Clovis Oncology Announces Notice of Allowance for Rucaparib High Dosage Strength Tablet Patent with Expiration in 2035

Published: Mar 08, 2018

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology Inc. (NASDAQ:CLVS) announced today that the Company has received a Notice of Allowance from the United States Patent and Trademark Office in United States Patent Application 14/828,065 with claims directed to high dosage strength rucaparib camsylate formulations. The patent is expected to issue shortly with claims that cover the commercial Rubraca product, including all commercial dosing strengths (200, 250 and 300mg). Upon issuance, the high dosage strength rucaparib formulation patent will expire in 2035, and will have the longest term of the multiple patents directed to rucaparib, rucaparib camsylate, and methods of treatment. This will be the 10th Orange Book-listed patent for rucaparib.

“Our development team has done a tremendous job developing high dosage strength tablets to help ensure that patients eligible for rucaparib are able to adhere to their daily dose in a straightforward manner,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “The Notice of Allowance recognizes that work and we expect will soon result in issuance of a patent that will not expire until 2035, complementing our already issued camsylate salt patents that expire in 2031. This is relevant not only to our current indication in ovarian cancer, but also to multiple tumor types based on our ongoing and substantial clinical development programs.”

About Rubraca® (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved on an accelerated basis as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for Rubraca for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. Rubraca is not a licensed medicinal product in countries outside the US.

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