Keryx Biopharmaceuticals Secures U.S. Patent For Use of KRX-101 Against Diabetic Retinopathy

BOSTON and JERUSALEM, Jan. 29/PRNewswire/ - Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; AIM: KRX), announced that the United States Patent and Trademark Office has granted Patent No. 6,080,732 for the use of KRX-101 (sulodexide) in the treatment of diabetic retinopathy, an eye-related complication of diabetes. The Company has exclusive U.S. rights to the patent under its licensing agreement with Alfa Wassermann, S.p.A. Issuance of this patent compliments the late-stage clinical development program Keryx has in place with KRX-101 for the indication of diabetic nephropathy, a kidney- related complication of the disease.

In addition to their work with KRX-101, the Company continues to advance its KinAce (TM) platform, a broad, post-genomics technology for the discovery of kinase-targeted drugs.

"Our current focus is on the advancement of the clinical program for KRX- 101 in diabetic nephropathy," said Morris Laster, M.D., Chairman and Chief Executive Officer, Keryx Biopharmaceuticals, Inc. "However, we believe that KRX-101 has long-term potential for other diseases and this patent provides a foundation on which to expand the compound's future clinical development.

In September, Keryx received U.S. Food and Drug Administration (FDA) approval to submit a protocol for a Phase III trial with KRX-101 for the indication of diabetic nephropathy, for which current therapy is inadequate. The Company is actively designing a protocol for this Phase III trial.

Retinopathy affects approximately 85% of those suffering from diabetes in the Western world. This condition is characterized by lesions on the retina, as well as damage to the blood vessels that are responsible for supplying the retina with blood, and may lead to distorted vision, or even blindness. Preliminary clinical observations have shown that patients with diabetic retinopathy who are treated with sulodexide demonstrate improvement of retinic lesions. About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is building a pipeline of drug candidates that target protein kinases by applying its proprietary bioinformatics technology to genomics data. Kinases, which play a key role in the way cells communicate, are implicated in a wide range of diseases. Using its KinAce(TM) drug discovery platform technology, the Company has established a rich and diverse pipeline of drug candidates in oncology, immunology, metabolic, and other disease areas. The most advanced of these candidates, KRX-123, is scheduled to enter clinical trials for advanced prostate cancer in the first half of 2001. The Company is also developing a late stage, in-licensed product, KRX-101 (sulodexide), for the treatment of diabetic nephropathy. Keryx recently received FDA approval to submit a Phase III clinical trial protocol for KRX-101. Keryx is traded on NASDAQ (KERX) and AIM (KRX). Web site address: www.keryxbiopharm.com

Statements contained or referenced in this news release that are not historical facts, including, but not limited to, statements concerning the possible approval and market potential of KRX-101, may be forward-looking statements, as the term is defined in the Private Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "anticipate", "estimate", "expect", "project", "intend", "plan", "believe" "scheduled" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Our actual results and the timing of certain events may differ significantly from the results discussed in forward-looking statements. Factors that might cause or contribute to such a discrepancy include, but are not limited to, the risks outlined in our Registration Statement on Form S-1 filed with the Securities and Exchange Commission.

The forward-looking statements contained in this filing or in our Registration Statement on Form S-1 include, among other things, statements relating to our drug development and regulatory strategy, growth strategy, use of proceeds, projected capital expenditures, research and development expenditures, other costs and expenses, revenue, profitability, and liquidity and capital resources.

Contacts:
Robert Gallahue
Chief Financial Officer
Keryx Biopharmaceuticals
Tel: (617) 512-6883
Email: bobgallahue@mediaone.net

Fredda Malkoff
Feinstein Kean Healthcare
(617) 577-8110
Email: fmalkoff@fkhealth.com

Ron Bentsur
Head of Investor Relations
Keryx Biopharmaceuticals
Tel: +972 (2) 541 2700
Email: ron@keryxbiopharm.com

Phillip Ward/Charlotte Stone
Gavin, Anderson and Co.
+44-20-7496-1439
Email:cstone@gavinanderson.co.uk


                        
 

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