Company Provides Update on Out-Licensing Effort for Gene-Activated(R) Proteins
CAMBRIDGE, Mass., Dec. 30 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced that it has entered into an
agreement with Orphan Australia for marketing and distribution of Replagal(TM)
(agalsidase alfa) for the treatment of Fabry disease in Australia and New
Zealand. Under the terms of this agreement, Orphan Australia will have
exclusive marketing and distribution rights to Replagal for 15 years.
In Australia, the Pharmaceutical Benefits Advisory Committee has
recommended Replagal be considered for funding under the Life Saving Drug
Category, which is an important step toward receiving government reimbursement
in Australia for Replagal. A final decision on Australian reimbursement
approval is expected in the first half of 2004. A decision on reimbursement
approval in New Zealand is pending.
"We are preparing to commercialize Replagal in a number of important new
markets in 2004. We look forward to working with Orphan Australia and believe
this agreement will enable us to best serve patients in Australia and New
Zealand," said Michael J. Astrue, President and Chief Executive Officer of
TKT.
"Replagal is an important addition to our portfolio of marketed products,
complementing our strategic and therapeutic focus in specialty hospital
products," said Mr. Alastair Young, Managing Director of Orphan Australia.
"With our company's expertise targeting niche segments of the hospital market,
Orphan Australia is well positioned to provide the necessary marketing support
to launch Replagal in this territory."
TKT also announced today that it will not out-license a Gene-Activated(R)
protein by the end of 2003, although it continues to work toward achieving
that goal as early as possible in 2004. The company is seeking to partner
several of its Gene-Activated protein products, which are versions of proteins
that would compete with proteins currently being marketed by third parties.
About Replagal
Replagal is a fully human alpha-galactosidase A protein, produced by
genetic engineering technology, intended for long-term treatment of Fabry
disease. It replaces the deficient alpha-galactosidase A with active enzyme
to halt or reverse the disease process. Since August 2001, Replagal has been
approved for commercial use in 27 countries, including the 15 countries of the
European Union, Australia and New Zealand. In the United States, Replagal is
an investigational product.
About TKT
Transkaryotic Therapies, Inc. is a biopharmaceutical company committed to
developing treatments for rare diseases caused by protein deficiencies with a
core focus on lysosomal storage diseases. The company markets one product,
Replagal(TM), an enzyme replacement therapy for Fabry disease in Europe and
other countries and is developing treatments for Hunter syndrome and Gaucher
disease. TKT's research pipeline is focused on rare diseases where a
significant unmet medical need exists. TKT was founded in 1988 and is
headquartered in Cambridge, Massachusetts, with additional operations in
Europe and Latin America. Additional information about TKT is available on
the company's website at http://www.tktx.com.
About Orphan Australia
Orphan Australia is a privately owned pharmaceutical company based in
Melbourne. It specializes in the development, marketing and distribution of
products typically used by specialists to treat serious and/or life
threatening disorders. Additional information about Orphan Australia is
available on the company's website at http://www.orphan.com.au.
This press release contains forward-looking statements regarding Replagal
and TKT's business development initiatives, 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 any of the company's products will achieve the
commercial success anticipated by the company; whether competing products will
reduce the market opportunity for such products; whether TKT will be
successful in finding a partner for it's Gene-Activated proteins; and other
factors set forth under the caption "Risk Factors" in the company's Quarterly
Report on Form 10-Q for the quarter ended September 30, 2003, 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.
CONTACTS:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
Daniella M. Lutz
Corporate Communications Specialist
(617) 349-0205
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
http://www.orphan.com.au
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CONTACT:
Justine E. Koenigsberg, Director, Corporate
Communications, +1-617-349-0271, or Daniella M. Lutz, Corporate
Communications Specialist, +1-617-349-0205, both of Transkaryotic
Therapies, Inc.
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