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Market
‘Differentiation through quality needs to be the success mantra’
16-28 FEBRUARY 2017, ` 40
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CONTENTS Vol.12 No.8 February 16-28, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS
All bluster and no lustre?
MARKET UTKARSH PALNITKAR Partner, KPMG in India, National Head – Infrastructure, Government
With little or no financial incentives in Union Budget 2017, the pharmaceutical industry remains deprived of a cure for its ailments | P12 -15
CHRISTOPHER STIRLING Global Chair, KPMG Life Sciences, KPMG International
Mumbai Sachin Jagdale, Usha Sharma,
‘The Budget has not specifically addressed imminent challenges directly affecting the sector’
Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja
Utkarsh Palnitkar,
New Delhi
National Head – Life Sciences Practice, KPMG India
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‘DIFFERENTIATION THROUGH QUALITY NEEDS TO BE THE SUCCESS MANTRA’
MANAGEMENT
Prathiba Raju
National Design Editor
‘The budget initiative of STRIVE would be of great help for the Indian pharma industry’
Bivash Barua
Hemant Deshpande,
Asst. Art Director
CEO, Pollux
DESIGN
16 20
Pravin Temble
Rekha Bisht
‘The budget provides the necessary impetus to sustain GDP growth at over 7 per cent’
Graphics Designer
Glenn Saldanha,
Gauri Deorukhkar
Chairman and MD, Glenmark Pharma
Senior Designer
Senior Artist
Photo Editor
‘We appreciate govt’s intent to amend Drugs and Cosmetics Act’
Sandeep Patil
Kanchana TK,
Rakesh Sharma, Vivek Chitrakar
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Regional Heads
Kailash Purohit – South
‘There will be significant increase in governmental spend on vaccination and medicinal therapy, hence pharma players in this space would stand to gain’
Debnarayan Dutta - East
Amit Mookim,
Marketing Team
GM, South Asia, QuintilesIMS
Prabhas Jha - North Harit Mohanty - West
E Mujahid
'There is no other major announcement to stimulate or accelerate growth of API manufacturing’
Mathen Mathew
Jayant Tagore Madireddy,
Nirav Mistry
President, Bulk Drug Manufacturers Association (BDMA)
Ambuj Kumar
‘PHARMA INDUSTRY IS HEAVILY REGULATED AND HIPAA COMPLIANCE MANDATES THAT THE INDUSTRY ENCRYPTS ITS DATA’
PHARMA LIFE
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Ajanta Sengupta
ONCOLOGY COMPANION DIAGNOSTICS MARKET WILL APPROACH $414 MILLION BY 2023: GLOBALDATA
PHARMA TECHNOLOGY REVIEW
Director General, OPPI
MARKETING
BETTING ON BEAT
ATTRITION AT THE FIELD FORCE LEVEL IS BETWEEN 20 - 30 PER CENT AND AT MANAGEMENT LEVEL BETWEEN 8- 15 PER CENT
Rajesh Bhatkal PRODUCTION
‘High allocation to rural sector has set the right tone’
General Manager
Rajiv Gandhi,
BR Tipnis
CEO & MD, Hester Biosciences
Manager Bhadresh Valia
Express Pharma®
Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar
Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
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EDITOR’S NOTE
Beyond the budget
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he hype around the Union Budget 2017-18, especially after Prime Minister Modi's December 31 address was high but the general consensus is that it has failed to address most of the issues facing the pharma sector. Once again. The Budget would have been a good time to announce certain fiscal incentives. For instance, weighted deduction on R&D would encourage innovation, while there could be an incentive scheme for patents. Exemptions of certain duties and taxes, encouraging API production, were other among other measures, on the pre budget wish list of pharma companies. There is no doubt that Finance Minister Arun Jaitley has a juggling act to do, with too much to do and too little (time of resources) to dole out. It is now hoped that dole outs to other related segments like healthcare, agriculture, MSEs, etc will help the sector in indirect ways. In fact, some industry leaders and associations are heaving a sigh of relief that no more taxes have been added to the pharma sector. In some cases, the FM has been very vague. For instance, his restating of the government's intent to amend the Drugs and Cosmetics Act to ensure availability of drugs at reasonable prices could give the pharma companies some sleepless nights, if the Act is amended to mandate the use of generics instead of brand names. Similarly, the scrapping of the Foreign Investments Promotion Board (FIPB), as part of the government's ease of doing business initiative, might prove to be one less hassle for foreign investors looking to invest in the sector. So even though other strictures continue, we might see more foreign investments into the pharma sector. Tax rates for MSMEs were reduced and this is expected to spread some cheer among pharma MSMEs. The increased fund allocation for vocational training could see more emphasis on and uptake of skill building courses in the pharma sector which will result in a better trained workforce. The biotech sector was completely bypassed in this budget, even though this is the next big opportunity as almost 10 blockbuster biologics are due for patent expiry by 2020. It is left hoping that the extra push on vaccinations will boost the earnings of vaccine manufacturers The healthcare segment has been luckier, with
The notification of the Medical Devices Rules 2017 a few days after Budget Day could mean that the reverberations of the FM's speech could continue through the year
budget estimates for health getting a boost of more than 27 per cent, from `37061.55 crores in 2016-17, to `47352.51 crores for 2017-18, focussing on public health measures. Two new AIIMS were announced, as well as 5000 new post graduate medical seats per annum. The FM also announced plans to eliminate infectious diseases like kala azar, filariasis and tuberculosis and convert 1.5 lakh health subcentres into health and wellness centres. In a bid to improve the health of pregnant women and their children, the FM announced aid of `6000/- if the delivery was institutional and if the child was immmunised. Senior citizens will now have separate health cards. But given the mammoth gaps, even this is being seen as too little. Another mention in the FM's budget speech on February 1 was the intention to come out with a separate set of rules for medical devices, focused on reducing cost of such devices. The draft Medical Devices Rules 2016 was notified in October last year and there have been consultations with difference segments of the medical devices sector. The FM's budget announcement was followed within two days with the notification of the Medical Devices Rules 2017 as of January 31 this year and to come into force from January 1 next year, giving the industry ample time to study them and engage in a dialogue with the government for changes. The reaction from the medical devices industry was mixed, with some sections claiming that the Rules were more stringent than global rules, even while claiming to be framed in conformity with Global Harmonisation Task Force (GHTF) framework. But the mere fact that the notification came a couple of days after the FM's announcement is a clear signal that he means business and will action every Budget Day promise (or threat). If this is so, the reverberations of the FM's Budget speech could continue through the year. For instance, if the Drugs and Cosmetics Act is amended to mandate generic names of medicines on prescriptions in a bid to break the monopoly of some brands, this could be a major inflexion point for the sector. Pharma companies will have to change their marketing tactics as the purchase decision shifts from doctors to chemists and pharmacists. We will just have to wait and watch.
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
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MARKET I N T E R V I E W
‘Differentiation through quality needs to be the success mantra’ Utkarsh Palnitkar, Partner, KPMG in India, National Head – Infrastructure, Government & Healthcare; and National Head – Life Sciences and Christopher Stirling, Global Chair, KPMG Life Sciences, KPMG International speak on trends driving the pharma sector in India and globally, emerging revenue and business models in volatile market conditions, growing role of R&D in Indian pharma and more, in an interaction with Viveka Roychowdhury. Excerpts How will President Trump impact India’s pharma sector? Palnitkar: The US is the single largest export destination for India; out of the total $15.2 billion pharma exports from India, the US share was $4.2 billion (27.9 per cent). From FY13 to FY15, exports to the US has increased by 15 per cent. The Indian pharma industry is aligned with President Trump’s vision of containing drug costs and making healthcare affordable. India is expected to remain a preferred source of safe, effective and affordable medicines to millions in the US, notwithstanding the recent comments of Trump’s administration on high drug prices and a new proposed process for bidding which could indicate a challenging environment for all generic players exporting to the US, including India. These are however early days to comment on how the new US administration will impact the sector. Comment on PM Modi's approach to healthcare initiatives like UHC. Palnitkar: Evident challenges around high out-of-pocket spending, inequality of services and fragmented social and regulatory standards are forcing stakeholders back to the policy drawing board. Further, with the voice for UHC gaining traction, it is becoming imperative for the government
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companies have slowly begun to deploy technology to engage more with patients. Sooner than later, a ‘patient-centric healthcare’ approach is expected to shape up as the driver of the life sciences industry where quality and affordability of care remain fundamental.
Utkarsh Palnitkar
Christopher Stirling
and other stakeholders to reassess and redesign the current healthcare system. While the government has always had positive intentions for healthcare in India, the missing pieces around implementation; effective oversight; competent policy framework and pertinent regulations to meet our national health goals and build UHC, need to be tackled without further delay. Stirling: The Netherlands model of mandatory health insurance has demonstrated that providing guaranteed quality and affordable healthcare is possible – an effort which has been praised around the globe. This model can stimulate Indian policymakers to embrace a health security model that aspires to deliver healthcare without having to suffer any fiscal hardship. How is the patient impacting
the life sciences business model, globally and in India? Stirling: Considering that the new patient pool is well-informed about treatments and medicines, in developed countries such as the US and the EU – payers (insurance companies) are looking forward to ink different healthcare plans with an outcome/value-based pricing model, especially for highpriced and specialty drugs — oncology drugs, Hepatitis C treatment, etc. Enhancing the patient experience via better efficacy of drugs drives valuebased pricing instead of volume-based pricing. These market dynamics have led global life sciences companies to think of transformative ways that could replace traditional blockbuster drugs, incremental innovation and physician-preferred models to patient-centric models. In India, life sciences
How do quality and pricing issues impact the revenue and business models of life sciences companies? What should be the top five focus areas of growth for life sciences CEOs ? Stirling: The pharma sector is at crossroads. In a heavily disrupted marketplace, characterised by shifting payer attitudes and patient empowerment, neither incremental adjustments nor steady evolution are likely to halt the decline of the traditional pharma business model. With rising demand for healthcare and falling budgets, governments and payers are exerting pressure to drive down prices. One bold example involves the Netherlands; not content with striking volume deals with the major pharma players, it is looking to utilise the power of the EU to create even greater economies of scale. At the moment, several member states are pooling together into a single procurement machine with much greater bargaining power. This initiative, in its early stages, is also being
looked at by other EU states seeking to cut their drug expenditure. Going forward, life sciences companies need to focus on new drugs to shore up growth, embrace technology to increase efficiency and compliance, emphasise on collaboration and partnerships, and focus on patient-centric business models. Life sciences companies that manage to embrace the evolving regulatory environment, and master disruption, will likely have the greatest chance to deliver real value. Many of the bigger Indian life sciences companies have invested in R&D. Are these viable bets? Palnitkar: The top 25 Indian companies increased their R&D expenditure from 7.1 per cent in 2014-2015 to almost 7.8 per cent of their consolidated net sales in 2015-16, however this is still low compared to global life sciences companies who spend over 17 per cent of their net sales on R&D. With enablers such as access to skilled manpower, presence of quality technical institutes, and exposure to global multinationals, the journey from generic to innovator has only just begun in India. This journey is expected to help Indian companies in an environment where there is high competition in generics, tighter scrutiny by drug regulators, higher usage of biologics drugs, and budget
cuts by government. How do Indian life sciences firms in the biologics arena fare? Are Indian laws on biologics good enough to create a promising ecosystem? Palnitkar: Indian life sciences companies have developed significant expertise in biologics; with almost 10 blockbuster biologics due for patent expiry by 2020. The global biosimilars market is forecasted to grow to approximately $24 billion in 2019 as compared with $5 billion in 2015. Simultaneously, Indian firms are increasing their investment in biosimilars to secure the early mover advantage. India has been a blooming biosimilars market with maximum approved biosimilar products (50) market as compared to 16 in Europe and only two in the US.
