BEIJING, Sept. 26 /Xinhua-PRNewswire/ -- Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: LTUS) ("Lotus" or the "Company"), a pharmaceutical products developer, manufacturer and distributor in the People's Republic of China ("PRC"), today announced that China's State Food and Drug Administration (SFDA) is evaluating the Company's drug Laevo-Bambutero for clinical trials.
Laevo-Bambutero is a drug used to treat asthma, and the Company views it as a more effective drug than a number of alternative drugs currently on the market. Lotus obtained the patent along with exclusive production rights in China for Laevo-Bambutero through a technology transfer agreement with Dongguan Kaifa Biomedicine, Inc. in May 2008.
The Company received formal notice from the SFDA that it has started to evaluate Laevo-Bambutero for clinical trials. This evaluation is expected to take from six to nine months and will determine if and when stringent clinical trials begin. If approved, those clinical trials should take approximately eighteen months. Pending final approval for manufacturing and distribution from the SFDA, Lotus plans to launch sales of Laevo-Bambutero by 2012.
"The news from the SFDA is an important first step of many steps needed for bringing Laevo-Bambutero to market," said Dr. Zhongyi Liu, Chairman, CEO and President of Lotus Pharmaceuticals, Inc. "We are pleased to have reached a new milestone in the commercialization of Laevo-Bambutero, which we look forward to adding to our product portfolio."
About Lotus Pharmaceuticals, Inc.
Lotus Pharmaceuticals, Inc. controls and operates Liangfang Pharmaceutical, Ltd. ("Liangfang") and Enze Jiashi Pharmaceutical, Ltd. ("Enze"), two pharmaceutical companies located in Beijing, China. Together, Liangfang and Enze ("Lotus East") undertake the development, production, marketing and distribution of pharmaceutical products. Lotus East has some of the most advanced pharmaceutical production equipment in China and its manufacturing facilities meet national Good Manufacturing Practices (GMP). The Company distributes its own portfolio of drugs and pharmaceutical products produced by other manufacturers in the PRC through an extensive national distribution network. Lotus owns ten pharmacies in Beijing through which it directly sells over 5,000 western drugs, Traditional Chinese Medicines (TCM) and medical equipment items.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including changes from anticipated levels of sales, future national or regional economic and competitive and regulatory conditions, changes in relationships with customers, access to capital, difficulties in developing and marketing new products, marketing existing products, customer acceptance of existing and new products, and other factors. Additional information regarding risks can be found in the Company's Annual Report on Form 10K filed with the SEC. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.
