Transkaryotic Therapies Inc has entered into a manufacturing agreement whereby Lonza Biologics plc will manufacture Dynepo, TKT's Gene- Activated erythropoietin product, at Lonza's cGMP production facility in Slough, England.
"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, executive vice president of TKT.
"Lonza is an ideal choice because they have a proven track record in successfully manufacturing proteins at commercial scale. Dynepo is a priority programme 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," he stated.
"We are extremely pleased TKT chose to work with us to manufacture Dynepo drug substance at our facility in Slough," Gerhard F Klement, head of Lonza's Biopharmaceuticals Business Sector said adding, "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 US and European patent litigation with Amgen Inc.
TKT has also retained an advisor on US antitrust law and European Union competition law, Dean Ronald Cass, former vice chairman of the international trade commission, to provide strategic counsel to TKT regarding potential activities by existing erythropoietin suppliers to block Dynepo's entry into the European market, the release from TTK said.
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 anaemia 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 haemoglobin 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.