Synthon Pharmaceuticals Successfully Concluded Phase I Clinical Trial for Trastuzumab

Synthon’s first truly biosimilar product now embarking on phase III study

NIJMEGEN, the Netherlands I 22 March 2012 I Synthon today announced that it has successfully concluded a phase I clinical trial for trastuzumab, a biosimilar to Herceptin © , for treatment of breast cancer and gastric cancer. The company will now initiate a phase III clinical trial for trastuzumab, bringing an affordable alternative for treatment of breast and gastric cancer closer to the market.

All in vitro and in vivo studies conducted so far showed biosimilar behavior of Synthon’s trastuzumab in comparison with the reference product, Herceptin ® . The outcome of the phase I clinical trial confirmed these results, showing bio-equivalence of Synthon’s trastuzumab to Herceptin ® .

“Trastuzumab is one of the most advanced biopharmaceutical products of Synthon’s pipeline, and is now ready to go into a confirmatory phase III clinical trial in breast cancer patients,” says Rudy Mareel, CEO Synthon. “Biosimilars are to Synthon a serious stepping stone towards the development of biosuperior and truly innovative biological products. We are very excited about our growing portfolio of new biological antiproliferative agents that is well positioned next to our biosimilars.”

Continues Mareel: “We are also making significant progress toward our specialty pharmaceuticals strategy, organized around the key therapeutic areas of multiple sclerosis / auto-immune diseases and oncology. We have a significant pipeline under development in these areas, across all our technological platforms of high quality generics, biosimilars and new biological and chemical entities. We are also capitalizing on the strength of our strategy, as a growing number of renowned companies pursue partnerships with Synthon to support our specialty pharma journey. This confirms our belief in our collaborative model and we remain open to research and commercial partnerships.”

*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 disease, 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

SOURCE: Synthon

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