Express Pharma (Vol.12, No.11) April 1-15, 2017

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‘We have to create an ecosystem where companies are encouraged to constantly pursue next generation products’

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CONTENTS

ROOTING OUT RUBELLA: MAKING ITMISSION POSSIBLE

Vol.12 No.11 April 1-15, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product

WORLD IMMUNIZATION WEEK APRIL 24-30, 2017

MARKET

Undeterred by challenges, the government is pulling out all stops to eliminate rubella from the country by 2020 | P22

Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua

PHARMA LIFE

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‘WE HAVE TO CREATE AN ECOSYSTEM WHERE COMPANIES ARE ENCOURAGED TO CONSTANTLY PURSUE NEXT GENERATION PRODUCTS’

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5TH ANNUAL PHARMA PROJECT MANAGEMENT CONFERENCE HELD IN MUMBAI

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DRUG DILIGENCE 2017 HELD IN COIMBATORE

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PHARMATECH EXPO TO BE HELD IN CHANDIGARH

MANAGEMENT

RESEARCH

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April 1-15, 2017

EDITOR’S NOTE

US-India relationship: Can it trump the odds?

A

ffordable and efficient healthcare systems is listed out as an area chosen for “Growing Convergence, Collaboration & Cooperation between United States and India” in a blog post dated March 14 on the US-India Business Council website.

In his speech on the same day to the Council, George Sibley, Acting Deputy Chief of Mission, US Embassy New Delhi criticised India’s recent decision to add coronary stents to India’s National List of Essential Medicines (NLEM). He cautioned that the US is concerned that “these types of actions send a worrisome signal that India is not in fact fully open for business. Worse, however well-intended the action, this may ultimately result in limiting patients’ access to the latest technologies.”

Sibley suggested that a better path forward would be to allow more trade of the two countries' respective healthcare products. He pointed out that the US is India’s number one export destination, buying more than 15 per cent of its exports of goods and approximately 60 per cent of its service exports.

“India is the number one supplier of generic medicines to the US and more than 80 per cent of the medicine consumed in the US is generic. So India’s exports truly benefit Americans and save American lives. By the same token, growing America’s exports can provide significant benefits to India, and I hope to see trade growing in both directions in the future.”

Speaking in the presence of CK Mishra, Health Secretary, Ministry of Health and Family Welfare, Sibley mentioned how the USFDA’s close engagement with Indian drug regulatory authorities, manufacturers and stakeholders was not to obstruct Indian access to the American market. He hoped they could work towards “a similar win-win ... collaborative model on medical devices here in India in the near future.”

Trade diplomacy is fully of such carrots and sticks, threats and promises. The US interest and

According to industry estimates, imports from MNCs across the world, including US companies, make up more than 70 per cent of India’s stent market

posturing is understandable as India is a huge market. According to industry estimates, imports from MNCs across the world, including US companies, make up more than 70 per cent of India’s stent market.

On the same day of the blog post and Sibley's speech, the Ministry of Chemicals and Fertilizers re-stated that it was mandatory for hospitals to issue detailed bills to patients, separately disclosing the cost of heart stents. The Ministry also advised state governments and state drug controllers to exercise their powers under Para 30 of the DPCO, 2013 to check artificial shortage of stents. Thus is it very evident that the government is not backing down.

Two days later, on March 16, the cabinet approved the National Health Policy 2017 (NHP 2017), in which the government is clear that there has to be engagement with the private sector. As Jagat Prakash Nadda, Minister of Health and Family Welfare says, "While the policy seeks to reorient and strengthen the public health systems, it also looks afresh at strategic purchasing from the private sector and leveraging their strengths to achieve national health goals." And lest there be any doubt, the Minister spells it out, "In order to provide access and financial protection, it proposes free drugs, free diagnostics and free emergency and essential healthcare services in all public hospitals."

The US will continue to put pressure to counter some of these moves. End April should see the release of this year's United States Trade Representative (USTR) Special 301 Review, in which India is sure to make it, once again, to the Priority Watch list. Can PM Modi soften the stance of President Trump’s administration during his slated visit in May? Both leaders have their own constituencies to play to and finding a win-win situation seems difficult ... but not impossible.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

‘We have to create an ecosystem where companies are encouraged to constantly pursue next generation products’ According to a white paper by Sathguru Management Consultants in association with CII on vaccines, India is at the cusp of a new era in vaccines as there is a need for self-financing of immunisation programme in the near future. Pushpa Vijayraghavan, Director, Sathguru Management Consultants, in an interaction with Viveka Roychowdhury, says that there is significant scope to make the pathway for vaccines more efficient

Why have traditional big Indian pharma players not entered the vaccines segment? Do you see some late entrants and if so, what are the triggers for this interest?

India has historically nurtured greater strength in chemistry as compared to biotechnology.

All biotechnology ventures have been dwarfed by larger pharmaceutical companies, not just in India but even in the global landscape. It is more so in India given the chemistry dominance.

The vaccine industry has been largely composed of

Indian biotech companies (such as Serum Institute of India, Bharat Biotech, Shantha Biotech) and a very few pharma companies with a common interest in biotechnology (Panacea and Biological E) and multinationals with global presence in vaccines (MSD, Sanofi, Pfizer et al).

The industry grew to approximately $1 billion in 2015 with a robust CAGR of 25 per cent between 2011 and 2015. As the industry grew in size, it has attracted attention of larger Indian pharma companies and continues to do so. For instance, Lupin has been

marketing certain MSD vaccines for the Indian market and Wockhardt has been importing and marketing the varicella vaccine. The more recently announced marketing collaboration between Cipla and Serum Institute brings together notable segment leaders from the Indian vaccines and pharma ends.

Amid this landscape of pharma companies that have engaged in marketing efforts and collaborations, Zydus Cadila stands out as one of the pharma companies which has invested more deeply in the segment with an extensive focus on

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product development and pipeline, manufacturing and markets. Zydus Cadila also enjoys an R&D edge, given the backbone of platform technologies and research strength gained through the acquisition of Etna Biotech (an Italian company), Crucell’s vaccine R&D arm. Aurobindo Pharma has also entered the segment through a strategic investment in a pioneering vaccine venture, Tergene Biotech. Given the significant growth potential, we perceive that such interest from cash rich market pharma companies will only expand.

MARKET

The Sathguru paper says, ''Focus on strong technology foundation has been the key enabler for success of the Indian vaccine industry and we would like to highlight the criticality of ensuring this strength is intensified in an appropriately rewarding ecosystem.' What kind of incentives would you recommend?

To ensure sustained competitiveness, we have to create an ecosystem where companies are encouraged to constantly pursue next generation products and enjoy technology-led global market leadership. This calls for attention to several elements: a. Larger quantum of nondilutive funding for R&D and product development so that certain amount of technology de-risking can be accomplished (common in EU and US where

extra mural grants amounts are more substantial). b. R&D tax breaks and fiscal incentives that are globally benchmarkable c. Rewarding private markets without the threat of price control. Crosssubsidisation is important in vaccines where public health supplies are at extremely affordable pricing. All vaccines covered under UIP are provided free of cost to all citizens and this negates the need to swing the sword of price control as a threat on vaccine companies d. Efficient public procurement system so that there is greater market maturity in national procurement systems and reward for innovation is easier to realise for Indian companies.

What are the regulatory

changes required to eliminate technology gaps and accelerate path to market for vaccines produced by Indian companies?

There is significant scope to make the pathway for vaccines more efficient. Facilitating an accelerated commercialisation pathway is critical for companies to realise value on their investments as well as for the government to be able to procure important life-saving vaccines from Indian companies.

As of now, all vaccines are classified as new drugs even if they are follow-on products to currently approved vaccines.

There are multiple agencies involved in the regulatory process and the overall timeline for product approval is very stretched. For instance, through the CII position paper, we were able to highlight the

inputs from the responding companies that on an average, waiting period for joint site inspections has been about four to six months and a similar range of waiting period for Form 29 issue has also been indicated.

'Indian UIP has been supported by GAVI since 2002.

India begins its transition towards self-financing its vaccine programme from 2017 and GAVI has recently announced funding support of $500 million for the period 2017-2020 after which India will completely graduate out from GAVI support. In order to actualise the set immunisation goals in the near term, in the base case scenario, the government spend on immunisation needs to be increased three fold.'

How will the Indian

government fund the UIP post 2020?

Once India graduates from GAVI support, the entire immunisation programme will be funded by national funding. In this context, it is encouraging to note that the recently approved National Health Policy 2017 reflects the intent to raise healthcare funding to 2.5 per cent of GDP. What have been the outcomes so far of Mission Indradhanush?

As per the ITSU immunisation dashboard, the nation’s full immunisation coverage stood at 87 per cent as at December 2016. The effort is ongoing but substantially higher attention is required in areas beyond routine immunisation strengthening health systems, continuous cold chain infrastructure etc.

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April 1-15, 2017

MARKET If Made in India vaccines would be an affordable option, how come scale-up capital and funding support of substantial quantum for vaccine developing companies is still lacking?

Where will this shortfall come from?

The shortfall is currently met by industry as well as philanthropic funding from global sources as well as global procurement agencies.

The challenges is hardest on companies developing complex and high investment pipeline products and especially younger ventures.

The capital intensive and rather long product development cycle implies that no ventures will be able to cross the valley of death unless the funding gap is bridged.

What is your opinion on the

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Inclusion of vaccines in NLEM is unwarranted and a deterrent for industry investments. Creating the looming threat of price control only serves as a negative message to the industry that freedom of pricing in private markets could also be curtailed vaccines that are included and should be included in the UIP? How should this choice be made?

Beyond pneumococcal conjugate vaccine (PCV) and inactivated polio vaccine (IPV), the Government has already announced that HPV will also be included in UIP. It is important we ensure HPV inclusion is done in a timely manner and IPV is expanded to three doses on UIP (vs the one dose currently announced). Beyond these, it is important we create a

robust and responsive surveillance system to identify emerging infectious disease threats and proactive protect against them to reduce impact of epidemics. Dengue could merit consideration if there are more effective vaccines developed. Additionally, campaign vaccination for cholera warrants consideration. Lastly, as stipulated in the NHT 2017, it is important we have strong programmes to protect against zoonotic diseases, an emerging and looming threat.

How are vaccine makers impacted by the pricing regime as they are included in the NLEM? The inclusion of vaccines in NLEM is unwarranted and is a strong deterrent for industry investments. The core objective of the NPPP of ‘ensuing availability of required medicines at reasonable prices’ doesn’t apply to vaccines given a specific programme for universal vaccination, the UIP. Under the UIP, all citizens have free access to vaccines

included in the programme.

Hence, the concern of access doesn’t arise in the case of vaccines and private markets largely cover discretionary vaccines (six-in-one, varicella, meningitis etc) are haven’t been considered by the Government as high public health priorities. All Indian companies supply vaccines for the UIP at very nominal prices based on government tendering process. The private market provides cross-subsidisation opportunity and financial sustainability to the industry.

Creating the looming threat of price control is unnecessary and only serves as a negative message to the industry that freedom of pricing in private markets could also be curtailed. In a high-capex industry such threats serve as severe investment deterrents. viveka.r@expressindia.com

MARKET POST EVENTS

5th Annual Pharma Project Management Conference held in Mumbai The two-day event threw light on diverse facets and challenges of project management through a conference - workshop model THE 5TH Annual Pharma Project Management Conference was recently held in Mumbai.

Hosted by CPhI Conferences, a division of UBM India, the event saw pharma industry professionals from across the country congregate to discuss and exchange knowledge on various aspects of project management.

Eminent speakers like Sanjay Bhanushali, International Business, Cipla; Cynthia Shafer, Associate Director - Project Management, Novartis; Sangbreeta Moitra, Corporate Speaker & Storyteller, Find The Speaker Within; Subbu Parameswaran, CEO, Learning Curve Life Skills Foundation; Bishnu Mohanty, Head Global Project Management, Alkem Lab; Rajaram Iyer, VP, Mankind Pharma; Shibasish Pramanik, Head of I&D India, Abbott; Abhishek Gupta, Director & Head - RDI, AstraZeneca; Ramakrishna Kasichainula, Associate Director, Dr Reddy’s Laboratories and Varada Bapat, Head - Project Management, Wockhardt, amongst others addressed the audience at the two-day conference.

Through a conferenceworkshop model, pharma project management experts covered pivotal topics such as ensuring successful delivery of projects, critical challenges faced by the project managers in the pharma industry such as risk management and budget management, global perspectives on project management, strategies for resource planning and management etc.

The experts at the conference also highlighted the cru-

cial role played by pharma project management for complex processes involved in drug and device development.

They also demonstrated the ability of effective project management to achieve sig-

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nificant impact in development of drugs and medical devices within shorter timescales. They also presented a comparative analysis between pharma project management and project

management in other industries. Case studies which demonstrated the practical aspects of handling projects for better execution and timely delivery of projects were also part of the two-day

event, followed by Q&A sessions.

The event also offered network opportunities galore to exchange ideas and form future alliances.

EP News Bureau

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April 1-15, 2017

MARKET

Drug Diligence 2017 held in Coimbatore Discussions were held about the importance of pharmacovigilance DR YK GUPTA, Professor & Head of the Department of Pharmacology at All India Institute of Medical Sciences (AIIMS), New Delhi, who is also the National Scientific Coordinator of the Pharmacovigilance Programme of India (under the Ministry of Health & Family Welfare, Government of India) inaugurated Drug Diligence 2017, a national level conference and workshop on pharmacovigilance was recently organised in Coimbatore on account of the fifth anniversary of Oviya MedSafe – a Coimbatore and London-based organisation providing global pharmacovigilance consulting and drug safety services to the pharmaceutical industry. The conference was organised and conducted by Coimbatore-based event management firm VHEO Ventures in knowledge partnership with Oviya MedSafe. More than 250 delegates, most of them being doctors and pharmacists attended the conference.

