Clinigen and Tesaro team up again to supply ovarian cancer drug in Europe

Clinigen Group PLC’s (LON:CLIN) Idis Managed Access division and US firm TESARO Inc (NASDAQ:TSRO) are to launch an early stage access program in Europe for niraparib, an investigational treatment for recurrent ovarian cancer.

Niraparib, a PARP 1/2 inhibitor, for patients with recurrent ovarian cancer has not been granted approval by the European Commission though it is under review by the European Medicines Agency.

The two companies worked together on early stage access for Niraparib in the US, where it has since been approved and branded Zejula as a treatment for women in complete or partial response to platinum-based chemotherapy.

Ovarian cancer is the fifth-most frequent cause of cancer death among women with 65,000 cases in Europe annually. Of these treated with platinum-based chemotherapy, 85% saw a recurrence of the disease after first line treatment.

Steve Glass, Clinigen’s chief commercial officer for North America and Europe, said: “Following the successful delivery of the niraparib Managed Access Program in the US, we are pleased to be partnering with TESARO once again, providing eligible women in Europe the opportunity to gain access to this important investigational therapy.”

Managed or early stage access programs allow doctors to prescribe unapproved treatments for named patients where no alternative drug is available.

Last month, Clinigen teamed up with French group Onxeo to make T-cell treatment belinostat (Beleodaq) available in Europe on a managed access basis.

Story by ProactiveInvestors