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Biopartners Receives European Union Marketing Authorisation for its Biosimilar Recombinant Human Growth Hormone - Valtropin(R) |
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04 May 2006 |
BAAR, Switzerland | May 04, 2006 | Biopartners, a privately-owned biopharmaceuticals company has received marketing authorisation for the European Union from the European Commission for its biosimilar medicinal product Valtropin, a recombinant human growth hormone used for the treatment of human growth deficiency in children and Turner's Syndrome. This is only the second biosimilar product to receive EU marketing authorisation from the European Commission and confirms Biopartners' position as a leader in the development of biosimilars. Biopartners, jointly with LG Life Sciences, has co-developed a number of biopharmaceutical products including Valtropin and a sustained release formulation of Valtropin. Biopartners in-licensed Valtropin from LG Life Sciences and has commercialization rights for Valtropin in Europe, Japan and other parts of Asia.
"We are delighted to have gained EU marketing authorisation for Valtropin" stated Mr Jean-Noel Treilles, CEO of Biopartners. "As the first product in our broad and advanced pipeline to gain authorisation, this marks a major milestone for Biopartners. We aim to make Valtropin available to healthcare professionals and patients through our distributors before the end of the year. Biopartners is currently developing a sustained release version of Valtropin that is currently in Phase III clinical trials."
Professor Paul Saenger, Professor of Paediatrics at the Albert Einstein College of Medicine in New York, USA and Immediate Past President, Lawson Wilkins Paediatric Endocrine Society also welcomed the marketing authorisation. "Valtropin will provide paediatric endocrinologists with a more cost-effective treatment option for growth disorders compared to the currently marketed growth hormone preparations and this in turn will allow us to treat more patients, which is great news."
About Biopartners
Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. Biopartners' mission is to develop biosimilars and innovative formulations of "first generation" biopharmaceuticals as well as advanced delivery systems that may improve patient compliance. Biopartners is developing a comprehensive range of biopharmaceutical products that may offer life-saving therapeutic benefits across many therapeutic areas, including oncology, virology, haematology, endocrinology and neurology.
Biopartners has submitted a second dossier to the EMEA and has two products in Phase III clinical trials.
Notes to Editors:
Biopartners is a DLJ Merchant Banking Partners investment. DLJ Merchant Banking is a part of Credit-Suisse private equity.
Biopartners has partnered with LG Life Sciences, Ltd. - the leading pharmaceutical company in South Korea with a firm foundation in R&D - and other cutting edge companies, for the development and manufacture of its portfolio of drugs.
SOURCE: Biopartners |
