Boehringer Ingelheim chief says the firm will focus more on introducing oncology, diabetes, cardiovascular and central nervous system drugs in IndiaBy Joe C. MathewGerman drug maker Boehringer Ingelheim, though a late entrant to India, is among the fastest-growing drug companies in the country today. The company has ended its marketing partnership with the US drug major Eli Lilly in India to go solo with its diabetic medicines. Andreas Barner, chairman of the Board of Managing Directors, Boehringer Ingelheim, shared his company’s plans in the country with BW Businessworld. Excerpts from the interview:Given the slow growth in the global pharmaceutical market, how critical are emerging markets like India for Boehringer?Emerging markets now play an increasing role in our strategy. This is why we have intensified our engagements in Russia, China, India and some other markets in the past 10 years. We also see that as the economic situation in these countries improves, they are showing greater interest in innovative drugs for diabetes as well as those for treating stroke and respiratory ailments.What drives Boehringer’s growth in India?Our portfolio of innovative drugs including Pradaxa, Trajenta and Trajenta-Duo drive the growth. Our consumer healthcare drugs such as Dulcoflex and Buscogast also play an important role.Tell us about your partnership strategies.Our global marketing alliance with Eli Lilly for diabetes drugs will continue. But in India, we ended the Lilly alliance on 1 June 2015. Since then we have been exclusively commercialising our respective molecules. At the same time, we continue to evaluate our partnership options on an ongoing basis given the competitive nature of the Indian branded pharmaceutical market.How much of Boehringer’s global product portfolio is in the Indian market?We have introduced almost 75 per cent of our global product portfolio in India. Going forward, we plan to introduce all major products in our research and development pipeline. Our areas of therapy focus will be oncology, diabetes, cardiovascular and central nervous system. Boehringer Ingelheim India has two molecules in oncology, Afatinib and Nintedanib, which have been approved for the treatment of lung cancer globally. Afatinib is the first molecule from our pipeline which has recently been launched in India. The second molecule, Nintedanib, is currently under regulatory review and would be launched in due course. Also, our first SGLT2 inhibitor in India, Jardiance (empagliflozin), is under regulatory review and would be launched soon.Boehringer’s Nevirapine was the first product that was challenged under India’s product patent law. Has it changed your product introduction strategy?For Viramune (Nevirapine), an HIV drug, Boehringer Ingelheim followed a two-sided strategy: on the one hand, we offered the drug free in poor countries to prevent mother-to-child infection as a single dose, and on the other hand, we offered non-assert declarations to the World Health Organisation (WHO) qualified drug manufacturers, allowing them to produce the drug in countries with lower costs, without paying us any royalty. With respect to tiered pricing, we are holding discussions with countries.How do you assess India’s clinical research environment?Boehringer Ingelheim always does its clinical trials in conformity with the legal requirements. We ensure that all patients participating in our trials sign informed consent papers. We appreciate the new Indian regulation, which also mandates making films of informed consents. Boehringer Ingelheim has its own in-house team for overseeing clinical studies in India and we still conduct trials in the country.Do you see generic firms as rivals or as entities that can co-exist with innovator firms in a litigation-free environment?We see a value for generic companies as they are in a good position to concentrate on cost-effective production, whereas research-driven companies play an important role in advancing medical progress. How important is your consumer healthcare business segment? Can India be a sourcing hub or an R&D base for such products?Our consumer healthcare business is among the top 10 over-the-counter corporations worldwide with a growth rate above the market average (no. 1 in laxatives and antispasmodics). The increasing purchasing power in emerging markets adds to the growth. In India, we have concentrated on consumer healthcare as an independent business since 2014. We analyse our opportunities as they present themselves.What is the future of the pharmaceutical industry as we know it today? If it is biologics, how big is the potential of biosimilars?Research will develop new chemical and biological entities. Boehringer Ingelheim has a history of more than 25 years in biopharmaceutical development and production. Its three pillars are: own new biological entities development, development and production ‘from mind to market’ for third parties, and development of biosimilars. Given our expertise, our talented personnel and production plants of highest standards, we are in a good position to become one of the market leaders in biosimilars.How does your animal health business fit into your extreme focus on biologics in critical care therapies?We do have a number of products from human research and development that were slightly modified and used afterwards as animal medications, so the animal health business makes a lot of sense for us. One of the growth drivers here is, of course, our animal vaccines business, which is completely separate from human medicine development. At present, we are in the sixth position in the global animal healthcare market. In India, we have Volvac and the Calvenza range of vaccines. Critical care therapies that we offer humans mainly centre around stroke treatment. All in all, our research and development initiatives focus on respiratory, immunology, central nervous system, cancer and cardiometabolic diseases.joe@businessworld.in@joecmathew(This story was published in BW | Businessworld Issue Dated 24-08-2015)
