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TKT Gains Early Access to Dynepo(TM) Oncology Data.

Publication: PR Newswire
Publication Date: 13-SEP-04
Format: Online
Delivery: Immediate Online Access

Article Excerpt
Transkaryotic Therapies, Inc. today announced that Sanofi-Aventis SA granted the company a license to clinical trial results from a controlled Phase III clinical trial evaluating Dynepo(TM) (epoetin delta), its Gene-Activated(R) erythropoietin product, for the treatment of anemia in cancer patients treated with chemotherapy. TKT expects that top-line results of the clinical trial will be available in the first half of 2005. If the data are positive, TKT intends to file an amendment to the European Dynepo product license in order to expand its approved indication to include anemia associated with cancer chemotherapy. In a March 2004 agreement, TKT regained marketing rights to Dynepo outside the United States but would only receive data from the cancer chemotherapy study upon completion of U.S. patent litigation. Dynepo was approved in the European Union in March 2002 for the treatment of anemia associated with renal disease in dialysis and pre-dialysis patients.

"We continue to anticipate the...

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