Uni Pharma to Market Convivia(TM) in Taiwan
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(TM), Raptor's proprietary oral formulation of 4-methylpyrazole ("4-MP"), in Taiwan.
Convivia(TM) 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(TM) in subjects with ALDH2 deficiency, in November 2008.
"Uni Pharma is an ideal partner for us to be working with in taking our Convivia(TM) program forward. Uni Pharma has tremendous clinical and commercial expertise," said Ted Daley, President of Raptor. "We believe Convivia(TM) 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 Convivia(TM) 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(TM) in Taiwan, with an option to expand the license to South Korea under the same terms. Uni Pharma will register Convivia(TM) for drug licensure for existing indications and will conduct a clinical trial and register Convivia(TM) for acetaldehyde toxicity resulting from ALDH2 deficiency. Uni Pharma will be responsible for marketing and sales activities for the commercialization of Convivia(TM) in the markets covered under the license agreement.
"Convivia(TM) 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 Convivia(TM) 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(TM) 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(TM) significantly reduced tachycardia, which is commonly experienced by ALDH2-deficient people who drink. Findings also indicated that Convivia(TM) 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.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) ("Raptor") is dedicated to speeding the delivery of new treatment options to patients by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. Raptor focuses on underserved patient populations where it can have the greatest potential impact. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, non-alcoholic steatohepatitis ("NASH"), Huntington's Disease ("HD"), aldehyde dehydrogenase ("ALDH2") deficiency, and a non-opioid solution designed to potentially treat chronic pain.
Raptor's preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein ("RAP") and related proteins that are designed to target cancer, neurodegenerative disorders and infectious diseases.
For additional information, please visit www.raptorpharma.com.
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FORWARD LOOKING STATEMENTS
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operation or future financial performance, including, but not limited to the following statements: that Convivia(TM) could become the first approved treatment for ALDH2 deficiency; that Raptor will license Convivia(TM) to other companies in East Asia; that Uni Pharma will register Convivia(TM) for drug licensure for indications which 4-MP is approved in the U.S., but not yet approved in Taiwan and South Korea; that Uni Pharma will conduct a clinical trial and register Convivia(TM) for acetaldehyde toxicity resulting from ALDH2 deficiency; that Convivia(TM) has the potential to serve a large patient population; that Uni Pharma will be successful in conducting its clinical trials of Convivia(TM), if at all; that Uni Pharma will be able to successfully commercialize the drug in Taiwan and South Korea; that Convivia(TM) may reduce tachycardia, peak acetaldehyde levels in the blood or total acetaldehyde exposure; that the genetic variant subset which Convivia(TM) may address represents 15 to 20% of the East Asian population; and Raptor's ability to successfully develop any of its product candidates. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results to be materially different from these forward-looking statements. Factors which may significantly change or prevent the Company's forward looking statements from fruition include that Raptor may be unsuccessful in developing any products or acquiring products; that Raptor's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; that Raptor is unable to retain or attract key employees whose knowledge is essential to the development of its products; that unforeseen scientific difficulties develop with the Company's process; that Raptor's patents are not sufficient to protect essential aspects of its technology; that competitors may invent better technology; that Raptor's products may not work as well as hoped or worse, that the Company's products may harm recipients; and that Raptor may not be able to raise sufficient funds for development or working capital. As well, Raptor's products may never develop into useful products and even if they do, they may not be approved for sale to the public. Raptor cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the Securities and Exchange Commission (the "SEC"), which Raptor strongly urges you to read and consider, including Raptor's current report on Form 8-K filed with the SEC on February 5, 2010; and Raptor's quarterly report on Form 10-Q filed with the SEC on April 9, 2010, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to Raptor or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in Raptor's reports filed with the SEC. Raptor expressly disclaims any intent or obligation to update any forward-looking statements.
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