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TESARO ANNOUNCES THIRD-QUARTER 2017 OPERATING RESULTS
· ZEJULA® was the most prescribed PARP inhibitor in U.S. with Q3 net sales of $39.4 million
· Positive CHMP opinion issued for ZEJULA in E.U.; commercial launch anticipated to begin by year-end
· Expansion of niraparib development program underway for multiple tumor types
· VARUBI® IV approved by U.S. FDA; commercial launch planned for November
· Phase 1 combination study of TSR-022 (anti-TIM-3) and TSR-042 (anti-PD-1) now enrolling patients
· Phase 1 study of TSR-033 (anti-LAG-3) now enrolling patients
WALTHAM, Mass., November 7, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for third-quarter 2017 and provided an update on the Companys commercial products and development programs.
Exiting the third quarter, ZEJULA achieved 60% market share of the ovarian cancer patient population treated with a PARP inhibitor. This is a result of our teams solid execution, and is supported by the feedback from physicians and patients, which continues to be excellent with regards to the benefit ZEJULA provides for women living with ovarian cancer, said Lonnie Moulder, CEO of TESARO. Looking ahead, we are actively preparing for two additional product launches in 2017 ZEJULA in Europe and VARUBI IV in the U.S. and expanding our niraparib development programs to broaden its use with the PRIMA Phase 3 first line ovarian cancer study and the initiation of multiple combination studies in ovarian, lung, and breast cancer. We are rapidly advancing our pipeline of immuno-oncology candidates with three antibodies now in the clinic, and we are excited about the potential for the combination of TSR-022 and TSR-042 to meaningfully benefit patients with advanced solid tumors.
Recent Business Highlights
· On October 25, 2017, the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of VARUBI® (rolapitant), and the U.S. commercial launch is planned for November. The unit demand for VARUBI oral capsules increased 74% for Q3 2017 vs. Q3 2016, as the brand continues to penetrate the U.S. oral NK-1 market.
· ZEJULA® (niraparib) is the most prescribed PARP inhibitor in the U.S., with approximately 2,500 patients treated during the month of September.
· The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for ZEJULA as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy.
· Pre-launch preparations continue in support of a European launch of ZEJULA by year-end 2017 beginning with Germany, pending European Commission approval.
· The niraparib expanded access program (EAP) in Europe has enrolled more than 350 patients to date.
The following information was filed by Tesaro, Inc. (TSRO) on Tuesday, November 7, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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