Industry Themes

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…

Invokana clean label thrills many on the street rising hopes that Invokana sales could cross $2.5b+ at peak. However we think that CV issues (dose dependent increase in LDL, CV events observed in first 30 days in CANVAS study), associated genital/UTI infections, compromised efficacy in renally impaired patients and long term safety study requirements by FDA (Table 1), should be seen in conjunction with the ‘clean label’. These issues will limit the initial uptake of Invokana to a small segment…

There are more than 1400 sustained or controlled release drugs have been approved all over the world. Revenues within the global generics market reached an estimated value of $265b in 2012, showing a growth of 9.3% throughout the year. The contribution of generics is approximately 20% of the overall international pharmaceutical market. The utilization of generic in terms of volume is higher in the US and lower in Japan, 89% and 24% respectively. The oral drug delivery market remains the…

The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than the U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (started in 2006 by launching various benefits for GE use at Pharmacy, hospital level) – now in 2014, Generic penetration of small molecules is changing the trend line and moving towards faster market penetration. While for…

Novel approaches to treat infection is growing as the need is urgent! Misuse/overuse of antibiotics accelerated antimicrobial resistance (AMR) and has resulted in the emergence of “super bugs” which are posing life threatening challenges world wide. Many of the advances in medical treatment like cancer therapy; organ transplants etc. would go waste if the ability to fight infections during the treatment were not available. If that fails, the gains made in life-improving modern medical advantages will be lost creating a…