Dr Gupta was the Chief Guest and delivered a keynote address on ‘Evolution of Pharmacovigilance in India’. In his address, he spoke about different stages of drug development including molecular modelling, animal studies and phases of clinical trials and further explained how adverse drug reactions can be identified and reported to drug regulatory authorities. He briefed about periodic safety update reports and signal detection. He elucidated on how benefit-risk balance of a medicinal product is assessed and answered the question on why India is using drugs which are banned in many other countries. Apart from sharing his perspectives on the overall safety of medicinal products, he highlighted that there is tremendous scope and lots of job opportunities in this field of pharmacovigilance taking up which means genuine service to the mankind.

Dr N Shanthi, Professor & Head of the Department of Pharmacology, Coimbatore

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Medical College, Coimbatore was the Guest of Honour. In her address, she said that if the mind knows the eyes will see. She encouraged the students to get oriented with pharmacovigilance and choose it as a career opportunity. She expressed pride that Dr Vijay was her student and she appreciated him for taking the lead in promoting academia-

industry collaboration in pharmacovigilance, which is much needed for advancing the science further.

Indu Nambiar, Senior Manager - Local Pharmacovigilance, Boehringer Ingelheim India, Mumbai, shared her perspective about the importance of having a robust pharmacovigilance system in place. She highlighted

that the continuous improvement is the key for keeping quality in the drugs and pharmacovigilance plays a major role in enabling the product quality, which serves the general public in patient safety. She recalled her interactions with Dr Vijay on various professional forums about pharmacovigilance issues in India and appreciated his ef-

forts in bringing together industry pharmacovigilance professionals for a dialogue with various policy-makers which is anticipated to result in more clarity on pharmacovigilance aspects and regulations for every stakeholder.”

Vasumathi Sriganesh, Honorary CEO, QMed Knowledge Foundation, Mumbai offered her felicitation. She highlighted the fact that how pharmacovigilance as a discipline is a significant component of patient safety measures and encouraged students to take up the opportunity of learning and practise pharmacovigilance. She emphasised the fact that the expertise in publishing and searching medical and scientific literature for information on adverse drug effects in the right manner is very important for medical and pharmaceutical industry professionals alike, as such literature is both a source and outlet of safety data.

She expressed immense happiness at Oviya MedSafe’s growth in the discipline of pharmacovigilance in balance with their passionate scientific pursuit for Patient Safety.

Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe, spoke about the journey of Oviya MedSafe. He remarked that Oviya MedSafe has addressed the knowledge and affordability deficit in the pharma industry in terms of pharmacovigilance services.

The function ended with the vote of thanks proposed by Dr CJ Arun Raja, Orthopaedic Surgeon at KTVR Group Hospital and Director of Oviya MedSafe.

A paper presentation contest for medical and pharmacy students was conducted on the theme of ‘Pharmacovigilance’, as part of Drug Diligence 2017. The winners and participants were awarded by the dignitaries in the valedictory function held at the end of the day. The event had been awarded 20 CME Credit Points by the Tamil Nadu Dr MGR Medical University under Category III. EP News Bureau

MARKET PRE EVENT

PharmaTech Expo to be held in Chandigarh The event from April 11-13, 2017 will see participation from over 3000 plus visitors THE 5TH edition of Pharma Tech Expo will be held in Chandigarh from April 11-13, 2017. More than 300 pharma companies are going to participate in the event apart from 125 exhibitors. The event will see participation from over 3000 plus visitors. LabTech expo will be concurrently held with the main event. The event will have a special focus on Ayurveda and nutraceuticals, cosmoceuticals, track and trace and vision inspection.

The event will have a special focus on Ayurveda and nutraceuticals, cosmoceuticals, track and trace and vision inspection PharmaTech Expo 2017 is a premier event dedicated to

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pharmaceutical innovation, technology and knowledge. It

has been emerged as a crucial platform for showcasing the latest innovation and technologies throughout all phases of the product lifecycle, focussing pharma manufacturing and processing technology, pharma systems and services. This year the focus will be on Nutraceutical, Food & Cosmeceuticals, and Ayurveda. Various kinds of high tech pharma machinery, lab and packaging equipment will be on display.

The previous events man-

aged by PharmaTechnologyIndex.com – PharmaTech Expo 2011,2013, 2015 and 2016 which were held at Indore and Ahmedabad have showcased the cutting-edge technologies in industrial expo in Pharmaceutical industry have gained immense interest from pharma companies and manufacturers all over the world.

Express Pharma is the media partner for the event.

EP News Bureau

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EVENT BRIEF APRIL TO SEPTEMBER-2017 11

PharmaTech Expo 2017

PHARMATECH EXPO 2017 Date: April 11-13, 2017 Venue: Parade Ground, Sector – 17, Chandigarh Summary: The 5th Edition of PharmaTech Expo 2017, an international exhibition on pharma machinery, lab and packaging equipment, will see a common platform for suppliers, manufacturers, industrialists, buyers and consultants. This year the focus will be on nutraceutical, food and cosmeceuticals and ayurveda. The event will be concurrently held with LabTec expo 2017.

More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display. With more than 5000 trade visitors took part in last year's event.

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Respiratory Drug Delivery (RDD) Europe 2017

Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

RESPIRATORY DRUG DELIVERY (RDD) EUROPE 2017 Date: April 25-28, 2017 Venue: Palais des Congrès d’Antibes, Nice, France Summary: RDD Online and Aptar Pharma will organise RDD Europe 2017, an event in the Respiratory Drug Delivery field in Europe. It will bring together pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise, and also provide a

3

dynamic forum for expanded opportunities for business networking. RDD Europe 2017 will feature podium sessions and debates, scientific poster sessions, technology exhibition and workshops sessions.

Academics, industrial and regulatory scientists involved in the research, development, investigation will take part in the event.

Contact details Joanne Peart: info@rddonline.com

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track &

PharmaTech Expo 2017

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Trace’ Expo 2017. This year, the focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display.

Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

INDIA LAB EXPO 2017/ ANALYTICAANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo,

India Lab Expo 2017/ analytica Anacon India

India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India.

Contact details MMI India INIZIO 507 & 508, 5th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 info@mmi-india.in

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18

EXPRESS PHARMA

April 1-15, 2017

MARKET GROWTH TRACKER

IPM valued at ` 9,032 crores in Feb 2017 Domestic companies continued to dominate the market with a 78 per cent share in MAT February 2017 with a growth of 10 per cent THE INDIAN Pharmaceutical Market (IPM) was valued at ` 9,032 crores in the month of February 2017 reflecting a growth of 3 per cent. On a MAT February basis, the industry was valued at ` 113,474 crores and reflected a growth of 9 per cent which was slightly lesser than 10 per cent growth of January 2017 MAT. Retail sector was valued at ` 7,603 crores with a growth of 3 per cent SPLY for the month of February 2017. The retail channel remained the largest channel in IPM contributing 84 per cent of the overall sales and reflected a 9 per cent growth on MAT Basis. The hospital and doctor channel contributed to 10 per cent and 6 per cent of the overall sales and reflected 8 per cent and 11 per cent growth respectively. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space. As per QuintilesIMS data which captures sales from trade stockists, more than 10 Therapy Areas in the IPM have already crossed a sale of ` 500 crores in the hospital segment and reflect healthy growth. Vaccines reflected de-growth on account of supply issues with key players in the market.

IPM continued to remain fragmented with top 10 companies occupying 43 per cent share. While top 10 companies grew at 10 per cent collectively, 11-20 companies reflected subdued growth at 8 per cent over previous year for the month of February 2017. Among the top 10 companies, five companies showed a double digit growth: Sun Pharma and Mankind Pharma grew at 11 per cent, Alkem grew at 12 per cent while Lupin and Macleods both grew at 13 per cent each.

TOP 150 COMPANY SNAPSHOT

The top 150 companies continue to account for 97% of IPM on MAT and month basis For the month,Top 10 companies have reflected stronger performance over the next category of companies while the highest growth is in the companies ranked between 31-40

● ●

Source: QuintilesIMS TSA & SSA, Feb 2017

TOP 40 BRANDS

Mixtard continues to be the top brand with a MS of ~0.5% Novomix and Janumet have grown by 52% and 74% in Feb 2017 ● Other brands with remarkable growth are Spasmo Proxyvon +, Duphaston, Pan D and Gluconorm-G ● ●

Source: QuintilesIMS TSA & SSA, Feb 2017

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EXPRESS PHARMA

19

April 1-15, 2017

MARKET Glenmark grew fastest among the 11-20 companies at 15 per cent followed by Aristo at 14 per cent.

Domestic companies continued to dominate the market with a 78 per cent share in MAT February 2017 with a growth of 10 per cent. MNCs on the other hand reflected a growth of 7 per cent for the MAT. Large MNCs like Abbott, GSK and Pfizer which contributed around 57 per cent of the total MNC share in the MAT reflected growths of 9 per cent, 4 per cent and 1 per cent respectively. GSK’s new launch Enteroplus (LACTOBACILLUS RHAMNOSUS) clocked a value of ` 90 lakhs in two months of launch.

Acute therapy remained the strongest pillar of IPM with a 64 per cent contribution to the total market which reduced from 67 per cent in the month of October 2016.

Acute therapy continued to reflect a slowdown with a 1.2 per cent growth for the month of February 2017. Chronic therapy area on the other hand outpaced acute therapy reflecting a growth of 6.4 per cent for the month.

Cardiac continued to be the largest therapy area for the month, clocking a revenue of ` 1088 crores. Amlodipine + Telmisartan (14 per cent), Telmisartan + HCT (11 per cent), Olmesartan (9 per cent) were among the fastest growing cardiac molecules for the month while Atorvastatin (-19 per cent), Amlodipine (-17 per cent) and Telmisartan (-12 per cent) were among the top molecules which reflected degrowth.

Anti-infectives retained its number two slot for the month with a value of ` 1070 crores.

Seven out of top 10 molecules reflected de-growth for the month. Amoxyclav solids (-4 per cent), Ceftrixone injection (-20 per cent), Cefixime solids (-14 per cent) and Azithromycin solids (-10 per cent) were among the top molecules reflecting de-growth.

Gastrointestinals continued to be the third largest therapy area for the month garnering a revenue of ` 953 crores with a 4 per cent

20

EXPRESS PHARMA

April 1-15, 2017

TA SALES IN HOSPITAL SEGMENT (IN INR CRORES) Anti-infectives

1,946

Cardiac

5%

1,190

Gastro Intestinal

9%

959

Pain / Analgesics

10%

843

Neuro / CNS Vitamins / Minerals / Nutrients Gynaec.

Anti Diabetic

9%

688

12%

673

11%

657

14%

648

15%

Respiratory

537

5%

Vaccines

512

-4%

TABLE 1: PHARMA MARKET SIZE IN MILLION $ USD BY COUNTRY All values in Million USD

January Month

Month Growth per cent

MATJanuary

MAT growth per cent

Global Pharma Mkt

85004

-15.4

1058245

3.8

US

34031

-23.97

450044

4.5

CHINA

7249

8.48

74628

-8.9

GERMANY

6527

1.7

40815

4.9

JAPAN

5613

-19.11

79767

8.6

BRAZIL

3552

-3.77

22011

14.2

FRANCE

2838

3.9

32282

1.3

ITALY

2407

5.69

27384

1

INDIA

2388

-1.95

15386

5.7

VENEZUELA

1861

-46.46

21504

69.6

UK

1829

-1.11

23592

-8

SPAIN

1787

-29.22

20153

-0.6

CANADA

1644

4.38

19204

1.1

AUSTRALIA

938

-16.17

13217

21.8

RUSSIA

886

-35.68

112956

-6.6

MARKET growth over SPLY. Dicyclomine combinations reflected a 35 per cent growth for the month. Pantoprazole + Domperidone and Rabeprazole + Domperidone continue to be the largest molecules in the segment reflecting a 15 per cent and 9 per cent growth respectively.

Anti-diabetics maintained its fourth position in IPM for the month of February 2017 clocking a growth of 15 per cent over SPLY. DPP4 inhibitors were the largest drug category in the anti-diabetic space with Teneligliptin contributing 21 per cent of the category by value. Seven out of top 10 molecules showed an impressive double digit growth, four out of them reflected a growth above 20 per cent: Glim + Met + Vogli combination (33 per cent), DPP4 inhibitors (28 per cent), Glime + Met (24 per cent) and SGLT2 inhibitors (138 per cent). Jardiance and Forxiga drove the spectacular growth of SGLT2 (138 per cent), each grew individually at 225 per cent and 52 per cent respectively for the month.

Dermatology, one of the fastest growing therapy areas in IPM registered the growth of 15 per cent SPLY for the month, with a value of ` 652 crores. Anti-fungals and Itraconazole (107 per cent) reflected highest growth among top categories with emollients continuing to dominate the therapy area with a value of ` 77 crores for the month.

Neurology reflected a 4er cent growth for the month over SPLY, Levetiracetam continued to be the largest molecule in the space clocking a value of ` 42 crores with a 12 per cent growth for the month. Oxcarbazepine reflected a healthy 17 per cent growth with a value of ` 17 crores for the month.