The Indian government has been proactive and has modified biosimilar guidelines from time to time, to reflect the latest regulatory thinking. The guidelines are expected to further evolve as new data and analysis technologies come into play to provide a promising ecosystem for biosimilar development in India. Have bigger Indian life sciences firms succeeded in evolving beyond the generics tag on a brand perception level? What should be their strategy? Stirling: Indian life sciences companies are still largely focused on a low-pricing approach. However, in the changing pharma landscape where margins are low and competitive pressure is high, companies need to diversify their product range, adopt differential strategies and focus
on evolving as innovators. An incremental shift in the business model, and a refocus on new fields of play, can help pharma firms adapt to disruption. Three type of ‘archetype’ are expected to prevail in the future life sciences industry. The active portfolio company: A company that is primarily active in several therapeutic areas within its portfolio. For e.g., those operating in pharma tech, genetics and immunotherapy are constantly looking for new forms of therapy, while simultaneously reappraising their product mix to match unmet needs. Such manifestation helps these modular organisations become flexible to take advantage of opportunities. The virtual value chain orchestrator: Companies that offer ‘virtual value’ through
various types of virtual solutions without owning anything physical. Similar to virtual platforms in healthcare where multiple advices are offered by the platform owner to patients virtually, from advice on diet and lifestyle, monitoring of conditions via wearables, and access to physicians, drugs, devices and possibly even replacement organs. The niche specialist: A smaller, organised player focused on a single therapeutic area or disease, who looks at the entire patient pathway from prevention to real cure like a Denmark Headquartered company, which focuses on diabetes. In the long run these players can become part of a portfolio company, to gain greater access to funding, to enable the provision of combined therapies, and/or to collaborate with a virtual value
chain orchestrator to connect with a broader client population. It is clearly up to the Indian companies to decide their way forward by adopting one of the above business models and differentiate themselves. The companies need to become more integrated with the health system/customer by offering services (training, supply chain management, operations outsourcing) and potentially, a more performance-based contract scenario. Differentiation through quality and moving beyond the product needs to be the success mantra. Domestic companies need to look into the Indian market for innovation instead focusing outside of India, where geopolitical and pricing pressures will likely only continue to make things challenging. viveka.r@expressindia.com
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cover )
All bluster and no lustre? With little or no financial incentives in Union Budget 2017, the pharmaceutical industry remains deprived of a cure for its ailments
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( ‘The budget has not specifically addressed imminent challenges directly affecting the sector’ he life sciences sector had great expectations from the Budget not only from a fiscal incentives perspective but also from a regulatory angle; more so, given the government’s vision of making India one of the top-three pharma markets by 2020. However, this year, too, no specific impetus was given to the sector. While the move to eradicate certain diseases; the proposal to set up two new AIIMS; additional post-graduate medical seats; proposed amendments in the Drugs and Cosmetics Rules; and new
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UTKARSH PALNITKAR NATIONAL HEAD – LIFE SCIENCES PRACTICE, KPMG INDIA
rules for medical devices are welcome, the Budget has not specifically addressed imminent challenges directly affecting the sector. In order to stay competitive in the overseas market and given the uncertain global climate, it was expected that specific impetus or incentives would be given to innovation in the form of weighted deduction on R&D, incentives for patents, exemptions of certain duties and taxes, etc. These demands remained largely unaddressed, giving no specific reason to cheer for the sector as a whole in 2017–18.
‘The budget provides the necessary impetus to sustain GDP growth at over seven per cent’ verall, the Union Budget 2017 that was presented earlier today is a step in the right direction. While it has focussed on economic reforms and liberalisation of the economy, it has also allocated funds to bring more irrigation, roads, electricity and sanitation to rural India. Even though the economic survey paints a sober picture for 16-17 primarily due to a weaker second half, the budget provides the necessary impetus to sustain GDP growth at over seven per cent. Lowering tax on MSME’s is a welcome step that would provide a much needed fillip – by creation of jobs and putting more money in their pockets in all sectors includ-
O
GLENN SALDANHA CHAIRMAN AND MD, GLENMARK PHARMA
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ing pharma. The government has shown its clear intent towards fast-tracking inflow of FDI, and the scrapping of FIPB is a notable step that would go a long way in supporting the objective of ease of doing business. Additionally government’s impetus to reduce the borrowing cost and increase access to credit will surely help businesses to grow. We see the biggest ever allocation to the infrastructure sector which would benefit all sectors, including the fast growing pharmas. The FM reiterates his commitment to keep current account deficit and fiscal deficit under control GST implementation as soon as possible.
THE MAIN FOCUS
‘The budget initiative of STRIVE would be of great help for the Indian pharma industry’ he budget has increased its allocation to `3016 crores, up by 67 per cent and 39 per cent over the budgeted estimate and revised estimate of the last budget. From a pharma industry perspective, the budget initiative of Skill Strengthening for Industrial Value Enhancement (STRIVE) to be launched in 2017-18 at a cost of `2,200 crores would be of great help for the Indian pharma industry, which has already gone global both in regulated and non-regulated markets.
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HEMANT DESHPANDE CEO, POLLUX
‘We hoped for some reform announcements on the regulatory front’
KANCHANA TK DIRECTOR GENERAL, OPPI PPI welcomes the commitment of the Government to - reduce infant and maternal mortality rates; eliminate certain diseases like TB, leprosy, measles and filaria and make structural reforms in medical practice and education. The Government’s intention of
O
transforming 1.5 lakh health sub-centres is encouraging. We also appreciate the Government’s intent to amend the Drugs and Cosmetics Act which will be a step towards ensuring patient safety. We had some expectations from the Union Budget 2017-18, given the Government’s past stated intentions of improving access to healthcare. Yesterday’s World Economic Forum said that that India’s public spending on healthcare is much lower than the global average. It is unclear whether the allocations will adequately address current healthcare challenges. We also hoped for some reform announcements on the regulatory front in the form of weighted deduction on R&D, incentives for patents, exemptions of certain duties and taxes, etc.
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cover ) ‘There will be significant increase in governmental spend on vaccination and medicinal therapy, hence pharma players in this space would stand to gain’
AMIT MOOKIM, GM, SOUTH ASIA, QUINTILESIMS
he Union Budget 2017 was presented in the backdrop of huge aspirations of the healthcare industry as we strive to make healthcare accessible and affordable to each and everyone in the country. Therefore, healthcare for ‘poor and underprivileged’ being one of the top themes of the government, is a positive sign for the industry. The focus has been largely on digitisation across sectors. The launch of Digi Gaon and Aadhar based health cards is a huge step towards digital revolution in healthcare delivery
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ecosystem enhancing overall patient care and experience. Access to tertiary health care in India is currently facing a huge challenge due to shortage of doctors. The move to open AIIMS hospitals in Jharkhand and Gujarat, increase in PG medical seats, and impetus to tertiary care centres and specialist doctors will help in addressing the challenge related to availability of healthcare professionals in hospitals and bridge the demand supply gap. The plan to transform 1.5 lakh health sub centres into health and wellness centres is a welcome move which will
play a role in decreasing the load on existing healthcare infrastructure and help in further evolution of primary care, prevention and screening, thus reducing the disease burden in the long run. Furthermore, the government’s plan to eradicate diseases like leprosy and TB is an important step as these constitute major public health challenge that undermine social and economic development of a nation. This action plan will mean that there will be a significant increase in governmental spend on vaccination and medicinal therapy, hence the pharma players in this space would stand to gain with large scale revamp of the current government campaign on such life threatening diseases. The plan implementation will also help in further evolution of other emerging models of healthcare with more private players being interested in this space. At QuintilesIMS, we capture close to 380 pharma companies who have a sales revenue of less than `50 crores. The number of active pharma companies having a turnover below `50 crores would be over two thousand. As per the current budget announcement, the corporate tax rate for MSMEs having revenues less than `50 crores will be down to 25 per cent. Providing tax relief to such players will improve their bottom-line and growth in the face of stiff pricing competition and high share of voice from the large pharma companies with an army of sales reps and complete portfolio of products.
'There is no other major announcement to stimulate or accelerate growth of API manufacturing’
JAYANT TAGORE MADIREDDY PRESIDENT, BDMA
he Union Budget 2017-18 has not made any effect on the pharma industry, other than MSMEs getting some reduction in the tax rate on the profit if they earn it. There is no other major announcement to stimulate or accelerate growth of API manufacturing or the pharma industry as such. It is a neutral budget and I'm glad that they (Central government) didn't add any tax burden on the users. As for the pharma industry, it has never been a favourite of the government unlike other industries like IT. We were the last looked at in terms of industry, we are what we are despite what the government did not do for us. So, we don’t expect any preferential treatment because we are into life sciences, a knowledge-based industry. We know how to survive in the world, if we can survive in 220 countries I'm sure we can manage in India. With our Prime Minister hoping for inexpensive good healthcare for general public, we would be continuing to make medicines at cheaper cost, without any incentives or enforcement of the government.
T
(
THE MAIN FOCUS
‘High allocation to rural sector has set the right tone’ www.pharmalab.com
CUSTOMER SUPPORT
RAJIV GANDHI CEO & MD, HESTER BIOSCIENCES
overnment’s objective is long term growth and it is trying to rationalise all issues for a good sustainable growth in years to come. High allocation to rural sector has set the right tone. Giving relief to smaller businesses and taxpayer was much needed to widen the tax net as well as incentivise businesses to come into the main stream of financial legitimacy. Initiatives on women empowerment, rural electrification, housing for all, more roads for villages and focus on employment generation will definitely strengthen the rural economy.
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BETTING on
BEAT Bouyed up with promising research results, Glenmark seems to be revving up for some major out-licensing deals. Do they finally have a blockbuster waiting in the wings? Will their bets pay off? By Viveka Roychowdhury
L
ast December, Glenmark Pharma unveiled its strategic blueprint for the next decade. In the 16 years since its IPO in 2000, the Mumbai-headquartered company has achieved many milestones. It has grown into a global entity, from two formulation facilities in 2000 to 17 facilities across four continents, seven of which are approved by the US FDA. International revenues have grown from eight per cent to 70 per cent of total revenues. Consolidated revenue went from $31 million in 2000 to $1.2 billion in 2016. But more importantly, the management realised that the generics game was not sustain-
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able as a sole business and hence took the first steps into new molecular entity (NME) research in 2000. The announcement in December was a reaffirmation of this stance, even though the company today is a leading player in the generic dermatology space in the US and has filed approximately 200 drug master files (DMFs) in various markets in the API business segment. Its three business segments clocked healthy CAGRs over the past five years, with APIs at 21 per cent, followed by generic formulations (20 per cent) and branded formulations (19 per cent). There have been seven
Products derived from the BEAT platform have the highest potential Dr Kurt Stoeckli President and CSO, Glenmark Pharmaceuticals
out-licensing deals since 2004, with the likes of global majors like Forest Laboratories and Teijin (2004-05) , Eli Lilly and Merck (2006-2007), and Sanofi (2010-11). In fact for 2011, a year after the IPO, the company won two awards from the Londonbased SCRIP as the 'Best Company in Emerging Markets' and 'Best Overall Pipeline'. Even though all three out-licensed molecules ultimately suffered setbacks before the Sanofi deal too fell through, Glenmark had clocked cumulative revenues of over $20 million.
