Six months after filing for bankruptcy, Clovis Oncology was hoping for a last gasp win for fading cancer drug Rubraca. But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy.
Four months after filing for bankruptcy, Clovis Oncology has found a buyer for its remaining assets including the rights to ovarian cancer drug Rubraca. nnPharma& Schweiz GmbH of Switzerland submitted the highest bid at an auction on March 30, Clovis said (PDF) in an SEC filing. The agreement is for $70 million up front, plus an additional $50 million tied to regulatory milestones and $15 million in sales-related milestones. nnIf the purchase agreement is not consummated, Dr. Reddy’s Laboratories of India has been identified as a “back-up bidder,” the filing says. nnIn December, when Clovis filed for bankruptcy, it also revealed as part of the procedure that it was selling a cancer candidate, FAP-2286, to Novartis for $50 million, with an additional $334 million due if milestones are hit and $297 million if sales goals are reached.
When it comes to PARP inhibitor Rubraca, Clovis Oncology is having a hard time executing on its plan.
Clovis Oncology filed for Chapter 11 bankruptcy and will sell its assets through a supervised process. The first asset, investigational cancer treatment FAP-2286, will be sold to Novartis for up to $700 million.
Dec 12 (Reuters) - U.S. drugmaker Clovis Oncology Inc (CLVS.O) on Sunday filed for bankruptcy protection in Delaware, hit by a fall in sales of its cancer drug and challenges in raising additional capital.
Clovis` Rubraca Receives Approval in Europe
With bankruptcy looming for Clovis Oncology, the company has defaulted on a loan by failing to make an interest payment that was due Nov. 1—with a 30-day grace period to Dec. 1, according to a securities filing (PDF).
Already teetering on the brink, Clovis Oncology was dealt another blow by the FDA.
BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the presentation of data from the TRITON3 Phase 3 trial in men with metastatic castration-resistant prostate cancer with BRCA or ATM mutations. The presentation titled, “TRITON3: A Phase 3 Study of Rucaparib vs. Physician’s Choice of Therapy in mCRPC Associated with Homologous Recombination Deficiency (HRD)” is being presented by Alan H. Bryce, MD, chair of the Division of Hematology and Medical Oncology at the Mayo Clinic and co-principal investigator of the TRITON3 trial during the session titled, “Novel Clinical Trial Updates” at the 29th Annual Prostate Cancer Foundation (PCF) Scientific Retreat.
Clovis Oncology is already fighting the FDA over expanding Rubraca into an earlier treatment line in ovarian cancer. Now, the company hopes the U.S. regulator could allow the troubled PARP inhibitor a similar move in prostate cancer—but the situation is complicated.