Ipsen, Active Biotech complete half of planned recruitment in tasquinimod phase III study for CRPC

May 21 2012

Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced that recruitment to the global, pivotal, randomized, double-blind, placebo-controlled phase III study of tasquinimod in patients with metastatic castrate-resistant prostate cancer (CRPC) has reached an inclusion of 600 patients, half of the planned accrual. This triggers a €10 million milestone payment from Ipsen to Active Biotech.

The aim of the Phase III study is to confirm tasquinimod's efficacy on metastatic CRPC in the prechemotherapy setting, with radiological progression free survival (PFS) as the primary endpoint and overall survival (OS) as secondary endpoint. The study will include about 1,200 patients in more than 250 centers. Recruitment is proceeding according to plan with top line results expected by the end of 2013.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen, said: "The on-schedule recruitment of the 600th patient in the tasquinimod phase III clinical trial is a testimony of the interest of the medical community in the drug's novel and differentiated mode of action. In a crowded prostate cancer space, we also recognize the quality and diligence of the work of our partner Active Biotech to bring new therapies to patients." Marc de Garidel added: "Ipsen is now in the final stage of designing the randomized supportive study to be initiated before year-end and is getting ready to investigate tasquinimod in additional indications."

Tomas Leanderson, President and CEO of Active Biotech, said: "The successful recruitment into the ongoing phase III study indicates the level of interest for tasquinimod as an alternative treatment for CRPC. The partnership with Ipsen has significantly increased the potential of this novel approach to treat cancer."