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FOR RELEASE ON FEBRUARY 19, 2015 AT 4:01 PM ET
TESARO ANNOUNCES FOURTH-QUARTER 2014 OPERATING RESULTS
· Enrollment in niraparib NOVA non-gBRCA cohort on track to complete during Q1 2015
· New QUADRA trial of niraparib for the treatment of ovarian cancer to begin in Q1 2015
· U.S. FDA PDUFA action date for oral rolapitant is September 5, 2015
· Cash and cash equivalents totaled approximately $257 Million as of December 31, 2014
WALTHAM, MA, February 19, 2015 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today reported financial results for fourth-quarter and full-year 2014 and provided an update on the Companys pipeline programs.
TESARO continues to make significant progress in advancing its pipeline of product candidates and in preparing for a commercial launch of rolapitant in the U.S. during the fourth quarter of 2015, said Lonnie Moulder, CEO of TESARO. We are committed to improving the treatment options for women with ovarian cancer and, as such, we are executing a comprehensive development program that includes patients, regardless of germline-BRCA mutation status, in both the treatment and maintenance settings. We continue to receive positive feedback from investigators regarding the breadth and potential of the niraparib program, and we look forward to initiating our QUADRA study for the treatment of patients with recurrent ovarian cancer this quarter. We also remain on track to complete enrollment of the non-germline BRCA cohort of patients within our Phase 3 NOVA trial during this quarter, and we expect the first data from NOVA to become available in 2015.
Recent Business Highlights
· The New Drug Application (NDA) for oral rolapitant is under review by the U.S. Food and Drug Administration (FDA), with a PDUFA goal date of September 5, 2015.
· A clinical trial is ongoing to compare the plasma exposure of the intravenous (IV) and oral formulations of rolapitant.
· Preparations are ongoing to initiate a new trial of niraparib (QUADRA) in patients with ovarian cancer who have received three or more prior lines of prior chemotherapy. Endpoints will include objective response rate (ORR) and duration of response for the entire population, as well as platinum sensitive, platinum resistant, germline BRCA and homologous recombination deficiency (HRD) patient subsets. This trial is anticipated to initiate during the first quarter of 2015.
· A strategy to incorporate a prospectively-defined biomarker (HRD) into the ongoing NOVA trial has been defined with FDA, and an HRD assay will be used to analyze tumor samples from patients who enroll in the niraparib ovarian clinical program.
· Patient enrollment continues in the Phase 3 BRAVO trial of niraparib, and planning continues to support initiation of additional clinical trials of niraparib in the small cell lung cancer and ovarian cancer settings.
The following information was filed by Tesaro, Inc. (TSRO) on Thursday, February 19, 2015 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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