ACUTE AND CHRONIC THERAPY TRENDS

Source: QuintilesIMS TSA & SSA, Feb 2017

TABLE 2: INDIAN COMPANY’S MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

January Month

Month Growth per cent

MATJanuary

MAT growth per cent

Indian Pharma Market Globally

1233

5.6

15386

5.7

SUN PHARMA

103195

10.7

1243220

7.2

ABBOTT

78776

5.8

986065

5.4

CIPLA

67010

5.3

794630

4.2

MANKIND PHARMA

46052

5.7

585107

8.2

LUPIN LABORATORIES

42193

12.1

503559

9.2

GLAXOSMITHKLINE

41986

5.2

498573

0.8

ZYDUS CADILA

41313

1.6

532566

1.9

MACLEODS PHARMA

38601

2.3

496915

9.5

INTAS

35915

6.4

433288

7

ALKEM

35589

4.3

478145

7.6

Global (January 2017) The global pharma market is valued at $1051 billion growing at 3.8 per cent. The US continues to dominate the market with 42 per cent market share with growth of 4.5 per cent.

Amongst the top market, India has moved a position up

and is ranked seventh in the month of January 2017. Only market which has shown value growth more than 5 per cent in the month of January globally is China in the Top 15 markets. Critical observation

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to be made in the month of January is; US, Japan, Venezuela, Spain, Australia and Russia have shown more than 15 per cent de-growth.

Indian companies hold 1.5 per cent share in the global

market and growing faster than the global market as per January 2017 data. For the month of January 2017, the IPM showed growth and all Top 10 companies showed growth.

(QuintilesIMS is a leading global information and technology services company providing end-to-end solutions to the life sciences and healthcare industry)

EXPRESS PHARMA

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April 1-15, 2017

cover )

ROOTING OUT RUBELLA: MAKING IT MISSION POSSIBLE The government needs to quash fears about safety of the rubella vaccine and establish its efficacy to achieve its goal of eliminating the disease by 2020

BY PRATHIBA RAJU

22 EXPRESS PHARMA April 1-15, 2017

(

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THE MAIN FOCUS

EXPRESS PHARMA

23

April 1-15, 2017

cover)

T

he Union Health Ministry is leaving no stone unturned to eliminate and control congenital rubella syndrome (CRS) by 2020, a disease that causes birth defects such as irreversible deafness and blindness in nearly 40,000 children every year. In a bid to eradicate the rubella virus and achieve success as in the case of polio and maternal and neonatal tetanus, the health ministry has launched a concerted, nation-wide measles-rubella vaccination (MR-VAC) campaign for children aged between nine months and 15 years.

However, phase-1 of the campaign which covers Karnataka, Tamil Nadu, Goa, Puducherry and Lakshadweep has encountered a roadblock in the form of a controversy. There is a rumour going around through Whatsapp messages, SMS alerts, text and AV clips on social media forums that the vaccine is banned in the US as it causes serious side effects which include damaging a child’s immunity and memory. It is being pushed in India by the global pharma industry which is looking for a market to dump substandard products.

However, the Ministry remains undeterred in its course. Claiming that the government faces these hurdles each time a new vaccination campaign is launched, Dr Pradeep Haldar, Deputy Commissioner (Immunisation), Union Ministry of Health says, “During the polio vaccine campaign, we faced a similar kind of situation where people had a mistrust on the immunisation programme. Whenever the government has a targeted eradication campaign and tries to reach the last mile on a targeted time frame such an issue arises. But the government is well prepared to overcome these challenges. However, now they are bigger as the size of the number of children to be covered is three times more than what we did for polio programme. We are covering from children aged from nine months to 15 years.”

Haldar gives further clarity on the action plan against the disease and says that the government included the rubella vaccine in the Universal Immunisation Programme in 2014. Until then, only private hospitals and clinics offered immunisation against rubella through the MMR vaccine. The government is now introducing the MR-VAC against measles and rubella, which will replace the measles vaccine that only protects against measles, in a phased manner across several states.

T Jacob John, Chairman of India Ex-

24 EXPRESS PHARMA April 1-15, 2017

Serum Institute of India is the only manufacturer of MR vaccine. From 1996 to 2016, one billion doses have been distributed globally till now. The quality of vaccines which we supplied helped to eradicate measles and rubella globally which ever country which has introduced it SUNIL BAHL, Director, Business and Regulatory Affairs, Serum Institute of India

During the polio vaccine campaign, we faced similar kind of situation where people had a mistrust on the immunisation programme.

Whenever the government has a targeted eradication campaign and tries to reach the last mile on a targeted time frame such issues arise.

But the government is well prepared to overcome these challenges DR PRADEEP HALDAR,

The first phase of the campaign vaccinating more than 35 million children in the age group of nine months to 15 years with MR (measles and rubella) vaccine demonstrates India’s commitment to improve health and wellbeing of its people by protecting children against vaccine preventable diseases Dr Poonam Khetrapal Singh WHO Regional Director for South-East Asia

Deputy Commissioner (Immunisation), Union Ministry of Health

pert Advisory Group on Measles and Rubella Elimination explains the rationale behind the move and says, “Elimination means absence of indigenous transmission of the causative virus in a large defined population, such as a country.

Eradication is global level elimination.

India’s measles elimination goal is part of the goal of global measles eradication.

Measles elimination requires the tactical use of immunisation to achieve near100 per cent immunity in all children.

When measles vaccine is given, the opportunity to piggyback rubella vaccine is obvious. Therefore, measles-rubella (MR) vaccine is being rolled out by the Universal Immunisation Programme.”

A noteworthy effort Fortunately, the programme has garnered support as well from various quarters. Terming that India’s measlesrubella vaccination campaign is a big step towards reducing childhood mortality and addressing birth defects, Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia says, “The first phase of the campaign is

significant as it is expected to accelerate the country’s efforts to eliminate measles also marks the introduction of rubella vaccine in India’s childhood immunisation programme to address CRS which causes birth defects such as irreversible deafness and blindness in nearly 40000 children every year. The campaign covering a total of 410 million children across the country over the next two years, is a truly remarkable, world-beating effort. Apart from improving the life-chances of millions of children in India, the campaign is expected to have a substantial effect on global measles mortality.”

“The first phase of the campaign vaccinating more than 35 million children in the age group of nine months to 15 years with MR (measles and rubella) vaccine once again demonstrates India’s commitment to improve health and wellbeing of its people by protecting children against vaccine preventable diseases,” states Dr Khetrapal Singh.

According to experts, most of the parents from the middle class who are reluctant to administer the vaccine into

When measles vaccine is given, the opportunity to piggyback rubella vaccine is obvious.

Therefore measlesrubella (MR) vaccine is being rolled out by the Universal Immunisation Programme T Jacob John Chairman of India Expert Advisory Group on Measles and Rubella Elimination

(

THE MAIN FOCUS

introduced it. For example, South America has totally eliminated the viral infection,” says Bahl. The Serum Institute of India has already supplied 45 million doses required by the government for phase I in Tamil Nadu, Karnataka on time. The institute will be supplying nearly 150 million doses for the second phase, informs Bahl.

Thus, the central and the state government in India, global health agencies and renowned doctors are trying to dispel the myths over MR-VAC shots and help expand immunisation coverage.

Strides to progress

their children should know that a single dose of the vaccination gives more than 95 per cent long-lasting immunity, which is similar to that induced by natural infection.

Allaying fears However, the rumours about the vaccine’s safety can derail the campaign and hence the government is taking measures to negate them. It informs that the vaccine is manufactured by the Serum Institute of India, the world’s largest producer of the vaccines. The health ministry also claims that MR-VAC is highly safe, immunogenic, efficacious and widely used across the globe.

Haldar explains, “There is a group of people against this vaccine and they have sent a negative message that it is a propaganda of sterilisation, which is false. The public should know that this vaccine is manufactured in India and in use since 40 years.” He also said that 47000 children die due to complications caused by measles. CRS affect nearly 40,000 children in the country and these complications can be

curbed through vaccination.

Trying to allay fears abut the vaccine’s safety, Sunil Bahl, Director, Business and Regulatory Affairs, Serum Institute of India clarifies, “The vaccine has been licensed since 1989 and WHO Geneva prequalifies a vaccine only after they do a quality assessment on the production and checking all the critical parameters. Since 2000, that is almost 17 years back, the vaccine has been prequalified by WHO for supplies to UN agencies. This vaccine is part of Routine Immunization (RI) in 50 countries in the world, which includes Africa, America, Europe, Western Mediterranean, South East Asia, Western Pacific and we have supplied the vaccine to 100 countries in the world for the past 10 years. From 1996 to 2016, one billion doses have been distributed globally till now.”

“We are the only manufacturer of this vaccine and we have been supplying the vaccine for a long time. The quality of vaccines which we supplied helped to eradicate the measles and rubella globally which ever country which has

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RIDDING RUBELLA: THE STORY SO FAR R

ubella, also called as German measles, is an acute, contagious viral infection which has been neglected in India, and its prevalence is less known. According to World Health Organization (WHO), children with CRS are likely to suffer from hearing impairments, eye and heart defects and other lifelong disabilities, including autism, diabetes mellitus and thyroid dysfunction – many of which require costly therapy, surgeries and other expensive care. The highest risk of CRS is in countries where women of childbearing age do not have immunity to the disease (either through vaccination or from having had rubella).

Before the introduction of the vaccine, up to four babies in every 1,000 live births were born with CRS globally.

The annual incidence of CRS in developing countries ranges from 0.4 to 4.3 per 1,000 live births. Globally, only Australia and four European countries — the Czech Republic, Slovakia, Slovenia and Sweden — have achieved a protective immunity of less than five per cent among women of childbearing age. CRS rates are highest in the WHO African and South-East Asian regions where vaccine coverage is lowest.

However, there are several global instances where immunisation programmes against rubella have been quite successful. Large-scale rubella vaccination during the past decade has practically eliminated rubella and CRS in many developed and in some developing countries.

Cuba declared the disease eliminated in the 1990s, and in 2004 the Centers for Disease Control and Prevention announced that both the congenital and acquired forms of rubella had been eliminated from the US. In April 2015, the WHO Region of the Americas became the first in the world to be declared free of endemic transmission of rubella.

Giving a rundown on the project's progress so far, Haldar informs, “We have covered 2.96 crore children out of our target of 3.48 crore. In Tamil Nadu, we have covered 1.35 crore out of 1.76 crore children, i.e. 77 per cent. In Karnataka, we have covered 1.55 crore children out of 1.65 crore children i.e. 94 per cent. In Goa, we have covered 3.08 crore children out of children 3.13 crore, i.e. 98 per cent.

In Lakshadweep out of 15000 children we have vaccinated 10,700 children, which is 69 per cent. Also, Puducherry out of three lakh children we have vaccinated 2. 37 children, i.e. 78 per cent. Overall, our vaccination coverage has been 55 per cent, we aim to cover atleast 95 per cent.”

Experts recommend that state health departments should address parental concerns about the vaccination though concerted efforts. They also emphasise on spreading awareness about the need to vaccinate children against rubella to protect them against complications which could be easily avoided. It is to be hoped that the government would be able to squash the rumours about the vaccine which is harming the campaign and make further strides in its goal to eliminate this health menace from the country. prathiba.raju@expressindia.com

EXPRESS PHARMA

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April 1-15, 2017

MANAGEMENT INSIGHT

Strict or stringent national regulatory authority for procurement of anti-tuberculosis medicines ?

John F Loeber,Chief Procurement Officer,UN Stabilisation Mission in Haiti (MINUSTAH) Port-au-Prince,Haiti,in this article examines the requirement of strict or stringent National Regulatory Authority (NRA) environments for procurement of anti-tuberculosis (TB) medicines,with specific focus on the World Health Organisation,United Nations Office for project services,Stop TB Partnership/Global Drug Facility and The Global Fund to Fight Aids,TB and Malaria

T

he Global Drug Facility (GDF) operates as the procurement arm of the Stop TB Partnership (TBP) Secretariat, hosted at the World Health Organisation (WHO), Geneva, Switzerland, from 2001 until 2014 and forthwith at the United Nations Office for Project Services (UNOPS).

The Stop TB Partnership is a network of some 1,300 governments, donors, industry, NGOs, academia and other partners, joined in the common fight against tuberculosis (TB)2. The TBP i.a. provides access for countries to quality assured, affordable anti-TB medicines via GDF. As of 2014 GDF has delivered medicines for 24 mn TB patients to 133 countries3 in 13 years of operation, financed by bilateral and multilateral donors such as USAID, The Global Fund to Fight Aids, TB and Malaria (GFATM) and UNITAID. GDF’s annual purchases of TB medicines amounted to about $200 mn in 20134, and the GFATM disbursed approximately $500 mn for TB in 20155.

Stringent NRA requirement A condition for procurement of anti-TB medicines by the GDF or its facilitation of direct procurement is that medicines are approved under the WHO Prequalification Programme6 or licensed for marketing by stringent National Regulatory Authorities (NRAs). This is established in the GDF Quality

26 EXPRESS PHARMA April 1-15, 2017

TABLE 1 ANTI-TB MEDICINES SOURCING ACCORDING TO GDF AND GFATM QA POLICIES Anti-TB Medicines Sourcing

WHO PQ Programme

Assurance Policy7. The same standard is applied by the GFATM8 as well as other financing institutions and procurement entities such as UNITAID9 and UNDP10.

On further examination, GDF and the GFATM define the term “stringent” as being a member, observer or associate of the International Council for Harmonisation (ICH)11. The ICH, founded in 1990, is an association which helps in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration12.