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Sixteen of the 55 stocks in the BSE healthcare index delivered more than 1,000 per cent returns to the investors since July 2005 to date, writes C H UnnikrishnanPharmaceuticals and healthcare companies have been one of the best wealth creators in India in the last one decade going by the growth in market capitalisation and return on investments of these companies during 2005 to 2015. Growth in stock valuation, which predominantly reflects the financial performance and the fundamental strengths of companies, therefore necessarily indicates that these companies have made better profits. A recent media analysis of key pharma stocks show that about one out of three companies have appreciated and had a return on investments (ROI) over 1,000 per cent during the period. The BSE healthcare index posted 422.28 per cent gains in the period. Sixteen of the 55 stocks in the BSE healthcare index delivered more than 1,000 per cent returns to the investors since July 2005 to date. C H UnnikrishnanAccording to market analysts, pharmaceutical companies in India have found a very niche model in the generic space, which has been executed very well, and that has boded well in creating shareholder value. The analysts do not expect this trend to change much, as they believe that the confidence in these sectors is strong, based on the projections for economic growth and also the subsequent demand that would be generated in the future. This is despite the facts that India has the lowest medicine prices in the world and it has been also one of the very few drug markets in the world which has an inherent price regulation imposed by the government. This essentially means the companies, especially the ones which do not have a sizable business in the export markets, have been able to earn good profits in this market. But, an obvious argument that is expected from the industry to defend its stand is that the profit is made from high margin export markets that many are increasingly focusing now. So let’s look at the companies, which are mainly focusing on the domestic and other low margin markets. One of the top performed stocks in the analysis was Ajanta Pharma Ltd, which had a return on investment of a whopping 15,393.56 per cent in the period under review. Ajanta Pharma has been mainly focusing on the domestic market and the low margin markets such as neighbouring Asian markets, Africa and Latin America till recently. Similarly, the Indian units of multinational drug makers, who are also part of the BSE Healthcare Index, are focussed totally in the local market. And, most of the leading local drug makers, who have been claiming double digit growth in earnings in the last several years, too can’t deny the fact that at least 20 per cent of their revenue comes from the price controlled local market. But, price control and the ‘lowest drug prices’ are still the biggest ‘concerns’ for Indian drug industry and the various groups in the sector, who often fight among each other as part of competition, are always one and united while addressing these baseless concerns.
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The Intellectual Property and Science business of Thomson Reuters, the world’s leading provider of intelligent information for businesses and professionals released of the 2015 CMR Pharmaceutical R&D Factbook, the biopharmaceutical industry’s leading resource of global R&D trends.Despite concerns around declines in R&D, the analysis identifies a surge in global sales with 2014’s $1 trillion milestone and forecasts sales to reach $1.3 trillion by 2018. It also reveals a positive shift in new molecular entities (NMEs) with 46 launches in 2014; the highest in over a decade.“This is an extraordinary year for the pharma,” said Basil Moftah, president, Thomson Reuters IP & Science. “Not only do the critical insights provided by the Factbook challenge negative perceptions, but it demonstrates this industry’s continued commitment to creating and employing innovative solutions to tackle its largest hurdles.”Diversification increases NME launches: One third of 2014 launches were for rare indications, mainly within Anti-cancer. More than 65 percent were specialty drugs for the treatment of Anti-cancer, Hepatitis C Virus and HIV.Anti-cancer dominates: Anti-cancer development continues to attract the highest amount of investments across all therapeutic areas; with the majority of recent launches receiving orphan drug status from regulatory authorities.Increase in failing fast and cheaply: Phase III pipeline volumes are steadily growing due to the improved ability to “fail fast and cheaply,” increasing the speed of potentially successful compounds through development.Since 2003, the CMR Pharmaceutical R&D Factbook has been built in collaboration with leading global pharmaceutical companies to assess productivity and to provide insights to strengthen planning and the effectiveness of R&D. It is based on proprietary, primary sources, competitive intelligence, and public sources covering key trends across the landscape, including R&D pipeline volume, success rates, cycle times, regional comparisons, therapeutic areas, and generics.
