Bangalore June 29, 2009
Biocon Limited today announced that it has executed a definitive agreement with Mylan Inc. (Nasdaq: MYL) for 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.
The generics segment in the pharmaceutical industry, which is currently based almost entirely on chemically synthesized drugs, is poised for a changing paradigm. The pressure to lower health care costs is galvanizing governmental efforts globally to facilitate the entry of generic bio-tech or protein derived drugs. An estimated $25 billion worth of biologics will have lost patent protection by 2016, creating a significant market opportunity for protein therapeutics like insulin and its analogs, erythropoietin, human growth hormone, monoclonal antibodies and many others. The complexity and costs involved in developing generic biologics are expected to see only a few players being able to gain entry into the highly regulated markets of Europe and USA. Bio-generics in the emerging markets are expected to grow from the current estimate of $1.5 billion at a projected rate of over 20% per annum over the next 5 years. Biocon is well positioned to capitalize on these opportunities through its early investments in research, development and manufacturing of high quality protein therapeutics, including both novel biologics and bio-generics. Combining this with Mylan's regulatory and commercialization capabilities in US and Europe creates a cost effective model to address a large, emerging opportunity for generic biologics recently supported by the Obama administration.
Biocon Chairman and Managing Director, Kiran Mazumdar-Shaw commented: "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. I am confident that our shared vision for the sector, complementary skills, mutual respect and work ethic will make this collaboration a remarkable success while bringing additional value to Biocon and its shareholders. 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 in both the developed and emerging economies."
Mylan's Chairman and CEO, Robert J. Coury commented: “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. This unique collaboration combines Biocon's scientific expertise; excellent product development track record; appreciation of complex regulatory requirements; and state-of-the-art, cost-efficient and scalable biologics manufacturing with Mylan's one-of-a-kind global commercial footprint and our regulatory expertise around the world. 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. Generic biologics, especially monoclonal antibodies, are expected to become the next great bolus of growth in the generic pharmaceutical industry, and 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.”
As part of this 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.
About Mylan Inc:
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest – and highest quality – product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
For more information, visit www.mylan.com.
About Biocon Limited
Established in 1978, Biocon Limited is one of India's premier biotechnology companies. Together with its group companies, Biocon forms a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research and clinical research which deliver products and solutions to partners and customers across the globe. Biocon launched the world's first recombinant human insulin, INSUGENâ in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFRTM.
A leading US trade publication, Med Ad News, in its 2007/08 listings has ranked Biocon 20th amongst the leading biotechnology companies in the world and the 7th largest Biotech employer in the world. Biocon recently received the 2009 BioSingapore Asia Pacific Biotechnology Award for Best Listed Company. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, Biocon offers novel therapies on a platform of affordable innovation. Biocon's strategic licensing partnerships provide market penetration and global access to deliver breakthrough therapeutics to millions of patients the world over.
This press release includes statements that constitute "forward-looking statements," including with regard to the collaboration and commercialization of the products, the company's future opportunities and the transaction's impact on future earnings. These statements are made pursuant to the safe harbor provisions contained in relevant regulations. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the content and timing of decisions by regulatory authorities related to the development and commercialization of the products; difficulties or delays in manufacturing; demand for and market acceptance for the products; the impact of competitive products and pricing; and the other risks. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.