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Synthon Pharmaceuticals Enters Into Global License Agreement With Amgen (AMGN) and Watson Pharmaceuticals, Inc. (WPI) for Biosimilar Trastuzumab


7/18/2012 9:18:09 AM

Nijmegen, the Netherlands, 18 July 2012 – Synthon today announced that it has entered into a global license agreement with Amgen Inc. (NASDAQ:AMGN) and Watson Pharmaceuticals, Inc. (NYSE:WPI) for Synthon’s trastuzumab, being developed as a biosimilar to Herceptin®, which is currently approved for treatment of breast cancer and gastric cancer. Earlier this year Synthon successfully completed a Phase I clinical trial in Europe showing bio-equivalence between its trastuzumab biosimilar and Herceptin®. The company was preparing for a confirmatory Phase III trial for Europe with this compound.

Under the agreement, Watson has acquired the license to the biosimilar program and has contributed it to the Amgen/Watson biosimilars collaboration. Amgen and Watson will assume responsibility for all future development work worldwide, including Phase III clinical trials, as well as global manufacturing and commercialization. Synthon will provide transitional support as set forth in the agreement. The deal entitles Synthon to an initial payment and potentially a milestone fee and royalties on net sales. Synthon will also receive compensation for its transitional support activities under the agreement. Synthon has retained rights to move forward independently with a HER2-targeted antibody-drug conjugate (ADC) candidate using its proprietary Linker-Drug technology.

Rudy Mareel, CEO of Synthon, commented: ”We are very pleased to partner with Amgen and Watson for our trastuzumab biosimilar, positioning it for success in the next phases of its development and commercialization. The agreement is testimony to the quality of Synthon’s science and our innovative strength, which we will continue to foster and invest in.”

‘’We are impressed with Synthon’s trastuzumab program and are anxious to advance it, consistent with our goal of reliably serving patients worldwide with high quality biosimilar products”, said Scott Foraker, VP/GM Biosimilars at Amgen.

“This transaction with Synthon reflects the determination of all three parties to maximize the value of biosimilar trastuzumab through accelerated product development, and demonstrates the flexibility of the collaboration between Amgen and Watson by combining our expertise to identify and execute on opportunities to participate at market formation,” said Fred Wilkinson, President, Watson Global Brands and Biosimilars.

Synthon’s trastuzumab is one of the most advanced products in the company’s biopharmaceuticals pipeline. It is one of the first trastuzumab biosimilar products to have completed a Phase I trial in Europe.

Additional details of the transaction were not disclosed.

*Herceptin® is a registered trademark of Genentech/Roche.

About Synthon

Synthon, with headquarters in Nijmegen, the Netherlands is an international fast-growing pharmaceutical company and a leader in the field of generic medicines. Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of auto-immune diseases – particularly multiple sclerosis - and oncology. Our products are currently approved by regulatory agencies in over 80 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,400 staff at 11 sites worldwide, and in 2011 it recorded a turnover of EUR 260 million. For more information, go to www.synthon.com.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.

About the Watson/Amgen biosimilars collaboration

In December 2011 Amgen and Watson announced that they will collaborate to develop and commercialize, on a worldwide basis, several oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients.



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