22.04.2013 – 14:30
Helsinn and DARA Announce U.S. Launch of Gelclair®, an FDA-Cleared Oral Gel for the Treatment of Oral Mucositis
The Swiss pharmaceutical Helsinn Group, a leading player in the cancer supportive care arena, announced today that DARA BioSciences, Inc., a U.S. specialty pharmaceutical company focused on oncology and oncology supportive care products, has launched Gelclair® into the U.S. market. Gelclair® is manufactured by the Helsinn Group and is an FDA-cleared product indicated for the treatment of oral mucositis.
Oral mucositis is a painful inflammation and ulceration of the surface of the mouth and throat, which can result from a variety of cancer treatments. Gelclair® provides oral mucositis patients rapid and effective relief of pain. Oral mucositis is common in cancer patients undergoing chemotherapy or radiation therapy and occurs when the protective oral mucosa is denuded, potentially resulting in pain, infection, weight loss, decreased quality of life, treatment delay and increased economic costs.
Helsinn Group Chief Executive Officer, Riccardo Braglia, said, ?We are pleased that DARA is launching Gelclair® in the United States, and importantly, that U.S. patients will again be able to benefit from this treatment. We believe this is an important milestone in building the long-term relationship between our companies. It will also add the most important market worldwide to the other 30 where Gelclair® is already marketed in Europe, Latin America and Asia.?
David J. Drutz, MD, DARA's Chief Executive Officer and Chief Medical Officer, stated, ?We are thrilled to be launching Gelclair®, our third product into the U.S. market, having recently introduced Soltamox® (tamoxifen citrate) oral solution, the first and only liquid version of tamoxifen citrate. We believe this underpins our mission of becoming a leader in the oncology and oncology supportive care market and exemplifies our commitment to executing against our corporate plan.?
About Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, the United States and China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn is an important player in cancer supportive care. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical /clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing a full range of product and scientific management services, including commercial, regulatory, financial, legal, and medical marketing advice. The active pharmaceutical ingredients and the finished products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland and supplied worldwide to its customers.
Further information on Helsinn Group is available at www.helsinn.com
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products.
For more information please visit our web site at: www.darabio.com
Safe Harbor 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.
For Helsinn Group
Paola Bonvicini Head of Communication & Press Office
For DARA BioSciences, Inc.
Investor Relations + Corporate Communications Advisor