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Save the Children teamed up with RB India to reduce children deaths from diarrhoea. They have jointly launched a campaign ‘IDCF 2015-Intensified Diarrhoea Control Fortnight’ which aims at reducing child mortality rates in India; one of the prime goals of the Millennium Development Goals (MDGs).Save the Children will work with the Department of Health and Family Welfare in their effort through the ground-breaking and ambitious ‘Stop Diarrhoea’ programme. Supportedby RB, the programme, for the first time will fully implement the internationally recognized 7-point plan to ensure comprehensive diarrhoea prevention, treatment and control across 4 key states - Delhi, Uttar Pradesh, Uttarakhand and West Bengal. The ‘Stop Diarrhoea’ program combines RB’s expertise in product development and research, and Save the Children’s experience of delivering life-saving work to help save thousands of young lives a year.Thomas Chandy, Chief Executive of Save the Children India, said: “The IDCF is a great initiative by the government and we need to have more campaigns like this to strengthen the ongoing effort to reduce childhood mortality. It is also important for civil society organisations and corporate sector to work together with the government to mobilise communities and create awareness about diarrhoea. Our ‘Stop Diarrhoea’ programme supported by RB is being reinforced by these intensive activities. We are happy to support the government in eliminating diarrhoea as a public health burden”Until 8th August, IDCF 2015 an initiative of the National Health Mission aims to conduct intensified activities for control of deaths due to diarrhoea across all States & Union Territories through advocacy and awareness raising activities, distribution of ORS-Zinc and promotion of Infant and Young Child Feeding (IYCF) activities. The aim is to empower communities by improving their knowledge, attitudes, beliefs and practices to prevent diarrhoea.The ‘Stop Diarrhoea’ programme will provide facilities such as Zinc-ORS depots and breast feeding corners. In addition, street plays, awareness rallies, home visits for demonstrations on ORS and Zinc usage, pocket meetings with mothers, hand washing demonstrations at Anganwadi Centres and schools will also be conducted to raise awareness around diarrhoea prevention. Meetings to engage with stakeholders like government ministries, development partners and health workers will also be an integral part of the plan.Nitish Kapoor, Chief Executive of RB India, said: “RB has been funding Save the Children programme in India since 2010 and has been able to see the real difference they have been making to the lives of Indian families. We believe that together RB and Save the Children can make a critical step towards a better understanding of water, hygiene and sanitation, which in turn will help reduce the number of children dying from diarrhoea in India.”Childhood diarrhoea continues to be a major killer among children in India, contributing to 10.4% of under five deaths in the country, the highest death rate in the world. Around 1.4 lakhs children die due to diarrhoea annually in the country, and it is estimated that 48% of Indian children below the age of five years are stunted, with diarrhoea being one of the main causes.
