RALEIGH, N.C., May 29, 2012 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) (the "Company" or "DARA"), an emerging oncology and oncology-support specialty pharmaceutical company, today announced several key changes in its organizational structure. These changes afford DARA the opportunity to better position the company for growth as it prepares for the launch of two new products. This growth is primarily attributable to the acquisition by DARA of the privately held Oncogenerix, Inc., earlier this year. The realignment of responsibilities will help ensure proper organizational structure as well as the staffing of a sales and marketing department to execute the successful launch of both products.
The Company announced that Christopher Clement, currently Chief Operating Officer, has taken on the additional responsibility of President. Mr. Clement has extensive commercial and product launch experience. As President, Mr. Clement will oversee the upcoming launches of Bionect® and Soltamox®. Bionect, a topical treatment for the management of skin irritation and burns caused by radiation therapy, is expected to be launched in June and was in-licensed from Innocutis Holdings, LLC. Soltamox, the only FDA approved liquid formulation for tamoxifen citrate, is expected to be launched later this year and was in-licensed from Rosemont Pharmaceuticals, Ltd. A small dedicated team of field based Regional Business Directors will coordinate these efforts across the United States. Each Director brings over 20 years of commercial experience as well as extensive expertise in product launches and niche product marketing.
David J. Drutz, M.D., currently CEO of DARA, will assume the additional title of Chief Medical Officer (CMO). This added responsibility will help the Company better manage and execute its overall clinical program, including neuropathic pain candidate, KRN5500, currently in Phase 2 development. Based on his clinical development experience, Dr. Drutz will be instrumental in providing medical oversight for all of DARA's clinical and commercial programs.
"In light of all the exciting activities taking place within the Company, we believe the changes in organizational structure were necessary to create both commercial and developmental success as well as secure appropriate medical oversight in the context of new products entering the marketplace," said Dr. Drutz. "These changes in responsibilities allow us the opportunity to effectively deploy our internal expertise as we advance the growth of the Company."
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, a product used widely 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 tablet formulations of this drug. DARA plans to begin marketing Soltamox in the U.S. in Q3 2012.
DARA has also obtained exclusive U.S. commercial rights from Innocutis Holdings, LLC for Bionect® (hyaluronic acid sodium salt, 0.2%) within the oncology and radiation oncology marketplace. Bionect is an FDA-cleared product indicated for the management of irritation of the skin as well as first and second degree burns. Bionect is currently being promoted and sold by Innocutis in the dermatology market. DARA plans to launch this product in 2Q 2012.
DARA has obtained, in addition, the U.S. right to gemcitabine, a widely used generic chemotherapeutic cancer drug, from Uman Pharma. The Abbreviated New Drug Application (ANDA) for gemcitabine is expected to be filed with the FDA later this year.
DARA is also developing KRN5500 for the treatment of neuropathic pain in patients with cancer. KRN5500 has successfully completed a Phase 2a study and has been designated as 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 considering further internal Phase 2 development.
In addition, 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. DARA also has rights to other PPAR and DPPIV-inhibitor compounds for which it intends to seek out-licensing or partnering opportunities.
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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® 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, Soltamoxor 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 the company 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.