CAMBRIDGE, Mass., Aug. 3 /PRNewswire/ -- Transkaryotic Therapies, Inc.
(Nasdaq: TKTX) announced today it has entered into a manufacturing agreement
whereby Lonza Biologics plc will manufacture Dynepo(TM), TKT's Gene-
Activated(R) erythropoietin product, at Lonza's cGMP production facility in
Slough, England. Financial terms were not disclosed.
"We are delighted to continue to expand our presence in the United Kingdom
and to take a critical step toward making Dynepo commercially available
throughout Europe," said David D. Pendergast, Ph.D. Executive Vice President
and Chief Operating Officer of TKT. "Lonza, one of the world's largest and
best contract manufacturing organizations, is an ideal choice because they
have a proven track record in successfully manufacturing proteins at
commercial scale. Dynepo is a priority program for us and, with the signing
of this contract, we expect to complete the necessary manufacturing and
regulatory requirements to support a commercial launch in the European Union
in late 2005 or early 2006."
"We are extremely pleased TKT chose to work with us to manufacture Dynepo
drug substance at our state-of-the-art facility in Slough," said Gerhard F.
Klement, Head of Lonza's Biopharmaceuticals Business Sector. "Our extensive
experience in the manufacture of protein therapeutics will allow us to produce
a high-quality commercial product and we look forward to meeting the needs of
TKT as they work to bring Dynepo to European patients."
TKT intends to market Dynepo in a manner consistent with applicable court
orders in the U.S. and European patent litigation with Amgen Inc.
TKT also announced today that it has retained an advisor on U.S. antitrust
law and European Union competition law, Dean Ronald Cass, to provide strategic
counsel to TKT regarding potential activities by existing erythropoietin
suppliers to block Dynepo's entry into the European market. Dean Cass is a
former Vice Chairman of the International Trade Commission and the former Dean
of Boston University School of Law. He is also a visiting professor of
comparative law at the University of Lyon in France and a senior fellow at the
International Centre for Economic Research in Torino, Italy.
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.
Other companies currently marketing erythropoietin products include Amgen
Inc., Johnson & Johnson, F Hoffman-La Roche Ltd. (Boehringer Mannheim GmbH),
Sankyo Company Ltd., Chugai Pharmaceutical Co., Ltd., and the pharmaceutical
division of Kirin Brewery Co., Ltd.
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 Latin America.
Additional information about TKT is available on the company's website at
http://www.tktx.com.
About Lonza
Lonza is a life sciences company, headquartered in Switzerland, which
generated sales of CHF 2.24 billion in 2003. It operates 18 production and R&D
facilities in eight countries and employs 5,660 people worldwide. Lonza is one
of the leading custom manufacturers of chemical intermediates and active
ingredients as well as biopharmaceuticals for the pharmaceutical and
agrochemical industries. In addition, Lonza also offers organic intermediates
for a wide range of applications and provides antimicrobial and associated
products as well as polymer intermediates and compounds. For more information
please visit the company's website at http://www.lonza.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the
manufacturing, regulatory and commercial prospects 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 TKT's ability to re-establish
manufacturing will succeed; whether Dynepo will achieve commercial success;
whether Dynepo will continue to demonstrate the safety and efficacy profile
demonstrated to date; 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 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 May 10, 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
Aventis Pharmaceuticals, Inc.
For More Information Contact:
Justine E. Koenigsberg
Transkaryotic Therapies, Inc.
(617) 349-0271
Additional Contacts: Daniella M. Lutz, (617) 349-0205 or Walter
Eschenmoser, Communications & Investor Relations at Lonza, +41 61 316 8363
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
Company News On-Call:
http://www.prnewswire.com/comp/120657.html
CONTACT:
Justine E. Koenigsberg, +1-617-349-0271; or
Daniella M. Lutz, +1-617-349-0205, both of Transkaryotic
Therapies, Inc.; or Walter Eschenmoser, Communications & Investor
Relations of Lonza, +41 61 316 8363
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