2016 will be a crucial for drug makers and consumers. During ‘Make-in-India’ week in Mumbai, Govt. highlighted many amendments or introduction of new policies with an aim to make India as a major hub for end to end drug discovery. To boost drug discovery, to promote manufacturing of certain drugs against life threatening diseases like AIDS, and to reduce our dependence on China, the Govt. has promised to offer many incentives (exemption from excise duty or tax) and also plans…

In this report- we analyzed therapy focus, changing Strategies, pipeline and key growth drivers of 12 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on their strategic action to withstand in domestic market and expand globally with their interest for inlicensing external innovation from the globe for increasing R&D productivity and priorities on M & A side. Japan Pharma Outlook 2016: JP Giants leaning in for becoming a Speciality Global Pharma Sakigake designation…

Filgrastim BS and Lantus BS Approval- Encouraging uptake and a lesson to fast track JP approval based on Ex-Japan data! Remicade biosimilar “NK” – A slow start does not pull back NK in starting PhIII for Herceptin BS in Japan Active companies in Biosimilar Space: Local Japanese Generic Giants- Opening the door for Biosimilars in Japan? - Will go for All or Niche in BS space???- Opportunities beyond 2020? Encouraging Uptake of Filgrastim BS and Lantus BS in 2015 in…

Non-Alcoholic SteatoHepatitis (NASH) is an unmet medical need and is becoming the leading cause of liver transplant. No FDA-approved therapies and a meager diagnosis, it poses a unique challenge in the design of studies for NASH. Therefore, there is a worldwide need for new therapies to treat the global epidemic of NASH and the cost to society will be huge if it is not addressed in the upcoming years! Besides, scarcity of treatment options, there is also an urgent unmet…

The new pricing system adopted in Japan from April -2014 (Annexure 1) is a game changer initiative. It pains most of the companies - whether generic or innovator. The most of the companies are revalidating their domestic (and thus overseas) strategies to adopt with new regulations. For the innovators – testing Authorized Generics (AGs) phenomenon for protecting their long-listed sales against generic could be one of new choice in Japan. The format and regulations for AG’s are still not clear…

All biotech companies - Gilead (GILD), Amgen (AMGN), Biogen Idec (BIIB) and Celgene (CELG), in past year, have given a positive return and hence increased the interest of biotech investors. These companies have been able to select therapy/niche indication where the high treatment cost justifies the need. While large pharma companies are active in M&A deals, the Mature biotech companies are sticking to its core expertise and venturing into unexplored/new therapy; e.g., GILD in anti-cancer and BIIB for hemophilia. Alike…

Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy Cash position- Will accelerate Next wave of targeted acquisition In the recent years' several new therapies have been approved in the area of diabetes (SGLT-2, GLP-1 agonists), Multiple Sclerosis, HCV, melanoma, and breast cancer from major pharmaceutical companies. Many of them are expected to reach multibillion dollars peak sales in the near-term which is likely to compensate the patent expiry loss in top-line revenue. Novel mechanisms like anti-PD1,…

With the recent development, Sri Lanka’s aim of developing a pharma industry should be to penetrate the global market since the internal market is not sufficient for any big firm to operate at optimum levels. According to a report published by Indian Council on International Relations in Dec. ‘14, the global market of pharma is about $1trillion, and India’s export of pharma products in 2013 amounted to $13bn, where as Sri Lanka was nil. Hence, pharma industry offers a very…

Innovative Therapies for treating diseases are being sought after with fresh vigor as new targets, approaches and biology is discovered. One field which is poised to bring a paradigm change in the way diseases are treated in the next decades is the Stem cell therapy/Regenerative Medicine space. The number of companies and products in the clinic have reached a critical mass warranting a close watch for those interested in keeping pace with the development of new medicines. The Regenerative medicine…