AlphaRx Announces Commencement of Clinical Trial of CoQ10 ER in People's Republic of China -- PRC --.Business Editors, Health & Medical Writers BIOWIRE2K RICHMOND HILL, Ontario--(BW HealthWire)--Dec. 4, 2000 AlphaRx Inc. (OTCBB:AHRX) today announced the commencement of a clinical trial of CoQ10 ER(TM) extended-release ubiquinone ubiquinone /ubi·qui·none/ (Q) (Q10) (u?bi-kwi-non´) a quinone derivative with an unsaturated branched hydrocarbon side chain occurring in the lipid core of inner mitochondrial membranes and functioning in the electron transport chain. In naturopathic practice it is used for a wide variety of indications; also used as a dietary supplement for its antioxidant properties. for use in the treatment of congestive heart failure. Based on AlphaRx's BCD drug delivery system, CoQ10 ER(TM) is the world's first water soluble, extended-release ubiquinone formulation. The clinical trial will assess the safety and pharmacokinetics 1. The process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. 2. The study of this process. phar of single doses of CoQ10 ER(TM) administered to healthy volunteers. The study will be conducted within the Beijing Capital Medical University under the leadership of S.H. Chui See CUI., M.D. and H.S. Sun, M.D. The Company's CoQ10 ER(TM) complies with the 4th Category New Drug status and, as such, only requires completion of a successful pharmacokinetics study for drug approval. AlphaRx expects to obtain this approval by the 3rd quarter of 2002.  ma·co·ki·net ic adj.Ubiquinone is one of the 1,400 domestic and foreign drugs which qualify for the Chinese government reimbursement system. There is no ubiquinone product currently approved for use in PRC. The estimated annual market for CoQ10 ER(TM) in China is around US$15M. Pharmaceuticals account for an estimated 30% of all health care costs in China, as compared to 8% in the United States. Sales in the Chinese pharmaceutical market are estimated at US$15 Billion for 2000 and are expected to grow at 20% annually for the next decade. Joint ventures and imported pharmaceutical products account for approximately 30% of the total Chinese market for the same time period. CoQ10 ER(TM) is AlphaRx's first entry into the PRC pharmaceutical market. The Company is planning to start clinical trials of its pain management products in China in the near future. About AlphaRx AlphaRx is engaged in the development of novel formulations of drugs that are insoluble or poorly soluble in water. For additional information, please visit our web-site at www.AlphaRx.com FORWARD LOOKING STATEMENTS: This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the Company. |
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