R&D roulette Pharma R&D has always been a high risk-high reward game, a
Russian roulette at best. And Glenmark has been one of many hopefuls, chasing dreams of a blockbuster, only to have them turn to dust. In October 2008, Eli Lilly stopped clinical trials of Glenmark's pain drug molecule after adverse findings. In August 2009, Glenmark's first outlicensed molecule, oglemilast, was terminated by Forest as Phase IIb dose range studies on the COPD molecule were not successful enough. Glenmark's deal on oglemilast with Teijin Pharma for the Japan market also met the same fate. Not all of the out-licensing deals were terminated because the molecule was snuffed out due to unimpressive data. For
instance, in October 2006, Glenmark had out-licensed melogliptin for type-2 diabetes to Merck. But less than two years later, in February 2008, the MNC decided to refocus its portfolio and stop further investments in diabetes R&D. This, in turn, led to R&D on Glenmark's molecule being terminated. Coming after these disappointments, the Sanofi deal in 2011 for one of Glenmark's first monoclonal antibodies, vatelizumab (GBR 500) was seen as a major positive for Glenmark, but Sanofi too decided to return the molecule in 2016. But Glenmark has not given up. It is very clear from the strategic blueprint released in December that going forward, the engine of the next level of transformation will clearly be the R&D pipeline, which seems to have three main areas of focus: oncology (the company has four NOEs from preclinical to Phase 1), dermatology (one NME in Phase 2) and respiratory (four NOEs, in preclinical to Phase 3). The 10th molecule is for pain and is in the Phase 2. Any one of these 10 NOEs are potential candidates for outlicensing deals in addition to four NOEs which have been classified as non-core assets. The market is already sniffing out the molecules with promise. The HDFC Securities report says that the company believes that GBR8383 (which is in preclinical phase) is going to be a groundbreaking product and is showing better efficacy than current treatments. Glenmark's earliest NDA/BLA filings, as per currently planned studies, is in 2019, for two respiratory molecules in the speciality area, GSP301, currently in phase 3 and GSP304 currently in phase 2. With a mission statement to "transition into an innovationled global pharmaceutical organisation over the next decade, the identified focus 'growth catalysts' besides NOEs, are filing as many as nine new drug application (NDA)/biologic license application (BLAs) in the next 10 years and targeting 30 per cent of total revenues from specialty and innovation segments over
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the next decade. The change in the distribution of ANDAs across segments also give a hint of Glenmark's chosen path. In FY12-16, the “ANDAs were distributed across just four segments: the bulk of 46 per cent in oral solids, followed by topicals (21 per cent),
onco injectables (18 per cent) and oral hormones (15 per cent). Contrast this with the projected picture for FY17-21, when oral solids will shrink to 22 per cent, topicals grow to 35 per cent, onco injectables reduce to 12 per cent, hormones reduce to eight per cent with two new
segments, drug-device combinations (16 per cent) and controlled substances (seven per cent) are sure to play a significant role.
Muted market reaction But Glenmark's R&D play in the last 16 years, has taken a toll on the balance sheet, as had cur-
rency fluctuations. The market is cautious about Glenmark's strategic blueprint. With a Neutral rating, an HDFC Securities Institutional Research report in response to Glenmark's strategy says, "Although we believe Glenmark's strategy to invest in three lucrative therapies
MANAGEMENT enthuse us, it is a long term play and monetisation remains the key. Due to the increase in R&D spend on specialty and novel pipeline, the possibility of debt reduction with gZetia cash flows could be limited. Free cash flows have been weak historically and the balance sheet is also heavily leveraged.” According to the company, it has around approximately 15 in-licensing deals either signed or in advanced discussion stage but most of these opportunities are likely to be monetised post FY19E. Hence external partnerships will be key to grow its business, with launches expected from 2HFY18. Estimates are that the total market size of deals under discussion is approximately $12 billion. Glenmark has already executed agreements for products such as generic Abraxane, g-Nuvaring and g-Suboxone. The company will also be launching inhalers in the next three-four years, looking to target multiple new dosage forms as a differentiator against competition. Two of these additional new dosage forms could be launched in CY18 and CY19.
At the helm So will Glenmark succeed this time? Will any of these NOEs turn out to be the blockbuster that Glenmark needs to validate its strategy? And is there anything different this time around when the company sits at the out-licensing deal table? Steering this next level of strategic growth on the R&D side, is Dr Kurt Stoeckli, President and CSO, Glenmark Pharma who joined the company last October. No stranger to India, he's quite familiar with the country, having visited several pharma R&D and manufacturing sites here during his two decades with MNC pharma companies Sanofi and Novartis/Sandoz. Clearly, he doesn't see the move from MNC to Indian pharma as a step down. “My motivation to join Glenmark is the potential of the pipeline and secondly, the vision of the leader, Glenn Saldanah.” As promoter and Chairman and MD of the company, Saldanah has ensured that the company set up by his father has more than held its
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Filings expected from Glenmark’s NME and specialty portfolio in the next decade
Source: Company presentation, above timelines are based on currently planned studies and may change based upon data, regulatory agencies feedback etc.
THE HEART BEAT OF GLENMARK'S ONCOLOGY PORTFOLIO The BEAT platform, which stands for Bispecific Engagement by Antibodies based on the T cell receptor, is built around the concept of binding at least two targets with one single bispecific antibody.Though an attractive concept to design new therapeutics, for the past two decades, bispecific antibodies have reportedly posed a challenge to the industry since all antibody formats developed so far have had stability and/or manufacturing issues. In terms of the biology of the BEAT platform, according to the company website, a major challenge in the engineering of bispecific antibodies is to produce a heterodimeric bispecific antibody without the presence of contaminating homodimeric antibodies. Glenmark’s scientists turned to nature to solve this engineering problem and designed a bio-mimicry strategy to establish a stable heterodimer. Hijacking the T-cell receptor (TCR) constant domain alpha/beta interface found on natural T-cells and grafting it onto the antibody CH3 homodimer interface results in two different heavy chains that readily assemble.This innovative solution results in an antibody highly similar to a natural one as only the buried interfaces of the CH3 homodimer domains are modified. On the technology side, BEAT antibodies have demonstrated excellent stability and production yields. By implementing a “built-in”purification technology, Glenmark has been able to achieve a very high degree of bispecific purity after a single Protein A chromatography step. The unique advantages which make BEAT a best-in-class technology to produce bispecific antibodies is the levels of stability, purity and scalability of the process, which have not yet been manufactured from a stable CHO cell line using standard processes. (Source: Company website)
own against it peers in India and globally. Stoeckli finds the pipeline attractive and his priority will be to make sure that we can realise what is there, turn it into late stage products and take them to market. “Coming from Big Pharma, I was always exposed to the challenge of moving out of Europe to establish small molecule manufacturing sites in India because of the cost effectiveness that we have here in this domain. Now, I find it quite interesting and remarkable being exposed to the opposite. The vision of Glenn (Saldanah, promoter and Chairman and MD) to expand into innovation globally is a good
vision to support.” You get a sense of the urgency when he says, “I want to make sure that we will rapidly follow up on the priorities,” by further selecting the top priorities within the focus areas of research portfolio and making sure that resources are aligned to pursue them. Stoeckli is in fact no stranger to Glenmark's R&D portfolio. While he was at Sanofi, in 2010, he was part of the decision to in-license one of Glenmark's first monoclonal antibodies, vatelizumab (GBR 500), an antagonist of the VLA-2 (alpha2beta1) integrin, for testing in a Multiple Sclerosis (MS) Phase II
clinical study. Sanofi ultimately decided not to pursue further vatelizumab as a potential Relapsing-Remitting MS therapy, following the results of a pre-planned interim analysis that revealed the primary efficacy endpoint was not met. This decision was not due to safety concerns and with termination of the contract with Sanofi becoming effective in Q1 FY 2017, GBR 500 is now one of Glenmark's top candidates for relicensing. In his role in Sanofi as Group VP, Global Biopharmaceuticals Division & CSO for R&D France, Stoeckli played a pivotal role in fostering and managing Sanofi's
JV with Regeneron Pharmaceuticals. He is known for his successful leadership of scientific teams responsible for discovery and development of both NBEs and NCEs, steering more than 20 projects as they advanced to clinical stages (ranging from Phase 1 through Phase 3) in the areas of autoimmune and inflammatory disorders, and oncology. With Glenmark's focus on biologics, his extensive industry experience in driving biologics from early research up to Phase 3 is obviously key to achieving the company's strategic blueprint for the next decade. His predecessor, Dr Michael Buschle has been designated as Glenmark’s Chief Scientific Mentor and will continue to work on the company’s worldwide drug discovery programmes and pharma development, according to a company release.
Betting on the BEAT platform Cherry picking from the pipeline of the top priority areas, it is clear oncology is first. As Dr Stoeckli reasons, "We put a lot of priority on the oncology sector. Which goes hand in hand with a number of things. First, Glenmark has done a great job in establishing a platform technology, BEAT, a second generation antibody platform, which is all about the engagers of immune cells. (See box: The heart BEAT of Glenmark's oncology portfolio) In my view, the products derived from this platform have the highest potential because they rely on very well understood mechanisms, validated targets. So we have combined validated targets with novel mechanisms of killing cancer cells. So we've de-risked at this point. And knowing how to deal with mechanisms means that we already have the ways to translate this into our clinical strategies. Having this information also allows our colleagues in clinical to size the studies properly, it’s not trial and error. The segment of patients can be selected. It is a targeted approach. And the alignment and full integration of research, in a patient centric way, makes for topnotch R&D today. That is how innovation can be
MANAGEMENT somehow controlled from a risk perspective." He also points out that as the three front liners, GBR1302 (which is a HER2 X CD3), GBR1342 (CD38 X CD3) and GBR1372 (EGFR X CD3), are in all segments, there is clearly a very high unmet medical need. Despite the fact that a lot of progress has been made, even the best standard of care, only reaches 30 per cent of patients. So, Glenmark clearly sees a huge opportunity. The focus on immunotherapy could not just see these molecules as novel monotherapies but also eventually as combination immunotherapies. Stoeckli points out that this is a big trend today with both big pharma and biotech companies as nobody can predict which combination will be the best in which indications. He mentions an example of a checkpoint combo programme, when Johnson & Johnson (J&J) looked to partner for Darzalex (daratumumab) in combination with an PD-L1 drug atezolizumab which came from Genentech. Similarly, another molecule, GBR 8383, which is a very strong (OX40R) agonist molecule, a check point regulator against multiple cancers, can also be used either in combination with Glenmark molecules or molecules from other companies. This according to Stoeckli, is the the greatest opportunity for Glenmark, both from a risk management and a business opportunity perspective. He agrees that Glenmark has not been making a lot of noise about research results for a long time. The December 2016 strategic blueprint is in a way a signal that Glenmark now has research results good enough to talk about. He doesn’t share names of potential partners, but says, "Be sure that we are in touch with a number of companies, big and small, on a continuous basis. It is actually a good place to be now." And the BEAT platform is at the heart of this turning point. "We realised that once we had the BEAT platform and it gave us such exciting results over the last couple of months. This gave us the opportunity to expand into innovations. Frankly, the platform technology we've
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developed and the ability and capacity to scale it up all the way up to manufacturing, is not the only factor, but certainly one of the key enablers of making this change happen now. Glenn was able to capture this very early, get new people on board and helping the team to realise this vision." The question is, will the
company get the finances to pursue these leads, upto a point where bigger companies get interested? The blueprint freezes R&D investments at 11 per cent of sales but is this adequate? As Stoeckli says, "If you look at R&D budgets, even the biggest ones (pharma companies) tell you that it’s not enough. I've just heard that the CEO of Hoffmann
Roche Genentech, who spends $10 billion every year on R&D, said that his researchers come back to him ask for three times more than what he could actually spend. You could always spend more (on R&D). But you have to be disciplined as well. We have decided for strategic reasons to keep it at this level in a very disciplined way.
