In another recent biosimilar activity,Mumbai based Lupin pharma and Japan’sNichi-Iko have forgeda partnership for distribution, promotion and sale of biosimilar Etanercept in Japan. Lupin’s Japanese arm and Yoshindo co-developed this biosimilar under the joint venture YL biologics. Nichi-iko is seeking approval from Japanese regulator Pharmaceuticals and Medical Devices Agency (PMDA) for launching the product. This reflects the trend of global biosimilar companies seeking local JV partners for development and marketing of their products in Japan. Notable examples include Celltrion’s marketing partnership with Nippon Kayaku, the Dong-A ST and Meiji Seika Pharma joint venture and Biocon’s partnership with FUJIFILM Pharm for insulin glargine. While Japan has been a relatively less attractive market for small molecule generics companies, the intensity of biosimilar partnerships reflects significantly higher potential in biosimilars.
Novartis’ Kymriah and Gilead Sciences’ Yescarta are currently approved chimeric antigen T-cell receptor (CAR-T) therapies by the FDA. With overlapping indications such as diffuse large B cell lymphoma (DLBCL), some level of head-on competition between products is inevitable. While intensifying competition usually signals price optimization and expansion of access to care, insuch high value therapies targeting rare indications, it could potentially be a threat to return on investment if accessible patient pool is limited. While we continue to be excited about expanding possibilities with this new paradigm of care,it is pertinent that business and pricing models evolve to ensure sustainability.
Besides focusing on accessingnovel platforms for vaccine development, vaccine majors are also directing attention to innovative delivery technologies. Netherland based R&D organization developing innovative vaccine platforms, Intravacc has partnered with Indian vaccine major Serum Institute of India to co-develop novel vaccine delivery system called Bioneedles that are administered under the skin with an applicator. The freeze-dried vaccine is delivered upon degradation of the bioneedle matrix which is a biomaterial made of starch like polymer.This minuscule biodegradable mini implant will be developed for measles and rubella vaccines and are freeze and heat-stable enabling cold chain free transportation.
Mandates – Ongoing Assignments and Partnering Opportunities
1. Brand Divestiture for a leading Indian cardiac brand
2. Outlicensing – liposomal, microsphere and nano-particle based complex generics from a leading Latin American company
3. Market Landscaping & Business Plan for Lab Animal breeding facility
4. Lung cancer incidence mapping & access model for biotech venture
5. India opportunity assessment & market access plan for critical care medical device
6. Valuation of API company for strategic investment
7. Technology scouting & licensing for prioritized vaccines
8. Handholding strategic collaborations for leading opthalmic institution
9. Private equity fund raising – leading Indian diagnostic company
10. Sell-side mandate for upcoming 200+ bed hospital in Tirupati