checkAd

     826  0 Kommentare DARA BioSciences Announces the Acquisition of Exclusive North American Rights to Oravig(R) (Miconazole Buccal Tablets 50mg), From Onxeo S.A.

    RALEIGH, NC--(Marketwired - March 10, 2015) - DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments, today announced that it has finalized a Commercialization Agreement with Onxeo S.A., an innovative company specializing in the development of orphan oncology drugs, granting DARA the U.S. rights to Oravig®, the first and only orally-dissolving buccal tablet approved for oral thrush. DARA has contemporaneously executed a co-promotion agreement with Mission Pharmacal Company, a privately held pharmaceutical company based in San Antonio, Texas, to co-promote Oravig in the primary care market.

    Under the terms of the Agreement, DARA will acquire the approved New Drug Application (NDA) and will have the exclusive rights to market and sell Oravig in the United States. DARA also has the right to pursue regulatory approval in Canada which, if granted, would give DARA exclusive rights to market and sell Oravig there. DARA will book all revenues on Oravig and will pay Onxeo S.A. certain milestone payments upon the achievement of defined sales thresholds; DARA has additionally undertaken to complete a pediatric study as part of a post-marketing commitment, which if successful, may provide DARA with both an expanded indication and market size for Oravig.

    "We are extremely excited to add an approved, branded, and unique product to our oncology supportive care portfolio," stated Christopher G. Clement, DARA CEO and President. "Combined with our current portfolio of products, Gelclair® for oral mucositis and Aquoral® for dry mouth, Oravig provides DARA the opportunity to offer a distinctive therapeutic armamentarium for patients suffering from side effects of the oral cavity due to their cancer treatments. We look forward to promoting this exciting new product in conjunction with our trusted partners at Mission."

    Seite 1 von 6





    Verfasst von Marketwired
    DARA BioSciences Announces the Acquisition of Exclusive North American Rights to Oravig(R) (Miconazole Buccal Tablets 50mg), From Onxeo S.A. RALEIGH, NC--(Marketwired - March 10, 2015) - DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer …