Pharming Group N.V. (Niels Bohrweg 11-13, 2333 CA, Leiden, The Netherlands; Tel: +31 71 524 74 00, Fax: +31 71 521 65 07; Website: www.pharming.com) has announced the issuance of U.S. Patent 6,118,045, with claims covering both pharmaceutical compositions containing human alpha-glucosidase and the production thereof. The patent discloses a viable production method for human alpha-glucosidase to treat Pompe's disease. The inventions claimed in this patent resulted from a collaboration between scientists from Pharming, the Erasmus University Rotterdam, and the University Hospital Rotterdam at the University of Leiden.
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. This patent applies to all production methods for hAG, not just the transgenic platform. Pharming has decided to use Chinese hamster ovary (CHO) cell culture for producing hAG.
"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. "The strength of our portfolio is increasingly recognized by others - just recently we closed an agreement with Genencor International, Inc., on the out-licensing of our large transgenes patent."
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 (One Kendall Sq., Cambridge, MA 02139-1563; Tel: 617/252-7500, Fax: 617/374-7368; Website: www.genzyme.com) for the development and commercialization of transgenic human alpha-glucosidase for Pompe's disease. Earlier this year, Genzyme acquired the exclusive rights to Pompase (CHO-produced human alpha-glucosidase) from Synpac, Inc.
Preliminary Phase I/II trial results indicate that the enzyme is capable of improving cardiac and skeletal muscle functions. Cardiomyopathy and heart failure usually lead to death in untreated patients before one year of age.
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