TKTX Transkaryotic Therapies (MM)

TKT Gains Early Access to Dynepo(TM) Oncology Data CAMBRIDGE, Mass., Sept. 13 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. (NASDAQ:TKTX) 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 European launch of Dynepo in late 2005 or early 2006 and believe the opportunity for Dynepo in Europe is compelling, particularly with a potential label expansion," said Michael J. Astrue, President and Chief Executive Officer of TKT. In 2002, Aventis completed a double-blind, placebo-controlled, Phase III clinical trial evaluating two doses of Dynepo versus placebo in cancer patients undergoing chemotherapy over twelve weeks. The study was designed to determine its effect on hemoglobin, red blood cell transfusion requirement, and hematocrit. TKT and Aventis have been involved in patent litigation involving Dynepo with Amgen Inc. and Kirin-Amgen, Inc. in the United States and United Kingdom, respectively. Additional information about the litigation is available online at http://www.tktx.com/legal/index.htm. TKT intends to market Dynepo in a manner consistent with applicable court orders in the United States and United Kingdom patent litigation with Amgen, including a pending case in the House of Lords. About Erythropoietin Erythropoietin is a hormone that stimulates the production of red blood cells and is used primarily as a treatment for anemia associated with renal disease or cancer chemotherapy. By stimulating red blood cell production, erythropoietin is beneficial in the management and improvement of anemia. About Dynepo Dynepo is a fully human erythropoietin product developed using TKT's patented gene activation technology and is approved for commercial use in the European Union for the treatment of anemia associated with kidney disease. As described in the European Public Assessment Report, or EPAR, treatment with Dynepo was comparable to epoetin alfa and was effective in raising hemoglobin and hematocrit levels in patients. In addition, there have been no reported cases of pure red cell aplasia, a condition in which the bone marrow fails to produce vital red blood cells, in patients treated with Dynepo. A copy of the EPAR is available online at http://www.tktx.com/ under the Product category. About TKT Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily focused on researching, developing and commercializing treatments for rare diseases caused by protein deficiencies. Within this focus, the company markets Replagal(TM), an enzyme replacement therapy for Fabry disease, and is developing treatments for Hunter syndrome and Gaucher disease. In addition to its focus on rare diseases, TKT intends to commercialize Dynepo(TM), its Gene- Activated(R) erythropoietin product for anemia related to kidney disease, in the European Union. TKT was founded in 1988 and is headquartered in Cambridge, Massachusetts, with additional operations in Europe, Canada and South America. Additional information about TKT is available on the company's website at http://www.tktx.com/. This press release contains forward-looking statements regarding the results of Dynepo clinical studies and the company's commercial opportunity for Dynepo, as well as statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including: whether Dynepo will continue to demonstrate the safety and efficacy profile demonstrated to date; whether Dynepo will be safe and effective as a treatment for anemia associated with cancer chemotherapy; whether results of earlier clinical trials will be indicative of results obtained in other clinical trials; whether future trials of Dynepo will be conducted; whether the EMEA will approve Dynepo for anemia associated with cancer chemotherapy on a timely basis, or at all; whether Dynepo will achieve commercial success in any or all indications for which it is approved; whether competitive products, including both existing erythropoietin manufacturers and generic competition, will reduce any market opportunity that may exist for Dynepo; the availability and extent of coverage from third party payors for Dynepo and receipt of reimbursement approvals for Dynepo; whether competitors will be able to limit access to markets in which TKT is attempting to sell Dynepo, through an injunction following an adverse House of Lords decision or other legal maneuvering; whether TKT will be part of current or future litigation that will impair its ability to market Dynepo; TKT's ability to bring Dynepo to patients consistent with legal considerations; whether materials to be used in production will adequately substitute for materials used in the original process; whether Amgen or Kirin-Amgen will challenge the transfer of the regulatory file after receiving notification of the transfer in accordance with the requirements of applicable court orders; and other factors set forth under the caption "Certain Factors That May Affect Future Results" in the company's Quarterly Report on Form 10-Q filed August 9, 2004, which is on file with the Securities and Exchange Commission and is incorporated herein by reference. While the company may elect to update forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its expectations change. Gene-Activated(R) is a registered trademark and Replagal(TM) is a trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of Sanofi-Aventis SA. For More Information Contact: Justine E. Koenigsberg Senior Director, Corporate Communications (617) 349-0271 Daniella M. Lutz Corporate Communications Manager (617) 349-0205 http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO http://photoarchive.ap.org/ DATASOURCE: Transkaryotic Therapies, Inc. CONTACT: Justine E. Koenigsberg, Senior Director, Corporate Communications, +1-617-349-0271, or Daniella M. Lutz, Corporate Communications Manager, +1-617-349-0205 Web site: http://www.tktx.com/ Company News On-Call: http://www.prnewswire.com/comp/120657.html

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