DARA BioSciences Announces U.S. Launch of Oravig(R) (miconazole), the First and Only Orally-Dissolving Buccal Tablet Available for Treatment of Adults With Oral Thrush

DARA BioSciences, Inc.

, 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, announced today the U.S. launch of Oravig -- the first and only orally-dissolving muco-adhesive buccal tablet approved to treat adults with oral thrush -- into the Oncology and Primary Care markets. Beginning this week, DARA and its marketing partner Mission Pharmacal Company, a privately held pharmaceutical company based in San Antonio, TX, will simultaneously begin promotion of Oravig with two separate sales forces focusing on the highest prescribing physicians of oral thrush therapy; DARA will promote Oravig exclusively in Oncology with its 20 person nationwide sales force and Mission will utilize its 40 person-strong sales team to promote the product exclusively to the Primary Care market. DARA was granted exclusive U.S. rights to Oravig in March 2015, under a Commercialization Agreement with Onxeo S.A., an innovative company specializing in the development of orphan oncology drugs. Oral thrush, an infection of the mouth caused by the Candida fungus, also known as yeast, can affect people of all ages, including older adults and those with weakened immune systems, and represents a large market opportunity. Of the approximately 28 million total prescriptions currently written, filled and dispensed annually in the U.S., more than 22 million prescriptions are filled for oncology and primary care patients, according to IMS Health. With today's announcement, Oravig becomes the only once-daily local therapy available for treatment of oral thrush. All other currently marketed, localized therapies for oral thrush require patients to take/administer their treatment a minimum of four times daily. The only other option is systemic therapy, which is not recommended by the Infectious Disease Society of America (IDSA) for mild cases of oral thrush, and which can be contraindicated for some of these patients who are on certain other, standard drug regimens. "The Oravig launch represents the achievement of a key milestone for DARA, and, allows DARA to offer adult oncology and adult primary care patients suffering from oral thrush a new treatment option with a unique delivery mechanism compared to other marketed therapies," stated Christopher G. Clement, DARA's President and Chief Executive Officer. "Combined with our current portfolio of products, Gelclair® for oral mucositis and Aquoral® for dry mouth, Oravig provides DARA a distinctive therapeutic armamentarium for patients suffering from side effects within the oral cavity due to cancer treatment, or other conditions. Together with our trusted partners at Mission, we look forward to filling this market need." Oravig will be supported by DARA's "No Coupon, No Co-pay, No Hassles" program, which provides a reduction or elimination of prescription copays by offsetting out-of-pocket expenses for qualified patients. The program is applied automatically to qualified prescriptions at more than 43,000 pharmacies, nationwide. DARA will also offer a Patient Assistance Program for qualified patients who are either underinsured or uninsured Terry Herring, Mission Pharmacal President, Commercial Operations, says, "We are committed to providing important products across the various patient populations we serve. With the support programs in place for Oravig, and its unique product profile, we are confident that Oravig will offer a needed option for health care providers to treat oral thrush within the primary care market. With this launch, Mission now adds 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." Dr. David J. Drutz, Chief Medical Officer of DARA, added, "Although topical, localized therapies for oral thrush are available, most are suboptimal due to the need to dose several times a day, a sugar content which itself can promote further yeast growth as well as dental caries - combined with an unpleasant taste, and difficulty of use in patients with dry mouth or oral ulcerations. Together, these limitations often necessitate the use of systemic agents which have the potential for unwanted side-effects including adverse drug interactions. In contrast, Oravig gives health care providers a much needed option, as an excellent localized therapy solution which adheres to the oral mucosa and provides sustained, local release of miconazole over a period of several hours with just one daily application." Judith Greciet, Onxeo CEO, said, "Working with DARA's team over the past months has confirmed both their professionalism and commitment to Oravig. We are convinced that DARA and Mission Pharmacal are the right partners to successfully promote Oravig in the U.S., in both the Oncology and Primary care settings." Oravig is stocked and available throughout the drug distribution channel nationwide.