With greater frequency, large pharmaceutical companies are turning to early stage development companies like DARA as an attractive and affordable option to grown-at-home drug discovery and development (which may cost as much as $1 billion dollars per drug and require more than 10 years from discovery to commercialization) or company acquisitions which may, in the end, have an even higher price tag in terms of financial arrangements, real estate expansions or sales, employee redundancies, operational revamping and drugs that simply don't materialize.
In fact, the Federal government recently announced that, because of the slowness of new drug development and cutbacks in research by large pharmaceutical companies, a new government drug development center will be established.
"Diabetes is the disease most underrated by the U.S. public," explains Richard A. Franco, who has been a pharmacist, senior strategist for a multi-national pharmaceutical giant, an entrepreneur and now, CEO/President of DARA BioSciences. "The general public doesn't have the appropriate fear of diabetes because it can be silent for years – advancing without overt symptoms. But make no mistake about it – it can lead to heart disease, kidney disease, blindness, stroke and death."
Franco cofounded DARA BioSciences in 2003, as a company devoted to identifying and licensing promising early stage development drugs that tackle some of the biggest disease threats. He says DB959's ability to impact lipids and lower blood sugar is novel. Preclinical studies demonstrated a good safety and efficacy profile for DB959. A Phase 1 clinical study determined that single doses of the drug were safe and well tolerated, and that the drug will likely be a once-a-day drug.
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About DARA BioSciences, Inc.
DARA BioSciences, Inc. (Nasdaq:DARA) is a Raleigh, North Carolina based biopharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept 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. The Company has a pipeline of diverse drug candidates at various stages of development, with 82 granted patents and 56 pending applications (US and foreign). 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 and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. The second drug candidate DB959 is a 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 for DB959 was successfully completed in 2010 with a multiple ascending dose trial planned for the first 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.