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The price of Hetero's biosimilar version, which should be much lesser than the branded one, was not disclosed, says C H UnnikrishnanHyderabad-based drug maker Hetero group has launched its biosimilar of blood cancer drug rituximab in India. This biological drug originally developed by Swiss-drug maker F Holfmann La Roche, is used for treating non-Hodgkin lymphoma and chronic lymphocytic leukaemia. Hetero's launch of this biosimilar (equivalent to generic copy chemistry based drugs) will help increasing access of this costly cancer medicine to Indian patients. A normal treatment course of rituximab is 1000 mg given intra venus over about 4 hours, with a second 1000 mg dose administered 2 weeks later. The average cost of this biological medicine (the branded version) for a 10mg/ml 10ml vial in the US is $582.19. Therefore, the medication cost for a two dose course of therapy at 1,000 mg per course would typically be $11,643.80. The price of Hetero's biosimilar version, which should be much lesser than the branded one, was not disclosed. Hetero, one of the leading generic pharmaceutical companies in India and a leading producer of anti-retroviral drugs for HIV/AIDS treatment in the world, has introduced this low cost version of rituximab in Indi a under the brand name Maball. Hetero 's marketing and distribution arm Hetero Healthcare Ltd will sell this drug in the domestic market. “The launch of MABALL strengthens Hetero’s position in the Biosimilar market, and has enabled the company to join select biotech companies with the capability to develop, manufacture and commercialize complex monoclonal antibodies, " said Hetero group chairman and managing director Bandi Parthasaradhi Reddy on Monday. “Biosimilars is one of the key strategic business areas for Hetero and we have invested in biosimilars and will introduce more such biosimilar drugs in the future," he added. "We also have plans to introduce affordable biosimilar rituximab into key markets outside India through our partners,” he said.
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Focusing on the fact that medical device industry is an innovation driven industry and needs to work with medical practitioners as well as paramedical professionals in close proximity, a meeting was organised by Minister of Chemicals & Fertilizers Anant Kumar to discuss the Universal Code for Pharmaceutical Marketing Practices (UCPMP). Himanshu Baid, chairman of CII Medical Technology Division (CII-MTD) and Pavan Choudary, co-chair of CII-MTD participated in the event. The gathering discussed the provision of current UCPMP not allowing industry to engage medical practitioner for continued medical education on latest technologies may be detrimental to the medical device industry. Baid said, “Medical Devices have a short product life cycle (18 to 24 months) and have frequently upgraded versions. Every new product which comes into market requires physicians to undergo sufficient trainings. The proposed code shouldn’t constraint Industry’s ability to provide no-frills training to Medical Practitioners.” Choudary said, “While CII-MTD welcomes any such code, at the same time we recommend that the code should be appropriate for medical device companies and industry practices, which are significantly different from pharma industry.” He further added, “the code in its current form needs more discussion and clarity on research grants or other support funds be regulated by this code as well as product donation, which is needed and is not recognized and hence no provision made for allowing this type of donations as long as desired documentation is maintained by companies.” Baid concluded that CII-MTD will recommend a distinct marketing practices code for Medical Device Industry, which will support Training, Education and Awareness Programs that improve patient outcome and would be pleased to work with Department of Pharmaceuticals in developing an appropriate Universal Code for Medical Device Marketing Practices (UCMMP).
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Dengue is currently the world’s fastest growing vector-borne disease, endemic in over 100 countries where almost half the world’s population resides. C H Unnikrishnan reportsSanofi Pasteur, the vaccines division of French drug maker Sanofi SA, said on Tuesday (28 July) that new data on the potential of vaccination against dengue in the endemic population has shown significant public health impact. The data published in the New England Journal of Medicine (NEJM) provide a comprehensive picture of the potential public health impact of vaccinating endemic populations from pre-adolescence to adulthood against dengue. The data analyses that the largest population is at risk of dengue globally. It also shows that the individuals 9 years of age and older also represent a highly mobile group capable of spreading disease more broadly during outbreaks and also contributing substantially to the economic burden of dengue including the number of lost school and work days due to the disease. The NEJM article reported results from a new pooled efficacy analysis of individuals 9 years of age and older at vaccination from the two Phase III studies of Sanofi Pasteur’s dengue vaccine. The new analysis documented that the vaccine protects two-thirds of these individuals (66 per cent) against dengue, providing even greater protection against two clinically-relevant manifestations of dengue, namely severe dengue (93 per cent) and prevention of hospitalizations due