The of Switzerland announced today that it has entered into an exclusive agreement with (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.”
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.
The consequences of mucositis are far-reaching and include pain, difficulty swallowing, interruption of chemotherapy or radiation treatment, administration of narcotics, hospitalization and, in the most severe cases, reliance on parenteral nutrition.
Gelclair provides a synergistic fit within DARA’s oncology supportive care portfolio. DARA’s three FDA-approved/cleared products (, and Gelclair), and a fourth, , due for ANDA submission by end of 2012, are focused on the needs of oncology patients. DARA licensed all four agents this year as part of its strategy to build a portfolio of niche opportunity products for the oncology and oncology supportive care markets.
DARA increased its focus in oncology treatment and supportive care products through its January 2012 acquisition of Oncogenerix, Inc. In June 2012, DARA launched its first product, Bionect, a topical treatment for skin irritation and burns associated with radiation therapy. It is preparing for the launch of Soltamox, the first and only FDA-approved oral liquid formulation of tamoxifen citrate, a widely used therapy for the prevention and treatment of breast cancer. Its product portfolio also includes , a novel therapy under development for the treatment of neuropathic pain in patients with cancer, a condition with no current adequate therapy.
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and the United States. 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 .
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. 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 plans to begin marketing Soltamox in the U.S. later this year. Additionally, in June 2012 DARA launched its first product, Bionect, a topical treatment for skin irritation and burns associated with radiation therapy.
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 IIa study, and has been designated as 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 considering 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 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.
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