Partnering would also help us in managing this." The proof of Glenmark’s strategic blueprint will only be visible 2019 onwards, when its first NDA is filed. Its first oncology BLA is projected to be filed in 2022. Hence, while the pipeline seems promising, will Big Pharma bite the bait? viveka.r@expressindia.com
MANAGEMENT REPORT
Oncology companion diagnostics market will approach $414 million by 2023: GlobalData APAC region to see highest growth rate driven by increased evidence and increasing uptake of low-cost molecular tests THE GLOBAL oncology companion diagnostic testing market across the 10 major countries of the US, France, Germany, Italy, Spain, the UK, Japan, China, India, and Brazil is set to rise from $260 million in 2016 to just under $414 million by 2023, representing a compound annual growth rate (CAGR) of 6.9 per cent, according to research and consulting firm GlobalData. The company’s latest report states that the Asia-Pacific (APAC) region is set to see the highest growth rate in this market, with China and Japan
expected to increase with CAGRs of 9.4 per cent and 7.9 per cent, respectively, driven both by increased incidence and increasing uptake of low-cost molecular tests. Companion diagnostics are devices which detect the presence of a specific biomarker that is linked to a disease condition or therapy in order to ascertain how a patient will respond to a particular treatment. To cope with rising costs, hospitals are moving to evidence-based care and treatment paradigms to lower expenditures.
Nadia McLurcan, GlobalData’s Analyst covering Medical Devices, explains, “It is widely recognised that not all drugs are effective for all individuals and the most ineffective drugs, such as those for cancer, are also the most expensive, and have the most profound and debilitating side effects. “Companion diagnostics enable physicians to better predict how individual patients will respond to treatment before it is administered, allowing physicians to choose the best possible dose from the
start of treatment. Costs might also be reduced, as there is no need to use expensive treatments on populations who are not going to respond.” One significant challenge in the companion diagnostic market is reimbursement. Adoption is highly dependent on reimbursement policies, so approval of new tests does not necessarily signify immediate adoption. If the molecular test cannot be reimbursed, adoption will be low. McLurcan notes, “The emergence of new companion diagnostic tests is also highly
dependent on the success of the drug pipeline. As a result of increased regulation, new companion diagnostic tests are being developed in parallel to their new drugs; thus, the fate of the companion diagnostic is tied to the success of the drug during clinical trials. “Diagnostic test manufacturers can eliminate the risk associated with this process through multiple partnerships, or by developing new companion diagnostic tests that are also aimed at stratifying patients for existing therapies.”
Asia-Pacific seasonal influenza vaccines market to surpass $1.7 billion by 2022: GBI Research Growth will primarily be driven by increasing affordability, rising healthcare access in India and China, and subsidised immunisation for the elderly in Australia, Japan and South Korea THE SEASONAL influenza market across the Asia-Pacific (APAC) region, which includes India, China, Australia, South Korea and Japan, is forecast to grow from $1.24 billion in 2015 to $1.71 billion by 2022, at a compound annual growth rate of 4.7 per cent, according to business intelligence provider GBI Research. The company’s latest report states that this growth will primarily be driven by increasing affordability, rising healthcare access in India and China, and subsidised immunisation for the elderly in Australia, Japan and South Korea. An increased incidence of seasonal influenza in the APAC region can be linked to its ageing population, mod-
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ernisation, changing dietary habits, excessive consumption of preserved food, and high incidence of influenza virus infection. Vivek Goswami, Analyst for GBI Research, explains, “Despite increasing demand driving growth in the APAC influenza vaccines market, the variability of this demand will prove the major obstacle in the treatment of the disease. Indeed, the demand for vaccines changes every season and is largely dependent on the weather, as well as the timing and severity of the influenza season. “Planning the production of a seasonal influenza vaccine is also difficult due to the slow egg-based manufacturing
The market will witness greater competition in the next six to seven years due to increased focus from large pharma companies
process currently in use. These factors render production a risky proposition, and vaccine manufacturers often supply more or less than demand.” Despite these issues, the approval of new quadrivalent vaccine therapies with novel administration methods and production technologies is expected to reduce the infection risk and improve compliance rates. It will also increase the coverage of influenza vaccines and boost revenue for manufacturers. In addition, the market will witness greater competition in the next six to seven years due to increased focus from large pharma companies. Goswami explains, “High
competition among large players will also help in bringing superior vaccines to the market and improve the supply of seasonal influenza vaccines in the APAC region. GBI Research’s analysis shows that the expected approval of various quadrivalent vaccines with novel routes of administration will decrease the market share of existing trivalent vaccines. “For example, the expected approval of both Daiichi Sankyo’s VN-100 and MEDI3250 in 2017 in the Japanese market will offset the impact of the currently available vaccines Flubik HA, Influenza HA Vaccine Kaketsuken TF, and Influenza HA Vaccine Seiken.”
MANAGEMENT
Antibacterial drugs market will hit $35.6 billion by 2022,as efforts increase to tackle antimicrobial resistance: GBI Research Use of protein synthesis inhibitors to grow but vaccines will be leading revenue generating drugs
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indications. “Merck’s blockbuster Prevnar, for example, has benefit-
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THE ANTIBACTERIAL drugs market is set to grow from $27.7 billion in 2015 to $35.6 billion by 2022, representing a CAGRof 3.97 per cent, as per GBI Research. The company’s report states that emerging companies and approvals of new products will drive this growth, along with the continued success of established marketed products Infanrix and Augmentin. Thomas Jarratt, Associate Analyst, GBI Research, explains, “In an attempt to tackle antimicrobial resistance, many companies are investing in the development of products active against bacteria that are known to be resistant to established classes of antibacterials. The use of protein synthesis inhibitors, for example, is expected to increase dramatically over the forecast period as a result of their effectiveness in treating drug-resistant bacterial infections.” With many protein synthesis inhibitors now off-patent, and with bacteria having developed resistance to a wide range of these drugs, GBI Research believes several of the pipeline drugs for the next-generation of protein synthesis will be approved and enter the market within the forecast period, and will benefit from the commercial focus on treating drugresistant infections. These include Solithera (solithromycin), Arikace (amikacin sulfate), Cadazolid (cadazolid), and Plazomicin (plazomicin sulfate). Jarratt continues, “Despite this influx of new protein synthesis inhibitors and the release of several new cell-wall synthesis inhibitors, vaccines will still be the leading revenue generating drugs in the antibacterial drugs market. Indeed, the lack of biosimilars for antibacterial vaccines means that generic competition does not impact on sales as it does for other types of drugs, and many developed countries implement schedules for vaccines preventing certain
ted greatly from this, and its efficacy in infants for the prevention of 13 serotypes of
streptococcus pneumonia, the causative agent in pneumonia, has led to widespread global
usage in vaccination schedules, culminating in very high revenue.”
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RESEARCH UPDATES
Agilent Technologies expands Dako’s CE Marked PD-L1 IHC 22C3 pharmDx companion diagnostics Patients with PD-L1-positive unresectable, advanced or recurrent NSCLC can now be identified for treatment with KEYTRUDA (pembrolizumab) using PD-L1 IHC 22C3 pharmDx
A
gilent Technologies ‘ CE marked Dako PD-L1 IHC 22C3 pharmDx can now be used to determine PD-L1 expression status to inform the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy manufactured by Merck or MSD as it is known outside the US and Canada. This intended use allows PD-L1 IHC 22C3 pharmDx to detect PD-L1 expression in both untreated and previously treated metastatic NSCLC patients. KEYTRUDA is now approved for the first-line treatment of metastatic NSCLC patients whose tumours express high levels of PD-L1 (tumour proportion score of 50 per cent or more) or for previously treated metastatic NSCLC patients whose tumours express PD-L1 (tumour proportion score of one per cent or more). This update of PD-L1 IHC 22C3 pharmDx means that the assay can be used to identify previously untreated patients with metastatic NSCLC expressing high levels of PD-L1 for
treatment with KEYTRUDA. Prior to this, chemotherapy was the standard first-line treatment for most NSCLC patients. Patients in the second-line or later treatment settings can also be identified for treatment with KEYTRUDA using PD-L1 IHC 22C3 pharmDx. PD-L1 IHC 22C3 pharmDx is the only assay shown to select NSCLC patients with benefit from first-line treatment with anti-PD-1 monother-
apy. “We are pleased that firstline metastatic NSCLC patients in Europe will now be included in the expansion of the intended use of PD-L1 IHC 22C3 pharmDx. With PD-L1 IHC 22C3 pharmDx, European pathologists have the ability to accurately identify the PD-L1 expression of a patient’s tumour, which ultimately enables the oncologist to provide the
best treatment for that particular patient” said Jacob Thaysen, President, Agilent's Diagnostics and Genomics Group. “Pathologists recognise the need for validated tests, and our companion diagnostic gives them a highly accurate tool to inform oncologists on PD-L1 expression.” “KEYTRUDA data continues to demonstrate the important role of PD-L1 testing in the
treatment of patients with nonsmall cell lung cancer in order to identify those patients most likely to respond to treatment,” said Dr Roger Dansey, Senior Vice President and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “The expansion of the companion diagnostic’s approval to include first-line evaluation means European oncologists have the ability to help even more patients with lung cancer.” NSCLC accounts for 80 per cent of all lung cancers. PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck & Co, Kenilworth, NJ, US, maker of the anti-PD-1 therapy KEYTRUDA. KEYTRUDA is a humanised monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. Reuters
Novartis' Votubia receives EU approval for new indication Votubia is used specifically for partial-onset seizures in children and adults with tuberous sclerosis complex NOVARTIS HAS broadened the indications for its Votubia drug, the company said, when the European Union approved its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex (TSC). Votubia
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is the first adjunctive treatment approved in the EU specifically for partial-onset seizures in children and adults with TSC, the Baselbased pharma company said in a statement. The decision marks the third TSC-related
TSC, a genetic disorder, affects up to one million people globally
indication for Votubia in the EU, where it is also approved to treat subependymal giant cell astrocytoma and renal angiomyolipomas. TSC is a rare genetic disorder affecting up to one million people worldwide. Ap-
proximately 85 per cent of individuals with TSC are affected by epilepsy, and uncontrolled seizures associated with TSC can be debilitating for patients. Reuters
Otonomy's ear infection drug succeeds in late-stage trial The drug, Otiprio, is approved for use in paediatric patients during tympanostomy tube placement surgery DRUG DEVELOPER Otonomy said its drug to treat Acute Otitis Externa (AOE), an infection in the outer ear canal, met the main goal in a late-stage trial. AOE, also known as swimmer's ear, is a type of bacterial infection causing inflammation in the external ear canal. The drug, Otiprio, is approved for use in paediatric patients during tympanostomy tube placement surgery. Children suffering from middle-ear infection, also known as Otitis Media with Effusion (OME), undergo a tympanostomy tube placement surgery to drain out ac-
cumulated fluid and simplify the administration of antibiotics. The company said it would submit a supplemental marketing application with the US Food and Drug Administration in the first half of 2017. Otiprio, which was approved in late 2015, generated sales of $300,000 in the third quarter of 2016. There are nearly four million cases of AOE each year in the US, according to the company. Reuters
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RESEARCH
Patients with Type 1 diabetes may need to check ketones more often Ketone monitoring is particularly important when patients with type I diabetes are sick MANY PEOPLE with Type 1 diabetes don’t check frequently enough for build up of ketones, acids that can cause serious damage to the kidneys and other organs, according to a US study. Ketone monitoring is particularly important when patients with type I diabetes are sick or have consistently high glucose levels, the authors write in Diabetes Care. “Ketones occur when the body burns fat instead of using carbohydrates for fuel,” lead author Anastasia AlbaneseO’Neill told. “If high glucose levels and ketones remain untreated, there is an increased risk for a life-threatening condition called diabetic ketoacidosis, which requires hospitalisation,” said Albanese-O’Neill, a paediatrics researcher at the University of Florida in Gainesville. Dangerously high ketone levels can happen to anyone with diabetes, though the problem is rare in people with Type II, according to the American Diabetes Association. People with Type I diabetes have lost the ability to produce
any insulin, so ketones can occur when insulin doses are missed, or when the body’s insulin requirements rise due to stress or illness, she said. “Monitoring for ketones as recommended allows for early detection and treatment. Ketone testing supplies are available over the counter without a prescription at a local pharmacy and online,” Albanese-O’Neill said. About five per cent of people with diabetes have Type I, according to the American Diabetes Association. Type I diabetes is most commonly diagnosed in young kids, and for that reason it used to be called juvenile diabetes. But the disease does not go away, and it can also be first diagnosed in adulthood. While children usually have caregivers to help them manage the disease, adults typically need to manage it themselves. Part of that management is regularly testing urine or blood for high levels of ketones. To see how well patients keep up with this requirement, researchers examined data from about 3,000 people who answered an online questionnaire
Participants included parents of children four to 12 years old and adults aged 18 to 89. More than 60 per cent of participants had urine ketone testing kits at home and 18 per cent had blood ketone monitors, researchers found. But about one third of the respondents did not have any ketone testing supplies in their homes at the time of the survey. If cost or other factors are a barrier to obtaining supplies, these need to be identified and remedied, Albanese-O’Neill said. Overall, 30 per cent of the study participants said they never checked for ketones, and 20 per cent said they rarely checked. Young kids were more
likely to have been tested for ketones compared to adults. “If they are uncertain when they should be checking for ketones, or don’t know how to test, they should ask their diabetes care team for additional education and training. This is a fundamental diabetes self-management skill for people with type I diabetes,” Albanese-O’Neill said. Diabetes care providers and educators should never assume their patients with type I diabetes know the proper protocol for ketone monitoring, she added. “Some may have been diagnosed before ketone testing was the standard of care, others may never have been taught, and
still others may have been so overwhelmed with the diagnosis that the knowledge was lost,” Albanese-O’Neill said. The diabetes care team has the opportunity during routine visits to evaluate patients’ understanding of ketone monitoring, and provide education and training as needed, she said. “Somewhere around 1 in 300 or 400 children in the US develop type I diabetes,” said Dr Michael Gottschalk, Associate Director, Pediatric Diabetes Research Center at the University of California, San Diego, who wasn’t involved in the study. There has been a steady three per cent annual increase in the number of cases in Europe and the US over the last decade, if not longer, he added. Gottschalk thinks parents are good at checking ketones in their young children. “But when it gets to adolescence that becomes an issue just in terms of compliance, and it seems that obviously, adults are no better or even worse than the adolescents,” he said. Reuters
Heartburn pills tied to serious bacterial infections Compared to people who didn’t use PPIs, those who did were at higher risk for a form of diarrhea caused by Clostridium difficile bacteria and Campylobacter infections, a form of food poisoning PEOPLE WHO take popular heartburn pills known as proton pump inhibitors (PPIs) may be more likely to develop intestinal infections than people who don’t take these medications, a Scottish study suggests. The pills work by stopping cells in the stomach lining from producing too much of the acid that can cause ulcers and reflux symptoms such as heartburn.
