TESARO Inc (NASDAQ:TSRO), an oncology-focused biopharmaceutical entity, reported that it had closed the private placement of 4.4 million shares of its common stock priced at $35.19 per share. As a result, the company recorded total gross proceeds of nearly $155 million, which it plans to use for supporting the advancement of its product pipeline. The offering was managed by NEA and Kleiner Perkins, each of which did an investment of nearly $50 million.
The buzz
In unrelated news, TESARO updated that that it has submitted the NDA for an intravenous preparation of rolapitant to the U.S. FDA. The product can be defined as a substance P/NK-1 receptor antagonist that is sold in tablet form in the U.S. under the brand VARUBI®. In September, 2015, the U.S. FDA permitted VARUBI for the prevention of deferred vomiting and nausea associated with repeat and initial courses of emetogenic cancer chemotherapy.
TESARO is committed to developing new therapeutic alternatives for patients with cancer, and the new drug application filing for IV rolapitant indicates a significant achievement for the firm. By advancing an intravenous dose of rolapitant, the company’s objective is to offer oncologists additional flexibility in selection of antiemetic treatments.
The plans
The new drug application for IV rolapitant is held by information from a clinical study that enrolled over 400 subjects and performed a bioequivalence trial and several other additional clinical and non-clinical trials. TESARO projects a standard one-year assessment timeline for the intravenous rolapitant NDA. TESARO lead candidate ‘VARUBI’ is contraindicated in enrollments receiving thioridazine. The inhibitory impact of a single dosage of drug on CYP2D6 lasts for at least 7 days.
In 2010, Opko Health Inc. (NYSE:OPK) bought rolapitant from Merck & Co., Inc. (NYSE:MRK), and after few years authorized it to Tesaro, which commenced U.S. sales of the drug last November. Varubi, the first ever commercial-stage candidate of Tesaro, is promoted as a medication that will most likely perform better as an IV infusion.
