DARA and HELSINN Announce U.S. Launch of Gelclair(R), an FDA-Cleared Oral Gel for the Treatment of Oral Mucositis
DARA and HELSINN Announce U.S. Launch of Gelclair(R), an FDA-Cleared Oral Gel for the Treatment of Oral Mucositis
Gelclair Launch Expected to Provide Additional Commercial Revenue for DARA in 2013
RALEIGH, NC and LUGANO, SWITZERLAND -- (Marketwired) -- 04/22/13 -- DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, and the Swiss pharmaceutical Helsinn Group, a leading player in the cancer supportive care arena, announced today that DARA has reintroduced GelclairÂ® 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, including radiation therapy and chemotherapy. 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.
David J. Drutz, MD, DARA's chief executive officer and chief medical officer, stated, "We are thrilled to be launching GelclairÂ®, our third product into the U.S. market, having recently introduced SoltamoxÂ® (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."
Helsinn Group Chief Executive Officer, Riccardo Braglia, said, "We are pleased that DARA is launching GelclairÂ® 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."
Internally conducted market research involving over 100 oncology physicians and nurses indicated strong familiarity with the Gelclair brand from its earlier presence in the U.S. market; a continuing preference for Gelclair over other products used to treat oral mucositis; and the likelihood that Gelclair would be prescribed in the majority of cases requiring an oral coating agent -- twice as frequently as the next available option.
To ensure patients and health care providers receive the highest level of satisfaction, DARA has instituted, in partnership with Onco360, a specialty single point of contact model, the Gelclair Access Program, to provide product access and affordability for patients together with ease of prescribing for health care providers.
Onco360 is an oncology pharmaceutical services company that features Board Certified Oncology Pharmacists (BCOP), and is dedicated to advancing the continuum of pharmaceutical cancer care for patients. Onco360 provides services to more than 1800 oncologists; 43 major BlueCross/BlueShield programs; commercial, Medicare, and Medicaid managed care payers; hospital systems; and several National Comprehensive Cancer Network (NCCN) Centers of Excellence, such as MD Anderson and Roswell Park, through its growing network of certified and JCAHO-accredited OncoMed pharmacies.
"Onco360 has developed specialized supportive care pharmacy programs that present an outstanding pathway for the launch of Gelclair. We are excited to work in partnership with DARA on this product launch by not only running the best in class Gelclair Access Program, to provide excellent service to patients and healthcare providers alike, but to also support Gelclair uptake with our well respected national sales team and proven oncology marketing programs," stated Burt Zweigenhaft, CEO of Onco360.
Dr. Drutz continued, "Partnering with Onco360, a leader in oncology pharmacy services, is a very important and strategic relationship for DARA, which we believe will enhance the availability and affordability of Gelclair to patients nationwide. Hundreds of thousands of cancer patients suffer from oral mucositis each year. The exclusive agreement with Helsinn for rights to commercialize Gelclair in the U.S. provides us with an important commercial product in an area of significant medical need."
About Onco360 Founded in 2005, Onco360 (www.onco360.com) has created a unique model to better serve the needs of oncology and hematology physicians, patients, payers, and manufacturers. In its focus to bring together the four major groups involved in the continuum of oncology pharmaceutical care, Onco360 has emerged as a unique and trusted partner. Onco360 executive offices are located in New York, NY and the company is licensed to deliver oncology pharmaceutical services across most of the country. Onco360 currently operates five dispensing pharmacies and provides a comprehensive inventory of oral, injected, and infused cancer therapies, including limited distribution products.
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. 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 SoltamoxÂ®, 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, BionectÂ®, 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. DARA also has exclusive U.S. commercial rights to GelclairÂ®, an FDA-cleared product for the treatment of oral mucositis, which DARA launched in April 2013.
DARA is also developing a cancer-support therapeutic compound, KRN5500, for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN) 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 FDA. DARA has created an improved, potentially commercializable formulation of this drug and is in active partnering discussions regarding further clinical development. DARA has also submitted an Orphan Drug Application to the FDA for the use of this drug in painful CCIPN.
In addition to its oncology products, DARA's research and development 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 BionectÂ®, SoltamoxÂ®, GelclairÂ® 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.
CONTACTS: For DARA BioSciences Jenene Thomas Head of Investor Relations +1-908-938-1475 firstname.lastname@example.org
For Helsinn Group Paola Bonvicini Head of Communication & Press Office PH +41 91-985-21-21 Infoemail@example.com