to dengue (80 per cent) that account for the greatest human and economic burden of dengue in endemic countries. In addition, the dengue vaccine candidate protected volunteers 9 years of age and older who were previously exposed to dengue (82 per cent) , as well as those who were naïve to dengue (52.5 per cent) prior to vaccination. The clinical development programme for the vaccine candidate includes studies with four-year, long-term follow-up phases, in line with the guidelines of World Health Organisation (WHO) for dengue vaccine development. The results from first 25 months of the two Phase III efficacy studies were published in 2014. Interim data from the third year of these studies and interim data from the third and fourth years of the Phase II extension study in Thailand were also published in the new NEJM article confirming the continuing reduction of hospitalized dengue in the vaccinated population of 9 years of age and older. The third-year interim data from the Asian Phase III study identified the need for further long-term surveillance in children under 9 years of age to assess the impact of the dengue vaccine candidate in these younger children. “It is not unusual to require additional data on a new vaccine to determine its value in a specific age group, particularly young children, whose immune response to the vaccine and the disease itself 2/3 may differ significantly from that of older children and adults,” says Tim Endy, professor at Upstate University Hospital, New York. Maria Rosario Capeding from the Research Institute for Tropical Medicine in the Philippines, who is a lead author on the NEJM article, points out the potential public health benefit of having a first dengue vaccine available to protect individuals 9 years of age and older. “This large, at-risk population includes the most dynamic members of the community who have the potential to spread disease widely and also contribute most to dengue’s heavy societal impact in terms of school absences and lost work productivity. Certainly, individuals 9 years of age and older represent a compelling target group for an immunization program against dengue aimed at significantly reducing overall disease burden.” she said. Dengue is currently the world’s fastest growing vector-borne disease, endemic in over 100 countries where almost half the world’s population resides. The disease also poses considerable economic and human burden in these endemic countries as it is prone to unpredictable outbreaks and spreads readily in densely populated urban areas, often paralyzing local healthcare systems and requiring cost-intensive intervention efforts. At present, no specific treatment or prevention for dengue is available, although the WHO has set objectives to reduce mortality due to dengue by 50 per cent and morbidity by 25 per cent by 2020. Introduction of an effective and safe dengue vaccine as an integral part of dengue prevention efforts will be critical to achieving this goal. Based on the totality of the safety and efficacy data for its dengue vaccine candidate, Sanofi Pasteur has decided to recommend a targeted age indication for the vaccine of 9 years of age and older in endemic countries, where the combination of disease burden and the vaccine’s proven impact profile in this age group point to the greatest potential for reduction of dengue disease burden in these countries.
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The company offers the plan both in cashless and reimbursement form and will give coverage against hospitalisation and outpatient treatment, reports Haider Ali KhanApollo Munich on Tuesday (28 July) launched an exclusive health insurance plan against dengue at an affordable cost of Rs 444 a unit. The 'Dengue Care' was launched in presence of brand advocate and former Indian cricket skipper Sourav Ganguly at a function in New Delhi. The product available at Rs 1.2 per day entails onetime payment of Rs 444 and provides Rs 50,000 inpatient and Rs 10,000 OPD coverage, the company said. The onset of the monsoon in India brings mosquito related diseases such as dengue. In 2014, there were over more than 40,000 dengue cases reported in India. However, the estimated number of unreported cases is 6 million.The dengue outbreak is prevalent during June and runs up till November, and results in increase in medical expenses for families across the country. On an average, hospitalisation for dengue treatment costs an individual Rs 35,000. "The diagnostic cost for dengue comes in the range of Rs 5,000-10,000 depending upon the locality of the patient. This is the first OTC (over the counter) product in India that covers infectious disease. "It serves multiple segments of people--those who never bought a health policy but have heard about dengue and those who already have a health insurance. It is a one premium plan for all ages," said Antony Jacob, CEO, Apollo Munich Health Insurance during a press conference. Citing example of his daughter, Ganguly urged everyone to pledge platelets to help people suffering from dengue. He further said that dengue is often supposed to strike those living in and around slums, but it is not necessarily true. Dengue mosquito breeds in dirty water and they can infect anyone. The product will also cover expenses of up to Rs 10,000 for diagnostic tests, consultation, home nursing and pharmacy. Apollo Munich offers the plan both in cashless and reimbursement form and will give coverage against hospitalisation and outpatient treatment.
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