SOURCE: AlphaRx Inc.

September 12, 2005 08:00 ET

AlphaRx Provides Update on Phase II Trial of Indaflex™ for the Treatment of Osteoarthritis of the Knee

MARKHAM, ON -- (MARKET WIRE) -- September 12, 2005 -- AlphaRx Inc. (OTC BB: ALRX), an emerging biopharmaceutical company, utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to provided an update on the clinical development of its lead product candidate Indaflex™, a topical Indomethacin drug expected to treat patients suffering from Osteoarthritis of the knee.

The 210-patient, randomized, multi-center, double-blind study has been designed to establish the efficacy and safety of Indaflex™ relative to placebo and vehicle-placebo after a 6-week treatment period.

Patient enrollment has started in six centres and several patients have already been randomized. The Company expects four more centres to commence enrollment in the near future.

Dr. Lee S. Simon, a clinical and regulatory consultant to the Company, recently commented, "This is a relatively selective study and should Indaflex™ meet the end points, we will know if the drug really works and something about its safety over a six week period."

About Indaflex

Indaflex is AlphaRx's topical NSAID (Non-Steroidal Anti-inflammatory Drug) formulation under clinical development for the treatment of arthritis symptoms. Osteoarthritis is the most common chronic disease in North America and afflicts an estimated 10% of the world's population. Indaflex's active ingredient, Indomethacin, has a long-standing and proven clinical treatment record. With AlphaRx's enhanced proprietary delivery system, the company believes its clinical effectiveness will be significantly enhanced compared to other topical preparations. Topical Indaflex delivery, the company hopes, may circumvent the significant GI side-effects commonly found with orally ingested NSAIDs.

About AlphaRx Inc. (

AlphaRx is an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs that are insoluble or poorly soluble in water or have yet to be administrable to the human body with an acceptable delivery method. The Company's product candidates address various pharmaceutical markets, including arthritis, tuberculosis, ocular infection, ocular inflammation and hospital acquired pneumonia.

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.

This press release is available on the company's official on-line investor relations site for investor commentary, feedback and questions. Investors are asked to visit and view the "AlphaRx" Investor Discussion and Contact Forum. In addition, investors are asked to e-mail all questions and correspondence to

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