OPKO Licensee TESARO Submits NDA For Rolapitant

(RTTNews) - OPKO Health, Inc. (OPK) said Monday that its licensee, TESARO, Inc. (TSRO) has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of oral rolapitant, an investigational neurokinin-1 receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting.

The NDA is supported by data from four controlled studies covering a spectrum of patients receiving chemotherapy that commonly causes nausea and vomiting.

Under the terms of OPKO's agreement with TESARO, OPKO is eligible to receive payments of up to $121 million, including up-front and additional payments based on regulatory and commercialization milestones, including acceptance by FDA of the NDA.

OPKO will receive double digit tiered-royalties on sales of rolapitant. In addition, TESARO and OPKO will share future profits from the commercialization of rolapitant in Japan, and OPKO will have an option to market the products in Latin America.