NEW YORK, NY--(Marketwire - August 24, 2010) - Aoxing Pharmaceutical Company, Inc. (NYSE Amex: AXN) (“Aoxing Pharma”), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the China SFDA has granted approval of the company’s New Drug Application to initiate the registration clinical trial of Buprenorphine/Naloxone sublingual tablets for opioid addiction treatment. The approval enables Aoxing Pharma to move forward to the final development stage with this therapy, which is novel in China as it is not yet available to patients.
The registration trial will be administered by the National Institute on Drug Dependence of China at Beijing University, the co-development partner of Aoxing Pharma. The patient enrollment will take place in at least three Compulsory Drug Dependence Treatment Centers. The trial is designed to establish the safety and efficacy of the Buprenorphine/Naloxone sublingual tablet therapy among patients who are suffering from opioid dependence.
“The SFDA’s clearance of our Buprenorphine/Naloxone sublingual tablet program is the most significant accomplishments to date for our drug addiction franchise and marks the beginning of a new chapter in medical therapies for Chinese opioid dependence patients,” said Zhenjiang Yue, the Chairman and CEO of Aoxing Pharma. “We look forward to starting patient enrollment in late 2010 and to finishing the clinical study by mid 2011. Under the current development schedule, the product launch is expected to take place in mid 2012. We believe that this drug could become an exciting therapeutic option for millions of patients and families in China who suffer painful drug dependence and its associated problems.”
The registration trial is a multi-center, randomized, double-blind and active-control study, which is planned to enroll approximately 280 patients registered at Compulsory Drug Dependence Treatment Centers. Subjects are randomized during a brief induction phase, a multi-week maintenance phase and a detoxification phase.
About the Drug Addiction Problem in China
Based on Chinese government data, drug abuse and addiction has become a serious social problem and the situation has been getting worse and worse over the last two decades. As of December 2009 there were 1.3 million registered drug addicts in China, an increase of 15% from the prior year. However, the real population of drug addicts is estimated about 13 million in China. The Chinese government has taken comprehensive measures to address the problem, including centralized compulsory treatment camp, community clinics, psychological consulting and pharmacological therapies. In 2009 approximately 200,000 individuals received compulsory drug addiction treatment at over 80 centralized treatment centers and other centers managed by the Chinese government. The direct cost of illegal heroin purchase in China was estimated at $4 billion USD, and the overall monetary cost in connection with illegal drug purchase in China was estimated at $30 billion USD in 2009.
About Buprenorphine/Naloxone Sublingual Tablets
Buprenorphine/Naloxone sublingual tablets are a combo formulation of buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine: naloxone. Total sales of the branded Buprenorphine/Naloxone sublingual tablets reached $900 million USD in 2009, sold by a global group of pharmaceutical companies in the US, France and many other countries.
The tablets are usually taken once a day and are prescribed to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists, and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone prevent withdrawal symptoms when someone stops taking opioid drugs by producing effects similar to those produced by the opioids.
About Aoxing Pharmaceutical Company, Inc.
Aoxing Pharmaceutical Company, Inc. is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (SFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. It also has strategic alliance partnership with QRxPharma, Phoenix PharmaLabs, Inc and American Oriental Bioengineering, Inc. For more information, please visit: www.aoxingpharma.com.
Safe Harbor Statement from Aoxing Pharmaceutical Company, Inc.
Statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. The economic, competitive, governmental, technological and other risk factors identified in the Company’s filings with the Securities and Exchange Commission, including the Form 10-K for the year ended June 30, 2009, may cause actual results or events to differ materially from those described in the forward looking statements in this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.
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