AlphaRx Receives Notice of Allowance for U.S. Patent on Its Drug Delivery Platform
MARKHAM, Ontario, Jan. 25, 2006 (PRIMEZONE) -- AlphaRx Inc. (OTCBB:ALRX message board, news, dd, quote), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, has received a Notice of Allowance from the United States Patent and Trademark Office for its patent application entitled "Vehicle For Topical Delivery of Anti-Inflammatory Compounds." The platform is an integral part of the Company's lead product Indaflex(tm), which is undergoing a Phase II clinical trial.
Michael Lee, President of AlphaRx Inc., stated, "We are extremely pleased about the allowance of this patent. This award helps protect our innovative drug delivery technology and further endorses our competitive position. We have 6 further patent applications pending and are hopeful that this is the first of many patents that will be receiving allowance."
AlphaRx Updates Binoxan Development, a Potential Non-Irritating, Twice-a-Day Eye Drop for Ocular Inflammation
MARKHAM, Ontario, Jan. 17, 2006 (PRIMEZONE) -- AlphaRx Inc. (OTCBB:ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to report positive toxicology data for ALRX IM, the active ingredient in Binoxan(tm). ALRX IM is an Indomethacin Ester, which has shown comparable biological activity to standard Indomethacin formulations in animal studies, but is substantially less toxic and less irritating than the existing non-steroidal therapy. Furthermore, as ALRX IM is more soluble than Indomethacin, when incorporated into the Company's colloidal delivery platform, it may have increased permeability and correspondingly higher efficacy.
ALRX IM breaks down into Indomethacin and its ester in equal parts in vivo. Indomethacin has superior anti-inflammatory, analgesic and antipyretic properties and is normally administered in capsular form for the treatment of systemic inflammatory diseases (arthritis, muscle pain, tendinitis, etc). The sodium salt of Indomethacin may be injected intravenously or used for topically for treatment of inflammatory conditions of the eye.
About Binoxan(tm)
Binoxan(tm) is a topical, non-acidic, non-steroidal anti-inflammatory pro-drug in a colloidal formulation, intended for the treatment of ocular inflammation, eye pain and photophobia. Based upon prescription data compiled by IMS Health, it is estimated that over 8.6 million prescriptions are written annually in U.S. for topical ophthalmic anti-inflammatory agents, with sales in excess of $400 M USD.
AlphaRx's Joint Venture Company Receives Marketing Approval for Flexogan Ultra in Hong Kong
MARKHAM, Ontario, Jan. 10, 2006 (PRIMEZONE) -- AlphaRx Inc. (OTCBB:ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to announce that its joint venture company, Alpha AP, Inc., located in Hong Kong, has received marketing approval for the sale of Flexogan Ultra in Asia.
Flexogan Ultra, which is a scaled-down version of Indaflex(tm), contains 1% Indomethacin. Indomethacin is used to relieve the pain, tenderness, inflammation (swelling), and stiffness caused by gout, arthritis, and other inflammatory conditions. With AlphaRx's enhanced proprietary nano delivery system, the Company believes Flexogan Ultra's effectiveness will be significantly greater when compared to other topical preparations available on the market.
Flexogan Ultra is the first product to be launched in Hong Kong and the only pharmaceutical product allowed by the health authority to make a "Nano Formulation" marketing claim. It is anticipated that Flexogan Ultra is one of the many innovative pharmaceutical products which will be licensed to Alpha AP to be marketed in Asia.
About Alpha AP, Inc.
The newly formed Joint Venture, Alpha AP, Inc. ("AAP"), is headquartered in Hong Kong. Under the terms of the Joint Venture agreement, Advance Pharmaceutical Co. Ltd. ("APC") will fund the Joint Venture manufacture and market the products in China, Hong Kong, Korea and Japan.
Under the terms of the licensing agreement, as amended, AlphaRx will provide 10 products to the Joint Venture, to be marketed under the APC brand. In addition to its 50% equity in the Joint Venture, AlphaRx will receive a 5% royalty from the Joint Venture's gross sales. AlphaRx will also receive a one time licensing fee of US$11M from the Joint Venture, contingent upon completion of its Hong Kong public stock offering.
AlphaRx Initiates Animal Study for Acusolin(TM), a Potential Eye Drop for Cataracts
AlphaRx Inc. (OTC BB: ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to announce that the development of the formulation for Acusolin(TM), its 3rd ophthalmic product, has been completed and in vivo studies are underway as scheduled.
The Company will investigate Acusolin(TM) using an established cataract animal model. This model is designed to demonstrate Acusolin(TM)'s ability to prevent and treat senile cataracts.
Cataract disease affects millions of individuals worldwide. Currently, surgery is the only effective method of treating vision loss caused by cataracts and over 1.4 million people have cataract surgery each year in the United States.
The Company hopes to begin clinical studies for Acusolin(TM) by end of 2006 and is seeking financial resources to support clinical development, either by out-licensing or a co-development arrangement.
