DARA BioSciences Announces Launch of Bionect for Treatment of Skin Irritation and Burns Associated With Radiation Therapy for Cancer
DARA's First Commercial Product Introduction
RALEIGH, N.C., June 6, 2012 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) (the "Company" or "DARA"), an emerging oncology and oncology-support specialty pharmaceutical company, announced the commercial launch of Bionectfor the treatment of skin irritation and burns associated with radiation therapy.
DARA has hired a dedicated team of five field-based Regional Business Directors who will coordinate the commercial introduction of Bionect for the cancer care market 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.
"This is a milestone event for DARA. In a very short period of time we have transformed ourselves into a fully integrated specialty pharmaceutical company. The launch of Bionect demonstrates our ability to execute against our corporate objective of making this transformation a reality. Our goal is to become the preeminent company in oncology supportive care. Bionect is the first step in that direction," said CEO Dr. David J. Drutz.
Nearly two-thirds of cancer patients will receive radiation therapy during their illness. This equates to approximately one million patients per year treated with radiotherapy. Up to 87 percent of these radiation oncology patients may experience moderate to severe radiodermatitis, during or after therapy. Such treatment breaks down skin barriers, which may lead to infection. The management of these skin reactions varies among cancer centers and is often based on personal preference and historical practices rather than clinical evidence. In a double-blind, randomized, placebo-controlled clinical trial, Bionect, the only low-molecular-weight hyaluronic acid available in the market, was shown to help resolve radiation-induced inflammation and also to postpone the first signs of acute epithelitis.
Dr. Drutz added, "Bionect can be a game-changer for both patients and health care professionals since it is the only hyaluronic-acid-based prescription product indicated for radiodermatitis that has demonstrated statistically significant clinical results in a well-controlled clinical trial. The Bionect launch combined with our outstanding patient support program (which assists patients with their out of pocket prescription co-payment) and DARA's well-trained commercial team show our commitment to this important patient population. The market availability of this product will help many patients avoid severe discomfort and enable them to more securely complete their prescribed course of radiation 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 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 Q2 2012.
DARA has obtained, in addition, the U.S. rights 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.
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, Soltamoxor 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 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 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 intellectualproperty 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 athttp://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.
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