RALEIGH, NC--(Marketwired - April 03, 2013) - DARA BioSciences, Inc. (DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today that it has signed an agreement with Prime Therapeutics Specialty Pharmacy LLC for distribution of its two lead proprietary products, Gelclair® (oral bioadhesive gel) for patients with oral mucositis and Soltamox® (tamoxifen citrate) oral solution to treat breast cancer patients.
Based in Orlando, Fla., Prime Therapeutics Specialty Pharmacy LLC is a wholly owned subsidiary of Prime Therapeutics LLC, a pharmacy benefit manager (PBM) serving nearly 20 million people. Prime Therapeutics is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of these plans.
Prime Therapeutics Specialty Pharmacy delivers medication to members and provides ongoing support through member education and guidance from experienced pharmacists and nurses to help manage the specialty condition and the pharmacy benefits.
"We are excited to work with DARA to be a preferred pharmacy for distribution of Gelclair," said Rachelle Wan, vice president of specialty solutions at Prime Therapeutics. "Both Gelclair and Soltamox help cancer patients better adhere to their prescribed medications and improve tolerance to therapy, all helping to continue uninterrupted cancer treatment."
DARA's chief executive officer and chief medical officer, David J. Drutz, MD stated, "Working in partnership with a premier supplier of health care services such as Prime Therapeutics Specialty Pharmacy is a significant opportunity to provide education to and raise awareness with appropriate patients managed by Prime's pharmacy, as well as provide availability and accessibility to the unique supportive care opportunities offered by both Soltamox and Gelclair." Drutz continued, "Our goal is to ensure we reach patients that could benefit from our products, and we are convinced our strategic collaboration with Prime Therapeutics Specialty Pharmacy is an important step in achieving this mission."
DARA intends to introduce Gelclair to the market in April 2013. Gelclair provides oral mucositis patients rapid and effective relief of pain. Oral mucositis (OM) is common in cancer patient undergoing chemotherapy or radiation therapy. Oral mucositis occurs when the protective oral mucosa is denuded, which may result in pain, infection, weight loss, decreased quality of life, treatment delay and increased economic costs.
Soltamox was launched at the end of 2012 and is the only FDA-approved tamoxifen citrate oral solution, fulfilling a vital clinical need for patients who either cannot tolerate existing solid tablet formulations of this drug or prefer liquid medications to help with daily compliance with long-term therapy.
About Prime Therapeutics Specialty Pharmacy
Prime Therapeutics Specialty Pharmacy LLC is dedicated to making it easier for members to obtain specialty medicines and manage complex conditions. The company offers a full suite of specialty pharmacy services, from care management to insurance billing to delivery of specialty medicines. Based in Orlando, Fla., Prime Therapeutics Specialty Pharmacy LLC is wholly owned by Prime Therapeutics LLC.
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. DARA also has exclusive U.S. commercial rights to Gelclair®, an FDA-cleared product for the treatment of oral mucositis, which DARA plans to launch 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, 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 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.