CAMBRIDGE, Mass., Oct. 21 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced that the House of Lords has
ruled in favor of TKT in a United Kingdom patent infringement suit involving
TKT and Sanofi-Aventis against Kirin-Amgen, Inc. The House of Lords upheld an
earlier unanimous Court of Appeal decision that activities relating to
Dynepo(TM) (epoietin delta), TKT's Gene-Activated(R) erythropoietin product
for the treatment of anemia, do not infringe European U.K. Patent No. 0 148
605 B2.
In its opinion, the court also invalidated the Amgen patent and stated,
"it is clear that Amgen have got themselves into difficulties because, having
invented a perfectly good and ground-breaking process for making EPO and its
analogues, they were determined to try to patent the protein itself,
notwithstanding that, even when isolated, it was not new."
"We are delighted to have our legal position vindicated again in the
British Courts. We remain on track for making Dynepo available to patients
in the European Union in late 2005 or early 2006," said Michael J. Astrue,
President and Chief Executive Officer of TKT.
Dynepo, a fully human erythropoietin product produced by TKT's patented
gene activation technology, was approved for commercial use in the European
Union in 2002 for the treatment of anemia associated with kidney disease. TKT
is establishing manufacturing for Dynepo at Lonza's cGMP production facility
in Slough, England in a manner consistent with applicable court orders in the
U.S. litigation with Amgen and expects to file an amendment to Dynepo's
product license in the third quarter of 2005 for the new manufacturing
facility.
In the European Public Assessment Report ("EPAR"), treatment with Dynepo
is described as comparable to epoetin alfa and effective in raising hemoglobin
and hematocrit levels in patients. In addition, the EPAR observes that among
Dynepo patients, there have been no reported cases to date of pure red cell
aplasia, a condition in which the bone marrow fails to produce vital red blood
cells. 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. Outside 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 TKT's
patent litigation with Kirin-Amgen and 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 the manufacture of Dynepo at
Lonza will be approved by relevant regulatory agencies on the timing expected
by TKT or at all; whether TKT will file for regulatory approval when expected;
whether Dynepo will achieve commercial success; whether Dynepo will continue
to demonstrate the safety and efficacy profile demonstrated to date in
clinical trials; the availability and extent of coverage from third party
payors for Dynepo and receipt of reimbursement approvals for Dynepo; whether
competitive products, including both existing erythropoietin manufacturers and
generic competition, will reduce any market opportunity that may exist for
Dynepo; whether competitors will be able to limit access to markets in which
TKT is attempting to sell Dynepo, through legal maneuvering or otherwise;
whether TKT will be subject to future litigation that will impair its ability
to market Dynepo; whether materials to be used in production will adequately
substitute for materials used in the original process; and other factors set
forth under the caption "Certain Factors Which 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 are 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.
For More Information Contact:
Justine E. Koenigsberg Daniella M. Lutz
Senior Director, Corporate Corporate Communications Manager
Communications (617) 349-0205
(617) 349-0271
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
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NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
Company News On-Call:
http://www.prnewswire.com/comp/120657.html
CONTACT:
Justine E. Koenigsberg, Senior Director,
Corporate Communications, +1-617-349-0271, or Daniella M. Lutz,
Corporate Communications Manager, +1-617-349-0205, both of
Transkaryotic Therapies, Inc.
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