OPKO Health, Inc., a multi-national biopharmaceutical and diagnostics company, announced that its licensee, Tesaro, Inc. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of oral rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).

This NDA is supported by data from four controlled studies covering a spectrum of patients receiving chemotherapy that commonly causes nausea and vomiting. The top-line results of three of the phase 3 studies were previously announced by Tesaro and were presented in detail at the American Society for Clinical Oncology (ASCO) annual meeting in June 2014.

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.

"We are pleased by the very professional work of the Tesaro team in completing the studies required to file the NDA. OPKO's other internal projects are progressing as planned and we are anxious to introduce these important new products to the market as rapidly as possible," commented Phillip Frost, chairman and chief executive officer of OPKO.

Rolapitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life that is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). NK-1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK-1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy. The safety and tolerability of single and repeat doses of rolapitant have been assessed in more than 2,500 healthy volunteers and patients. Rolapitant is being developed both in oral and intravenous formulations. Tesaro licensed exclusive rights for the development, manufacture, commercialization and distribution of rolapitant from OPKO.

CINV is estimated to afflict over 70% of cancer patients undergoing chemotherapy and, if not prevented, may possibly result in a delay or even discontinuation of chemotherapy treatment. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization.