Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq:RPTP), announced that it has entered into an exclusive agreement with Uni Pharma Co., Ltd. ("Uni Pharma") to commercialize Convivia™, Raptor's proprietary oral formulation of 4-methylpyrazole ("4-MP"), in Taiwan.
Convivia™ is designed to reduce systemic acetaldehyde exposure and related symptoms in liver enzyme aldehyde dehydrogenase ("ALDH2") deficiency, or ethanol intolerance, following alcohol consumption. Currently, 4-MP is the active pharmaceutical ingredient in an existing intravenous therapeutic approved by the U.S. Food and Drug Administration ("FDA") for unrelated indications. Raptor announced positive results from a Phase 2a clinical trial of Convivia™ in subjects with ALDH2 deficiency, in November 2008.
"Uni Pharma is an ideal partner for us to be working with in taking our ConviviaTM program forward. Uni Pharma has tremendous clinical and commercial expertise," said Ted Daley, President of Raptor. "We believe ConviviaTM is an exciting product candidate that could become the first approved treatment for ALDH2 deficiency, a disorder that affects approximately 50 percent of East Asian populations. This is the first of what we expect will be a franchise of out-licensing transactions to develop ConviviaTM in various countries throughout East Asia."
Under terms of the agreement, Raptor will grant to Uni Pharma an exclusive license under all relevant patent applications, trademarks and future patents controlled by Raptor to market Convivia™ in Taiwan, with an option to expand the license to South Korea under the same terms. Uni Pharma will register Convivia™ for drug licensure for existing indications and will conduct a clinical trial and register ConviviaTM for acetaldehyde toxicity resulting from ALDH2 deficiency. Uni Pharma will be responsible for marketing and sales activities for the commercialization of Convivia™ in the markets covered under the license agreement.
"ConviviaTM represents exactly what Uni Pharma looks for in a licensing candidate – a drug supported by a strong clinical history that has the potential to serve a large patient population," remarked Terry Lin, general manager of Uni Pharma. "We welcome the opportunity to work with Raptor to further ConviviaTM through the clinic and, if all goes well, commercialize the drug in Taiwan and South Korea."
ALDH2 deficiency, sometimes referred to as "Asian flushing syndrome" is an inherited metabolic disorder affecting 40 to 50 percent of East Asian populations, impairing the activity of the liver enzyme ALDH2. When people with ALDH2 deficiency drink alcoholic beverages, there is an accumulation of acetaldehyde, a carcinogenic intermediate in the metabolism of ethanol, in blood and tissues. Published retrospective studies have observed a significant correlation between recurrent drinkers with ALDH2 deficiency and an increase in risk for digestive tract cancers and other serious health disorders. Elevated acetaldehyde levels also result in acute symptoms, including facial flushing, tachycardia (rapid heart rate), headache, nausea and dizziness.
In 2008, Raptor conducted a Phase 2a study of Convivia™ in 32 patients of Japanese descent with a history of symptoms of inborn altered ethanol metabolism with concomitant ethanol exposure. Results of the study showed that Convivia™ significantly reduced tachycardia, which is commonly experienced by ALDH2-deficient people who drink. Findings also indicated that Convivia™ significantly reduced peak acetaldehyde levels in the blood and total acetaldehyde exposure in a subset of study participants who had specific genetic variants of liver ADH and ALDH2 enzymes. Raptor estimates that this genetic variant represents about 15 to 20% of East Asians.
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