Current ICH regulatory members or associates are Brazil, Canada, the EU, Japan, South Korea, Switzerland and the US13. In regard to ICH members having newly acceded to the EU such as Cyprus, Lithuania, Malta, Poland and Latvia, the GDF Quality Assurance Policy principles additionally provide that “GDF will consult with relevant WHO experts on the progress

Stringent NRA

ERP Process

Member, Observer or Associate of the International Council for Harmonisation (ICH) in adjusting their pharma legislation to EU laws before recognising the approval by the national health authorities”14.

From 2015, a range of Regulatory Authorities joined the ICH as observers, namely Australia, Chinese Taipei, Cuba, India, Kazakhstan, Mexico, Russia, Singapore and South Africa 15. Both GDF’s and the GFATM’s Quality Assurance Policies, which antedate 2015, limit recognition to “an ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic, Health Canada and World Health Organisation (WHO) (as may be updated from time to time)”16. Despite the closing adjustment clause, given the significant development in ICH Observers and the generally restrictive nature of both organisations’ policies, including the specific formulation of this provision, referring mainly to associations and only

to one individual authority, moreover now an ICH “Standing regulatory member”17, it cannot be deduced that the nine new ICH observers are currently recognised as representing stringent regulatory environments. The conclusion must also be drawn in view of issuance of tenders for firstand second-line anti-TB medicines in October and February 2016 with reference to the unchanged GDF Quality Assurance Policy18. Hence apparent lack of sourcing from those countries on the basis of ICH observer status, as well as the absence of media releases to the contrary or other forms of clarification by the two organisations since 2015 on these significant developments at ICH. As a further qualifying option, according to the GDF Policy it will be sufficient that products are “approved or subject to a positive opinion under the Canada S.C. 2004, c. 23 (Bill

C-9) procedure, or Art. 58 of European Union Regulation (EC9 No. 726/2004) or US FDA tentative approval”19, i.e. interim approvals have been given by this set of countries/intergovernmental organisation. A next to identical regulation is found in the GFATM’s Quality Assurance Policy20.

In the event that none of the above requirements are met, GDF’s Quality Assurance policy then allows that “Products shall be found acceptable to the GDF through a quality risk/benefit assessment process involving an Expert Review Panel (ERP)”21. While this specific, exceptional process was managed by the GDF itself until 2009/2010, the ERP assessment was forthwith handled by the GFATM, in cooperation with GDF. The GFATM respectively refers to this process on its website and linked material22. Under this backup process, for which approvals are limited to a 12month period23, product submissions must be pending with either the WHO Prequalification Programme or a stringent NRA. Also, the product must have been produced at a manufacturing site that was inspected and found acceptable by either the WHO Prequalification Programme, a stringent NRA or a regulatory authority participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/S)24.

PIC/S was established in 1995 as an extension to the

TABLE 2 WHA RESOLUTION 62.15 OF 22 MAY 2009 Resolution WHA 62.15 on “Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis”of 22 May 2009 urged WHO Member States “to achieve universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis … by means of: (h) ensuring uninterrupted supply of first- and second-line medicines for tuberculosis treatment, which meet WHO prequalification standards or strict national regulatory authority standards”(Art. 1 (1) (h))

Pharmaceutical Inspection Convention (PIC) of 197025. There are currently 49 participating authorities (members) in PIC/S, including beyond the 10 founding members from EFTA the following new entrants from 2000: Argentina (2008), Chinese Taipei (2013), Hong Kong (2016), Indonesia (2012), Israel (2009), Korea (Rep. of) (2014), Malaysia (2002), New Zealand (2013), Singapore (2000), South Africa (2007), Thailand (2016) and Ukraine (2011)26.

In regard to accepting PIC/S, the GDF Quality Assurance Policy nevertheless contains a similar caveat as for the ICH, stating that “For any new PIC/s Member GDF will consult with relevant WHO experts on the level of equivalence of the GMP inspection level to those of old members PICs countries.”27

Strict NRA standard The above definitions, despite developments in recent years in expanding membership and observers of ICH and PIC/S, remain in stark contrast to a meanwhile long-standing respective resolution of 2009.

Resolution WHA 62.15 on Prevention and control of multidrug-resistant TB and extensively drug-resistant TB, adopted by the World Health Assembly (WHA) on 22 May 2009, urged Member States in its Art. 1 (1) (h)28: “to achieve universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis … by means of: (h) ensuring uninterrupted supply of first- and second-line medicines for tuberculosis treatment, which meet WHO prequalification standards or strict national regulatory authority standards” The particular wording “strict” instead of “stringent” in regard to NRA standards was agreed on as a compromise after debate among Member States lasting several days since the start of the WHA on 18 May 2009. Draft wordings on either end of the spectrum were put forward, favouring no specific qualification in referring to regulatory authority standards (China29), to maintaining the term “stringent” (US, Canada30). The discussion resulting in the term “strict” was driven i.a. by Thai-

land, supported by other developing and middle income countries. Finally, before closing of the WHA on 22 May 2009, the proposed wording “strict” was agreed upon for Resolution WHA 62.15.

While reaching agreement on the Resolution in the final session of the 2009 WHA31, the text nevertheless omitted to define the new term “strict”.

Though the change in terminology was recognised in the subsequent period in some discussions or on an individual level, there is no identifiable public record of formal attempts of stakeholders to capture or further specify the term32. It could e.g. have been expected that a Working Group of Experts had been established, deliberating on the term and advising on possible consequences. A risk-based categorisation scheme for procurement could have e.g. been an output from such Group, coupled with recommendations on supplementary needed quality control in procurement (pre-shipment inspection, sampling and laboratory testing, postdelivery monitoring and control). Similarly, proposals for simultaneous strengthening of national regulatory authorities which had thus been newly qualified for sourcing pharmaceuticals could have been made by the Group.

In this vein and/or as a consequence, since 2009 no principle change in approach in pharma procurement for TB medicines, in particular in respect of the applicable quality assurance policy, could be identified at WHO, the Stop TB Partnership/GDF, the GFATM or UNITAID. This appeared as a missed opportunity, as the change of terminology provided the chance to strengthen sourcing for TB, i.e. widening the supplier base. For such expansion, improved availability and lead times for pharmaceuticals as well as lower prices could regularly have been expected. This would have freed up funds to reach more patients, particularly for drug-resistant TB, and/or provide TB care or meet other related public health needs, for which there was continuous shortage of funds.

Considering the text of the WHA Resolution and taking into account the history of its drafting process and the

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EXPRESS PHARMA

27

April 1-15, 2017

MANAGEMENT achieved agreement among Member States after days of debate, WHA 62.15 appeared as a clear direction to view anti-TB medicines meeting strict national regulatory authority standards as being necessary and sufficient under technical and fair competition aspects in public procurement.

Fixing the broader term strict as a starting position, the WHA Resolution would then have the innate intent to expand procurement to forthwith include a next tier of advanced countries among the sources from which medicines could be purchased to treat TB. The positive development of additional members or observers recently joining ICH and PIC/S, after otherwise years of inaction by TB stakeholders, cannot replace or render WHA Resolution 62.15 obsolete in this regard. A dedicated examination of the Resolution’s meaning and its consequences remain indicated, identifying and closing gaps for implementation.

Moreover, as established above, it cannot be deduced that the regulatory authorities having joined ICH as Observers since 2015 indeed meet GDF’s and the GFATM’s definition of stringent Regulatory Authorities.

Additionally, the caveats contained in GDF’s quality assurance policy in ultimately in fact recognising new members as equivalent, i.e. reserving the right to disregard the status of such new entrants, is not systemic and appears unwarranted.

In considering contenders for such second-tier sourcing opportunities for TB medicines, aside from necessary regulatory, administrative and legislative assessments, annual pharma export volumes may serve as in indication. According to data published by The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)33, the following countries - whose national regulatory authorities are currently not ICH Members, Associates or Observers (nine new ones since 2015) - are among the leading pharmaceutical exporters in the world, with more than $500 million in

28 EXPRESS PHARMA April 1-15, 2017

annual sales:Argentina, China, Hong Kong, Israel, Jordan, Panama, Turkey34.

National regulatory authorities from these countries would therefore need to be examined with respect to their qualification as strict national regulatory authorities, or runner-ups thereto. Substantial potential sales in global supply markets for TB-medicines, worth several hundred million dollars annually36, are currently also not being realised due to this categorisation, particularly since nearly all TBmedicines are off-patent. Some advanced industrialised countries appear as clear contenders for procurement of TB medicines, particularly those already admitted to PIC/S. Progress in countries such as India and China in recent years to reach global standards has also been noteworthy. Furthermore, national regulatory authorities from countries with lesser sales, but nonetheless reputable regulatory systems may be considered under the new categorisation, such as Indonesia, Malaysia, New Zealand, Thailand, Ukraine, Vietnam and several countries in the Mediterranean region.

Under the existing quality assurance policies of the major TB medicines procurers considered herein, manufacturers from these next tier countries would be limited in qualifying their products under the WHO Prequalification Programme, applying/awaiting ICH Membership/Observer status, interim procedures with the Canada, EU, US regulatory authorities, or otherwise the exceptional ERP process. This raises also the political and diplomatic question whether manufacturers from these advanced countries can indeed be expected to submit dossiers under the WHO Prequalification Programme in order to be considered for anti-TB medicines procurement. This appears unlikely and could also be a reason why manufacturers from these countries are not widely seen engaging in the business of anti-TB medicines supply or investing in it.

Overriding institutional and functional concerns also raise general doubt on the approach

TABLE 3 COMPARATOR TABLE PHARMACEUTICAL SALES 2013 AND CURRENT ICH, PIC/S AFFILIATION, GDF/GFATM QUALIFICATION35 (*EXCLUDING PUERTO RICO SALES, 40420 MN US$) Country

Pharmaceutical Exports (mn US$)

ICH Affiliation

PIC/S Member

NRA recog-nised as stringent by GDF/GFATM

Germany

69483

Y

Y

Y

Switzerland

56628

Y

N

Y

Belgium

47864

Y

Y

Y

United States*

36215

Y

Y

Y

France

35414

Y

Y

Y

United Kingdom

30763

Y

Y

Y

Ireland

24715

Y

Y

Y

Italy

22909

Y

Y

Y

Netherlands

21077

Y

Y

Y

Spain

12487

Y

Y

Y

India

11444

Y

N

N

Austria

8317

Y

Y

Y

Sweden

7054

Y

Y

Y

Israel

6030

N

Y

N

Singapore

5850

Y

Y

N

Denmark

5559

Y

Y

Y

Canada

5007

Y

Y

Y

Hungary

4095

Y

Y

?

China

3550

N

Y

N

Australia

3285

Y

N

N

Slovenia

2992

Y

Y

?

Poland

2935

Y

Y

?

Japan

2826

Y

Y

Y

Mexico

1503

Y

N

N

Czech Rep.

1499

Y

Y

?

Hong Kong SAR China

1498

N

Y

N

Greece

1357

Y

Y

Y

Panama

1338

N

N

N

Brazil

1221

Y

N

Y

Romania

1208

Y

Y

?

South Korea

1102

Y

Y

Y

Finland

1005

Y

Y

Y

Argentina

957

N

Y

N

Bulgaria

872

Y

Y

?

Portugal

863

Y

Y

Y

Turkey

709

N

N

N

Norway

677

N

Y

Y

Russia

648

Y

N

N

Jordan

615

N

N

N

Croatia

518

Y

Y

?

MANAGEMENT taken in sourcing TB medicines. There is first the issue of UN organisations accepting tied aid from donors. Second, for the core question of determining the markets from which products can be sourced, it does not seem appropriate for public procurement functions of organisations in the UN System to outsource such central issue – moreover without an established accountability relationship - to an external entity, however well qualified it may be37. Determining eligible supply sources, or defining these so as to enable direct identification, remains a core function of public procurement in the UN. These could, as mentioned, be well linked to a risk assessment scheme.

In conclusion, TB stakeholders are called on to set about establishing a definition of strict national regulatory authorities and to align their quality assurance policies with such definition. Such undertaking will achieve compliance with WHA 62.15 and would be serving the public interest by realizing fair competition and thereby regularly increasing access to affordable medicines.

For TB, this would mean an improvement in global TB-control and contributing to ultimate elimination of TB, both for drug-resistant and drugsusceptible forms of TB.

References: 1.Procurement Team Manager and Principal Officer for Contracts and Commercial Affairs at the Global Drug Facility, Stop TB Partnership, World Health Organization, 2007 - 2014. Responsible for procurement of anti-TB medicines (drug-susceptible TB; drug-resistant TB 2007 – 2009) and diagnostics.

Currently, Chief Procurement Officer, UN Stabilization Mission in Haiti (MINUSTAH).

Note that the views expressed in this article are those of the author and do not necessarily reflect the views of the United Nations.

2.See http://www.stoptb.org/.

Since 2015 the TBP is hosted at the United Nations Office for Project Services (UNOPS).

3. http://www.stoptb.org/gdf/ 4.Fig. 4, p. 8, GDF Activity Report 2012 – 2013,

http://www.stoptb.org/gdf/what is/documents.asp 5.Data line on TB in the figure “Disbursements”,http://www.th eglobalfund.org/en/financials/ 6. http://apps.who.int/prequal/ 7.GDF Quality Assurance Principles,http://www.stoptb.org/gd f/drugsupply/quality_sourcing_process.asp, in particular points B and C. 8.GFATM, Quality Assurance: Medicines, http://www.theglobalfund.org/en/sourcing/qa/medicines/. The same requirement is also set for antiretrovirals (ARVs) and antimalarial medications (ibid).

