Pfizer Inc. and Mylan Inc. have signed a definitive agreement to establish an exclusive long-term strategic collaboration to develop, manufacture, distribute and market generic drugs in Japan. The collaboration is designed to build upon each company's highly complementary strengths and quality assets.

Under the terms of the agreement, Pfizer's responsibilities primarily consist of the commercialization of the combined generics portfolio, managing a combined marketing and sales effort using its strong brand reputation and exceptional track record of bringing new products to the market. Mylan's responsibilities primarily consist of managing operations, including research and development and manufacturing, building upon the company's strong global reputation for development of difficult to formulate products, quality manufacturing, supply chain reliability and service excellence.

The collaboration between Pfizer and Mylan will include a portfolio of more than 350 marketed products across a broad range of therapeutic categories, as well as more than 125 additional products in development. Products included in the collaboration are expected to be sold under the strong Pfizer brand with joint labelling.

"We are pleased with the opportunity to collaborate with Mylan to meet the ever-growing demand for high-quality generics in Japan. We believe this collaboration will enable both companies to effectively build upon each other's core capabilities to help meet the needs of more patients and customers in Japan than ever before," said Albert Bourla, president and general manager of Pfizer's Established Products Business Unit. "Over the past 59 years, Pfizer Japan has built trust with patients and customers, and developed a very strong Pfizer brand. We are committed to delivering high quality medicines and believe this agreement will help us accelerate our ability to achieve our vision: Transform the Japanese Healthcare Environment with Established Products by 2020."

Mylan's CEO, Heather Bresch, commented: "We are very excited to have the opportunity to be partnering with Pfizer to build upon our existing assets and drive an even stronger, more sustainable generics business in Japan—one which will be well-positioned to take advantage of anticipated growth in generic utilization in this market and other significant growth opportunities. As a leading global biopharmaceutical company and a leader in the Japanese market, we expect Pfizer will bring significant benefits to the collaboration, particularly in the commercialization of products, and will complement the strengths of our existing Mylan business. With contributions from both companies, we believe the collaboration will result in a powerful generics platform that we believe will be a leader in Japan in terms of scale, scope and quality.

"We expect the collaboration with Pfizer to enhance the contribution of Japan to our overall business in the near- and long-term and provide exciting opportunities to our employees across all areas of the business in Japan. Importantly, by accelerating our growth and penetration in Japan, this collaboration will bring Mylan another step forward towards achieving our mission of providing high-quality medicine to the world's 7 billion people," concluded Bresch.

Japan is the second-largest pharmaceutical market in the world, behind the US, and the sixth largest generic retail prescription market worldwide, with sales of approximately $5.2 billion in 2011. The Japanese market offers attractive growth prospects due to factors such as its ageing population, numerous impending drug patent expiries and a broad array of government initiatives aimed at reducing health care expenditures. The Japanese government intends to grow the current volume of generic utilization from approximately 24 per cent to 30 per cent by the end of 2012.

Under the agreement, Pfizer and Mylan will each continue to operate independent entities in Japan, but will collaborate on current and future generic products, sharing the costs and profits resulting from the collaboration. The transaction remains subject to the satisfaction of certain closing conditions. Transaction terms remain confidential.

Pfizer strives to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Its diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products.

Mylan is a global pharmaceutical company committed to setting new standards in health care.