SkyePharma picked as Kowa's statin partner
Japan's Kowa has selected SkyePharma of the UK to act as its partner forthe scale-up and manufacturing of Phase III clinical batches of the former's new lipid-lowering agent NK-104 (itavastatin). Under the terms of the agreement, SkyePharma will be responsible for providing materials for the European and US clinical trials at its facility near Lyon, France.
NK-104 has been submitted for marketing authorization in Japan, and Phase II trials have been completed in Europe. Phase II trials are expected to start this spring in the USA, where the product will be co-promoted by Sankyo Pharma, while it is hoped that, if approved, the statin will be sold by a Kowa affiliate and Negma of France.
Michael Ashton, SkyePharma's chief executive, stated that the contract highlights the expertise in product development and manufacturing within the company "and, in particular, the value of Lyon as a manufacturing partner for our clients."
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