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Researchers examined data on about 188,000 people who used these drugs and about 377,000 similar individuals who didn’t take PPIs. Compared to people who didn’t use the drugs, those who did were at higher risk for a severe form of diarrhea caused by the Clostridium difficile bacteria. Their odds of this infection were 1.4 times higher when they were hospitalised and 1.7 times
higher when they weren’t in the hospital. In addition, PPI users had a 4.5 times greater risk of getting Campylobacter infections, a common form of food poisoning, if they were hospitalised and a 3.7 times higher risk when they weren’t hospitalised. “Reducing stomach acid, which acts as a barrier to infection, increases the chance of get-
ting a GI infection,” said senior study author Dr Thomas MacDonald, a pharmacology researcher at the University of Dundee in Scotland. “The main risk of PPIs are gastrointestinal infections,” said MacDonald. MacDonald and colleagues analysed data on stool samples collected from patients in Scotland between 1999 and 2013. Overall, there were 22,705 posi-
tive test results for bacterial infections. This included 15,273 people with C. difficile and 6,590 cases of Campylobacter, the authors reported in the British Journal of Clinical Pharmacology. Researchers also tested for Salmonella, Shigella and Escherichia coli, or E. coli, but didn’t find an association between PPIs and these infections. One limitation of the study is that it only
RESEARCH
included data on people who took PPIs with a prescription, even though these drugs have been available in Scotland since 2004 without a prescription, the authors note. Researchers also lacked data on other factors that can influence the risk of bacterial infections such as obesity, smoking and alcohol use. Previous research on PPIs and infections has produced mixed results, with some studies suggesting an association and others failing to establish a connection, noted Dr Wojciech Marlicz, a gastroenterology researcher at Pomeranian Medical University in Poland who wasn’t involved in the study. Millions of people worldwide
FDA approves generic version of Jazz Pharma's sleep disorder drug The approved generic is developed by Roxane Laboratories THE US Food and Drug Administration said it had approved the first generic version of Xyrem, Jazz Pharmaceuticals' drug to treat patients with narcolepsy, a kind of sleeping disorder. The approved generic is developed by Roxane Laboratories, the FDA said. Xyrem is the only approved treatment for both excessive daytime sleepiness and cataplexy in patients with narcolepsy, a chronic neurological disorder. Cataplexy, one of the primary and the most debilitating symptoms of narcolepsy, causes a sudden loss of muscle control, leading to physical collapse. About 70 per cent people with narcolepsy suffer from cataplexy, the FDA said. Reuters
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take PPIs, which are available without a prescription in Europe and the U.S., which means even a slight increase in the odds of bacterial infections can still impact a lot of patients. “The main problem with PPI
use is their general overuse,” Marlicz said. “These drugs are very potent and safe when used according to indication.” “Some patients will gain clear benefits from PPIs as they have stomach problems, such as ulcers which
will heal better with less acid,” said Dr Claire Steves, a researcher at King's College London who wasn’t involved in the study. “However other patients may take these as preventatives, or for mild symptoms,” Steves
added. “This study would prompt us to reassess the risk and benefit for each individual, and in some cases alternatives – such as changing diet or lifestyle – may be better options.” Reuters
RESEARCH
Lundbeck bets on shark antibodies for new brain drugs Sharks, as the most evolutionarily ancient animal species to have an immune system similar to humans, may offer a solution DANISH DRUGMAKER Lundbeck is betting that shark antibodies may offer a new way of getting drugs into the brain to fight Alzheimer's and other diseases, after successful early research with privately owned US biotech firm Ossianix. The two companies said that Lundbeck had made an undisclosed payment to Ossianix, which has labs in Britain, following experiments in mice showing the effective transfer of potential drugs across the blood-brain barrier. Getting modern large-molecule medicines across the barrier that protects the brain is a major challenge for drug develop-
ers. Sharks, as the most evolutionarily ancient animal species to have an immune system similar to humans, may offer a solution. Ossianix has found a way to attach therapeutic proteins to shark-derived antibodies, allowing treatments to be shuttled across the barrier into the brain where they bind to a drug target. The technology is still years away from producing a marketed medicine but Lundbeck research head Kim Andersen said it had "significant potential" to benefit patients by delivering antibody-based medicines and other complex drugs into the brain. Reuters
Gene-edited cells keep cancer babies well more than one year on Initial Phase I clinical trials using the cell therapy, known as UCART19, are now underway in both children and adults TWO BABIES rescued from previously incurable leukemia after receiving infusions of gene-edited immune cells are doing well at home more than a year after initial treatment, scientists said. Layla Richards became the first person in the world to get the 'off-the-shelf' cell therapy developed by French biotech firm Cellectis at Britain's Great Ormond Street Hospital in 2015. A second girl was treated soon afterwards. Now the team involved in both cases have published details of their work in a peer-reviewed journal, reporting that the two girls remained disease-free 18 and 12 months after treatment respectively.
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Waseem Qasim, a consultant immunologist at the London hospital, said the two cases showed the gene-edited cells were working, although longterm monitoring was still required. "While both patients are now at home and are doing well, we must treat these results with some caution as we don't yet know if the technique will be successful in treating a larger number of patients," he said. Initial Phase I clinical trials using the cell therapy, known as UCART19, are now underway in both children and adults. The idea of genetically altering immune cells called T cells so that they can attack cancers more effectively is currently one of the hottest areas of
The idea of genetically altering immune cells called T cells so that they can attack cancers more effectively is currently one of the hottest areas of medical research medical research. But while other drugmakers such as Novartis, Juno and Kite have treatments that use modified T-cells extracted from individual patients, UCART19 is derived from healthy donors and aims to be a
universal therapy. That should make it cheaper to produce and particularly suitable for patients who do not have sufficient quantities of healthy T cells to start with, such as very young children. One risk is that
such a universal approach could trigger graft versus host disease (GVHD), where the patient's body reacts against the donated cells. Writing in the journal Science Translational Medicine, Qasim and colleagues reported that Layla did indeed develop GVHD in the skin two months after treatment but the problem was resolved after she received steroids and a bone marrow transplant. Simon Waddington of University College London, who was not directly involved, said the findings showed the promise of this new type of cell therapy and would help teach scientists how to improve the process both in terms of efficiency and safety. Reuters
RESEARCH
Thermo Fischer & TUM announce milestone on human proteomes Report on synthesis of a library of over 330,000 reference peptides to analyse human proteomes THERMO FISHER and the Technical University of Munich (TUM) announced a milestone for analysis of human proteomes. In an online manuscript in Nature Methods, ProteomeTools scientists report on the synthesis of a library of over 330,000 reference peptides (termed PROPEL) representing essentially all canonical proteins of the human proteome. All peptides were analysed by multi-modal liquid chromatography-tandem mass spectrometry (LC-MS/MS), creating a compendium of millions of high quality reference spectra (termed PROSPECT). The study illustrated utility of these reagents and data to verify protein identifications from sparse observations and to predict the behaviour of peptides during LC-MS. The data has been made freely available to the scientific community via data analytics platform ProteomicsDB and the data repository PRIDE. The ProteomeTools project intends to generate a further one million peptides and corresponding spectra with a focus on splice variants, cancer mutations and post-translational modifications like phosphorylation, acetylation and ubiquitinylation. Using new resources, ProteomeTools scientists will study human proteomes to turn the vast amount of molecular information on the human proteome into new reagents, equipment, workflows, assays and software to enhance the application of proteomics in both science and medicine. Professor Bernhard Kuster, Chair, Proteomics and Bioanalytics, TUM, and coordinator of the project said, “Representing the human proteome by tandem mass spectra of synthetic peptides alleviates some of the current issues with protein identification and quantification. The libraries of peptides and spectra now allow us to develop new and improve upon existing hardware, software, workflows and
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reagents for proteomics. Making all the data available to the public provides a wonderful opportunity to exploit this resource beyond what a single
laboratory can do. We are now reaching out to the community to suggest interesting sets of peptides to make and measure as well as to create LC-MS/MS
data on platforms not available to the ProteomeTools consortium.� The project is funded in part by the German Federal
Ministry of Education and Research (BMBF), JPT Peptide Technologies, SAP, Thermo Fisher Scientific and TUM. EH News Bureau
PHARMA TECHNOLOGY REVIEW I N T E R V I E W
‘Pharma industry is heavily regulated and HIPAA compliance mandates that the industry encrypts its data’ Rahul Kumar, Country Manager,WinMagic throws light on the importance of data security solutions and the need to adopt encryption by the pharma industry, in a tête-à-tête with Mansha Gagneja
which creates a lot of IP and it is imperative that the customer is able to ensure that their IP is secure and with them. How widely is the pharma sector adopting these solutions as it is often labelled as a technology laggard? The industry is fairly good in adopting the technology primarily because of compliance. However, what we have seen in the market is that pharma customers have troubles with encryption. Once they are aware about solutions available for managing encryption, it will be hassle-free. That is what we bring to the table and customers are very happy about it.
