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DARA BioSciences Announces the Acquisition of Exclusive North American Rights to Oravig(R) (Miconazole Buccal Tablets 50mg), From Onxeo S.A.
DARA Signs Agreement With Mission Pharmacal to Promote Oravig in the Primary Care Market; DARA to Promote Oravig in the Oncology Market; Deal Significantly Strengthens DARA's Oncology Supportive Care Portfolio
RALEIGH, NC -- (Marketwired) -- 03/10/15 --
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."
There are more than three million prescriptions written in the U.S. annually for oral thrush, with the majority of these written in the primary care segment. In order to maximize the commercial opportunity for Oravig, DARA has signed an agreement with Mission Pharmacal to promote Oravig in the primary care market. DARA currently in-licenses two products from Mission Pharmacal for promotion exclusively within the Oncology market: Aquoral for dry mouth and Ferralet® 90 for anemia. Additionally DARA's field sales organization is contracted through Alamo Pharma services, a subsidiary of Mission Pharmacal.
"Our partnership with DARA is extremely important to us," stated Terry Herring, Mission Pharmacal President. "We are committed to providing important products across the various patient populations we serve. Oravig allows Mission to add a significant therapeutic to our primary care division's promoted product portfolio, while further strengthening and expanding upon our existing relationship with the DARA team."
Oravig is an approved product in the U.S. market and was previously promoted by third parties.
"Topical localized therapies for oropharyngeal candidiasis are available; unfortunately these therapies are not optimal due to the need for dosing several times a day, short contact time of the active agent with the oral mucosa, sugar content which can promote yeast growth, unpleasant taste, and difficulty of use in patients with a dry mouth or oral ulceration. Together, these limitations contribute to reduced compliance and efficacy of these topical agents, often necessitating the use of systemic agents which have increased side-effects for patients," stated Dr. Rajesh V. Lalla, Section of Oral Medicine, University of Connecticut Health Center. "Oravig provides an excellent localized therapy solution for the treatment of oropharyngeal candidiasis because Oravig adheres to the oral mucosa and provides sustained local release of miconazole over a period of several hours with just one daily application," Dr. Lalla concluded.
DARA is planning to launch Oravig later this year.
Locust Walk Partners, a transaction advisory firm for the biopharmaceutical industry, served as exclusive advisor to Onxeo.