SOURCE: DARA BioSciences, Inc.

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October 14, 2014 07:00 ET

DARA BioSciences Product Gelclair® Attains Market Leadership Position in U.S. Retail Market

Gelclair® Attains No. 1 Position for Prescriptions Filled in Retail Market Vs. Other Oral Gel Barrier Products

RALEIGH, NC--(Marketwired - October 14, 2014) - 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 that its product, Gelclair®, indicated for the management of oral mucositis, has attained a major milestone in the U.S. market by becoming the number one oral gel barrier prescription product in the retail sector.

Based on Symphony Health Solutions data, Gelclair has had more prescriptions filled in the retail sector than any other prescription oral gel barrier agent. Starting in June of this year, Gelclair became the most frequently prescribed retail oral gel barrier agent and continues to be the leader in this class as reported through August 2014. The latest data (through August 2014) indicates that Gelclair is the only product in the oral gel barrier class to show continued month over month retail prescription growth since February of this year.

Christopher G. Clement, DARA CEO and President, stated, "The increase in retail Gelclair prescriptions demonstrates a strong brand image and product awareness among prescribers and patients. This allows our team to achieve continued expansion of Gelclair into the artificial saliva and magic mouthwash markets, which each contain products with broad use but limited scientific documentation in treating oral mucositis. Furthermore, this milestone and the success of Gelclair affirm our belief in the commercial strategy of establishing DARA as a leader in oncology supportive care, as well as our confidence in continued positive sales momentum."

Clement continued, "Gelclair has also recently been approved for preferred formulary position by both national payers and leading cancer institutions, giving millions of people access to the product. These recent placements combined with DARA's 'No Coupon, No Co-Pay, No Hassles' program have made Gelclair the number one choice in gel barriers in the retail segment among prescribing health care providers. We anticipate additional formulary approvals as interest in the product continues to grow."

DARA CMO and Chairman of the Board, David J. Drutz, M.D., added, "We are particularly excited about the recent publication of a randomized trial by Rasero et al*, which showed significant oral mucositis pain control benefit in patients undergoing hematopoietic stem-cell transplantation. Oral mucositis is encountered in 30-90% of this in-hospital patient population, depending on the intensity of pre-transplant induction therapy, and is one of the most distressing and debilitating complications of this procedure. These new data indicate that Gelclair can be of substantial value in managing the painful symptoms of oral mucositis in this group of seriously immunosuppressed patients. Oral mucositis is a common side effect of cancer treatment regimens, with approximately 400,000 patients developing the condition each year. Among the most seriously affected are recipients of bone marrow transplants or patients receiving chemoradiation for head and neck cancer. These and other cancer-related patient populations represent important emerging marketing opportunities for Gelclair."

* Rasero L, Marsullo M, Dal Molin A. Assessing the effectiveness of Gelclair® in the prevention and therapy of stomatitis in patients undergoing hematopoietic stem-cell transplantation: a randomized trial. Professioni infermieristiche 2014, 67:15-20 (English abstract available on PubMed (PMID:24762768))

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 both Soltamox® (tamoxifen citrate) oral solution and Gelclair®. DARA licensed the U.S. rights to Soltamox® from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair® from the Helsinn Group in Switzerland. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%).

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 postmenopausal 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 www.soltamox.com/prescribing-information.

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. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%) a topical treatment for skin irritation and burns associated with radiation therapy, in U.S. oncology/radiology markets. Bionect should not be used by patients with known hypersensitivity to any of its ingredients. For further information on Gelclair and Bionect and the Full Prescribing Information please visit www.Gelclair.com and www.Bionect.com.

In early 2014, DARA kicked off its new partnership with Alamo Pharma Services, a subsidiary of Mission Pharmacal, in deploying a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA's products Soltamox, Gelclair and Bionect, this specialized oncology supportive care sales team also provides clinicians with access to three Mission Pharmacal products: Ferralet® 90 (for anemia), BINOSTO® (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis), and Aquoral® (for chemotherapy/radiation therapy-induced dry mouth).

Important Safety Information and full Prescribing Information for Mission Pharmacal's products may be found at: www.Ferralet.com, www.Binosto.com, and www.Aquoral.com.

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, chronic chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics (CCIPN).

For more information please visit our web site at www.darabio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the implementation our "No Coupon, No Co-pay, No Hassles" program, the intended effects of the program, our ability to increase the availability and distribution of our Gelclair product, the expected effect of the program on demand for our Soltamox and Gelclair products and our ability to increase sales of our Soltamox and Gelclair products, including through the implementation of the "No Coupon, No Co-pay, No Hassles" program. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from those projected in forward-looking statements include the "Risk Factors" described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 filed with the Securities and Exchange Commission (the "SEC") and in our other periodic filings with the SEC.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

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