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DARA BioSciences Announces Submission of KRN5500 to FDA for Orphan Designation

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RALEIGH, N.C.--(BUSINESS WIRE)--

DARA BioSciences, Inc. (DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500, a compound in development to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN). The FDA provides orphan drug status to products that treat rare conditions for which there may be few adequate therapies. No approved treatments currently exist for CCIPN. Orphan designation qualifies the drug developer for tax credits, the waiver of the prescription drug user fee and seven-year market exclusivity. DARA engaged consultants with extensive FDA experience to guide the preparation of the Orphan Drug Application.

In October 2011, the FDA designated KRN5500 a "Fast Track" drug. The Fast Track process expedites the development and review of drugs that treat serious diseases and fill an unmet medical need. Fast track designation may support accelerated approval of such drugs, and orphan designation would provide seven year exclusivity on KRN5500 for the orphan indication.

KRN5500 is an intravenously administered, non-opioid analgesic with rapid onset of action and prolonged pain mitigation, as demonstrated in both pre-clinical and clinical studies. KRN5500 is being developed to treat the painful form of CCIPN. Painful CCIPN is characterized by the persistence of chemotherapy-associated pain for at least twelve weeks after chemotherapy has stopped.

Peripheral neuropathy is caused by nerve damage, a potential complication of treatment with platins, taxanes and other cancer drugs. The disorder comprises numbness and tingling of the arms and legs, including hands and feet. A subset of these patients develops a chronic, painful form of the condition. The pain can be extreme and continuous, and can be elicited by stimuli such as touch and cold, which do not normally elicit a pain response. Painful CCIPN interferes with activities of daily living and significantly reduces the quality of life of cancer patients. Since CCIPN has no current approved therapies, KRN5500 addresses a significant unmet medical need, especially since people with cancer are living longer due to improved treatments and therapies.

DARA CEO, David J. Drutz, MD, stated, “Painful CCIPN can be truly debilitating. Taking just a single step can cause tremendous pain. Currently, clinicians treat CCIPN with a number of prescription medications, botanicals and dietary supplements. However, none has been proven effective in placebo-controlled clinical trials. In fact, several large trials testing many of these products have failed to demonstrate any efficacy when compared to placebo. Conversely, KRN5500 demonstrated statistical and clinical superiority over placebo in a small Phase 2a clinical trial conducted in patients that had both advanced cancer and the painful form of CCIPN. It is important to note that each of the trial participants was also prescribed other pain medications, none of which alone or in combination had resulted in a reduction of pain due to CCIPN.”

Given the promising results from its Phase 2a trial, DARA is currently seeking potential development partners, with the intention of initiating a Phase 2b trial for KRN5500 in 2013 once collaboration has been established.

In addition to seeking orphan designation, DARA has simplified the formulation of KRN5500 to make it easier to administer at the bedside. Instead of requiring a two-step mixing process, the new formulation is a solution that can be added directly to an IV bag. DARA has filed new patents for this formulation and has established a drug supply chain to support future clinical trials.”

“KRN5500 fits well within DARA’s portfolio of cancer support products,” Dr. Drutz continued. “Cancer supportive care is an underserved area with unmet medical needs, as CCIPN illustrates. DARA’s mission is to bring therapies to oncology patients beyond those specifically directed to the treatment of their cancer.”

About DARA BioSciences, Inc.

DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA has comprehensive commercial coverage across the national oncology market through a series of agreements with a number of specialty pharmacy providers, leading group purchasing organizations (GPOs), retail partners, reimbursement experts, and an industry-leading third-party logistics provider. As part of an integrated national network with annual sales of over $1 billion in cancer therapeutics, DARA has significant commercial scale and capabilities. Its distribution network consists of more than 45,000 retail pharmacies, mail order pharmacies, and long-term care facilities. This provides DARA with established reimbursement and logistics expertise, as well as partnering opportunities with more than 300 sales and marketing personnel uniquely focused on oncology and oncology support products. This comprehensive network of partners is rare if not unique among companies in the oncology supportive care area and provides DARA a strong foundation for product introductions into this underserved market.

DARA increased its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, which is widely used in the treatment and prevention of breast cancer. Soltamox is the only FDA-approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who cannot tolerate existing solid tablet formulations of this drug. DARA launched Soltamox in October 2012 to coincide with National Breast Cancer Awareness Month. DARA has exclusive U.S. rights to Soltamox through a license from Rosemont Pharmaceuticals, Ltd. Additionally, in June 2012, DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy. DARA has rights to market Bionect in the US oncology/radiology markets under license from Innocutis. In September 2012, DARA entered into an exclusive agreement with the Helsinn Group of Switzerland for U.S. commercial rights to Gelclair®, an FDA-cleared product for the treatment of oral mucositis. DARA plans to launch Gelclair in the first quarter of 2013.

Prior to acquiring Oncogenerix, DARA was focused on the development of a cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic pain in patients with cancer. This product is an excellent fit with DARA’s strategic oncology focus, has successfully completed a Phase 2a clinical trial, and has been designated a Fast Track Drug by the FDA. DARA is working with the National Cancer Institute (NCI) to design an additional clinical trial under joint DARA-NCI auspices while continuing further Phase 2 development. DARA has submitted an Orphan Drug Application to the FDA for KRN5500.

In addition to its oncology products, DARA’s pipeline includes DB959, a novel, non-TZD dual delta/gamma PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase 1 testing of DB959 and is presently pursuing opportunities to out-license this product.

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

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. 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 develop and bring new products to market as anticipated, 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 develops and 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 http://www.sec.gov. 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.