NEW YORK, Nov. 20 /PRNewswire-FirstCall/ -- China Aoxing Pharmaceutical Company, Inc. , which has the largest manufacturing facility and product pipeline for highly regulated narcotic medicines and pain medication in China, today announced that the China State Food & Drug Administration (SFDA) granted the Company and its partner National Institute of Drug Dependence at Beijing University an important research and development license of Buprenorphine/Naloxone sublingual combo tablet to treat opioid dependence, a growing social and medical problem in China.
Mr. Zhenjiang Yue, the CEO of CAXG, said: “We are very pleased to be on the road to help China deal with its large and growing issue of opioid addicts. Here we are developing a very new and important maintenance therapy for the China market. To secure a R&D license is a key step for a drug company to start a particular narcotic drug program in China. Today’s approval is recognition of the trust and support from the China SFDA, and also speaks to our commitment to advance new narcotic therapeutic paradigm for the China market.”
Ms Liying Yang, the Vice President of R&D, commented, “This project has been a joint effort of scientists from our Company and Beijing University since April 2005. This new combo therapy is expressly designed to combine the proven effectiveness and tolerability of buprenorphine with a lower potential for misuse, underlining our commitment to this therapy area. There is much peer-reviewed evidence of superior efficacy and safety profile for this therapy. Our formulation is the first in the Chinese market and, as the innovator, assuming we receive full approval by the SFDA, we expect to have seven years of exclusivity in the Chinese market. Even after the exclusivity period is over, due to the nature of highly regulated narcotic drug business, we only expect no more than two licenses in total to be given out by the SFDA. The company is planning to conduct clinical study in 2008 and bring this effective medical treatment to China in early 2009.”
Opioid dependence has become a seriously medical and social challenge in China. As of 2006, there were approximately 1.2 million registered individuals addicted to opioids in China. This figure is estimated to grow at 10% per year while the number of un-registered drug addicts could be significantly higher. It has been an enduring issue in the Unites States, as of 1998, only about 115,000 methadone maintenance treatment (MMT) slots were available for opioid dependence therapy, however, during the same time period, approximately 980,000 individuals in the United States were addicted to heroin. Furthermore, in 2002 an estimated 4.4 million people were users of prescription pain medication, and 936,000 of them were estimated to have non-medical dependence upon prescription pain medications.
About Buprenorphine/Naloxone Treatment for Drug Dependence
Opioid dependence is a chronic, relapsing medical condition that requires long-term treatment and patient support. Current standard maintenance therapies are methadone and buprenorphine, both of which bind to the opioid receptors in the brain. A combo therapy was developed based on Naloxone, an opioid receptor antagonist, alongside Buprenorphine, which is designed to limit the potential for misuse and potentially lower the street value and the incentive for diversion. This combo therapy was approved by the US FDA in late 2002, and just became available in the UK in 2007, sold by a Fortune 500 global pharmaceutical company.
About China Aoxing Pharmaceutical Company, Inc.
China Aoxing Pharmaceutical Company, Inc. is a pharmaceutical company in China specializing in research, development, manufacturing and distribution of a variety of narcotics and pain management products. Headquartered in Shijiazhuang City, the pharmaceutical capital of China, outside of Beijing, the Company has the largest product pipeline and largest manufacturing facility (1.2 million sq. ft.) for highly regulated narcotic medicines, addressing a very under-served market in China. Its facility is one of the few GMP facilities licensed for narcotics medicines. The Company has two drugs on the market and has received China SFDA licenses for seven more medications such as Oxycodone, Tilidine and Pholcodine. The Company is working closely with the Chinese government and SFDA to assure the availability of narcotic drugs and pain medicines throughout China.
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulation, and other risks contained in statements filed from time to time with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by the cautionary statements and any other cautionary statements which may accompany the forward-looking statements. You are urged to read the Company’s filings with the Securities and Exchange Commission, including, but not limited to, the risk factors contained therein. In addition, the Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
CONTACT: Dr. Hui Shao, Senior Vice President of China Aoxing
Pharmaceutical, +1-201-420-1075
Web site: http://www.aoxingyaoye.com/
