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Mistral starts clinical studies for generic



13th August, 2005:Montreal-based Mistral Pharma is expecting the results of the preliminary trials of its first unnamed generic product during autumn 2005. If the trials are successful, the product will enter Pivotal Clinical trials, the last important step before submitting the product to the FDA for approval, the company announced in a press release.

The news came with an announcement that ratiopharm has informed Mistral it is ending the two development agreements the two firms have signed. ratiopharm and Mistral entered into the product development, collaboration and licensing agreements in March and November 2004. The agreements were for two undisclosed generic controlled delivery products, including the one now entering clinical trials, along with a manufacturing agreement with ratiopharm and Confab Laboratories.

Under the terms of the agreements, ratiopharm was to finance the development work for two products for the US and Canadian markets, using Mistral Pharma's proprietary technology, and was to pay Mistral a series of milestone payments upon completion of successful developmental stages as well as royalties.

Mistral said with the termination of the agreement, it will pursue its collaboration with Confab for commercial manufacturing of the products.
Mistral added that according to ratiopharm, the decision to end the agreement had come following a review of ratiopharm's development programme, and was not related to Mistral's technologies or product development status. Mistral will continue to pursue the development work of its generic and branded products.

Mistral Pharma Inc. is a pharmaceutical company specializing in the development of controlled-delivery generic and branded drug products. The company formulates, develops and commercializes controlled-release, oral pharmaceuticals. Mistral Pharma licensed worldwide rights to Procise, an oral, controlled-release, drug delivery technology developed and patented by GlaxoSmithKline (GSK), based on a constant surface area concept. In addition, Mistral Pharma licensed from Savit Consulting Inc. the exclusive worldwide rights to Savit and Chronop, two next-generation surface area controlling oral drug delivery technologies.

Ratiopharm is a privately-held company based in Ulm, Germany. Founded in 1974, it now claims to be the leading generic company in Germany, and the third largest pharmaceutical company overall, in terms of prescriptions.Sales in 2004 amounted to just under 1.2 billion euros, of which just over half was generated in Germany. The company also has a major presence in other European countries, such as the UK and the Netherlands. ratiopharm has only a very limited presence in North America, although it has recently been expanding its Canadian operations.
ratiopharm's latest major acquisition was Magnafarma, a Dutch generic company. This was purchased in February 2004 and has now been renamed ratiopharm BV. ratiopharm has a generic biologic subsidiary named BioGeneriX. BioGeneriX has a number of alliances with potential biogeneric companies around the world.

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