FDA Grants First Approval For A Product Derived From Pichia Pastoris

Main Category: Public Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Dec 2009 - 2:00 PDT

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RCT licensee Dyax Corp. has received approval from the U.S. Food and Drug Administration for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

The approval of KALBITOR® is a first for a product produced in the Pichia pastoris yeast expression system. Tucson-based Research Corporation Technologies (RCT) has licensed the Pichia system to numerous companies in the biotechnology, pharmaceutical, animal health and food industries.

HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. KALBITOR®, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the United States.

Based in Cambridge, Mass., Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's first product is KALBITOR® (ecallantide).

"We are pleased by the approval of KALBITOR® for the treatment of HAE, and the fact that our Pichia technology played a role in the development of this product. We expect that this will be the first of many new biologic-based products to be produced in Pichia," says Kurt R. Gehlsen, RCT's Chief Scientific Officer.

Pichia has become an important major protein expression platform, and its use has grown and progressed over the last several years, producing an ever-expanding variety of proteins. Especially significant have been the modifications created under the Pichia GlycoSwitch™ system, which make the production of proteins with human-like glycosylation possible.

RCT is a technology investment and management company that provides early-stage funding and development for promising biomedical companies and technologies.

Source
Research Corporation Technologies

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