CAMBRIDGE, Mass., Dec. 30 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. 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.
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.
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.
Justine E. Koenigsberg
Director, Corporate Communications
Daniella M. Lutz
Corporate Communications Specialist
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Transkaryotic Therapies, Inc.