9.UNITAID: http://www.unitaid.eu/en/resources/results/9uncategorised/437-quality-assurance-for-all-unitaid-purchas ed-products.

10.Under its partnership with GFATM, UNDP subscribes to the latter’s quality assurance policy for purchases of medicines, http://www.undp-globalfundcapacitydevelopment.org/en/fun ctional-capacities/developingfive-functional-capacities/procurement-and-supply-management/ (“To ensure procurement and supply chain policies, guidelines and procedures … are compatible with … Global Fund requirements.”). Correspondingly, in respective procurement notices UNDP requires product compliance with GFATM’s Quality Assurance Policy, e.g. as established in an Invitation to Bid for Second-Line Tuberculosis Medicines, issued by the UNDP Country Office Uzbekistan on 26 October 2016, http://procurementnotices.undp.org/view_notice.cf m?notice_id=33836, viewed 19 November 2016. The partnership with The GFATM is also highlighted on UNDP’s main website, http://www.undp.org/content/undp/en/home/operations/ procurement/about-us/, as well is in the promotional brochure available at that link, UNDP Procurement Services Unit, August 2016, pp. 4, 15.

11.Footnote 2 at GDF Quality Assurance Principles, ibid; for The GFATM: Quality Assurance: Medicines, ibid, both with reference to ICH’s former name International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human

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Use. The organization was renamed in 2015 to its current form in the context of several organizational changes, see http://www.ich.org/about/organisational-changes.html.

12.http://www.ich.org, http://www.ich.org/about/organisational-changes.html.

13.http://www.ich.org/about/me mbership.html 14.Footnote 4 at GDF Quality Assurance Principles, ibid.

15.Ibid; on the dates of accession to ICH as Observers see Zachary Brennan, Regulatory Focus, posted on 01 July 2016, http://raps.org/Regulatory-Focus/News/2016/07/01/25264/IC H-Adds-14-New-ObserversAdopts-New-Guidelines-at-Lisbon-Meeting/. While Brennan’s article does not list Cuba, Kazakhstan and South Africa, it must be concluded that these Authorities joined later, either in 2015 or 2016.

16.While Footnote 2 at GDF Quality Assurance Principles, ibid, refers only to “ICH observer”, it appears this should be read together with Footnote 4, which elaborates further “ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic, Health Canada and World Health Organization (WHO) (as may be updated from time to time)”. Similarly, while GFATM’s website: Quality Assurance: Medicines, ibid, refers only to “regulatory authorities participating in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)”, the document linked at the bottom of that website PSM_QAPharm_Policy_en titled “GLOBAL FUND QUALITY ASSURANCE POLICY FOR PHARMACEUTICAL PRODUCTS (as amended and restated on 14 December 2010” in the definition of SRA under para. 2 contains the same limiting phrase as GDF’s.

17.http://www.ich.org/about/me mbership.html 18.GDF Procurement Notices of 18 October 2016 and 01 February 2016 at http://www.stoptb.org/gdf/drug supply/procurement_notice.asp (first-line medicines) and http://www.stoptb.org/gdf/drug supply/procurement_notices_ar

chive.asp (second-line medicines).

19.Footnote 2 at GDF Quality Assurance Principles, ibid.

20.Footnote 3, para. 7 (i) in “GLOBAL FUND QUALITY ASSURANCE POLICY FOR PHARMACEUTICAL PRODUCTS (as amended and restated on 14 December 2010”, ibid.

21.Point D, GDF Quality Assurance Principles, ibid.

22.Section headed “Expert Review Panel”, Quality Assurance: Medicines, ibid; paras. 6 – 10 in “GLOBAL FUND QUALITY ASSURANCE POLICY FOR PHARMACEUTICAL PRODUCTS (as amended and restated on 14 December 2010”, ibid.

23.GDF: Point D 2, GDF Quality Assurance Principles, ibid; GFATM: para. 14, “GLOBAL FUND QUALITY ASSURANCE POLICY FOR PHARMACEUTICAL PRODUCTS (as amended and restated on 14 December 2010”, ibid.

24.https://picscheme.org/ 25.https://www.picscheme.org/e n/about 26.https://www.picscheme.org/e n/history, https://picscheme.org/en/members. Other new entrants from 2000 are Croatia (2016), Cyprus (2008), Germany (2000), Greece (2002), Italy (2000), Latvia (2004), Lithuania (2009), Malta (2008), Poland (2006), Slovenia (2012), US (2011).

27.Footnote 5, GDF Quality Assurance Principles, ibid.

28.Available at http://www.who.int/tb/publications/resolutions/en/ 29.Draft resolution proposed by the delegation of China at the 62nd WHA, A62/A/Conf. Paper No. 3, 20 May 2009.

30.Draft resolution proposed by the delegation of China incorporating amendments proposed by the delegations of Canada, Czech Republic, Japan, Sudan, Thailand and United States of America at the 62nd WHA, A62/A/Conf. Paper No. 3 Rev. 1, 22 May 2009.

31.http://www.who.int/mediacentre/events/2009/wha62/jour nal5/en/ 32.See e.g. the document “Implications of the 2009 World Health Assembly resolution on the Prevention and control of multidrug-resistant tuberculosis (MDR-TB) and extensively

drug-resistant tuberculosis (XDR-TB)” at http://www.who.int/tb/features_archive/wha62_15_tb_res olution/en/, which makes no mention of the change in terminology related to NRAs. 33.IFPMA, The Pharmaceutical Industry and Global Health, IFPMA Facts and Figures 2015, published 03 December 2015, Annex 3, available at http://www.ifpma.org/resourcecentre/facts-figures-2015/. Data is in regard to 2013 sales.

34.This list of countries whose NRAs are not recognized as “stringent” by GDF and GFATM goes beyond the nine new ICH Observers Australia, Chinese Taipei, Cuba, India, Kazakhstan, Mexico, Russia, Singapore and South Africa, for which ”stringent” compliance could not be deduced, as well as new entrants to the EU, given GDF’s caveat in recognising these.

35.Source: IFPMA, ibid.

36.Cf. amounts cited in para. 2, page 1 of this article.

37.GFATM’s quality assurance policy for diagnostics of 14 December 2010, as amended on 05 February 2014, similarly outsources qualification by referring to manufacturing sites “compliant with … an equivalent Quality Management System recognized by one of the Regulatory Authorities of the Founding Members of GHTF” or a product “authorized for use by one of the Regulatory Authorities of the Founding Members of GHTF when stringently assessed (high risk classification)” (Articles 7 (i), (ii), 8 (iii) of The Global Fund QA Policy for Diagnostic Products, at http://www.theglobalfund.org/en/sourcing/qa/diagnostics/). Regulatory Authorities of the Founding Members of the GHTF (Global Harmonization Task Force on Medical Devices, succeeded in 2012 by the International Medical Device Regulators Forum (IMDRF), http://www.imdrf.org/, https://en.wikipedia.org/wiki/Gl obal_Harmonization_Task_For ce), are those of the US, the EU, Japan, Canada and Australia (Definitions Section, The Global Fund QA Policy for Diagnostic Products, ibid.).

(The author declares there are no competing interests in relation to the article)

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MANAGEMENT REPORTS

Fatty liver disease prevalence leads pharma companies look to first in-class drugs According to GBI Research, fatty liver disease has increased rapidly in the past several decades and is now estimated at 20-45 per cent in the general population DUE TO the increasing global prevalence of fatty liver disease (FLD), which comprises a spectrum of chronic liver disorders characterised by excessive lipid accumulation in the liver (steatosis), potentially leading to inflammation (steatohepatitis) and fibrosis, pharmaceutical companies are looking to firstin-class treatments to help to address increasingly urgent unmet needs, according to business intelligence provider GBI Research.

The company’s latest report states that FLD is the most common chronic liver disease in the world. Its global prevalence has increased rapidly in the past several decades and is now esti-

mated at 20-45 per cent in the general population, 70 per cent in diabetic patients, and 50-90 per cent in obese people.

Jennifer Goossens, Associate Analyst for GBI Research, explains, “Although FLD is increasingly recognised as a major global health problem, the treatment market is still in its infancy, with no FDA-approved drugs and only a small number of generic drugs approved in certain European and Asia-Pacific markets in recent years.

These include the antioxidative and antifibrotic drugs silibinin and ursodiol. Lifestyle changes and reduction of body weight are the primary recommendations to control FLD, while liver transplantation is the only defin-

itive option for patients with severe disease, meaning there is an urgent unmet need to develop safe pharmacologic therapies.”

Due to the pathophysiological complexity of FLD and its diverse population, different therapeutic agents are likely to be needed in order to tackle the lipotoxic, inflammatory and fibrogenic effects seen in FLD. The treatment pipeline is relatively large, with 173 products in active development and a sizeable proportion of first-in-class drugs.

Goossens continues, “The degree of first-in-class innovation is 15 per cent above the industry average, which is very promising considering the level

of unmet need and lack of approved treatment options. Furthermore, a high proportion of first-in-class products with no prior involvement in licensing or co-development deals have been identified, which demonstrates that there are strong investment opportunities for first-inclass product development within the FLD landscape. The majority of these products are small molecules in the early drug development stages. They also target a range of first-inclass molecular targets, with several different molecular target classes represented. This provides diverse opportunities for potential investors.”

EP News Bureau

Global cancer supportive care therapeutics market to see negligible growth to $12.4 billion by 2022 According to GBI Research, negligible growth can be attributed to the patent expiries of some of the therapy area’s most commercially and clinically important drugs early in the forecast period THE GLOBAL cancer supportive care market, which covers chemotherapy-induced neutropenia, chemotherapy-induced anaemia, chemotherapyinduced nausea and vomiting, cancer pain, bone metastasis, and oral mucositis, is set to experience a low level of growth from $11.7 billion in 2015 to $12.4 billion by 2022, at a compound annual growth rate of 0.9 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that this negligible growth can be attributed to the

30 EXPRESS PHARMA April 1-15, 2017

patent expiries of some of the therapy area’s most commercially and clinically important drugs early in the forecast period. These include Neulasta (pegfilgrastim), Aranesp (darbepoetin alfa), and Neupogen (Filgrastim), and their expiry will allow new biosimilars and generics to enter the market, which will lead to major markets decreasing in size.

Ross Wilkinson, Associate Analyst, GBI Research, explains, “Generics will be responsible for the market’s growth globally, as they will open up opportunities in low

and middle income countries due to their lower prices. Amgen is currently market leader and will remain so over the forecast period. However, the expiration of some of the company’s products including Neulasta, Aranesp, and Neupogen will lead to a decline in revenue of $2 billion by 2022.”

In line with lost revenue, Amgen’s market share will decrease from 70.8 per cent in 2015 to 51 per cent by 2022. Additionally, despite 15.4 per cent of Amgen’s pipeline being made up of cancer supportive care products, none will be ap-

proved over the forecast period. The company’s Xgeva, which was approved in 2010, will be its only product to see its revenue increase during the forecast period.

GBI Research believes six companies will begin generating revenue from the cancer supportive care therapy areas by 2022, two of which are top 20 pharmaceutical companies.

However, the most successful new entrant will be the small public company Heron Therapeutics, which will market two products in the therapy area – Aprepitant and Sustol. These

are forecast to generate $206 million and $429 million respectively in 2022.

Wilkinson concludes, “Not only is the cancer supportive care pipeline relatively small compared to other oncology therapy areas, there are also no companies that are highly active in the pipeline. Each company has on average only one or two products in development, and of the companies with products in late-stage development, Pfizer and Amgen are the only two that are top 20.”

EP News Bureau

RESEARCH STUDY

Cubosomes –Aliquid crystalline marvel Dr Pradnya Palekar Shanbhag, Professor in Pharmaceutics, Saraswathi Vidya Bhavan’s College of Pharmacy, shares a study on cubosomes, its properties and its potential for use in diverse areas

N

anoparticulate systems characterised by different morphology and dimensions depending on production procedures have been obtained, namely cubosomes, nanovesicles, solid lipid nanoparticles and liposomes.

The discovery of cubosomes is a unique story and spans the fields of food science, differential geometry, biological membranes, and digestive processes. Cubosomes are well-defined, three dimensional structures consisting of coexisting lipophilic and hydrophilic nano domains that can be either interconnected or isolated, depending on the phase structure. The hydrophobic effect drives amphiphilic molecules in polar solvents to spontaneously self-assemble into a rich array of thermodynamically stable lyotropic liquid crystalline phases with characteristic lengths on the nanometer scale. Cubosomes possess a sufficient average degree of molecular orientation order, characterised by their structural symmetry despite their liquid state, and often form in aqueous surfactant systems at relatively high amphiphile concentrations.

Bicontinuous cubic phases consist of two separate, continuous but non-intersecting hydrophilic regions divided by a lipid bilayer that is contorted into a periodic minimal surface with zero average curvature.

They have potential for controlled release through fictionalisation and they are an attractive choice for cosmetic applications as well as for drug delivery.

Properties Size range: Large cubosomes (diameter >200nm) Smaller cubosomes and

vesicles (diameter < 100nm) Important properties are: ◗ Temperature stability ◗ Bicontinuous structure ◗ High internal surface area ◗ Solid-like viscosity ◗ Low cost of raw materials ◗ Optically isotropic ◗ Solid like liquid crystals with cubic crystallographic symmetry ◗ Biocompatible and bioadhesive in nature ◗ Cubosomes were found to get disintegrated by whole plasma as a result of the interaction with plasma components.

