Julie Megee, a Wrentham resident and breast cancer survivor, will appear on The Balancing Act ® airing on Lifetime Television in October, National Breast Cancer Awareness Month. In conjunction with the educational segment about breast cancer, Ms. Megee is sponsoring a fundraiser for Breastcancer.org at Perceptions Hair Studio, which she owns and operates in Norton, Mass.
DARA holds exclusive U.S. marketing rights to Soltamox ® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, used for the treatment and prevention of breast cancer. Soltamox ® offers a choice to patients who prefer or need a liquid form of tamoxifen. Gelclair ® is an alcohol-free bioadherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. DARA licensed the U.S. rights to Soltamox ® from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair ® from the Helsinn Group in Switzerland. Under an agreement with Innocutis, DARA also markets Bionect (hyaluronic acid sodium salt, 0.2%), a topical treatment for skin irritation and burns associated with radiation therapy, in US oncology/radiology markets.DARA is focused on expanding its portfolio of oncology supportive care products in the US, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and DARA is seeking orphan status for the treatment of CCIPN. About Breastcancer.org Breastcancer.org is the #1 online resource for breast health and breast cancer information and support, with more than 6,000 pages of expert-reviewed information and a robust, dynamic peer support community. A nonprofit organization, Breastcancer.org receives more than 12 million visits each year. About The Balancing Act ® on Lifetime Television Now in its 6th year, The Balancing Act ® continues to empower women in all aspects of their lives. The mission at The Balancing Act ® is simple -- the show strives to help today’s modern woman balance it all by bringing them exceptional solutions to everyday problems. Entertaining, educational and trusted by women, viewers can watch America’s premier morning show The Balancing Act ® weekday mornings on Lifetime television at 7 a.m. (ET/PT). For additional information or to view a segment visit www.thebalancingact.com. IMPORTANT SAFETY INFORMATION Tamoxifen citrate is contraindicated in patients with known hypersensitivity and also in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus. As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen. If hypercalcemia does occur, appropriate measures should be taken and, if severe, tamoxifen should be discontinued. There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during tamoxifen therapy. When tamoxifen is coadministered with chemotherapy, there may be a further increase in the incidence of thromboembolic effects. Adverse reactions to tamoxifen are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients.
WARNINGIn Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events were associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-855-273 0468 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. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption “Risk Factors” in DARA’s most recent Annual Report on Form 10-K, filed with the SEC on March 28, 2013. 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. Keywords: Balancing Act, DARA BioSciences, tamoxifen, liquid tamoxifen, Soltamox, ductal carcinoma in situ, node-positive breast cancer, Tennessee Oncology, St. Thomas Midtown Hospital, breast cancer, estrogen receptor positive, liquid formulation.