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Axcan, Nordmark to develop novel pancreatic enzyme preparations
Quebec | Friday, February 21, 2003, 08:00 Hrs  [IST]

Axcan Pharma Inc has entered into an agreement with Nordmark Arzneimittel GMBH & Co. KG (Nordmark) of Germany, the manufacturer of Panzytrat. Under the terms of the agreement, Axcan and Nordmark will create a joint venture to develop patent-protected novel enzyme preparations (NMK 150 for the treatment of pain in chronic pancreatitis and NMK 250 for the treatment of steathorrea). Once these products are approved, the joint venture will hold the right to manufacture the bulk active ingredients, while Axcan will hold worldwide marketing rights for all finished dosage forms. Financial terms of the agreement were not disclosed.

"This agreement represents an ideal synergy from which both parties will benefit since Nordmark is a highly specialized manufacturing company while we are successful marketers," stated Leon F. Gosselin, President and Chief Executive Officer of Axcan. "These new enzyme formulations will allow us to build on the strength of our existing brands, Ultrase, Viokase and the recently acquired Panzytrat, and should considerably extend the life-cycle of enzyme-based products. Axcan expects to absorb its portion of the development costs within its existing research and development budget," he concluded.

NMK 150, a high-protease, pancrelipase preparation for which a patent application has been filed, should enter Phase I clinical trials during fiscal year 2004. The preparation will be developed for the treatment of pain associated with chronic small duct pancreatitis, a disease affecting at least 100,000 persons in North America and for which an orphan drug designation is expected to be requested. If approved, Axcan anticipates launching NMK 150 in fiscal 2006.

NMK 250, a patented bio-engineered, viral-free lipase developed through a fermentation process, should enter a Phase I clinical trial in fiscal 2004. This new formulation should promote better compliance and increased efficacy in correcting steathorrea in cystic fibrosis patients and in other patients suffering from pancreatic enzyme deficiencies. If approved, Axcan expects to launch this product in fiscal 2007. Approximately 32,000 patients suffer from cystic fibrosis in North America and 49,000 in Europe.

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