Cubic phase structure Monoglycerides are polar lipids having poor water solubility that exhibits aqueous phase behaviour, which are structurally mimicking to non-ionic surfactants. Lutton results the mono glycerides whose hydrocarbon chain lengths between c12 and c22 (Fig.1) of all the monoglycerides, particularly monoolein exhibits larger region of cubic phase. Monoolein is an unsaturated, c18 monoglyceride.

Cubic phases are often found sandwiched between lamellar and hexagonal liquid crystalline phases, especially in non-ionic surfactant systems.

The monoolein-water system uniquely possess a cubic phase region and contains broad compositional and temperature

Dr Pradnya Palekar Shanbhag

range. Normally monoolein has continuous hydrophilic headed, hydrophobic tail end, producing reversed or inversed cubic phases, indicating the phases towards polar medium so that the cubic phase structures can be described using the concept of differential geometry and periodic minimal surfaces. Minimal surfaces are best described by analogy with soap films. Based on their curvatures, three types of minimal surfaces, studied in cubic phases was discovered mathematically by Schwarz.

The monoolein water system forms the D-surfaces at high water levels, and the G-surface at lower levels. The P-surface is formed in the monoolein water system, but only when a third component

such caseins or amphiphilic block copolymer are added.

Normally, using copolymers like poloxamer407-monooleinwater system because of the polymers utility it provides colloidal stability to cubosomes by recoalescence to bulk cubic phases. Poloxamer (peo99ppo67-peo99), the ppo copolymer exists either at surface of cubic phase particle or with in bilateral structure, whereas the peo chain remains in the bulk water phase resulting in the formation of three-phased regions.

Drug release from cubosomes Cubosomes have been proposed as a controlled release, intravenous drug delivery system. The pressure ultrafiltration method and equilibrium dialysis were used to elucidate the in vitro drug release mechanisms. On dilution of cubosomes, lipophilic compounds were released rapidly when studied by the pressure ultra-filtration method. In contrast, equilibrium dialysis incorrectly indicated sustained drug release from cubosomes.

Research shows that cubosomes should be burst release delivery systems where drug is released by diffusion from the cubic phase matrix, and that pressure ultrafiltration may have benefits over dialysis

Research shows that cubosomes should be burst release delivery systems where drug is released by diffusion from the cubic phase matrix, and that pressure ultrafiltration may have benefits over dialysis methods for measurement of drug release from colloidal particle-based drug delivery systems

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methods for measurement of drug release from colloidal particle-based drug delivery systems.

Structural Characterisation X-Ray diffraction, Cryo-Transmission electron microscopy (cryo-TEM), Photon correlation spectroscopy (PCS), Atomic force microscopy and NMR investigations have been performed. X-ray diffraction measurements and C NMR are used to study the internal structure of liquid crystalline dispersion.

Using high resolution freeze-fracture electron microscopy direct visualisation of the internal structure of the 3-D cubosomes of double diamond type formed upon spontaneous lipid/protein assembly in excess of water.

Preparation Cubosomes are usually produced by combining monoolein and water at 40°C for 24 hours.

The resultant cubic liquid crystalline gel is dispersed into particles via the application of mechanical or ultrasonic energy.

Two main approaches can be used to prepare cubosomes: Top-down approach: It applies high energy to fragment bulk cubic phase. It is the most widely used in research area, where by bulk cubic phase is first produced and then dispersed by high energy processing into cubosomes nanoparticles. Bulk cubic phase is resembles a clear rigid gel formed by water swollen crossed linked polymer chains.

The bottom-up approach forms cubosomes from molecular solution by, for example, dilution of an ethanol-monoolein solu-

EXPRESS PHARMA

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April 1-15, 2017

RESEARCH

tion. They require formation of cubosomes prior to their use in a product.

Bottoms-up techniques: It avoids high-energy drawbacks and allow formation of cubosomes in use by a consumer or during product formulation.

Both techniques require a colloidal stabiliser, like the tri-block copolymer Poloxamer 407, to prevent cubosome aggregation. For cubosomes in consumer products and pharma products, the most commonly envisioned uses are diffusive uptake/release of materials and/or deposition onto skin or tissue. In some cases, the bottom-up dilution process is favoured so that cubosomes form only during consumer use, such as by dilution via ingestion or sweating. Cubosomes are formed by sufficient dilution of liquid precursors prepared in the binary monoolein-ethanol system.

Liquid cubosome precursors High-energy processes for formation of cubosomes can be expensive, difficult to scale up, and harmful to fragile temperature-sensitive active ingredients like proteins. The hydrotrope dilution process is found to consistently produce smaller, more stable cubosomes. In concept, particles are formed by nucleation and growth. This is achieved by dissolving the monoolein in a hydrotrope, such as ethanol, that prevents liquid crystalline formation. Subsequent dilution of this mixture spontaneously 'crystallises' or precipitates the cubosomes. The liquid precursor process allows for easier scale up of cubosome preparations and avoids bulk solids handling and potentially damaging high energy processes.

Powdered cubosome precursors Powdered cubosome precursors are powders composed of dehydrated surfactant coated with polymer. Hydration of the precursor powders forms cubosomes with a mean particle size of 600 nm. Spray dry-

32

EXPRESS PHARMA

April 1-15, 2017

bioavailability ◗ Decrease of unwanted side effects, ◗ Improvement of intracellular penetration

Applications

Fig. 1: Monoolein Structure

Cubosomes are intriguing self-assembled materials with great potential in diverse areas.

Interdisciplinary research in engineering, biology, medicine and chemistry is essential to bind together existing cubosome research and provide comprehensive understanding of these fascinating particles ing produces encapsulated particles from a dispersion of solid particles in a concentrated aqueous polymer solution. The continuous and dispersed phases are sprayed through a nozzle to create suspension droplets that are contacted with a heated, dry air stream flowing in the opposite direction. Excess water immediately evaporates, leaving dry powder particles composed of the dispersed phase encapsulated by the dissolved polymer. Finally, the polymer coating on the powder imparts surface properties to the hydrated cubosomes that can be tailored by proper selection of the encapsulating polymer. The production of starch-coated cubosome powder precursors requires high shear treatment of monoolein in aqueous starch solution to form a coarse cubosome dispersion that is then pumped through a nozzle and dried.

The powder with the 3:1 ratio exhibits good encapsulation of the monoolein and small particle size.

Functionalised cubic phase liquid crystals Functionalisation is achieved by incorporating amphiphilic molecules into the liquid crystal; the hydrophobic portion of the amphiphile inserts into the bilayers of the cubic phase and the hydrophilic portions extend into the water channels. It is assumed that the loading and release properties from cubic phase liquid crystals are governed solely by the solubilised active. In a more simplified manner, higher affinity of the active for the liquid crystal leads to higher loading. At lower pH, the active is more hydrophobic and can be loaded to higher levels. This is observed for a wide range of actives including Lidocaine, Prilocaine and Clomethiazole (CMZ) and Phenol Butylamine.

Proposed advantages ◗ Patient/clinical value ◗ Increased convenience and compliance (orally, topically and intravenously). ◗ Improved bioavailability due to size

◗ Improved efficacy ◗ Decreased side effects associated with high initial plasma levels from rapid drug release on injection (drug burst) ◗ Decreased health care costs due to simplified handling and less frequent administration ◗ Decreased risks of drug misuse and misdirection

Pharma value ◗ Means of solubilising, encapsulating, and transporting APIs. ◗ Broadly applicable (to small molecules, nucleotides, peptides and proteins). ◗ Enormous surface area of several hundred square meters per gram ◗ High drug loading ◗ Allows true controlled release ◗ Stability enhancement (improved shelf-life and/or in vivo stability) ◗ Allows targeting (e.g. of cancer drugs) ◗ Means of protecting sensitive molecules from degradation in vivo. ◗ Solubilisation of poorly watersoluble drugs could improve

◗ Monoglyceride-based cubosome dispersion can be proposed for topical use, such as for perctuneous or mucosal applications. Because of the microbicidal properties of monoglycerides, could be used to design intravaginal treatment of sexually transmitted diseases caused by viruses (e.g.

HSV, HIV) or by bacteria (eg.

Chlamydia trachomatis and neisseria genorrticae). ◗ Due to similarity between the cubic phase structure and the structure of the stratum corneum, it is reasonable to suppose the formation of mixture of cubosomal monolein with stratum corneum lipids.

This kind of interaction might lead to the formation of a cubosome depot in this layer, from which drug can be released in a controlled fashion.

The cubosome technology is used to develop a synthetic vernix. ◗ Indomethacin is an antiinflammatory drug with potential side effects when administrated orally. The indomethacin-loaded cubosomes were suitable nanocarriers for efficiently prolonging anti-inflammatory activity and for controlling drug release. ◗ Cubosome particles are used as oil water emulsion stabilisers and pollutant absorbents in cosmetics. ◗ Cubosomes as an ophthalmic drug delivery system for Flurbiprofen (FB) to reduce ocular irritancy and improve bioavailability. ◗ As site-directed drug delivery or drug targeting, such formulation principles are of major interest in cancer chemotherapy, certain malignant diseases, for good prognosis which requires removal of the primary tumour by surgery as well the prevention of the development of lymphatic metastases. Current research and experimentation on the antineoplastic drugs e.g Darbazine loaded onto cubo-

RESEARCH somes has been carried out successfully. ◗ Cubic phase is attractive for controlled release because of its small pore size (ca. 5–10 nm); its ability to solubilise hydrophobic, hydrophilic, and amphiphilic molecules biodegradability by simple enzyme action. ◗ Cubic phase is strongly bioadhesive and is thought to be a skin penetration enhancer. ◗ Cubosomes find applications in Parkinson’s disease using Bromocryptine and Levodopa. ◗ An oral lipid cubosomal formulation for delivery of insulin had been proposed by Chung et al (2002).

different doses.

Another clinical-stage product is CAM2029, a long-acting formulation of Octreotide, for the treatment of acromegaly, carcinoid syndrome and vasoactive intestinal peptide (VIP) producing tumours.

Conclusion

Clinical evaluation of skin conditioning by cubosomes The first study contrasts the effects of two cubic phase formulations with two standard barrier creams containing petrolatum as the primary lipid base. The results indicate that the cubic phases are highly permeable to water and fail to exhibit a clear dose response as a function of film thickness.

The formulations in the clinical study include: 1) 75 per cent monoolein, 25 per cent water, 2) 75 per cent monoolein, 20 per cent water, 5 per cent glycerin 3) petrolatum (long chain hydrocarbon mixture, 0 per cent water), and Eucerin cream (petrolatum, lanolin, 17 per cent water) The effects of the various treatments on water handling properties are evaluated by means of the sorption-desorption test. In this standardised test, surface electrical capacitance readings are measured prior to and at measured intervals following topical application and removal of exogenous water.

The preliminary studies allow the following general conclusions: 1. Bulk cubic phases are difficult to handle and difficult to apply to human skin. In contrast, the relatively anhydrous lamellar phase of the monoolein-water admixture is relatively fluid and easy to apply.

2. The paradoxical addition of exogenous water to the lamellar phase of a topically applied monoolein-water admixture results in formation of the more viscous cubic architecture. Thus, the simple addition or removal of exogenous water provides a means of controlling the phase behaviour and, thus, the physical nature of the topical gel.

3. The cubic phase is highly vapour permeable when measured over human skin. Vapour permeability combined with a physical barrier is a desirable characteristic in wound healing applications. High viscosity and high vapour permeability are two physical properties distinguishing monoolein-water cubic phases from occlusive skin ointments such as petrolatum.

4. The cubic phase is hygroscopic on human skin as judged by instrumental tests such as the sorption-desorption test.

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5. In the study presented, twice daily application of a cubic phase to the dry lower legs of normal adult females evoked increased erthyema, increased visual dryness, and increased trans-epidermal water loss compared to a standard glycerin-containing, petrolatumbased emollient.

Cubosomes as injectable formulations The lipid liquid crystal gel technology is known as FluidCrystal and the nanoparticle systems featuring Cubosome as one of the nanoparticle carriers.

1. FluidCrystal is applied in the formulation of depot injection products for subcutaneous, intramuscular and intracavital administration.

2. FluidCrystal NP is applied in the formulation of intravenous (IV) products.

Be it in a prefilled syringe or

vial, the product is presented as a simple non-aqueous liquid pre-concentrate. Only after injection, in situ on contact with minute quantities of aqueous fluid, does the inactive precursor transform into the active delivery system – a controlled release liquid crystal matrix.

Products under development Testosterone derivatives and opiates; multiple peptide agents including, Octreotide, Leuprolide, Somatostatin, Salmon Calcitonin, GLP-1 and analogues; and several therapeutic proteins have been used in the liquid crystalline formulations.

Two injectable products are currently in clinical development, including CAM2032, a long-acting LHRH agonist for the treatment of prostate cancer after a single subcutaneous administration of three

Cubosomes are intriguing selfassembled materials with tremendous potential in areas as diverse as medicine, materials science, and consumer products. The discovery of cubosomes has urged a broad level of investigation that, as proposed applications become financially attractive, will continue to narrow and fill in many of the current gaps in our knowledge of cubosome formation and performance. Bicontinuous cubic liquid crystalline phases, either in bulk or cubosome form, offer unique properties of particular interest to the personal care industry for use in treatments of skin, hair, and other body tissue.

Interdisciplinary research in engineering, biology, medicine, and chemistry will be especially essential to bind together existing cubosome research and to provide a comprehensive understanding of these fascinating particles. The ability to form cubosomes either in use, during formulation, or during manufacture offers greatly enhanced flexibility for product development efforts.

