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Who Is This Drug Company That's Manufacturing On The Iom?


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January 16, 2006

 

PROMETIC PRODUCT USED IN THE MANUFACTURE OF AN FDA-APPROVED BIOTHERAPEUTIC

 

 

Montreal, Quebec (Canada), January 16, 2006 – ProMetic Life Sciences Inc. (TSX-PLI.SV) reported today that Halozyme Therapeutics, Inc. (Amex: HTI), a client of PLI’s subsidiary ProMetic BioSciences Ltd, has received U.S. Food and Drug Administration (FDA) approval for Hylenex recombinant (hyaluronidase human injection), for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. As part of its manufacturing process, Hylenex is purified using a proprietary synthetic-ligand affinity adsorbent manufactured by ProMetic BioSciences Ltd.

 

 

 

ProMetic BioSciences Ltd specializes in the development and manufacture of robust affinity separation materials which provide very high levels of purification. This is achieved by use of small chemical affinity ligands designed to specifically bind the target biomolecule. In view of their use for the production of therapeutics, ProMetic’s affinity products are manufactured to strict quality standards at the company’s GMP compliant manufacturing facility located on the Isle of Man.

 

 

 

“It is pleasing to see ProMetic’s clients gain regulatory approval for their products and we would like to congratulate Halozyme on the approval of its NDA filing,” said Dr. Steve Burton, Executive Vice President of ProMetic BioSciences Ltd. “ProMetic places great emphasis on the quality of its products and the provision of supporting regulatory information to its customers. Halozyme joins a growing list of companies that manufacture approved biotherapeutic or biomedical products using ProMetic’s purification materials and technology.”

 

An FDA approval of a client’s product contributes to ProMetic’s recurring revenue by way of ongoing adsorbent supply for product manufacture.

 

 

 

Prometic BioSciences Ltd offers a range of products and services to its clients which include the sale of proprietary products, the development and manufacture of affinity materials for specific applications, and the development of purification processes which incorporate ProMetic’s advanced purification technology. Unlike other ligand companies ProMetic offers a total package including adsorbent synthesis, method optimization, GMP manufacture, and regulatory and after-sales support to provide its customers with a comprehensive and cost-effective solution to their purification problems.

 

 

 

About ProMetic Life Sciences

ProMetic Life Sciences Inc. is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic LigandTM enabling technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of inflammation and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic “drug-like” protein mimetics. Headquartered in Montréal (Canada), ProMetic has R&D and manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and MENA countries (Middle East and North Africa).

 

 

 

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology and oncology communities. The company's portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.

 

 

 

Forward Looking Statements

This press release contains forward-looking statements about ProMetic’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, the Company’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 15 of the Company’s Annual Information Form for the year ended December 31, 2004, under the heading “Risk Factors”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason.

 

 

 

For further information please contact:

 

 

 

ProMetic Life Sciences Inc:

 

Investor Relations

Nicole Blanchard, Sun International Communications

(450) 627-6600, nicole.blanchard@isuncomm.com

 

 

Link:-http://www.prometic.com/en/news.htm

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