updated 5/3/2011 8:46:27 AM ET 2011-05-03T12:46:27

RALEIGH, N.C., May 3, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) today announced the issuance of nine patents in the United States, Europe and other foreign jurisdictions relating to its development pipeline of compounds to treat diabetes and associated conditions including obesity, cardiovascular disease, Syndrome X; and compounds to treat neuropathic pain. The World Health Organization estimates that more than 220 million people worldwide struggle with diabetes. The global cost of diabetes care exceeds $41 Billion annually. 

According to recent publications, neuropathic pain is one of the worst types of pain for the patient to experience and the oncology clinician to treat. Also, CIPN (Chemotherapy Induced Peripheral Neuropathy) is a debilitating condition affecting patients with cancer or who are recovering from cancer. No medication specifically targets this unremitting type of pain.

"These patents mark another important step in establishing DARA's value to provide new drug discoveries for potential pharmaceutical company partners," said Richard A. Franco, CEO/President of DARA BioSciences, Inc. 

U. S. Patent No. 7,714,004 (the '004 patent), which issued May 11, 2010, provides protection for indane acetic acid derivative compounds currently in DARA's DB900 program and also protects methods of treating a variety of clinical indications including diabetes and related disorders, obesity, cardiovascular disease and Syndrome X. U.S. Patent No. 7,906,653 (the '653 patent) issued March 15, 2011 and provides protection for methods of manufacturing indane acetic acid derivatives, including compounds in the DB900 program. In addition, the European Patent Office granted European Patent No. EP 1578715 (the '715 patent) on March 2, 2011, which protects indane acetic acid derivatives, including compounds in the DB900 program, and the use of these compounds to treat diabetes and related disorders, obesity, cardiovascular disease, Syndrome X and secondary causes of diabetes. The '004, '653, and '715 patents are exclusively licensed under an agreement with Bayer Pharmaceuticals Corporation. 

A number of international patents have been granted that provide additional patent protection for compounds in the DB900 program as well as one of DARA's lead compounds, DB959. Japanese Patent No. 4510447 issued on May 14, 2010 and protects indane acetic acid derivative compounds including DB959 and compounds in the DB900 program. Korean Patent No. 10-0956898 was granted on April 30, 2010 and provides further protection for these compounds. Related patents have also issued in the past year in Mexico and Taiwan. These patents are all exclusively licensed under an agreement with Bayer Pharmaceuticals Corporation.   

European Patent No. EP 1328236 was granted on April 6, 2011 and protects the use of spicamycin derivatives to provide pain relief, including particular coverage for the use of these derivatives to provide relief for neuropathic pain. The uses of the specific derivatives SAN and SAN-Gly, metabolites of KRN5500, are specifically protected. A related Canadian patent has also recently issued, which protects the use of SAN-Gly to provide pain relief, including relief of neuropathic pain. These patents are exclusively licensed from The General Hospital Corporation.  

About DARA BioSciences, Inc.

DARA BioSciences, Inc. is a clinical biopharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept (pre-phase III) in humans for subsequent sale or out-licensing to larger pharmaceutical companies. Presently DARA has two drug candidates with cleared IND (Investigational New Drug) Applications from the United States FDA advancing through clinical development:

  1. KRN5500 for the treatment of neuropathic pain – successfully completed a Phase II study and plans to initiate a second Phase II study (Q2 2011) in conjunction with the National Cancer Institute focusing on the treatment of chemotherapy induced peripheral neuropathy (CIPN); and
  2. DB959 for the treatment of type 2 diabetes – successfully completed a Phase Ia study and has initiated a Phase Ib study (Q1 2011).

In addition, the Company has a pipeline of diverse drug candidates at various stages of development, with 88 US and foreign granted patents and 60 pending applications. The first drug candidate KRN5500 has successfully completed a Phase 2 clinical trial treating neuropathic pain in patients with cancer. KRN5500 met its primary endpoint of reduction of pain from baseline and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. In addition, DARA has entered into a Clinical Trial Agreement with the National Cancer Institute to study the prevention and treatment of neuropathic pain in cancer patients. The second drug candidate DB959 is an oral, highly selective, non-thiazolidinedione (TZD), first-in-class dual PPAR (peroxisome proliferator activated receptor) delta/gamma agonist in development for type 2 diabetes. A Phase 1a clinical study has been completed and the positive results were announced. A second Phase 1 clinical study has commenced and the Company plans to announce results in the second half of 2011. In addition, DARA owns CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800 PPAR agonists of various molecular modalities. PPAR receptors are found throughout the human body and recent publications report that PPAR agonists may be useful in the treatment of Alzheimer's disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Because its diverse PPAR library has the potential to address the unmet medical needs of these diseases, the Company plans to explore several of these indications.

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 current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the potential delisting of DARA's common stock from the NASDAQ Capital Market, DARA's limited operating history which may make it difficult to evaluate DARA's business and future viability, DARA's ability to retain its managerial personnel and to attract additional personnel, DARA's ability to successfully develop and outlicense its drug candidates as anticipated, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, potential product liability risks that could exceed our liability coverage, competition from other pharmaceutical companies, biotechnology companies and other research and academic institutions, the strength of DARA's intellectual property, the intellectual property of others 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.

CONTACT: Investor Contact: Cameron Associates, Inc.
         Kevin McGrath
         Media Contact: Wyatt Communications LLC
         MJ Wyatt
         212 661-9610

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