FSC / Press Release
AlphaRx and Proprius Pharmaceuticals Achieve Enrollment Objective in Phase II Trial of Indaflex(tm) for Osteoarthritis of the Knee
San Diego CA. and Markham, Ontario CANADA, December 11, 2006 /FSC/ - AlphaRx Inc. (ALRX - OTCBB), and Proprius Pharmaceuticals, Inc. today announced that 210 patients have now been enrolled in the Indaflex(tm) Phase II osteoarthritis (OA) clinical trial being conducted in Canada. The companies anticipate that the trial will be completed and results will be announced in the first half of 2007.
Michael Lee, President & CEO of AlphaRx commented, "We are very pleased to see the trial progress through the accomplishment of this significant milestone, and look forward to announcing the results in the coming year."
Michael J. Walsh, President & CEO of Proprius Pharmaceuticals stated, "Indaflex(tm) has great potential as an alternative for addressing local joint pain in this chronic and debilitating condition affecting some 25-30 million Americans. Our continued interactions with experts in osteoarthritis and pain management reinforce this belief, and underscore the significant level of interest from U.S. physicians in having access to a highly effective, safe and tolerable topical NSAID."
"With the achievement of our enrollment objective for this Phase II study of Indaflex(tm) for OA of the knee, we look forward to a successful completion of the trial," remarked David W. Anderson, Ph.D., Chief Scientific Officer for Proprius Pharmaceuticals. "We are on track to file an Investigational New Drug application with the U.S. Food and Drug Administration in the coming months and advance Indaflex(tm) into pivotal safety and efficacy trials in 2007."
In April 2006, AlphaRx licensed Indaflex(tm) to Proprius Pharmaceuticals, Inc. Under the terms of the agreement, AlphaRx is eligible to receive milestone payments of up to $116 million for the successful development and commercialization of Indaflex(tm), as well as double-digit royalties on worldwide sales. In addition, Proprius has assumed all clinical development costs.
About Indaflex(tm)
Indaflex(tm) is a topical NSAID (Non-Steroidal Anti-inflammatory Drug) formulation currently in Phase II clinical development for the reduction of signs and symptoms associated with OA of the knee. Arthritis is the most common chronic disease in North America and afflicts an estimated 10% of the world's population. The active ingredient in Indaflex(tm), indomethacin, has a long-standing and proven clinical treatment record. Delivered through the skin using proprietary technology developed by AlphaRx, the companies believe Indaflex(tm) will have an attractive safety, tolerability and efficacy profile in comparison to oral treatments and other topical preparations.
About AlphaRx Inc.
AlphaRx is a clinical stage 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 and inflammation, cataracts, hospital acquired pneumonia and sepsis.
About Proprius Pharmaceuticals, Inc.
Proprius Pharmaceuticals is a fully-integrated specialty pharmaceutical company that develops and markets personalized medicine solutions in rheumatology and autoimmune diseases. This novel combination of proprietary therapeutics and diagnostic services provides a strategic and differentiated approach to commercialization. Proprius is a privately-held and venture-backed organization, with financing provided by Fog City Fund, and Windamere Venture Partners, LLC.
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 companies.
For more information, please contact:
For AlphaRx Inc.:
AGORACOM Investor Relations Corp.
Web: http://www.agoracom.com
E-mail: ALRX@Agoracom.com
For Proprius Pharmaceuticals, Inc.:
Michael J. Walsh, President & CEO
Web: http://www.propriuspharma.com
Email: mwalsh@propriuspharma.com
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