DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology support products, announced today it has a completed 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. DARA believes these agreements provide the company comprehensive commercial coverage across the national oncology market. As part of an integrated national network with annual sales of over $1 billion in cancer therapeutics, DARA has significantly enhanced its commercial scale and capabilities. Its distribution network now consists of more than 45,000 retail pharmacies, mail order pharmacies, and long-term care facilities. This network provides DARA with established reimbursement and logistics expertise, with more than 300 sales and marketing personnel uniquely focused on oncology and oncology support products, and further provides the company with additional partnering opportunities. DARA’s vertically integrated platform is headed by a team of five U.S. regional business directors who will coordinate and execute the commercialization of DARA’s growing suite of products. Each director has more than 20 years of commercial experience, as well as extensive expertise in product launches and niche product marketing. “Our goal is to become a leading oncology and oncology supportive care company in the United States,” said David J. Drutz, MD, DARA’s chief executive officer. “These partnerships represent an important step toward that goal. The relationships we’ve developed across commercial players provide benefits to DARA, healthcare providers, patients, and caregivers alike. We have a broad platform from which to educate people about our products and their value. Through our specialty pharmaceutical relationships, we have the ability to create a strong presence in all oncology market segments. We provide flexibility to patients who receive prescription medicine through mail order or retail pharmacies, as well as make available to them financial support. Most importantly we are establishing DARA as a long-term, committed player in oncology and oncology supportive care.”
DARA’s robust platform supports the synergy within the company’s portfolio, which includes commercial products that target oncology-related skin damage, mouth and throat ulcers, in addition to direct cancer treatments and a developmental compound that targets neuropathic pain. This comprehensive network of partners is rare among companies in the oncology supportive care area and provides DARA a strong foundation for product introductions into this underserved market.DARA’s next launch will be Soltamox®, the first and only FDA approved liquid form of tamoxifen citrate, which DARA expects to launch in October to coincide with National Breast Cancer Awareness Month. Following Soltamox, Gelclair ® an oral mucositis treatment is planned for launch in the first quarter of next year. The company is currently marketing Bionect®, a treatment for skin irritation and burns caused by radiation cancer therapy. About DARA BioSciences, Inc. DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. 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. Additionally, in June 2012, DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy. Most recently, 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 study, and has been designated as a Fast Track Drug by the United States Food and Drug Administration. 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.
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 I 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.