What are the different data security options available and why is encryption of data becoming a more favoured option? Securing data is the priority for Chief Information Security Officer of an organisation. The only way to
28 EXPRESS PHARMA February 16-28, 2017
secure data is by encrypting it. This ensures that the data is not accessible to unauthorised users. What will be the application of encryption in the pharma sector? Pharma industry is heavily
regulated and HIPAA compliance mandates that the industry encrypts its data. The compliance is aimed at securing the data at rest, thereby ensuring that the research data is secure and can’t be compromised. This is one of the industries
What are the encryption challenges that exist in the changing tech world? The challenges have really been the same for a couple of decades. User experience is one of the biggest challenge when it comes to end-point encryption. Encryption industry has not seen a lot of innovations in the space and we are the only company that focuses on this area and we bring a seamless user experience for the customer. How are your solutions helping pharma companies secure their data? How are they different from the existing solutions?
Pharma companies like the fact that we bring in a solution which helps them manage encryption, a perpetual pain area, better. The users are now happy using this technology as it is simple and does not interfere with their working. The bottom line is – encryption was a word which used to push customers away and now – customers know that a better world exists. What is your market share? Tell us about your major clientele. We have some of the key enterprise customers in India. Our clientele includes four big consulting houses, three top pharma companies, three insurance companies and three retail companies. We have more than 110 customers in India now and we are reaching a stage where customers, when they think about encryption, think about us. Are there any other solutions or upgrades in the pipeline for the pharma industry? We have recently come up with a solution to help customers secure their cloud infrastructure. We are seeing a lot of traction for this as customers have been wary about the security of their virtualised environments. manshagagneja@gmail.com
I N T E R V I E W
‘We provide end-to-end digitalisation for pharma companies’ Krishna Singh, Founder, CMD, Globalspaces Technologies speaks on his company’s offerings that can facilitate a smooth entry into the digital age for pharma players, in an interaction with Mansha Gagneja Give us an overview of the solutions you offer for the pharma sector. We have different solutions that assist pharma and healthcare professionals. For instance, GloDigitAll is an endto-end solution for organisations undergoing digital transformation. With the aid of the devices and software from GlobalSpace, organisations can transform their traditional process of sales and marketing to digital. We provide fully integrated solutions for organisations to facilitate their entry into the digital age with supreme level of confidence. GloEDGE is another software for E-Detailing, a process used by medical representatives to present their products to the clients on a digital medium. This is one of the first steps that organisations take when they start their journey. GloSFA is a sales force automation platform which is used for sales reporting, analytics and a host of other things. When integrated with GloEDGE it becomes a brute force for medical professionals and reduces their workload so
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PHARMA TECHNOLOGY REVIEW that they can concentrate on their primary responsibilities. GloKIOSK is a solution that can be implemented anywhere to acquire customers, educate customers and for marketing purposes. The end usage of GloKIOSK is only limited by your imagination. We can implement KIOSK PAN India as we provide end-to-end turnkey support. We have already deployed 5000 GloKIOSKs all over India. GloConsult is the assessment of digital maturity of pharma companies. It is a digital consultancy service covering wide range of parameters. With GloConsult we help pharma companies with the digital transformation of their Sales and Marketing features. With high domain experience, we provide end to end digitalisation for pharma companies. Can you tell us about some of your installations in the pharma industry? Benefits to one of our reputed client are as follows: Mobility on the go: - Cost of creating or changing a collateral has reduced significantly as everything is digital and it is shared with teams on one click. Real time analytics: Productivity has gone up as real time analysis is available to
the teams. Engagement has gone up due to better UI and user experience. Reporting: - Reporting has become super easy with these solutions and field teams like it as they don’t have to create a report separately. All forms of conventional marketing are stopped and only digital marketing is used. The complete solution brought down the cost of marketing significantly. The seamless process manages this with ease and without any external intervention. While formulating solutions, do you seek advice from pharma and healthcare industry. What are the key takeaways ? We always seek advice and have discussion with the pharma and healthcare industry on what their mission or goals are for the next five years. The solution that we provide helps them achieve these goals. Also, we see to it that there is a smooth transition from their traditional methods to the new digitalised process. The discussion and sessions we have with them is also to boost their confidence level. Key takeaways will be to see firsthand how our solution is helping them and how to resolve any queries they might have, not only for them
Challenges faced may vary from client to client. But some of the common ones are: ◗ Life Science industry is a niche industry. ◗ Lack of need to change ◗ Lack of need to invest
GlobalSpace is going to come out with an IPO.We wish to invest the funds towards business expansion and R&D but also for other clients. What are the challenges faced while designing solutions for the life sciences vertical?
What are the unique advantages you offer to your clients? How widely are your solutions accepted within the pharma sector? GlobalSpace offers an unbeatable solution, not only for the field but also the office workforce. It consists of two- inone convertible device (laptop cum tablet) of which we are OEM. it provides e-Detailing solution, Mobile Device Management (MDM) solution, Microsoft Office productivity suite and interactive ondemand content to be used by field force. The tablet acts as an information carrier for the field teams where corporate teams can broadcast message, deploy content and see analytics. The field force can present interactive content, complete reporting and customise their sales pitch. The major problem with respect to content creation, deployment and logistics are solved by the eDetailing solution. The active time spent by sales team on product content is also recorded for analytical purpose.
We have deployed end-toend solutions which have over 25000 users from different clients. How fast is the life sciences sector going digital? The life sciences industry is moving very fast towards digitalisation but slower than any other industry. Most of the companies are reluctant in going digital due to lack of funds or some other issue. But they are catching up slowly and steadily and we are there to boost their confidence and help them take the necessary steps towards digitalisation. What is your market share in India? What does the pharma sector contribute to it? We are the market leaders in providing Enterprise Mobility Solution (hardware and software - bundled solution). We primarily cater to the pharma industry. We are entering into the BFSI and education space in a big way. Are there any new investments in the pipeline? GlobalSpace is going to soon come out with an IPO. This change will help us in growing and we wish to invest the funds primarily towards business expansion and research and development. manshagagneja@gmail.com
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PHARMA TECHNOLOGY REVIEW INSIGHT
Market trends driving new advanced drug delivery devices in injectable space Kirat Majumdar, Business Director, BD Medical - Pharmaceutical Systems elaborates on how companies like BD are catering to varied patients’ requirements through advanced innovation and solutions in drug delivery that are tailored to meet their specific needs
THE MEDICAL device sector in India, though relatively small, has witnessed an expeditious growth over the last few years. Valued at $5.5 billion, the sector has showcased an annual growth rate of 13-14 per cent over the last few years and is expected to continue with this growth in the coming decade. From patients’ perspective, the recent growth in the medical devices sector has proved significantly prudent, catering to extensive patient-centric requirements in a more effective manner. India is placed fourth in terms of medical device market size in the APAC region, after Japan, China and South Korea, while figuring in the top 20 markets globally. This growth can be largely attributed to socio-economic factors such as increase in healthcare expenditure, insurance coverage potential, number of doctors and unserved population. Although, these factors lead to a greater demand of healthcare facilities, substantially defining the market trends for the drug delivery devices sector, they also act as barriers on many fronts for the Indian medical device manufacturers. The extensive nature of the medical device sector, coupled with varying patient demand, has posed a challenge for domestic medical device manufacturers in making an immersion in all aspects of the sector. Currently, approximately 70 per cent medical device demand is met through
imports, with only 70-80 Indian medical device companies out of 800 boasting a turnover of more than `500 million. While domestic players are conspicuous in the low-priced and high volume segments, the innovation in the sector is largely driven by MNCs, with noticeable market presence in highend products (especially diagnostic equipment and instruments) augmenting the efforts of the domestic sector. In a broad sense, the stunting of the domestic medical device manufacturers can be boiled down to poor regulatory systems, void of harmony
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PHARMA TECHNOLOGY REVIEW with global standards and the lack of quality testing infrastructure. Furthermore, domestic manufacturing is neglected in the face of imports due to inverted duty structure. MNCs have proved substantially assistive in this regard, lending technological know-how and necessary skill to improve innovation in the domestic sector. Becton Dickinson (BD), a global medical technology company, is working actively in India for the past several years to help advance its health sector by encouraging medical discovery, diagnostics and healthcare delivery. The company leads in patient safety and the technologies that enable medical research and clinical laboratories, as well as provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes. The company partners with organisations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower healthcare delivery costs, increase efficiencies, improve health care safety and expand access to health. As part of this, the company offers dedicated departments (regulatory, supply chain, quality, marketing, etc.) focussed on ensuring good products and value added services, regulatory support including online support and worldwide operations – BD Medical – Pharmaceutical Systems plant to ensure business continuity. Although, India’s contribution to global sales is very limited, the company sees it as a market with a lot of opportunity and a market with a great potential form medical intervention, primarily due to drug delivery devices space in the country.