Cubic phase systems hold promise as drug delivery vehicles and platforms for adhesives, skin protectants, and biomonitoring devices. The utility of these binary nanostructured systems can be extended by the ability to control the physical phase of the system; e.g., the transition from lamellar to cubic phase and the use of cubosome powder precursor. Probably the most compelling direction of research into these systems seeks to understand the interactions between bicontinuous structures and biological systems in general.

(With inputs from Sucheta A D’sa, Priyank R Parikh, Rajvi J Wani from Saraswathi Vidya Bhavan’s College of Pharmacy, Dombivli and Vivekanand Education Society’s College Of Pharmacy, Mumbai)

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RESEARCH

Diabetes in pregnancy tied to altered fat cells in adult offspring Babies of mothers with diabetes may be exposed to high blood sugar levels in the womb, a condition known as fetal hyperglycemia WHEN PREGNANT mothers have diabetes, their children may have altered fat cells that make metabolic diseases in adulthood more likely, a small Danish study suggests.

Babies of mothers with diabetes may be exposed to high blood sugar levels in the womb, a condition known as fetal hyperglycemia.

“Foetal hyperglycemia affects fat stem cells and these defects can be detected several years later,” said lead study author Ninna Schioler Hansen of the University of Copenhagen in Denmark.

In lab tests, adult offspring of women who had diabetes

during pregnancy appeared to have larger fat cells and more leptin, a protein made by fat cells that influences hunger.

“If (high blood sugar) or diabetes is present during pregnancy, our study supports the importance of aiming at normal blood glucose levels to reduce the negative impact on the cells of the unborn baby,” Hansen added by email “Women who are lean and fit before pregnancy have a reduced risk of developing gestational diabetes during pregnancy,” Hansen said.

Hansen’s team studied 206 adults, including some whose mothers had diabetes before

pregnancy, others whose mothers developed a condition known as gestational diabetes during pregnancy, and a control group with mothers who didn’t have diabetes at all.

Adult offspring of women with diabetes in pregnancy showed 'fundamental changes' in the size of their fat cells, their ability to store fat as well as the way their bodies produced the hormone leptin, which influences appetite regulation in the brain, Hansen said.

It’s possible that differences between adults with and without mothers who had diabetes during pregnancy might

be explained by other factors that happened during fetal development, the authors note in the Journal of Clinical Endocrinology and Metabolism.

Even so, the results offer clues to explain the increased diabetes risk among children born to mothers with diabetes, said Dr Joachim Dudenhausen, an obstetrics and gynaecology researcher at Weill Cornell Medicine in New York who wasn’t involved in the study.

Changes induced by hyperglycemia in the mother “can be responsible for diabetes of the child in later life,” Dudenhausen said by email.

The best prevention is for women to start pregnancy at a normal weight and gain a healthy amount of weight while they’re growing their babies.

Women who start out at a normal healthy weight should gain 25 to 35 pounds during pregnancy, while women who are overweight to start should gain no more than 25 pounds, according to the US Centers for Disease Control and Prevention.

“One of the highest risk factors for gestational diabetes is being overweight before and during pregnancy,” Dudenhausen said.

Reuters

Novartis heart drug portfolio hit by failed serelaxin study Serelaxin had a troubled trial history, having already failed in 2014 to win the approval of European and US regulators NOVARTIS' HEART failure drug serelaxin flopped in a late-stage trial by not cutting cardiovascular death or slowing disease progression, marking the likely demise of a drug hopeful the Swiss firm had promoted as a potential blockbuster.

The failure will put pressure on Novartis to ramp up sales of its Entresto heart failure drug that has got off to a slow start, analysts said.

Serelaxin had a troubled trial history, having already failed in 2014 to win the approval of European and US

34 EXPRESS PHARMA April 1-15, 2017

regulators. Novartis pressed on in the hope of eventually gathering enough evidence to change regulators' minds, but the recent announcement that the drug failed dashes those aims.

"We are disappointed this study did not confirm the efficacy of RLX030," said Vas Narasimhan, Novartis's drugs development Chief, adding he will continue to analyse the results to help determine where serelaxin went wrong.

With the failure, Novartis's stable of potential new blockbusters has now been

trimmed to 12 medicines.

Serelaxin was originally seen as a way for Novartis to fill the gap left by expiries on heart drugs such as Diovan, which lost US patent rights in 2012.

An open submission to the FDA is now likely to be put on ice after Novartis said recently after its RELAX-AHF2 phase III study did not meet its target of reducing cardiovascular deaths or worsening heart failure in patients with acute heart failure when added to standard therapy.

"This is a major disap-

pointment: we viewed Serelaxin as one of the major sources of upside to our longterm Novartis estimates," said one Zurich trader, who estimated the drug could have had 2 billion Swiss francs ($2.01 billion) in sales by 2020.

Acute heart failure is a medical emergency where patients become short of breath as the heart struggles to pump blood.

The condition is a major cause of hospitalisation for people over 65, with around one in five patients not surviving the year following hospi-

talisation.

Serelaxin was meant to relax blood vessels to ease the burden on the heart.

Analysts said the drug was always a risky proposition, given its previous stumbles with regulators.

"The failure of serelaxin will refocus the importance of Entresto to meet consensus long-term sales expectations as well as the importance for management to bolster its pipeline," Deutsche Bank analyst Tim Race wrote in a note to investors.

Reuters

RESEARCH

Mild electric shocks on the arm might help ease migraine pain The experimental gadget has been designed to stimulate nerves under the skin in the arm and block pain signals from reaching the brain WHEN A migraine strikes, patients might one day be able to make the experience less painful by using a smartphone-controlled device to deliver mild electric shocks to their arm, a company-funded experiment suggests.

The experimental gadget, Nerivio Migra, is a patch with a battery, electrodes and a computer chip that can wirelessly communicate with mobile devices. It’s designed to stimulate nerves under the skin in the arm and block pain signals from reaching the brain.

“All stimulation treatments given so far have been in the head,” said lead study author Dr David Yarnitsky, an advisory board member for Theranica, the company developing the device.

“We worked on stimulation at a far away location, which makes the treatment more convenient and more discrete so people can use it even during working hours without anyone noticing,” Yarnitsky added by email. The study involved 71 people with episodic migraines who had two to eight attacks a month and had not taken drugs to prevent the episodes for at least two months.

Participants were typically in their mid-to-late 40s and had been experiencing about five migraines a month. Most of them were female, and more than half of them reported experiencing what’s known as aura Overall, participants had a total of 299 migraines during the study period.

Researchers asked participants to put the device on their upper arm as soon as possible after the start of a migraine and use it for 20 minutes. They were also asked not to take any medicines for migraines for two hours after the start of the episode.

For the experiment, researchers randomly programmed the devices to give either placebo stimulation at a very low frequency or deliver one of four levels of active elec-

trical stimulation treatment.

The four active treatment programs were set at a pulse rate of 80 to 120 Hertz (Hz) with pulse widths of 200, 150, 100 and 50. People feel less stimulation at lower pulse widths. At higher pulse widths than this device used, people might feel their muscles contract.

When researchers excluded the lowest pulse width, they found 64 per cent of people in the other active treatment groups had at least a 50 per cent pain reduction two hours after treatment, compared with 26 per cent of people in the placebo group.

At the highest level of stimulation, 58 per cent of the people who started out with moderate to severe pain reported little or no pain after treatment. So did 24 per cent of people in the placebo group.

The timing of treatment also mattered.

People who started using the device within 20 minutes of the start of a migraine reported average pain reductions of 47 per cent, compared to a 25 percent

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reduction in pain for people starting the device later.

Even though the study’s participants were not told whether they were assigned active or placebo treatment, one limitation of the experiment is that

participants often stopped placebo treatments before the recommended 20-minute course of stimulation was done, the authors note in Neurology.

The technology known as transcutaneous electric nerve

stimulation (TENS) that was tested in the current study has been examined in other devices for migraine pain for decades, said Dr. Jean Schoenen, a neurology researcher at the University of Liege in Belgium who wasn’t involved in the current experiment.

One shortcoming of the current study is that researchers didn’t examine how long the pain relief lasts beyond two hours, Schoenen said by email.

“Rapid and sustained relief is what patients want,” Schoenen added.

If the device works in larger trials and becomes widely available for migraine patients, it might offer an alternative for people who can’t tolerate migraine drugs or an option patients could try in addition to medication when they don’t get enough pain relief from drugs alone, Schoenen said.

“The percentage of attacks for which TENS is sufficient as sole treatment and allows sustained pain relief remains to be determined,” Schoenen cautioned.

Reuters

Mylan recalls 81,000 EpiPens outside US after reports of failure The recall affects devices distributed in Australia, New Zealand, Europe and Japan GENERIC DRUGMAKER Mylan has recalled about 81,000 EpiPen devices in countries outside the US, following two reports of the lifesaving allergy shot failing to work in emergencies.

In both situations, patients were able to obtain treatment through the use of an alternate EpiPen, Mylan said recently.

The recall affects devices distributed in Australia, New Zealand, Europe and Japan only, according to the company.

Mylan said it is working with the regulatory

authorities, where appropriate, to inform them about the recall.

The US drugmaker, which is the focus of multiple federal investigations, has come under fire for staggering price increases on the emergency shot in the US. Mylan has also been heavily criticised for classifying EpiPen as a generic rather than a branded product, which led to much smaller rebates from the company to state Medicaid programmes.

Reuters

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April 1-15, 2017

PHARMA ALLY VENDOR NEWS

Thermo Fisher Scientific announces cloud-based application for connectivity to electronic pipettes The new application has been ergonomically constructed to reduce the strain on the user’s eyes and hands

L

ife science researchers working across many applications can now benefit from the first-ever webbased pipetting application, developed to enable seamless connectivity with electronic pipettes for optimized performance and safe, efficient and rapid sharing of protocols.

Developed for use in conjunction with the new Bluetooth-enabled Thermo Scientific E1-ClipTip electronic pipettes, My Pipette Creator is

the first cloud-based application designed to enable efficient, centralised programming of connected pipettes, as well as secure storage and sharing of protocols between pipettes and colleagues within the lab. Offering a library of pre-programmed protocols for the E1-ClipTip pipettes and Thermo Fisher Scientific reagent kits, the My Pipette Creator application allows users to save time, enhance consistency and minimise pro-

gramming errors to help achieve reproducible, reliable and traceable results.

“Programming protocols for use with individual electronic pipettes can be a timeconsuming, tedious and inefficient process that is prone to human error,” said Kelly Miller, Senior Business Director for liquid transfer products, Thermo Fisher Scientific. “We are excited about the launch of the My Pipette Creator application, as it allows multiple

users to connect and sync several electronic pipettes at once using their PC, enabling increased laboratory efficiency and productivity.”

The new application has been ergonomically constructed to reduce the strain on the user’s eyes and hands commonly experienced with repeated operation of individual pipettes. In addition to Bluetooth, connectivity with the E1ClipTip pipettes can also be achieved using a micro USB ca-

ble, depending on the user’s preference.

The My Pipette Creator application is part of Thermo Fisher Connect, a cloud platform encompassing scientific data analysis and storage, remote instrument access and collaboration tools designed to enable scientists to accelerate their research and for lab managers to boost their lab’s productivity.

EP News Bureau

Waters introduces Proteolabels software Product extends the functionality of Progenesis QI for Proteomics applications WATERS CORPORATION announced that it will now offer Proteolabels, a new software that has been designed as an extension for Progenesis QI for proteomics users and researchers. Proteolabels supports studies involving stable isotope labels, such as 'SILAC' and dimethyl labelling in duplex or triplex. Waters is offering Proteolabels through an exclusive agreement with Omic Analytics, an innovative start-up based in Liverpool, UK. “Waters takes great pride in working with innovative research groups like Omic Analytics to develop effective solutions to solve customer needs,” said Dr. Steve Smith, Vice President

36 EXPRESS PHARMA April 1-15, 2017

Proteolabels was engineered with a focus on performance and usability, empowering scientists to explore their data and achieve high-quality results Informatics at Waters. “Proteolabels extends the use of Progenesis QI for proteomics, a need for many of our customers working in health sciences, along with a growing number in food and environmental research.”

Proteolabels was engineered with a focus on performance and usability, empowering scientists to explore their data and

achieve high-quality results.

Features include ◗ Co-detection: The workflow builds upon the Progenesis QI for proteomics co-detection feature, in which features are aligned across LC-MS runs to improve sensitivity and reproducibility ◗ Auto-detect: Proteolabels makes a first pass through the

data to suggest optimal parameters, simplifying the analysis. ◗ Peptide scoring: Proteolabels contains novel metrics for scoring the quality of pairs/triples detected, enabling users to measure the reliability of quantitation down to the level of each peptide. ◗ Intelligent protein inference: Intelligent weighted averaging of different peptide-level

signals is performed, to give more accurate protein-level quantitation results. ◗ QC metrics: Proteolabels contains a large number of QC metrics and data plotting options, enabling users to interact and explore their data, and, where needed, make decisions as to how arrive at the best protein set.

“At Omic Analytics, we are excited to be collaborating with Waters on this new venture. We look forward to seeing Proteolabels in action with scientists all over the world,” said Prof Andy Jones, Director of Omic Analytics, UK. EP News Bureau

PRODUCTS

Gandhi Automations unveils high speed self-repairing door PRIME RESET is a unique high speed self-repairing door with the latest technology that prevents downtime of the door system. In case the curtain is impacted accidentally it will cause the curtain to move out of the guides without damage. The movement of the door is designed in such a way it can be recovered with a simple opening and closing operation.

