DARA BioSciences Obtains U.S. Rights to Co-Promote Bionect(R), an FDA Approved Topical Hyaluronic Acid, Exclusively in the Radiation and Oncology Markets
Bionect(R) Strengthens DARA's Growing Portfolio of In-Licensed Oncology and Oncology Supportive Care Products
RALEIGH, N.C., March 26, 2012 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced today that it entered into an exclusive agreement with Innocutis Holdings, LLC ("Innocutis") for U.S. commercial rights to Bionect® (hyaluronic acid sodium salt, 0.2%) within the oncology and radiation oncology marketplace. Bionect® is an FDA-approved 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.
Bionect® is the third oncology-based agent DARA has licensed to date as part of its strategy to build a focused portfolio of niche opportunity products for the oncology and oncology supportive care markets. DARA expects to launch Bionect® in the second quarter of 2012.
David J. Drutz, MD, DARA's President and Chief Executive Officer, stated, "The exclusive agreement with Innocutis for rights to commercialize Bionect® in both radiation oncology and medical oncology is an important step that provides DARA with an additional commercial opportunity and shows DARA's ability to execute on its strategic plan for adding cancer and cancer-support products through ongoing licensing efforts. We believe there is considerable upside potential in the oncology supportive care market."
The principal component of Bionect® is a patented low molecular weight hyaluronic acid, a biological polysaccharide which is a major component of the extracellular matrix of connective tissues. Bionect® is FDA approved for the treatment of skin irritation-- a well-documented side effect of radiation and chemotherapy treatment.
Clinical studies have shown that as many as 90 percent of breast cancer patients treated with radiotherapy will develop some degree of radiation dermatitis. Researchers have also reported that therapeutic doses of radiation can cause persistent skin erythema, desquamation, rash, pain, itching and ulceration that increases the risk of infection. Chemotherapy has also been shown to significantly increase the severity of acute radioepithelitis. Thus, DARA believes that there is a significant need for Bionect in the oncology and radiation oncology markets.
Earlier this year, DARA obtained U.S. rights to Soltamox® and gemcitabine. Soltamox®, the only FDA approved oral liquid form of tamoxifen, is for breast cancer patients who have difficulty swallowing tablets or simply prefer a liquid form of this widely prescribed hormone blocking therapy. DARA intends to launch Soltamox® later this year. Gemcitabine posted $780 million in sales under the Lilly brand Gemzar® in 2010 and is still widely prescribed as a 'gold standard' chemotherapeutic for breast, ovarian, lung and pancreatic cancers. An ANDA filing for gemcitabine is planned for later this calendar year.
About Innocutis Holdings LLC
INNOCUTIS is a pharmaceutical and medical device company specializing in the development and commercialization of therapies and devices focused on medical treatment of dermatological conditions. INNOCUTIS' current products consist of an established portfolio of branded prescriptions as well as a novel surgical device for skin closure.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA sharpened its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®. Soltamox® is a novel oral liquid formulation of tamoxifen, a product used widely in the treatment and prevention of breast cancer. Soltamox® is the only FDA approved oral liquid version of tamoxifen 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 the third quarter of 2012.
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 and has successfully completed a Phase IIa study and has been designated as a Fast Track Drug by the United States Food and Drug Administration. We are 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 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. 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®, Soltamox® or other products given DARA's lack of a current sales force and 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 US 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.