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Important United States patent secures Pharming's position on human alpha-glucosidase.

Pharming Group N.V. (Leiden, Netherlands; +31 71 5247 429) announced the issuance of United States Patent 6,118,045, with claims covering both pharmaceutical compositions containing human alpha-Glucosidase and the production thereof. Through this patent, a viable production method for human alpha-Glucosidase to treat Pompe's disease was disclosed for the first time ever.

The patent covers two types of claims, the first protects all transgenic animals capable of producing human alpha-Glucosidase (hAG) in their milk and the use of these animals to produce hAG, the second protects pharmaceutical compositions containing hAG for parenteral use, independent of the production method used for hAG. The second set of claims is of particular interest to Pharming in light of the earlier decision to move to CHO cell culture for the production of hAG. This patent applies to all production methods for hAG, not just the transgenic platform. The inventions claimed in this patent have resulted from a fruitful collaboration between scientists from Pharming, the Erasmus University Rotterdam and the University Hospital Rotterdam at the University of Leiden.

"This is a clear demonstration of Pharming's strategy to obtain protection throughout the development track, from technology to product," according to George J.M. Hersbach, Pharming's president and chief executive officer. He continues: "With already 32 patents issued to Pharming worldwide on different aspects of transgenic technology, products and applications, we have ensured a strong and broad protection of both our technologies and products. The strength of our portfolio is increasingly recognized by others, just recently we closed an agreement with Genencor International, Inc. (Rochester, NY; 716-256-5200), on the out-licensing of our large transgenes patent."

Jan van Heek, executive vice-president of Genzyme Corporation (Cambridge, MA; 617-252-7500), adds: "This patent will be extremely important in ensuring the successful development and commercialization of human alpha-Glucosidase. It is also testament to the substantial expertise that Pharming brings to our collaboration to develop a therapy for Pompe's disease. Genzyme and Pharming share a common commitment to helping patients who are suffering from this terrible disorder, and we are working as quickly as possible to make a treatment available."

Human alpha-Glucosidase is under development as an enzyme replacement therapy for Pompe's disease, a hereditary, lethal muscle disorder that affects 5,000-10,000 people in the Western World. In 1998, Pharming formed a joint venture with Genzyme for the development and commercialization of transgenic human alpha-Glucosidase for Pompe's disease. Earlier this year, Genzyme acquired the exclusive rights to Pompase from Synpac, Inc. This enzyme replacement therapy for Pompe's disease is based on human alpha-Glucosidase produced in CHO-cells. The newly formed Genzyme-Pharming Alliance LLC, will further develop and commercialize Pompase on a 50/50 basis.

Pharming focuses on the development, production and commercialization of human therapeutic proteins to be used in highly innovative therapies. Pharming has developed a proprietary production platform of transgenic animals, capable of producing human therapeutic proteins at high levels in their milk. The company's product portfolio is aimed at treatments for genetic disorders, surgery and trauma, infectious and inflammatory diseases, tissue and bone repair and blood-related disorders. Pharming has operations in Belgium, Finland, the Netherlands and the USA and currently employs more than 200 people.
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Comment:Important United States patent secures Pharming's position on human alpha-glucosidase.
Publication:BIOTECH Patent News
Article Type:Brief Article
Geographic Code:1USA
Date:Sep 1, 2000
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