CAMBRIDGE, Mass., Aug. 3 /PRNewswire/ -- Transkaryotic Therapies, Inc. 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.
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/.
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/.
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.
Additional Contacts: Daniella M. Lutz, (617) 349-0205 or Walter Eschenmoser, Communications & Investor Relations at Lonza, +41 61 316 8363
Transkaryotic Therapies, Inc.