Gandhi Automations manufactures doors of the highest quality that meet the issue for greater flexibility desired by clients. High speed self-repairing door in PVC is the most suitable solution in the field industries, it lowers the time of transition from one facility to another, avoiding any human error which can cause damage to the high speed door and all this thanks to the innovative anti crash system.

Gandhi Automations provides a world class product with great security.

tem ◗ Can be equipped with PVC vision windows ◗ Self-Lubricating maintenance free guide ◗ Smooth and silent opening and closing ◗ Protects traction unit, enables rapid wiring and safety photocell ◗ Flexible curtain in self-extinguishing material ◗ Self-resetting without intervention ◗ Quickly back to operation ◗ Control panel designed for an intensive continuous service

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Phenomenex xpands Kinetex F5 (Pentafluorophenyl) HPLC/UHPLC Core-Shell Line to 5 μm for Preparative LC PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has introduced a new 5 µm particle size to its family of Kinetex F5 pentafluorophenyl propyl (PFP) core-shell columns, extending the versatility of F5 to preparative LC and purification work. Kinetex F5 is a robust PFP core-shell phase that overcomes reproducibility and performance limitations of other PFP and F5 products on the market and significantly reduces method development time with its dynamic and responsive chemical functionality.

With five retention mechanisms and five separation modes, Kinetex F5 is an effective orthogonal alternative to the widely used C18 and C8 phases.

Kinetex F5 is an ideal solution for HPLC/UHPLC development work with its combination of polar and non-polar interactions, including hydrogen bonding, electrostatic, hydrophobic, aromatic and steric/planar mechanisms. The versatility of this phase gives scientists the ability to use reversed phase, 2D-LC, HILIC, SFC or even 100 percent aqueous separation modes.

Now available in three particle sizes – 1.7, 2.6, and the new 5

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µm – Kinetex F5 is fully scalable from UHPLC to HPLC to preparative chromatography, making method transfer seamless between different lab or site instrumentation. The new F5 5 µm media is also available in high-performance Axia-packed preparative columns from 21.1 mm to 50 mm ID. Kinetex F5 delivers all the advantages of Phenomenex’ Core-Shell Technology including better resolution, higher efficiency, easy method transferability and cost savings from reduced solvent consumption.

The new 5µm particle delivers performance that is comparable

to or better than 3 µm conventional fully porous media, at lower backpressures. Users who upgrade existing 5 µm methods to Kinetex 5µm F5 can achieve greater performance at the same backpressure.

Contact details Jennifer Dahlgren, Dahlgren Communications Phone: (530) 263-6817 E-mail: dahlgrenpr@comcast.net Simon Lomas, Phenomenex Phone: (310) 212-0555 Ext. 2267 E-mail: simonl@phenomenex.com

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PHARMA ALLY I N T E R V I E W

'Over next three to five years, we intend to expand the existing capacities of large and small volume parenterals to meet the expanding demand' Amanta Healthcare, an Ahmedabad-based, mid-sized pharma company had introduced Steriport â&#x20AC;&#x201C; a new generation concept of IV fluid system in India. Bavesh Patel, Managing Director, Amanta Healthcare divulges more information about the company, its offerings, Steriport, its advantages and more, in an exclusive interview with Usha Sharma What are the solutions you offer to pharma companies?

Amanta is in manufacturing and marketing of sterile dosages. Under product partnering vertical, we cover products in fluid replacement, respiratory and eye care.

Apart from manufacturing, we collaborate in product development and process engineering.

The company offers solutions to the critical care segment, tell us more about it?

Being a dedicated manufacturer of sterile dosages especially Fluid Therapy, we automatically find ourselves in critical segment. We have pan India presence apart from numerous export destinations. Fluid Therapy, both, in conventional PE bottles as well as SteriPort offer almost entire range of Fluid Replacement Solution for critical and intensive care.

Our additional portfolio in critical care includes fever management (Paracetamol) and anti-infective (Ciprofloxacin, Ofloxacin, Metronidazole, Linezolid) segments. SteriPort is a portfolio enhancer in the critical care segment as it is widely used in intensive care.

Recently, Amanta launched SteriPort-new generation of IV Fluid, how is it different from other IV fluids?

Global guidelines (PIC/s, EP, IP, WHO) for IV Fluid container includes

38 EXPRESS PHARMA April 1-15, 2017

assurance level unlike the most commonly used containers in India which are sterilised at 108o C (ii) Two-port closure system which enables supplemental medication (iii) Glass like transparency which helps in visual inspection

Sterilization at 121 °C, TwoPort Closure system and Transparency for visual inspection. Most of the containers commonly available in Indian Market are made up of Polyethylene (PE) and do not comply with these standards.

SteriPort meets global standards. It has high sterility assurance level (sterilised at 121o C), is as transparent as a glass container and has two port closure systems.

The unique feature of SteriPort is that it is compatible with most of the oncology products for IV administration, which is not the case with polyethylene (PE) bottles.

SteriPort has superior tensile strength, optical property and barrier properties compared to PE containers.

Why should private and government hospitals use SteriPort?

Selection of IV Fluid container is crucial for patient safety.

Global guidelines are very specific and emphasise on 121o C, two-port closure system and transparency. (i) SteriPort is sterilised at 121o C which ensures higher sterility assurance level. PE Containers are sterilised at 108o C. (ii) SteriPort has two-port closure system which helps in supplemental medication and ensures drug compliance.

Most of the commonly used PE containers do not have closure system and tends to leak, compromising on compliance. (iii) SteriPort is glass-like transparent. Widely used PE containers are translucent which makes visual inspection difficult.

Why do you think that SteriPort is going to be the choice for corporate hospitals?

SteriPort complies with all the international standards for an ideal IV container: (i) It is sterilised at 121o C which ensures higher sterility

Tell us about the packaging material of SteriPort and what advanced technologies have you used for it? How user friendly is it?

SteriPort is made of Random Co-Polymer of Poly Propylene (RCPP). This polymer resists temperature up to 125oC, which enables SteriPort to be sterilised at 121oC. It has superior tensile strength, optical and barrier property.

The polymer of RCPP used for manufacturing SteriPort is Drug Master File (DMF) grade material.

SteriPort is an innovative container which is userfriendly for paramedics. It is a combination of unique packaging material (RCPP) and manufacturing process.

Amanta is the first in India to launch such an innovative IV container.

Globally, who are your competitors and why?

Competition varies from country to country. Most of the countries like North Europe and North America prefer IV bags and glass bottles. Some countries in Europe, Asia and Africa see overwhelming use of PE bottles. The bottle made of

RCPP is relatively new concept. Globally, there are MNCs like Baxter, Otsuka, Fresenius Kabi and B. Braun.

There are no of Indian companies who have strong market presence in Asia and Africa.

What makes Steriport a great value proposition?

SteriPort was a new concept when it was launched. The cost of manufacturing is also higher as compared to conventional PE bottles. In the initial phase, the focus was more on establishing the concept and convincing the doctors and paramedics about the benefits. Although the product is little costly, the advantage is in terms of patientâ&#x20AC;&#x2122;s safety and drug compatibility, which makes SteriPort a great value preposition.

Tell us about the company's future plans. What are the new technologies/products that the company is planning to launch? How soon will they be seen in the market?

Over next three to five years, we intend to expand the existing capacities of large and small volume parenterals to meet the expanding demand as well as set up a facility for sterile injections and other dosages form. We also have plans to install glass and bag lines for total parenteral nutrition range of products. u.sharma@expressindia.com

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PHARMA LIFE I N T E R V I E W

‘We intend to train 35,000-40,000 students and professionals over a three-year period’ Pollux Life Science Solutions has been mandated

by Life Science Sector Skills Development Council (LSSSDC) established under the Ministry of Skill Development to upgrade skill-sets among emerging pharmacists. Hemant Deshpande, Managing Partner, Pollux Life Science Solutions, shares more details about the mandate, the gap between academia and the industry and his vision to bridge this gap, in a têtê-à-têtê with Lakshmipriya Nair Tell us about your partnership with LSSSDC? What does it entail and how would it help build skills in the pharma industry, both in qualitative and quantitative terms?

The Ministry of Skill Development along with stakeholders in the pharma industry had established LSSSDC with the broad objective of skilling aspiring workforce and existing working professionals in the pharma spectrum. We, at Pollux Life Science Solutions, have been affiliated by LSSSDC as their training partner for the state of Maharashtra. We have initiated the process with a set target of 5000 students and professionals to begin with for various roles in the pharma industry, by bringing together academic institutions and the industry on the same platform.

As part of the training module, we will additionally

50 EXPRESS PHARMA April 1-15, 2017

provide intangible, soft skills for candidates in segments of quality control and assurance, production and medical sales representatives, which cover over 70 per cent of the job roles in the pharma space.

Apart from bridging the gap between the academia and the industry, we will also upgrade professionals to address modern day challenges of the regulatory and policy makers at the shop floor level.

Reportedly, on a pan-India basis, LSSSDC aims to certify skilled workforce of 21 lakh over the next 10 years. Of that, how many people do you intend to skill in the next three years?

With support from LSSSDC, Pollux Life Science Solution has started off with two pharma clusters in Mumbai and Pune. We are in the process of adding Nashik, Aurangabad, Nagpur, Goa, Daman and Indore to our geographical spectrum. Going

by our initial estimate and limited cluster of two cities, we intend to train 35,00040,000 students and professionals over a threeyear period. However, we are hopeful of scaling up our training modules across pharma clusters in the Western region to ensure that the target set by LSSSDC for these geographies are achieved by us.

What are the skill sets that need to be developed in the fast-evolving life sciences industry in India to ensure its growth momentum?

As part of the training module, LSSSDC has already documented technical proficiency and competency skills in the curriculum and we have added analytical and responsive skills that are significant to industry needs.

These skill sets are based on evolving regulatory issues from the remunerative market that has far reaching impact

on the industry, for instance, the notices received by the Indian pharma companies. The objective of skill upgradation is to ensure that India maintains its numero uno status as a lowcost producer of quality formulation drugs in the globe several decades down the line.

How will Pollux help bridge the gap between the academia and industry, and improve the employability of students?

In terms of remuneration, currently an Indian pharmacist is one-sixth that of a US-based equivalent professional. However, though the fresh pharmacist is well equipped with the fundamental theory as part of his scope of work, it is found that they are not adequately exposed due to the application of theory. This we intend to effectively inculcate in them by ensuring practical working at shop floor of pharma companies as intern

In terms of remuneration, currently an Indian pharmacist is one-sixth that of a US-based equivalent professional. However, though the fresh pharmacist is well equipped with the fundamental theory as part of his scope of work, it is found that they are not adequately exposed due to the application of theory during the training period.

This process would ensure seamless transition from a student to a working professional with immediate effect and help them rise to the evolving regulatory challenge and other modern day work culture.

Can you elaborate on the curriculum on which the courses have been designed?

How are they aligned to develop the National Occupation Standards

devised by LSSSDC? Broadly, Indian workforce stands at 3.7 per cent in terms of the National Occupation Standards laid down while it is 97 per cent in South Korea and 50 per cent in China. This calls for an urgent need in bridging the gap vis-à-vis the academia and the industry and hence the curriculum has been devised with deliberations and inputs from functional experts. The curriculum has been aligned to specific needs of each job role in terms of theoretical conceptual

knowledge and practical application of it. The execution methodology of the curriculum has also been defined in terms of number of hours to be spent on each topic and internship with the industry.

Stringent global regulatory norms have made it imperative to develop a highly skilled workforce which would be competent to effectively meet quality standards and support the industry growth. What are

your initiatives in this direction?

Unlike in the past, when one could learn through trial and error, the current market environment does not leave any scope for making a mistake at any level. Hence a solitary mistake at the shop floor by a low-end employee has the potential to invite regulatory attention, which could be disastrous from a financial as well as good-will perspective for the company in particular and the country in general.

With functional experts in the saddle, Pollux intends to take up case studies and failure analysis of those historical event that had a bearing on the Indian pharmaceutical industry and the solutions that needs to cope with such eventuality. These initiatives will considerably eliminate the errors that may otherwise threaten to blow out of proportion. lakshmipriya.nair@expressindia.com

CAMPUS BEAT

MCOPS bags recognition The rankings were based on academic reputation, employer reputation and research impact MANIPAL COLLEGE of Pharmaceutical Sciences (MCOPS) has been recognised

by QS World University Rankings of 2017.

"It is a remarkable achievement. We've always been proud of our pharmacy college," said Dr. H. Vinod Bhat, Vice Chancellor, Manipal University. He further said, “We are happy that the pharmacy and pharmacology stream of Manipal University has featured in the QS World University Ranking

by Subject 2017. This is the first time that Manipal University's subject stream is getting into world rankings, and it is a very high entry at 251-300 range. I am sure we'll see more subjects offered by this University like dentistry, medicine and engi-

neering, and will also feature in the world rankings in months

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to come.”

The rankings were based on

academic reputation, employer reputation and research im-

pact. "Coming after the No. 1 rank in India by NIRF, the QS Ranking is a shot in the arm for MCOPS to do better. As a premier institution under Manipal University, MCOPS has been in the forefront of education and research," said Dr Mallikarjuna Rao, Principal of the Pharmacy College.

The University support for infrastructural development and the several grants for research from government and non-government funding agencies have helped in the growth of MCOPS. The students and staff of the college are excited about the new status of the college. Dr Rao added, "We will work assiduously to move up the ranking."

EP News Bureau

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