DARA BioSciences Announces the U.S. Launch of Soltamox®
DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has launched Soltamox® (tamoxifen citrate) oral solution in the United States. Soltamox is a new treatment option for breast cancer patients who are prescribed tamoxifen therapy. DARA has exclusive U.S. rights to Soltamox from Rosemont Pharmaceuticals, Ltd, UK.
Soltamox, liquid version of tamoxifen citrate (Photo: Business Wire)
Since its approval in 1977, tamoxifen has been used to treat millions of women and men diagnosed with hormone-receptor-positive breast cancer. Treatment with tamoxifen lowers the risk of breast cancer recurrence, breast cancer in the opposite breast, and death from breast cancer.
Breast cancer remains a serious medical issue with over 2.6 million patients in the U.S. with a history of the disease and an estimated 240,000 new patients diagnosed each year. Breast cancer is the leading cause of cancer death in women between the ages of 15 and 54, and the second-leading cause of cancer death in women 55 to 74.
Helping patients who may have difficulty swallowing pills
Prior to DARA's launch of Soltamox, tamoxifen was only available in the U.S. as a solid oral tablet. Difficulty swallowing pills is not uncommon and certain breast cancer patients may experience such difficulties as a result of surgical, pharmaceutical, radiation, or chemotherapy treatments. Discomfort or problems when swallowing may lead patients to miss doses or discontinue their treatment. Soltamox provides an oral liquid medication option that may provide an opportunity for patients to remain compliant with prescribed tamoxifen therapy.
DARA CEO, David J. Drutz, MD, stated, “Compliance and adherence to prescribed tamoxifen therapy is a critical issue in patient care and may affect treatment outcomes. Soltamox provides a unique treatment option for those patients with swallowing difficulties or who simply prefer an oral liquid over tablets or pills. We are excited to provide breast cancer patients an alternative to their current tamoxifen formulation that may help them achieve long-term treatment success.” Dr. Drutz added, "The launch of Soltamox represents a major milestone for DARA in our quest to become a premier provider of important oncology treatment and supportive care products."
“Treatment of breast cancer with tamoxifen is a long-term commitment for patients if they are to have the best chance of preventing the disease from recurring,” said oncologist Jivesh Sharma, MD, clinical faculty member at Presbyterian Hospital in Dallas, Texas. "As the only liquid version of tamoxifen, Soltamox offers an important new option to both doctors and patients that may improve patient compliance and adherence to this long-term therapy."
DARA is marketing Soltamox through its team of five U.S. regional business directors who will execute the commercialization of DARA's growing suite of oncology and supportive care products. Each director has more than 20 years of commercial experience, as well as extensive expertise in product launches and niche product marketing. These business directors will work in conjunction with the vertically integrated platform of partnerships DARA has established with specialty pharmacy providers, leading group purchasing organizations (GPOs), retail partners, reimbursement experts, and an industry-leading third-party logistics provider. These partnerships afford Soltamox immediate and comprehensive commercial coverage across the U.S. oncology market.
DARA is proud to launch Soltamox during Breast Cancer Awareness Month. As part of an ongoing commitment to the cancer field, DARA has made unrestricted grants to a number of leading breast cancer patient advocacy groups to support important patient education and awareness initiatives.
Swallowing assessment tool
DARA is committed to providing educational tools for both patients and health care providers. In addition to working with patient advocacy groups, as part of this launch, DARA is also making available to patients and caregivers the EAT-10 tool, a clinically validated tool to assess swallowing difficulties. The EAT-10 tool will help in the proper assessment and diagnosis of patients with swallowing difficulties. The EAT-10 tool can be accessed at www.swallowingdifficulties.org. DARA has also instituted a patient program to assist patients with the initiation of Soltamox therapy.
About Rosemont Pharmaceuticals
Rosemont Pharmaceuticals is dedicated to improving the health and wellbeing of people through the development, manufacture and supply of liquid medicines for patients who have difficulty in swallowing solid medications or those who need a precisely measured dose not available in a solid tablet.
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA has comprehensive commercial coverage across the national oncology market through 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. As part of an integrated national network with annual sales of over $1 billion in cancer therapeutics, DARA has significant commercial scale and capabilities. Its distribution network consists of more than 45,000 retail pharmacies, mail order pharmacies, and long-term care facilities. This provides DARA with established reimbursement and logistics expertise, as well as partnering opportunities with more than 300 sales and marketing personnel uniquely focused on oncology and oncology support products. This comprehensive network of partners is rare if not unique among companies in the oncology supportive care area and provides DARA a strong foundation for product introductions into this underserved market.
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. DARA launched Soltamox in October 2012 to coincide with National Breast Cancer Awareness Month. DARA has exclusive U.S. rights to Soltamox through a license from Rosemont Pharmaceuticals, Ltd. Additionally, in June 2012, DARA launched its first product, Bionect®, a topical treatment for skin irritation and burns associated with radiation therapy. DARA has rights to market Bionect in the US oncology/radiology markets under license from Innocutis. 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 clinical trial, and has been designated 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 1 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.
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