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BD SUCCESSFULLY PARTNERS WITH
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OF THE
TOP PHARMA COMPANIES IN THE WORLD
94
PER CENT OF THE LEADING GLOBAL BLOCKBUSTER DRUGS AVAILABLE IN PREFILLABLE SYRINGES ARE FILLED IN BD HYPAK GLASS PREFILLABLE SYRINGES
BD also collaborates with the pharma companies to help them select the right device which is optimised for the patient and integrates device design through industrialisation, thereby ensuring successful commercialisation of the drug The Indian drug delivery devices market is largely driven by increased prevalence of chronic disease, technological advancements, increase in individual therapy, increased understanding about drug metabolism among the population and requirement of controlled drug release. Despite the extensive demand, the growth of this industry is hampered by several restraints. Injuries and infections fear while usage, high
cost of development, and strict regulatory framework are the core issues facing the market. Patient safety plays a pivotal role in overcoming these challenges and in turn, improving the healthcare provision. BD Pharmaceutical Systems has a renowned history of drug delivery devices, dating back to 1898 and starting with the first all glass syringe developed by H Wulfing Luer. Since, the company has taken
long strides in the injectable space, making its mark as one of the leading medical device companies in the world. In 1925, BD received the Luer – Lok syringe patent which provided simple and secure method for needle attachment, heightening stability in drug delivery and ensuring patient safety. The next major milestone came in 1954, with first completely disposable syringe used in large scale field test of polio vaccine by Dr
Jonas Salk, defining the trend in the injectable space. In the year 1975, BD Hypak glass disposable prefillable syringe was developed. Today, BD Pharmaceutical Systems is a market leader in high-quality, clinically proven prefillable parental drug delivery systems. With one of the most diverse portfolios in the medical device sector, BD offers a wide array of drug delivery systems and services, including glass prefilled syringes, plastic prefilled syringes safety and shielding systems and self-administration injection systems, with customisable solutions befitting patients’ requirements. These solutions are developed with a conscious focus on various governing issues like disease indications, ease of administration, convenience and affordability with respect to the market and patients profile. In addition to developing innovative drug delivery devices, BD also collaborates with the pharma companies to help them select the right device which is optimised for the patient and integrates device design through industrialisation, thereby ensuring successful commercialisation of the drug. An integrated approach as such can enhance the efforts of different players in a demographically, economically and geographically diverse country like India and catalyse formulation of an effective way forward. BD successfully partners with 27 of the 30 top pharma companies in the world. This, in turn, results in capacity building, with worldwide production capacity of 2.5 billion syringes per year. This also helps significantly in performance enhancement, as majority of high-quality drugs are injected through BD prefilled syringes. Moreover, 94 per cent of the leading global blockbuster drugs available in prefillable syringes are filled in BD Hypak Glass Prefillable Syringes. BD’s integrated solutions ensure Safety and Performance of drug delivery systems that helps to cater to the increasing demand for
PHARMA TECHNOLOGY REVIEW The Indian drug delivery devices market is largely driven by increased prevalence of chronic disease, technological advancements, increase in individual therapy, increased understanding about drug metabolism among the population and requirement of controlled drug release combination products that require complex container systems. The company has developed a systems approach to integrating the multiple components into a unique system that meets each patient’s needs, such as, compatibility of drug with key container components, deep understanding of interactions between all components and functions, safety solutions that adapt seamlessly to existing container, healthcare worker and patient safety, rigorous compatibility testing of packaging components and seamless integration of BD components into the supply chain. The most successful example in this regard is BD’s partnership with a biosimilar insulin drug to develop BD Vystra, a Disposable Liquid Pen (DLP), which was not only launched in the domestic market but also for other export markets. Additionally, BD has been actively engaging/partnering with patients in India, especially when it comes to them being a knowledge partner. BD has been carrying out one on one discussions with patients in addition to extensive strategic workshops to understand detailed patients’ perspective and therefore, cater to different patients’ needs. The company has also been engaging with the industry stakeholders through their flagship programme 'Technovation', which has been a 'value differentiator' from the patients’ perspective. Technovation shares global trends, new regulation and latest technologies in the field of pre-fillable syringes with the pharmaceutical companies. BD, being a pioneer in this space, has scaled up the initiative with the object of maximising participation. As part of this, BD annually contributes the latest topics of interest to be shared over the platform of Technovation. To tackle the challenges of the diverse medical device sector in India, BD’s approach has evidently been a step in the right direction. Through
understanding different patients’ perspectives, BD has been able to cater to varied patients’ requirements through advanced innovation and solutions tailored to meet their specific needs. With the help of its thoughtful initiatives and extensive engagement with stakeholders and experts from the industry, BD has mastered in understanding the medical device market dynamics in India and serving them through long-term investment in quality innovation. Keeping in mind the diverse needs of the Indian patients, BD delves into a wide range of therapeutic classes including vaccines, anaesthesia, antibiotics, cardiovascular, diabetes, hepatitis, oncology and Parkinson’s disease from a total of 37. This innovation is backed by consistent product quality and compliance, as all plants are certified according to international quality standards ISO 9001 and ISO 13485 - and complimented with multiple checks; every BD Prefilled syringe batch undergoes a stringent battery of tests to ensure consistent quality across batches. India’s healthcare needs are constantly evolving, be it technological advancements in the sphere of medical device and diagnostic equipment, or the changing disease profile stunting collective health. In this context, understanding patients’ needs take precedence, with a conscious focus on the provision of quality health care delivery to suit their specific profile. BD has been investing in improving the healthcare innovation system in the past several years, spending approximately six per cent of sales revenue in R&D. The company continues to build capacity in the overarching mechanism of social care in India by rigorously boosting medical discovery and health care delivery. BD’s efforts must be scaled in all aspects of the medical device industry to compliment the work of the domestic market, thus advancing the healthcare sector as a whole.
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PHARMA TECHNOLOGY REVIEW VENDOR NEWS
PMMI to release 2017 Global Packaging Trends report at interpack It will be released at interpack, an international packaging fair, to be held at Düsseldorf, Germany THE ASSOCIATION for Packaging and Processing Technologies (PMMI) Business Intelligence will release 2017 Global Packaging Trends report at interpack to be held at Düsseldorf, Germany from May 4–10, 2017. The report explores key trends driving packaging innovations such as increasing awareness of health and wellness and growing concerns about environmental impact while identifying hot spots for packaging growth in all regions of the world. More than 165 members of PMMI will represent the lucrative North American market, while showcasing global processing and packaging
34 EXPRESS PHARMA February 16-28, 2017
machinery solutions at a triannual international trade fair for packaging and related processing industries, interpack serves the food, beverage, confectionery, bakery, pharma, cosmetics, non-food and industrial goods sectors. As the biggest and most influential packaging and processing association in the largest economy in the world, PMMI is the strongest partner to facilitate North American business through its PACK EXPO portfolio of trade shows, PMMI Media Group and business drivers that equip the industry to succeed in a global marketplace. PMMI is the number one gateway to the North American market.
“PMMI offers invaluable resources to manufacturers wanting to do business in North America,” says Charles D Yuska, President and CEO, PMMI. “Our three business units work together to connect suppliers with customers year-round and drive the innovation needed to move the industry forward. We do this through our PACK EXPO portfolio of trade shows, PMMI Media Group and business drivers that provide the industry tools to succeed in a global marketplace.” The PMMI booth will offer a thorough primer on its worldclass PACK EXPO portfolio of trade shows. As the leading processing and packaging shows
in North America, each is designed to connect consumer goods companies with manufacturing solutions. “The next installment of the PMMI portfolio of trade shows, PACK EXPO Las Vegas, takes place at the end of September and is an unparalleled resource for those aiming to break into the North American market while connecting with even more PMMI companies,” says Jim Pittas, Senior VP, PMMI. In addition, representatives from PMMI’s Media Group will be on-hand to showcase its leading publications, events and online media connecting the global supply chain. PMMI’s Media Group produces information for
processing and packaging professionals, bringing together solution providers and end users of packaging, processing and industrial automation. The PMMI booth (Hall 12; Stand F01) will have pocket guides readily available that attendees can use to locate PMMI member companies exhibiting at the show. The pocket guide identifies these members alphabetically, cross-referenced by the types of machines they produce. “PMMI members are globally renowned for making the highest quality equipment, offering responsive service and committing to meeting their customers’ needs,” Yuska said. EP News Bureau
PHARMA TECHNOLOGY REVIEW
HP and Redington launch India’s first Indigo centre of excellence in India The centre of excellence will showcase latest HP Indigo Digital Press technologies HP AND REDINGTON India have launched India’s first centre of excellence in Chennai. The centre of excellence in Guindy Industrial Estate will showcase HP Indigo’s digital offset presses along with a host of pre press, post press and web-to-print solutions for commercial, photo, publishing and labels and packaging segments. The centre of excellence is equipped with HP Indigo 5900, 7900 and the latest 12000 digital presses. It also has a wide range of pre press and software solutions including Esko Graphics, Haiyaa, Colour Logic, Human Eyes, Enfocus and HP Mosaic. The centre is also equipped with a wide range of finishing equipment.
Customers who visit the centre of excellence will have experience of the end-to-end solutions. A sizeable portion of the centre of excellence is dedicated for brand owners and print buyers, who can get to see some of the best print applications from across the world and hear the stories behind some of the world’s most successful digital print campaigns. The application gallery also host a Digital super market that has the best of labels and packaging applications that can serve as a gold mine of information to packaging development managers. To provide a superior pre-sale customer experience, the centre of excellence is
developed on a total budget of $3 million. Inaugurating the centre of excellence, Alon Bar Shany, GM, HP Indigo division said, “This centre of excellence is specifically targeted towards customers who are new to the HP Indigo family of digital offset printing presses. The centre will not only give our customers a hands-on experience of the products but also enhance the technical knowledge, enabling them to make the most out of their HP Indigo Presses.” A Appadurai, Country Manager, Indigo and Inkjet Web Press, Graphics Solutions Business, HP India, who was also present at the event, said, “HP
& Redington India, are happy to announce the inauguration of the first HP Indigo Centre of excellence in India. We believe the printing industry, our customers and the brands will hugely benefit from this. We are proud to be associated with Redington India which has made this significant investment towards their commitment to the digital printing technology and the Industry overall.” Kasturirangan, Wholetime Director, Redington added, “We are proud to partner with HP who are unparalleled champions of digital printing. There is a huge opportunity for HP Indigo digital presses in the country and this Centre
of Excellence will help in reaching out to them and give them a one of a kind pre-sale experience.” The HP Indigo 7900 and HP Indigo 12000 are the latest digital presses which were first showcased in DRUPA 2016. The HP Indigo 12000 digital press offers two sides photograph printing and guarantees photo life of up to 200 years. Both the digital presses offer 40 per cent higher productivity and there is an automatic Alert Agent, which performs realtime error detection while printing, which results in waste reduction and helps increase productivity. EP News Bureau
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Q A
PHARMA TECHNOLOGY REVIEW
&
Mikrotron launches machine vision cameras
Q
CoaXPress cameras EoSens 25CXP+, EoSens 12CXP+ and CameraLink camera EoSens 25CL+ were showcased at SPIE Photonics West 2017 MIKROTRON PRESENTED its new line of extremely compact high-resolution high-speed CoaXPress and CameraLink machine vision cameras at SPIE Photonics 2017, which was held in San Francisco. All three new camera models, namely EoSens 25CXP+, EoSens 12CXP+ and EoSens 25CL+ are powered by an advanced OnSemi PYTHON CMOS sensor. The high resolution of the CMOS global shutter camera models, combined with a precise trigger and synchronisation, a high frame rate and short integration times , give a perfect image quality and allow, for example, capturing even the smallest details of components in PCB assembly in high speed. The extremely photo-sensitivity of the high-speed cameras of 5.8 V/lux*s @550nm delivers reliable image information even in lowlight conditions. All camera models are based on a unique, robust and compact design (80 x 80 x 66 mm) and are engineered for use in rough environments. The fanless design guarantees vibrationfree operation. The CXP+ models come with a 4-channel CXP6 CoaXPress V1.1 interface, transmitting data at speeds up to 25 Gigabits per second in real time;
while the CL+ camera takes advantage of CameraLink technology. EoSens 25CXP+ offers 80 frames per second at 5,120 x 5,120 pixel resolution. EoSens 12CXP+ offers 165 frames per second at 4,096 x 3,072 pixel resolution. Windowing down the image resolution further increases the frame rate up to 765 frames per second for 1,024 x 768 pixel resolution. EoSens 25CXP+ offers up to 80 frames per second at the extremely high 5,120 x 5,120 pixel resolution. Due to their outstanding performance and functionality, the new camera models meet the requirements for the most demanding tasks in all areas of application. They are ideally suited for all classical machine vision and scientific applications that combine the demand for high resolution as well as high speed. All models of the new high–resolution high-speed camera family are GenICam and EMVA 1288 compliant, enabling easy handling and integration. Mikrotron is a global leader in digital highspeed and high-resolution cameras as well as highspeed recording cameras and systems. EP News Bureau
Biofortuna expands its immunoassay development and manufacturing services The expansion has been driven by the success of current customer projects and demand from the market BIOFORTUNA is expanding its IVD service portfolio to provide a greater focus on immunoassay design, development and manufacture. The company has made a significant investment in its production capabilities to include plate coating, washing, drying and quality control, creating an exceptional manufacturing suite for immunoassay kits. Biofortuna already has extensive experience in immunoassay development, and
36 EXPRESS PHARMA February 16-28, 2017
this expansion has been driven by the success of current customer projects and increasing demand from the market. These enhanced manufacturing capabilities will further strengthen the company’s existing immunoassay service and offer more flexibility to clients. This focus on immunoassay products will complement Biofortuna’s highly successful molecular IVD services, which include ISO 13485 accredited and
FDA registered contract research, lyophilisation, air-drying, manufacturing, dispensing and kitting of diagnostic products. Dr Simon Douglas, CEO, Biofortuna, commented, “The success and growth of current projects has fueled the desire to increase our immunoassay offering. This expansion will allow for large scale manufacturing of ELISA-based kits to meet our customers’ growing needs.” EP News Bureau
A
Q A
WITH SCHOTT GLASS INDIA
How can I protect my drug against light? Certain drugs are sensitive to light especially the light in the area of 200 - 400 nm. This is e.g. true for the vitamins A, B, D, E, K and C. These drugs have to be packed in a special packaging that blocks the light from getting through. For glass packaging this is done by adding either Iron (Fe) and Titanium (Ti) to the composition or Iron and Manganese (Mn). They absorb the uv light ensuring the protection. Additionally the light transmittance can also be controlled by the wall thickness of the glass container. The thicker the wall is the less light goes through it. And another factor is the annealing oven. Here the temperature plays an important role. The higher the temperature is in the oven the darker the glass gets and the less light is going through.
