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Helsinn Grants To DARA Exclusive U.S. Commercial Rights To Gelclair®, An FDA-Cleared Oral Gel For The Treatment Of Oral Mucositis

The Helsinn Group of Switzerland announced today that it has entered into an exclusive agreement with DARA BioSciences, Inc. (Nasdaq: DARA) for U.S. commercial rights to Gelclair ® . Gelclair is an FDA-cleared product indicated for the treatment of oral mucositis. DARA plans to launch Gelclair in the first quarter of 2013.

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 is a topical gel used to coat and protect the oral cavity to reduce pain.

David J. Drutz, MD, DARA's chief executive officer, stated, "The exclusive agreement with Helsinn for rights to commercialize Gelclair is a significant milestone that provides us with an important commercial product in an area of significant medical need. Hundreds of thousands of cancer patients suffer from oral mucositis each year.” Dr. Drutz continued, “Helsinn offers DARA a respected partner with extensive experience in the oncology supportive care market. Our joint undertaking also provides the potential opportunity for a meaningful and long-term commercial and developmental relationship between our two companies.”

Helsinn CEO, Riccardo Braglia, said “We are excited to have a partner, in DARA, who has the same commitment to the oncology supportive care market as we do. We believe DARA will support Gelclair with the programs necessary to ensure health care providers and patients have this valuable product available as part of their treatment regimen. The shared vision of both Helsinn and DARA provides a sound foundation for a successful, long-term collaboration.”

About oral mucositis

The American Cancer Society estimates that approximately 400,000 patients annually will experience oral mucositis as a result of cancer treatment. The National Cancer Institute estimates that almost 100 percent of patients receiving radiation therapy for head and neck cancers experience oral mucositis, as do 80 percent of patients undergoing hematopoietic stem cell transplantation and 40 percent of patients receiving standard-dose chemotherapy.

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