SOURCE: DARA BioSciences, Inc.

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October 17, 2013 08:00 ET

Gelclair® Placed on Memorial Sloan-Kettering Cancer Center Formulary as Exclusive Product to Treat Patients With Oral Mucositis

DARA BioSciences Continues to Drive Gelclair Adoption Since Q2 2013 Launch

RALEIGH, NC--(Marketwired - October 17, 2013) - DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to therapy and manage side effects arising from cancer treatment, today announced that Memorial Sloan-Kettering Cancer Center (MSKCC) has placed Gelclair® on its formulary as the exclusive therapeutic to treat oral mucositis (OM). Oral mucositis is a painful acute inflammation and ulceration of the surface of the mouth and throat that commonly complicates treatment with chemotherapy or local irradiation in patients with cancer. Without appropriate treatment, OM may lead to dehydration and malnutrition based on impaired oral intake, both being serious impediments to overall recovery.

David J. Drutz, MD, DARA BioSciences' Chief Executive Officer and Chief Medical Officer, said, "We are excited to work with MSKCC, a preeminent and internationally renowned cancer treatment institution with an unmatched tradition and history of providing patients with exceptional care. MSKCC has chosen to use Gelclair as the exclusive therapeutic for patients suffering from oral mucositis. As the sole product on formulary to treat the symptoms of OM, Gelclair will address this often debilitating side-effect and, importantly, improve the quality of life for patients at MSKCC in need of therapeutic intervention." 

MSKCC joins an increasing number of institutions, nationwide, where Gelclair is currently approved on formulary. "Gaining formulary acceptance at a cancer treatment center as large and well-respected as MSKCC is an important overall driver for Gelclair adoption and success in the marketplace. Since we launched Gelclair only six months ago, we are confident in our ability to establish Gelclair as a market leader in short order," concluded Dr. Drutz.

DARA has exclusive U.S. commercial rights to Gelclair, a uniquely formulated FDA approved prescription oral gel for treating the painful symptoms of OM. Gelclair, launched in April 2013, is one of the three products in DARA's synergistic portfolio of cancer care and oncology supportive care products. As part of Breast Cancer Awareness Month, Gelclair, Soltamox® and Bionect® will be featured on The Balancing Act®; airing on Oct. 14 and 21, 2013 on LifeTime Television. 

About Oral Mucositis

Oral Mucositis (OM), characterized by painful acute inflammation and ulceration of the surface of the mouth and throat in cancer patients, is caused by chemotherapy and radiation treatment, which disrupts rapidly dividing epithelial progenitor cells. It is estimated that approximately 400,000 cases of OM are diagnosed annually. OM can be an intensely painful condition that often leads to difficulties swallowing food and fluids, potentially leading to dehydration and malnutrition. OM can also lead to delays in cancer treatment, through chemotherapy dose reductions, breaks in radiation treatment, cessation of cancer therapy, hospitalization and reliance on parenteral nutrition. Whereas OM is a common complication of treatment with broadly cytotoxic chemotherapeutic agents or even targeted cancer drugs, it is particularly severe in patients receiving radiation therapy for head and neck cancer and in patients receiving high-dose chemotherapy conditioning prior to hematopoietic stem cell transplantation.

About Gelclair (Bioadherent oral rinse gel):

Gelclair® is an easy-to-use bioadherent oral rinse gel for the management and relief of pain associated with oral mucositis, a condition which can occur in cancer patients due to chemotherapy and radiation treatment. Gelclair has a unique hyaluronic acid-based formulation and, unlike Mugard™, Episil® and Magic Mouthwash contains no alcohol, thereby reducing the risk of painful burning and drying. Gelclair has been broadly studied, demonstrating rapid and effective relief of pain, improvement in ability to eat and drink and reduction in the need for rescue analgesics. DARA has exclusive U.S. commercial rights to Gelclair through a license with The Helsinn Group in Switzerland.

For additional information, including a copy of the Full Prescribing Information, please visit the Gelclair product web site at

About DARA BioSciences, Inc.

DARA BioSciences Inc. 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 Soltamox (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, used for the treatment and prevention of breast cancer. Soltamox offers a choice to patients who prefer or need a liquid form of tamoxifen. Gelclair is an alcohol-free bioadherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. 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%) a topical treatment for skin irritation and burns associated with radiation therapy, in US oncology/radiology markets. 

DARA is focused on expanding its portfolio of oncology supportive care products in the US, 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 DARA is seeking orphan status for the treatment of CCIPN.

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. 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 28, 2013. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox®, Gelclair® or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect, Soltamox, Gelclair or other products in the U.S. or elsewhere, DARA's ability to in-license and/or partner products, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the current regulatory environment in which DARA sells its products, the market acceptance of those products, 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, risks and uncertainties relating to DARA's ability to successfully integrate Oncogenerix 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.

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