Clovis Oncology, Inc. CLVS announced that the United States Patent and Trademark Office has issued a new patent for Rubraca (rucaparib). The United States Patent '636 issued by the office covers methods of treating cancer with high dosage strengths of Rubraca. The patent covers all the available commercial doses of Rubraca - 200mg, 250mg and 300mg - and will expire in 2035. This is the 11th patent for Rubraca as listed in the Orange Book.
Rubraca, a PARP inhibitor, is approved for two indications in ovarian cancer in the United States. The drug can be used as maintenance treatment in second-line setting for treating ovarian cancer, irrespective of BRCA mutation. It is also approved in third or later-line setting for BRCA-mutant ovarian cancer.
Following the news, shares of Clovis were up 5.3% on Nov 20. However, the company's shares have plummeted 74.5% so far this year compared with the industry 's decline of 20.3%.
Clovis holds several other patents protecting Rubraca in the United States which includes composition of matter, salts/polymorphs, dosage forms and formulations, and methods of use. The company remains on track to get additional patents for Rubraca. These patents are not limited to ovarian cancer, currently approved indication for Rubraca, but also to several potential additional indications for which Rubraca is being developed in clinical studies.
Clovis is developing Rubraca in additional setting for ovarian cancer and other cancer indications as well. A phase III study, ATHENA, is currently enrolling patients and evaluating Rubraca in combination with Bristol-Myers' BMY Opdivo in first-line maintenance setting for advanced ovarian cancer. A mid and a late-stage study - TRITON2 and TRITON 3 -respectively, is evaluating Rubraca in metastatic castrate-resistant prostate cancer (mCRPC) patients with BRCA mutations and ATM mutations. The company is evaluating the drug for treating bladder cancer in phase II ATLAS study.
However, Rubraca is facing challenges in its adoption as a second-line treatment and consequently its sales growth is slower than expected. It also faces stagnancy in PARP inhibitor's market share in ovarian cancer market and competition from other approved PARP inhibitors - AstraZeneca's AZN Lynparza and TESARO, Inc.'s TSRO Zejula. These patents will provide a relief to Rubraca as these will delay the launch of a generic which is likely to intensify competition and drag down prices.
Clovis Oncology, Inc. Price
Clovis Oncology, Inc. Price | Clovis Oncology, Inc. Quote
Clovis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
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Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportAstraZeneca PLC (AZN): Free Stock Analysis ReportBristol-Myers Squibb Company (BMY): Free Stock Analysis ReportClovis Oncology, Inc. (CLVS): Free Stock Analysis ReportTESARO, Inc. (TSRO): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment Research