Lotus receives Chinese SFDA approval for R-Bambuterol Hydrochloride Phase I human clinical trials

Oct 28 2010

Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: LTUS) ("Lotus" or the "Company"), a fast-growing, profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China ("PRC"), announced today that it received approval from the State Food and Drug Administration ("SFDA") Ethics Committee to commence Phase I human clinical trials of R-Bambuterol Hydrochloride, the Company's proprietary drug candidate for the treatment of asthma. Lotus plans to initiate Phase I trials, including drug tolerance and pharmacokinetics studies, in the near term.

R-Bambuterol Hydrochloride is categorized as a Class I new drug. Lotus has patent protection for the drug until 2022. In preclinical studies, R-Bambuterol Hydrochloride demonstrated a promising efficacy and safety profile.

R-Bambuterol Hydrochloride entered the Phase I clinical stage in August 2010. Over the past two months, Lotus has completed the clinical trial design and finalized its preparations for the upcoming Phase I trials. Additionally, the Company began recruiting healthy volunteers for the clinical studies. Obtaining permission from the SFDA Ethics Committee is required for advancing the Phase I clinical program. Phase I trials will be conducted by Beijing Zenith International Medical Science and Technology Development Company Limited, a full-service clinical research organization, and will be carried out in the Third Hospital of Peking University, a top-ranked AAA hospital in China.

The Phase I studies will evaluate the drug's safety, tolerability, and pharmacokinetics. In the drug tolerance study, Lotus plans to test single-dose tolerance for 6 dosing levels, as well as multiple-dose tolerance for 2 dosing levels, in a total of 78 healthy volunteers. For the pharmacokinetics study, Lotus plans to evaluate the pharmacokinetics of the drug with food intake and 3 dosing levels in 34 volunteers. Lotus expects that the drug tolerance and pharmacokinetics studies will take 4 to 6 months to complete. The Phase I trials will enable Lotus to find the optimal dose(s) of R-Bambuterol Hydrochloride for late-stage clinical trials.

According to IMS Health, a pharmaceutical market research firm, the anti-asthma and chronic obstructive pulmonary disease market in China reached approximately $300 million in 2009. IMS Health estimates that 30 to 40 million people in China have asthma.

Chairman and Chief Executive Officer Mr. Zhongyi Liu stated, "The SFDA approval represents an important step forward in our clinical development program. R-Bambuterol has shown greater efficacy and fewer side effects compared to bambuterol in preclinical studies, and we believe that our product has the potential to effectively address China's large and growing asthma market. We look forward to initiating Phase I clinical trials and will share further developments with our investors as they occur."