Denmark’s Genmab has been boosted by the news that its partner Roche has filed a clinical trial application with the UK’s Medicines and Healthcare products Regulatory Agency for an antibody developed under the companies’ collaboration.
The antibody was the third developed with Roche and created by Genmab to reach the clinical phase, and the Copenhagen-based group now has eight products in clinical development. Under the terms of its pact with the Swiss drugs giant, Genmab will receive an undisclosed milestone payment, though it will have no effect on its 2007 financial outlook.
If all goals are reached, the value of the collaboration to Genmab, whose shares rose 3.5% on the filing in the UK, could be $100 million plus royalties.
HuMax-CD20 study design altered
The news came days after Genmab amended the design of an ongoing pivotal study of HuMax-CD20 in rituximab refractory follicular non-Hodgkin’s lymphoma to a single arm trial to include 81 patients. All patients will receive one infusion of HuMax-CD20 (ofatumumab) 300mg followed by seven weekly infusions of 1,000 mg.
The original study design included 162 patients, who would have received one infusion of 300mg of the drug followed by seven weekly infusions of either 500mg or 1,000mg. The 500-mg dose was eliminated to reduce the number of patients and ensure each of them received the maximum dose, said Genmab, which is being developed with GlaxoSmithKline.
