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
SOURCE Transkaryotic Therapies, Inc.
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CONTACT:
Justine E. Koenigsberg, Senior Director,
Corporate Communications, +1-617-349-0271, or Daniella M. Lutz,
Corporate Communications Manager, +1-617-349-0205
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