TESARO Announces Initiation of Rolapitant IV Clinical Program

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WALTHAM, Mass., Sept. 30, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that an open label, dose-finding and escalation study has been initiated to evaluate the pharmacokinetics, safety and tolerability of an intravenous (IV) formulation of rolapitant in healthy volunteers. Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). Data from this Phase 1 study will be used to select the intravenous dose that will be advanced into a subsequent clinical study.

"We are pleased to be advancing both oral and IV formulations of rolapitant. Intravenous antiemetic formulations comprise approximately 80% of the CINV market opportunity and enable healthcare providers to ensure that their patients receive medication to prevent chemotherapy-induced nausea and vomiting when administered immediately prior to treatment," said Mary Lynne Hedley, Ph.D., President of TESARO. "We remain on track to report top line results from the rolapitant pivotal program by the end of 2013."

About Rolapitant

Rolapitant is a potent, highly selective, and long-acting NK-1 receptor antagonist that is currently being evaluated as an oral formulation in Phase 3 trials for the prevention of chemotherapy-induced nausea and vomiting, or CINV. TESARO is investigating whether a single dose of rolapitant will significantly improve prevention of both nausea and vomiting during the 5-day at-risk period for cancer patients receiving emetogenic chemotherapy when administered along with the current standard of care (a 5-HT3 receptor antagonist plus a corticosteroid), as compared to the current standard of care alone.

Rolapitant is an investigational agent and, as such, has not been approved by any regulatory agencies.


TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.

To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. Rolapitant is an investigational agent and, as such, has not been approved by any regulatory agencies. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Form 10-K for the year ended December 31, 2012.

CONTACT: Investor/Media Contact: Jennifer Davis Sr. Director, Corporate Development & Investor Relations +1.781.325.1116 or jdavis@tesarobio.com

Source:TESARO, Inc.