AlphaRx Reports No Material Change to Business Affairs
AlphaRx Inc. (OTC BB: ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations, today confirmed there has been no material change or event that would adversely affect stock performance.
Commenting on recent share price activity, AlphaRx President and CEO stated, "We fully acknowledge and appreciate the recent comments of shareholders who have inquired about any correlation between share price activity and our business activities. As reported on October 11, Phase II of our Indaflex™ trial is accelerating and on target to be completed in February of 2006. At the same time, development of new products such as Vansolin™ and Binoxan™ continue as expected. In short, AlphaRx fundamentals have never been better. Though our share price as of late does not reflect our achievements, my extensive experience in this industry has taught me that markets eventually reward and reflect performance. As such, we continue to remain focused on development of novel formulations utilizing our drug delivery technology, with the single goal of bringing products to market."
AlphaRx to Accelerate Indaflex(TM) Phase II Trial
AlphaRx Inc. (OTC BB: ALRX), today announced the addition of three new sites for its Phase II multi-center clinical trial of Indaflex(TM), a topical Indomethacin drug expected to treat patients suffering from Osteoarthritis of the knee.
The Company believes that the three new sites, in addition to the existing ten sites, will accelerate patient enrollment toward the targeted completion date of Feb. 2006.
"Clinically, there is an urgent need to offer an alternative to oral NSAIDs and COX2 inhibitors for Osteoarthritis patients with the withdrawal of some COX2 inhibitors due to their potential cardiovascular side-effects. From a business point of view, Indaflex(TM) may well be the product to fill this need. Taking these factors into consideration, it is in the best interest of the Company to accelerate this clinical trial," said Michael Lee, President of AlphaRx.
AlphaRx Completes Formulation Development of Vansolin(TM), a Novel Vancomycin Formulation in Nanoparticles Intended to Treat Life-Threatening Infectious Disease
AlphaRx Inc. (OTC BB: ALRX) today announced that it has completed the formulation development of a novel antibiotic formulation using its patent pending solid lipid nanoparticle delivery platform. The new product is under the trade name Vansolin(TM); the active ingredient is Vancomycin, a very powerful antibiotic being used mainly in hospitals around the world to treat life-threatening infectious disease such as hospital acquired pneumonia, ventilator associated pneumonia and severe sepsis. Vansolin(TM) is the Company's 4th product employing proprietary nanotechnology intended to increase the efficacy of existing drug compound while reducing its side effects.
Vancomycin was introduced into hospitals more than forty years ago in response to new strains of Staphylococci that were growing resistant to penicillin. Vancomycin is now seen as the last-resort drug because it is often the last opportunity that a physician may have to eliminate a bacterial infection, since bacteria have become resistant to so many other drugs.
The Company believes that encapsulating Vancomycin into nanoparticles may increase its efficacy. According to published research papers, in vitro the uptake of Vancomycin nanoparticles by white blood cells is 20 times more than free drug. The Company hopes that these white blood cells will absorb Vansolin(TM) nanoparticles after IV infusion and carry them to the site of inflammation, thereby increasing the local concentration of Vancomycin and ultimately increasing its bactericidal activity.
The Company announced earlier that it has completed formulation development of Zysolin(TM), a novel antibiotic nanoparticles intended to treat hospital acquired pneumonia and outlined its clinical development strategy. Vansolin(TM) will be developed using the same strategy. The Company expects to advance Vansolin(TM) into clinical phase by end of 2006.
AlphaRx Provides Update on Phase II Trial of Indaflex(TM) for the Treatment of Osteoarthritis of the Knee
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(TM), 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(TM) 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(TM) 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.
AlphaRx Completes Formulation Development of New ProductAlphaRx Begins Toxicology Studies for Binoxan(TM), a Potential Non-Irritating, Twice-a-Day Eye Drop for Ocular Inflammation
AlphaRx Inc. (OTC BB: ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to announce that development of the formulation for Binoxan(TM), its 2nd ophthalmic product, has been completed and toxicology studies are underway as scheduled.
Binoxan(TM) is a topical, non-acidic, non-steroidal anti-inflammatory pro-drug in a colloidal formulation intended for the treatment of ocular inflammation, eye pain and photophobia.
Based upon prescription data compiled by IMS Health, it is estimated that over 8.6 million prescriptions are written annually in the U.S. for topical ophthalmic anti-inflammatory agents with sales in excess of USD$400 MM.
The Company hopes to begin clinical studies for Binoxan(TM) by mid-2006 and is seeking financial resources to support ongoing development, either by out-licensing or a co-development arrangement.
About AlphaRx Inc. (www.AlphaRx.com)
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.
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 http://www.agoracom.com and view the "AlphaRx" Investor Discussion and Contact Forum. In addition, investors are asked to e-mail all questions and correspondence to ALRX@Agoracom.com
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