SOURCE: DARA BioSciences, Inc.

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October 05, 2015 08:00 ET

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

DARA's Salesforce to Launch Oravig Into Oncology Market, While Marketing Partner, Mission Pharmacal, Launches Into the Primary Care Market; Over 28 Million Prescriptions Filled Annually for Oral Thrush in the U.S.

RALEIGH, NC--(Marketwired - October 05, 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, 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.

About DARA BioSciences, Inc.
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology supportive care 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.

DARA holds exclusive U.S. marketing rights to Gelclair® oral rinse gel, Oravig® (miconazole) buccal tablets and Soltamox® (tamoxifen citrate) oral solution. DARA licensed the U.S. rights to Gelclair from the Helsinn Group in Switzerland, Oravig from Onxeo S.A. in France, and Soltamox from Rosemont Pharmaceuticals, Ltd, a U.K. based manufacturer and a subsidiary of Perrigo Company, plc.

DARA partners with Alamo Pharma Services, a subsidiary of Mission Pharmacal, to deploy a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA's products Gelclair, Soltamox, and Oravig, this specialized oncology supportive care sales team also provides clinicians with access to two Mission Pharmacal prescription products: Ferralet® 90 and Aquoral® Important Safety Information and full Prescribing Information for Ferralet 90 and Aquoral can be found at: and

Gelclair is an alcohol-free bio-adherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. Gelclair should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients. For further information on Gelclair and the Full Prescribing Information please visit

Oravig is the first and only muco-adhesive buccal tablet formulation of miconazole approved to treat oropharyngeal candidiasis (OPC), also known as oral thrush, in adult patients in the United States. Oravig should not be used in patients with a known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.

Soltamox (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, is indicated for the treatment of metastatic breast cancer, the adjuvant treatment of node-positive breast cancer in premenopausal women, the reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS), and for the reduction of the incidence of breast cancer in women at high risk for breast cancer. Currently, there are more than 1.8 million prescriptions of tamoxifen written on an annual basis in the United States. Between 30 and 70 percent of patients fail to complete their prescribed course of treatment, thereby diminishing its benefits in reducing the risk of breast cancer recurrence.

Tamoxifen Important Safety Information
Tamoxifen citrate is contraindicated in women who require concomitant coumadin-type anticoagulant therapy, in women with a history of deep vein thrombosis or pulmonary embolus, and in women with known hypersensitivity to the drug or any of its ingredients.

Serious and life-threatening events associated with tamoxifen in the risk reduction setting women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism.

The most common adverse reactions to tamoxifen treatment are (incidence > 20%) hot flashes, fluid retention, vaginal discharge, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal events.

Tamoxifen carries the following Boxed Warning:

WARNING -- For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing Information.

**See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies in Prescribing Information.

The full Prescribing Information for Soltamox is available at

DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and has granted DARA two separate Orphan Drug Designations for the treatment of multiple myeloma and for the treatment of painful CCIPN that is refractory to conventional analgesics.

For more information please visit our web site at

Safe Harbor Statement
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties. These statements are based on the current expectations, estimates, forecasts and projections regarding management's beliefs and assumptions. In some cases, you can identify forward looking statements by terminology such as "may," "will," "should," "hope," "expects," "intends," "plans," "anticipates," "contemplates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negatives of those terms. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in DARA's most recent Annual Report on Form 10-K, filed with the SEC on March 3, 2015, and DARA's other filings with the SEC from time to time. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Gelclair, Oravig, Soltamox, or other products, DARA's ability to achieve the desired results from the agreements with Mission and Alamo, compliance with FDA promotional regulations and other regulatory risks relating to DARA's ability to market Gelclair, Oravig, Soltamox, or other products in the United States or elsewhere, DARA's ability to in-license and/or partner products, the current regulatory environment in which DARA sells its products, the market acceptance of those products, DARA's ability to develop KRN5500 into an FDA-approved commercial product or otherwise successfully partner the product candidate, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, the ability to consummate the merger with Midatech PLC, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.

About Mission Pharmacal Company
Mission Pharmacal Company is a privately held pharmaceutical company based in San Antonio, Texas. For nearly seven decades, the company has been improving the lives of people through every stage of life by identifying unmet healthcare needs and delivering innovative, high-quality prescription, over-the-counter, and dietary supplement products to meet these needs using only the purest ingredients and FDA-approved methods of manufacturing. Mission is recognized as a pioneer and leader in the therapeutic areas of women's health and urology and also offers leading products through its pediatric, dermatology, primary care, and long-term care service lines. Using an innovative business model, Mission has created wholly-owned subsidiaries, BioComp Pharma, a generic drug manufacturer, and Alamo Pharma Services, a specialized contract sales organization, to diversify its offerings and build forward-thinking partnerships with other pharmaceutical and biotech companies. Mission Pharmacal is a proud national supporter of the March of Dimes Foundation®, whose mission is to improve the health of babies by preventing birth defects, premature birth, and infant mortality. To learn more, please visit

About Onxeo
Onxeo has the vision to become a global leader and pioneer in oncology, with a focus on orphan or rare cancers, through developing innovative therapeutic alternatives designed to "make the difference". The Onxeo team is determined to develop innovative medicines that provide patients with hope and significantly improve their lives.

Key orphan oncology products at the advanced development stage are:

Livatag® (doxorubicin Transdrug™): Phase III in hepatocellular carcinoma

Validive® (clonidine Lauriad®): Phase II in severe oral mucositis: Positive final results

Beleodaq® (belinostat): Registered in the US in 2nd line treatment of peripheral T-cell lymphoma

For more information, visit the website

Contact Information

  • DARA BioSciences Contact
    Steve Silver
    Senior Vice President
    Rx Communications Group

    Mission Pharmacal Company Contact
    Drew Deeter
    Deeter USA Integrated Marketing and Communications