I experience a pH shift with my drug solution. What is the reason and what can I do? When glass gets in contact with an acidic or aqueous solution Hydrogen from the solution and Sodium from the glass are exchanging. This reaction leads to an elevated pH value. The amount of Sodium that is released into the solution also depends on the converting process. The more heat is used while forming the bottom of the container the more of Sodium Borates are evaporating from the glass. These Sodium Borates are condensing on the glass again and are being "burned" onto the glass again in the annealing oven. In the end they dissolve in the solution after autoclaving leading to a pH shift towards higher values. But also the ratio of glass inner surface to filling volume plays a role. Worst would be a 2ml container filled only with 0.5ml solution. The size of the container should be adjusted to the filling volume. There are some other smaller things that can be done. However, the mentioned ones have the biggest influence.
PHARMA TECHNOLOGY REVIEW PRODUCTS
Gandhi Automations launches efficient dock levellers GANDHI AUTOMATIONS, India's number one entrance automation and loading bay equipment company, is ISO 9001: 2008. Since its inception in 1996, we have been manufacturing, importing, distributing and installing products that are problem free and easy to operate. The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses. Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only “a bridge for connecting a vehicle”, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.
Efficient loading and unloading the goods The importance of efficient loading the goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised which leads to damage in the goods. The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost. It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings. The loading bay remains with the Dock Leveller in rest position and the sectional overhead
ble to drive directly on and off with forklift trucks etc. The selfcleaning lip hinging system does not retain rubbish with automatic end-of-run, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349. ●
door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers. The sectional overhead door is then opened only when the vehicle is positioned, brakes applied and engines shut off .This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of
the dock leveller connects to the truck bed for loading / unloading to take place. At the end of the loading/unloading the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process. Following are the two types of dock levellers ●
Radius lip dock levellers Radius Lip Dock levellers allow the dock to connect with the truck bed, thus making it possi-
Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc. These types can be supplied with a lip extending up to 1 m. Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories. Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email : sales@geapl.co.in www.geapl.co.in/docklevelers.html
Oven Industries offers 5R7-573 thermoelectric controller THE OPEN BOARD temperature controller is specifically designed with a proportional integral control algorithm to provide the most precise control to thermoelectric (Peltier effect) modules at the most economical price. The H bridge control provides a seamless transition between heating and cooling, eliminating dead spots. A red LED for heat and green LED for cooling indicate mode. Pulse Width Modulation controls the power level in the thermoelectric
To subscribe: bpd.subscription@expressindia.com
module at a base frequency of 900Hz. Power resolution is one of ±255 steps in the load circuit control. Oven Industries, Inc. (OI) was founded in 1964 and specialises in the development of custom electronic temperature controllers and sensors along with extensive turnkey contract manufacturing capabilities and international sourcing. OI also carries a full line of standard products, purchasable online, including temperature controllers and sensors, power supplies, heat
sinks, thermistors and thermocouples. OI supplies precision electronic devices that serve an array of clients not limited to these industries; aerospace, automotive, biomedical, defence markets, medical and semiconductor. With a superior design engineering staff and complete production facilities, the company is a leading technology and development company. Contact www.ovenind.com
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PHARMA TECHNOLOGY REVIEW
Virosil Pharma: ASwiss eco-friendly disinfectant SANOSIL BIOTECH, a Mumbai-based company is the first company to pioneer the novel concept of ecofriendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can
be used where other chlorinebased disinfectants have been feared. Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, Ranbaxy, J&J, Abbott, Serum Institute, Dr Reddy’s Laboratories, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively
RESULTS TABLE 1- Count of standard culture B subtilis used CFU/ml
Log Value
B subtilis
270000000
8.4313
Disinfecting biofilms using Virosil Pharma Virosil Pharma not only successfully penetrates bio-films and eliminates bacteria but also maintains a long residual level of disinfection in water tanks and pipelines. Using Virosil Pharma overcomes the disruption problem
MIC DETERMINATION - METHOD BASED ON MODIFIED BSEN13704 (SPORICIDAL) TEST ORGANISMS: 1) BACILLUS SUBTILIS ATCC 6633 Standard Culture
protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; Instruments, equipment, water tanks and pipelines – can now be pathogen free. What’s more, there’s no need to re-wash disinfected surfaces or instruments since H2O2-based Virosil Pharma safely decomposes into water and oxygen. The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India.
because it is absolutely safe to leave it in the water. Better still, the longer it’s in the water, the better the results since it will attack the biofilms which harbour most of the bacteria populations.
RESULTS TABLE2- Microbial Counts Post Disinfectant Exposure in CFU/ml
B subtilis
Microbial Counts in CFU/ml
Microbial Counts in Log Values
Log Reductions
Log Reductions
Virosil l0%
Virosil l0%
Virosil l0%
Virosil l0%
5 mins
30 mins
60 mins
5 mins
30 mins
60 mins
5 mins
30 mins
60 mins
5 mins
30 mins
60 mins
4900
2300
310
4.7411
5.0696
5.94
3.6901
3.36178
2.4913
99.9981
99.9991
99.9998
38 EXPRESS PHARMA February 16-28, 2017
The company also offers a customised disinfection audit on its website; www.sanosilbiotech.com Contact details Dev Gupta, CEO, Sanosil Biotech Warden House, 1st floor, Sir PM Road, Fort, Bombay 400 001 Tel No: 022 22872295 / 43112700/ +919820016292 Email: info@sanosilbiotech.com
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DUPHAT Expo 2017 - 22nd Dubai International Pharmaceuticals and echnologies Conference and Exhibition
for Food & Bio-Pharma Industries
Date : 7th - 8th - 9th March 2017 Stall # : Booth #B-17 (Hall #5) Venue : Dubai International Convention & Exhibition Center
Imavac™ - Silicone Hose reinforced with SS 316 helical wire
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Multiple Products Under One Roof We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets and customized polymer solution for food, medical and pharmaceutical industries application.
Imaprene™ - Thermoplastic Elastomer Tube (TPE)
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Silicone Inflatable Seals & Gaskets
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info@amipolymer.com
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introduce
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Your First Step in Pharmacy Automation Rx Count Corporation 17945 Sky Park Circle, Ste. B Irvine, CA 92614
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Construction: durable, FDA-approved polymer plastic Dimensions: 7” high x 10 1/2” wide x 12 1/2” deep Portability: weighs only 3 KG
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Product List Humidity Chamber
Walk in Chambers I Humidity ( Stability) Chambers Cooling Chambers I BOD Incubators Bacteriological Incubators I Deep Freezers Ovens I Photo Stability Chambers I Vacuum Oven Muffle Furnace I Auto Clave I Water Chillers
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Walk in Chamber Cooling Chamber
Most Preferred Chambers for USFDA & UK-MHRA etc. approvals Accurate Controls & Uniform Conditions. Alternative PLC with touch screen display with Ethernet with automatic change over facility. Computer Interface with 21 CFR Compliance software. Complete validation package comprising DQ, IQ, OQ & PQ. 24 x 7 Online service support.
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OSMOMETER 3250
Milk Cryoscopes Available
127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India
Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in
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Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber
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Reduces handling & seed train expansion step for therapeutic production Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India. Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com
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PHARMA LIFE I N T E R V I E W
â&#x20AC;&#x2DC;Attrition at the field force level is between 20 - 30 per cent and at management level between 8- 15 per centâ&#x20AC;&#x2122; Ankit Agarwala, Director, Michael Page India talks about his preference for building in-house capabilities for activities like sales force training, in an interaction with Viveka Roychowdhury, wherein he shares insights about hiring trends and attrition rates in the pharma industry Which areas in the pharma industry will see hiring in 2017 ? What are the drivers ? Increased attrition in these areas or increased demand? Marketing (both traditional & digital), strategy, business development, market access and manufacturing are the functions within pharma which are expected to see the greatest demand in 2017. The drivers are mainly additional roles being created due to expanded manufacturing operations, large volume of mergers and acquisition and growth of consumer healthcare businesses. What is the average attrition rate in pharma companies in India? Attrition varies substantial by level. At the field force level, this is usually between 20 - 30 per cent and at management level between 8- 15 per cent. How does this compare with attrition levels and hiring in global pharma? Generally speaking, these rates are higher as compared to global pharma setups. How much pharma talent is India losing to global roles and positions? The main locations where Indian talent in pharma is going abroad is to regional headquarters of organisations in Singapore, or global headquarters in continental Europe and the US. These
54 EXPRESS PHARMA February 16-28, 2017
cases are generally few and mostly applicable at business head or functional head levels. With the expansion of the local Indian pharma sector there are more exciting opportunities for the best performing senior executives and hence cases of moving overseas have reduced. Do you see such talent coming back, given that there is a contraction in the industry, layoffs and consolidation, overseas? We certainly see an increasing trend of talent coming back both due to contraction of overseas opportunities as well as exciting opportunities being available in India. Senior executives are also coming back due to personal and family reasons, such as being close to ageing parents. We also see an increased interest from pharma companies in India to hire senior professionals with international experience. Indian pharma companies are also hiring globally for global roles. How successful are these moves, in terms of cultural adjustment? Any examples you'd like to comment on? When Indian pharma companies are looking for foreign talent for overseas based senior management roles, this is often very challenging as they donâ&#x20AC;&#x2122;t yet enjoy a very strong brand
then expatriating this person to an overseas location for a fixed period of time such as two or three years.
Greater investment from the organisation in meaningful training in areas like consultative selling builds more employee loyalty value in overseas markets. Hence, in many cases they are locally hiring an Indian, and
Pharma companies are faced with reputation losses due to non-compliance with ethical marketing codes. How are they dealing with this, in terms of hiring and training their sales force? We see a substantial increase in training of sales force and also demand for senior training and sales force excellence professionals. We also see organisations trying to get their medical representatives to work in a more consultative manner and are thus investing more in technical and product training. Is training an in-house or outsourced activity? How much on an average, as a percentage of revenues, or overall training budgets, is spent on sales force training? Training is increasingly an in-house activity with heavy demand for in-house sales force excellence professionals. What are the reasons for the shift from oursourced to in-house sales training modules? In-house sales training allows organisations to better maintain consistency in their training processes over a period of time. Also, in the
case of foreign MNCs, in-house training allows them to align their training to regional and global training processes and benchmarks. In-house training also allows for better product specific technical sales training as the product and market knowledge is internal to the organisation. As attrition rates are higher in India than the global norm, is there a hesitation to invest in training medical representatives? There has been a hesitation traditionally, however organisations now realise that training their front line is a critical factor in a competitive industry. How could training be deployed as a talent retention strategy, especially for the pharma sales/field force? Training certainly provides an upliftment in skill for pharma sales/field force, which is an important factor that employees in these jobs are looking for, other than the best possible remuneration. Greater investment from the organisation in meaningful training in areas like consultative selling also builds more employee loyalty towards the organisation and hence can help in better retention. viveka.r@expressindia.com
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