plus shares the general purpose Do/Di of 1.55 with earlier MEGA models, with the added features of a continua shaft for improved safety and reliability apart from the availability of STEER proprietary line of conveying and mixing elements. In addition STEER offers OMICRON 12. This machine will process RESOMER (PLGA Polymer), an EVONIK brand product. OMICRON 12 PHARMA co-rotating twin-screw laboratory extruder is specially designed for pharma industry. The ability of this hot melt extrusion system is to generate outstanding dispersive and distributive mixing. It can produce material at an extremely low output rate, which helps in lowering the cost of development of new products. STEER’s Alpha and OMEGA line of extruders features a process section with a Do/Di of 1.49 and 1.71 respectively. Both extruders have the tightest and most optimized screw to screw gaps in the industry. The result is a lower shear signature during processing and enhanced product quality due to narrowed residence time distribution. For more information, please contact: STEER Engg Pvt Ltd 290, 4th Main, 4th Phase, Peenya Indl Area Bengaluru, Karnataka 560 058 Tel: 080-23723309, Fax: 91-080-23723307 E-mail: info@steerworld.com
Pharma Bio World
final product.indd 63
December 2013 63
04-01-2014 14:17:48
events diary BANGALORE INDIA BIO
QbD in PHARMA Development
Dates: 10-12 February 2014 Venue: The Lalit Ashok, Bangalore
Dates: 24-25 th February 2014 Venue: Ramada Powai Hotel and Convention Centre, Mumbai
Bangalore INDIA BIO is an annual event organised by Department of IT, BT and S&T, Government of Karnataka, under the guidance of Vision Group on Biotechnology, an apex advisory body comprising of members from Government, Public and Private Sectors including Industry and Academia. Since 2001, Bangalore INDIA BIO has been instrumental in promoting the inherent strength of the Indian Biotech Industry to the outside world and is now acknowledged as the biggest and India’s National event on Life Sciences. The focal theme of Bangalore INDIA 2014 is “Biotech for a better tomorrow”.
The event is especially designed to discuss the implementation case studies, success stories and issues and challenges faced while implementing QbD principles at industry level.
th
Contact: Event Secretariat MM ACTIV Sci-Tech Communications 9, UNI Building, Thimmaiah Road Millers Tank Bund, Vasanthnagar Bengaluru 560 052 Tel +91-80-41131912/13 Email: enquiry@bangaloreindiabio.in
BioAsia 2014 Dates: 17-19 th February 2014 Venue: Hyderabad International Convention Centre (HICC), Hyderabad Research and surveys unveil that future NEXT is BIO, showcasing immense opportunities for Bio-business. The global economy, tomorrow, revolves around Bio-innovations & hence the 11 th edition of BioAsia shall unveil promising Lifescience-innovations and offer excellent opportunity for new business ideas. Be a part of BioAsia 2014, the future-driving bio-business platform to Discover & Deliver Tomorrow, Today. Contact: BioAsia Secretariat 204, B-Block, Imperial Apartment Greenlands circle, Ameerpet, Hyderabad -500016 Tel: +91 40 66446477/6577 Email: info@bioasia.in 64 December 2013
Events.indd 64
It will offer definitive benefits to the scientists from academia and industry working in the domains of Product Development, Process R&D, Scale-up, Manufacturing, Quality Assurance, Global Regulatory Affairs, API, Excipients, Pharmaceutical Analysis and Technology Transfer. The speakers will articulate on all the pertinent areas of QbD Implementation including API, Analytical Development, Excipients and Formulation. Contact: Select Biosciences India Pvt Ltd SCO 28, 29,30 Sector 9 D Chandigarh 160009 Tel: +91-9814412082/9041725050 Email: india@selectbio.com
4th Annual Vaccine World Summit 2014 Dates: 4-6th March 2014 Venue: Hyderabad
The Vaccine World Summit is the most sought after vaccine conference for India and rest of the developing country manufacturers. The Summit will be the definitive meeting place for vaccine industry players to come together to establish and renew partnerships to help develop new products, acquire new technologies, and establish new relationships. Contact: Chamindika Konara Tel: +65 6493 2097 Email: chamindika.konara@imapac.com Pharma Bio World
04-01-2014 14:18:47
bookshelf Pharmaceutical Packaging Technology [Hardcover] Authors: D A Dean (Editor), E R Evans (Editor), I H Hall (Editor) Price: USD 433.70 No of pages: 646 pages About the Book: Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.
Pharmaceutical Packaging Handbook [Hardcover] Author: Edward Bauer Price: USD 170.95 No of Pages: 350 pages About the Book: Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods. Complete and straightforward, the book lists information in an easy to follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.
Pharma Packaging Innovations Author: Sandeep Kumar Goyal Price: USD 2.78 No of pages: 81 pages About the Book: This publication comes after the success of Ideas & Opportunities 2013 held on 19 th July 2013 in India. Various innovations were presented during the one day workshop by the expert consulting team of Sanex packaging Connections Pvt Ltd popularly known as Team PackagingConnections. Idea behind this is to bring the innovations to wider group of professionals to meet the mission of packaging knowledge sharing and that too cost effectively. This publication will further fill the project pipelines of companies and improve the standards of packaging. Many professionals either do not have the access or time to go through so many innovations together. This publication will fill that gap.
Pharma Bio World
Bookshelf.indd 65
December 2013ď&#x201A;&#x201E; 65
04-01-2014 14:19:36
ad index Sr No
Client’s Name
Page No
1
Arctic Sales (Bry-Dry)
2
B & R AUTOMATION
3
Bhavya Polymers
4
Chemtech World Expo 2015
5
Citizen Industries
6
Cole Parmer
Inside Cover
7
CRI PUMPS
Inside Cover II
8
Emjay Engineers
31
9
Gardner Denver Engineered Products India Pvt Ltd
10
10
HRS Process Systems Ltd
11
11
Karnavati Engineering Ltd
13
12
Kevin Enterprises Pvt Ltd
5
13
M K Silicone
33
14
Markem-Image India Pvt Ltd
21
15
NNE Pharma Plan
16
Pharma World Expo 2015
17
Rittal India Pvt Ltd
18
Schmersal India Pvt Ltd
19
SDK Engineers & Traders
31
20
Steer Engineering Pvt Ltd
17
21
Technofour Electronics Pvt Ltd
19
22
Warade Automation Solution Pvt Ltd
66 December 2013
Ad Index.indd 66
33 Front Cover 35 Inside Cover I 25
26 & 27 Back Cover 15 9
7
Pharma Bio World
07-01-2014 10:37:50
december ads.indd 27
06-01-2014 18:42:28
R.N.I. No.: MAHENG/2002/08502. Date of Publication: 1â&#x20AC;&#x2122;st of every month. Postal Registration No: MH/MR/SOUTH-284/2011-13 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 68
Back cover.indd 15
07-01-2014 11:22:01