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MARKHAM, Ontario—AlphaRx Inc. and Venturepharm Group have announced a collaboration to establish a drug development center in China Medical City, Taizhou, China, that is expected to be used as a platform for the development of innovative drug products for the fast-growing China pharmaceutical market.   

Under the terms of the agreement, AlphaRx will incorporate its China-based research and development facility into Venturepharm's state-of-the-art, preclinical development complex which is comprised of a 200,000 square-foot chemistry center, a 200,000 square-foot, multi-product pilot plant to support pilot scale formulation and clinical trial material manufacturing of biopharmaceutical products and a 500,000 square-foot animal testing center (under construction).

The in-house pharmaceutical research facilities provide specialized equipment for most aspects of drug research and development. AlphaRx, an emerging biopharmaceutical company that uses proprietary drug delivery technology to develop novel formulations of drugs, will be responsible for all of its own product development costs and will in turn retain the intellectual property rights relating to any developed products.

"Venturepharm provides the equipment and physical infrastructure to further establish our presence in China and reduces our start up investment costs," says Michael Lee, president of AlphaRx. "As AlphaRx continues to build its presence in China, this collaboration with Venturepharm marks an important step in our overall strategy to commercialize current products and to develop new therapeutics for the world fastest-growing pharmaceutical market."

Lee says Venturepharm, a China-based life science leader that provides CRO, CMO and CSO services, as well as venture capital and merchant banking for the biotechnological and pharmaceutical industries, proved to be a perfect candidate for the collaboration.

"Venturepharm runs the most successful CRO in China and it is the only Chinese CRO listed in the Hong Kong stock exchange. Therefore, Venturepharm definitely has the experience, expertise and the credibility to get our drugs approved in China," he says.

Bill Guo, president of Venturepharm, says the new trend for R&D outsourcing is transferring from specialty CRO to one-stop integration outsourcing services, and as a result, the collaboration makes sense at this time. According to Guo, the chemistry center is in operation, the pilot plant will be in operation by February and the animal testing center will go into operation by early 2011. He added the facility will feature researchers from both companies working together under one roof.

"Scientists from both companies will be working in concert in the pilot scale plant whereby AlphaRx will be responsible solely for formulation and analytical development," he says.

While the financial terms were not disclosed, Lee notes that so far, Venturepharm has invested more than $20 million to build the infrastructures in Taizhou, and AlphaRx is prepared to invest $5 million over the next three years. Should the researchers' efforts bear fruit in the form of drug candidates, the partners are prepared to ensure that they find their way to market.

"Venturepharm runs a very successful CSO in China with 1,000 representatives," notes Guo. "Therefore, Venturepharm will be responsible for the marketing of drug products developed through the collaboration."

Ultimately, success of the collaboration will be measured by the number of novel drug candidates that reach market.

"Success is always measured by product approval," Lee says. "Our goal is to have a total of 5 large market drugs developed and approved by China SFDA by 2015."

Guo points out that the collaboration has tremendous upside for both companies.

"I consider the collaboration is both good for AlphaRx and Venturepharm even the career of Chinese healthcare," he says. "It is a kind of win-win collaboration."
 

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