Notwithstanding the recent setback to the image of Indian pharma companies with Sun Pharma locking horns with US Food & Drug Administration, Bangalore-based Biotech major, Biocon Ltd on Monday went ahead and entered a ?definitive agreement? with US-based Mylan Inc, a Nasdaq-listed pharma major getting into an ?exclusive collaboration? on the development, manufacturing, supply and commercialisation of multiple, high-value generic biologic compounds? for the global market.
As part of the collaboration, Mylan and Biocon would share ?development, capital and certain other costs? to bring the products to market. Mylan would hold ?exclusive commercialization rights? in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free TradeAssociation countries through a profit-sharing arrangement with Biocon, while in the rest of the world, the two companies would share ?co-exclusive commercialisation rights? with Biocon. As per a company release, all other financial terms and product details would remain confidential.
Chairman and managing director of Biocon Kiran Mazumdar Shaw said, ?Biocon is extremely pleased to have found a partner as strong as Mylan to accelerate our work in generic biologics and take it to the next level around the world, especially in regulated markets.?
According to Biocon, its early investments in bio ? generics research, development and manufacturing of high quality protein therapeutics, including both novel biologics and bio-generics along with Mylan?s regulatory and commercialization capabilities in the US and Europe created a cost effective model to address a large, emerging opportunity for generics biologics recently supported by the Obama administration.
The bio?generics market, which is currently estimated to be worth $1.5 billion, is projected to grow at 20% per annum for the next five years. Mazumdar Shaw added, ?Monoclonal antibodies are emerging as the most dominant class in biologics. Through this partnership we hope to deliver high quality, affordable bio-generic antibodies and biologics, thereby addressing a critical need to lower spiraling healthcare costs.?
Mylan?s chairman and chief executive officer, Robert J. Coury also said that generic biologics, especially monoclonal antibodies were expected to become the next great area of growth in the generic pharmaceutical industry.
?Through this alliance, Mylan and Biocon have covered all four corners of what any organization would want or need to have secured to offer a highly competitive and distinct generic biologics product portfolio with tremendous growth potential for the coming decade,? said Coury.
Per Coury, the pact would aim to combine Biocon?s scientific expertise, product development track record, understanding of regulatory requirements, and cost-efficient and scalable biologics manufacturing with Mylan?s ?one-of-a-kind global commercial footprint and regulatory expertise around the world.?
Following the announcement, Biocon gained 2.75 points on the BSE, closing at Rs 229.50 after having opened the day at Rs 227.75. For its FY09 ending December 31, 2008, Mylan reported revenues of $4.14 billion and Biocon?s revenue for FY09 ending March 31, 2009, was Rs 1673 crore.