Visterra is also one of the few start-ups globally with pipeline of novel biologic candidates for infectious diseases such as dengue. It is poignant to note that the dengue program was one of the earliest to attract partnership interest from India’s Serum Institute but lost its lead status to the Inflenza program as Visterra advanced its pipeline. While it is encouraging to note that Otsuka’s interest spans CNS, oncology, kidney diseases, cardiovascular and infectious diseases, we wrap up this deal discussion with hope that Visterra’s infectious diseases programs aren’t deprioritized with Otsuka now steering the company forward.
Reflecting the Trump administration’s intent to lower healthcare costs, the FDA released a Biosimilar Action Plan (BAP) focusing on 4 major topics:
- Improving the efficiency of biosimilars and interchangeable product development and approval process. Impact: New application review template specifically for biosimilars, Information resources and development tools for sponsors to improve over-all process
- Maximizing scientific and regulatory clarity for biosimilar product development community. Impact: Acceptance for non-US comparators and greater use of real-world evidence. One of the immediate impacts will be reduced cost of trials and time to market
- Developing effective communications to improve understanding of biosimilars among patients, clinicians and payers. Impact: Greater understanding of the biosimilars and acceptance from all stakeholders
- Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition. Impact: By coordinating with FTC and legislators, any loopholes will be closed, that may delay competition
This comes at the heel of the recent Pegfilgrastim approval for Mylan-Biocon with speculation of more aggressive benchmarks in price erosion. It has been reported that Mylan will have the steepest until now discount of 33% on wholesale acquisition cost in comparison to the innovator pricing. While FDA’s BAP is a loud signalling of policy efforts to eliminate market access challenges for biosimilars, it is also clear that opening up of markets will be accompanied by gradually expanding pricing pressure. Market expanse predicted will now be a reality, but price erosion is anticipated to be more than double of erstwhile industry expectations.
CDSCO creates Veterinary Medicines Cell – Triggered by announcement at the CSFD-INFAH One Health India Summit
In May 2018, the Cornell Sathguru Foundation & Indian Federation of Animal Health Companies (INFAH) organized the first multi-stakeholder One Health Summit in India emphasizing the inter-connectedness of animal health, human health, food and environment. The historic summit triggered foundational discussions on several challenges at the intersection – AMR, zoonotic diseases and food safety. Most notably, it also led to a significant announcement by the Drug Controller General of India who inaugurated the Summit. The landmark announcement is now a reality for industry – earlier this month CDSCO officially announced creation of the Veterinary Medicines Cell with dedicated team of regulators. With an aggregate size exceeding $500million, the Indian animal health industry is rapidly expanding across segments and is emerging as at attractive growth opportunity for both multinationals and Indian companies.
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