Bolus of growth

Mylan chooses Bangalore’s Biocon as global generic biologics partner

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BANGALORE, India—Based on the expectation that generic biologics, especially monoclonal antibodies, will become the next great "bolus of growth" in the generic pharmaceutical industry, Biocon Ltd. and Mylan Inc. have formed an alliance that promises to provide "all four corners of what any organization would want or need to offer a highly competitive and distinct generic biologics product portfolio with tremendous growth potential for the coming decade," says Biocon chairman and managing director Dr. Kiran Mazumdar-Shaw.

The agreement with Mylan maps out an exclusive collaboration on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds for the global marketplace. Through this partnership, "Mylan and Biocon bring together highly complementary capabilities that will significantly advance their efforts to secure a leading position in the emerging generic biologics industry," their announcement states.

Biocon's Mazumdar-Shaw summarizes the partners' strength this way: "Biocon offers scientific expertise; an excellent product development track record and state-of-the-art, cost-efficient and scalable manufacturing of high-quality protein therapeutics, including both novel biologics and bio-generics, with an appreciation of complex regulatory requirements. Mylan brings a global commercial footprint and significant regulatory expertise around the world. Together, this creates a cost-effective model to address a large, emerging opportunity for generic biologics recently supported by the Obama administration. Biocon also has a unique corporate culture that is very similar to Mylan's. All of these attributes will provide a critical synergy and create a strong and effective long-term partnership, addressing a critical need to lower spiraling healthcare costs in both the developed and emerging economies."

Mylan Chairman and CEO Robert J. Coury commented: "Biocon is a first-class, highly respected organization, and I am extremely excited to be able to announce what I consider to be one of the more comprehensive and high quality biologics initiatives reported within the industry to date. After conducting extensive due diligence, I can tell you that Biocon is truly an ideal partner for Mylan."

"Monoclonal antibodies are emerging as the most dominant class in biologics," Mazumdar-Shaw notes. "Through this partnership, we hope to deliver high-quality, affordable biogeneric antibodies and biologics. We would anticipate launching in 'outside the U.S.' major markets before launching in the U.S., with opportunities to launch the same products in less regulated markets potentially even sooner. This will depend on a number of factors including adoption of legislation and the expiry of relevant patents. We do believe, however, that our first launch in a regulated market will likely occur outside the U.S."

As part of the collaboration, Mylan and Biocon will share development, capital and certain other costs to bring products to market. Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries through a profit sharing arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world. All other financial terms and product details remain confidential.

Established in 1978, Biocon, together with its group companies, forms a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research and clinical research. The company launched the world's first recombinant human insulin, INSUGEN, in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, Biocon offers novel therapies with an emphasis on affordable innovation.

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