Bengaluru: Global pharmaceutical major Mylan has entered into an agreement with Bangalore-based Biocon for the global development and commercialization of the latter's generic insulin analog products (long lasting insulins), which has a global addressable market of $11.5 billion.
The Rs 1,600-crore Indian biotech player has developed a generic insulin analog Glargine, which retails in India as Basalog with a 85% market share in the vial category, and has two more generic insulin analogs, Lispro and Aspart, that are expected to enter the clinical trial phase soon.
These three generic insulin analogs will be co-developed and exclusively marketed by Mylan in the US, Canada, Australia, New Zealand, the European Union and the European Free Trade Association countries through a profit share arrangement with Biocon. For the rest of the world markets and emerging markets, both companies can pursue their own marketing arrangements.
"There is an upfront licensing fee payable to us by Mylan, a large part of which will be reflected in this quarter," said Kiran Mazumdar-Shaw, CMD, Biocon. Shaw expects the Mylan partnership to yield profits from 2016. Biocon will share the development costs of their analog products in the global markets with Mylan.
Three months ago, in November, Biocon had entered into an agreement with New York headquartered Bristol-Myers Squibb (BMS) for the development of its potentially game-changing novel molecule for the treatment of diabetes, oral insulin IN-105.
These global partnerships had become necessary for Biocon following Pfizer early last year scrapping their $350-million pact entered into in 2010 to market Biocon's insulin portfolio.
Heather Bresch, CEO of the $6.13-billion Mylan, said of the Biocon partnership: "This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential."
Shaw said the generic insulin analog market was the most valuable part of the insulin space and the combined addressable market value of their insulin analogs was approximately $11.5 billion. The innovator product companies in this space include Sanofi, Eli Lilly, and Novo Nordisk.
"Diabetes is a growing global pandemic and insulin therapy is pivotal to the treatment of diabetes," said Shaw.
Biocon already has a working partnership with Mylan, which it entered in to three years ago, under which both the companies are co-developing five monoclonal antibodies for the treatment of autoimmune diseases.
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