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Acuity Pharmaceuticals Continues Pipeline Expansion By Licensing A Novel Broad Spectrum Anti-Infective For Ophthalmic Use



4/20/2006 11:22:32 AM

PHILADELPHIA, April 20 /PRNewswire/ -- Acuity Pharmaceuticals, Inc., a clinical stage, product-focused ophthalmic pharmaceutical company, today announced that it has in-licensed exclusive worldwide development and commercialization rights to N-chlorotaurine (NCT), a novel, clinical stage, small molecule agent for the treatment of ophthalmic infections and other conditions. Acuity's lead compound, Cand5, is in clinical trials for wet age- related macular degeneration and diabetic macular edema, and represents the first clinical use of the gene-silencing technology called RNA interference.

NCT, which is a derivative of a naturally occurring substance in the body, has already completed pilot Phase II studies in Europe, where it has been shown to have promising anti-microbial activity and to be safe and well- tolerated in such applications as sinus and ear infections, as well as in viral conjunctivitis. NCT combines broad-spectrum anti-infective activity with very good tolerability, and its natural sterility and absence of preservatives make it a good candidate for ocular applications.

The first indication Acuity will pursue for NCT is for conjunctivitis, or pink eye, a common eye inflammation that is a major source of acute medical visits for eye care. NCT is expected to have utility in both bacterial and viral conjunctivitis, providing a major advantage since there currently is no approved treatment for the commonly occurring, viral form of the disease.

"NCT is a good fit with our expanding pipeline and supports Acuity's strategic focus of leadership in the development and marketing of novel therapies for ophthalmic diseases, particularly conditions that are currently poorly treated," said Dale Pfost, president and CEO of Acuity. "As a novel mechanism, broad spectrum anti-infective with properties that make it particularly suited for ophthalmic uses, NCT is an excellent addition to our portfolio. We believe that the clinical pathway to approval of NCT should be relatively straightforward, and its clinical and commercial potential across multiple ocular indications is significant."

In preclinical and clinical studies, NCT has demonstrated potential as a potent anti-microbial agent in the treatment of a broad range of bacterial, viral and fungal infections, and its nonspecific oxidation mechanism is less susceptible to the development of drug resistance than conventional anti- infectives. The license includes proprietary modifications and formulations that are designed to optimize NCT for ophthalmic use.

Following a planned Phase I clinical trial for ophthalmic applications, Acuity will have sole responsibility for clinical development and commercialization of NCT in ophthalmic indications. The company will pay licensor Pathogenics, Inc., up-front and license fees, as well as development milestones and royalties. Further details of the agreement were not disclosed.

About Acuity Pharmaceuticals

Founded in 2002, Acuity Pharmaceuticals is a product-focused ophthalmic pharmaceutical company applying proprietary technologies to the treatment and prevention of ophthalmic diseases. Acuity's lead clinical compound, Cand5, a small-interfering RNA (siRNA) therapeutic targeting VEGF, is in clinical trials for two of the leading causes of adult vision loss. Acuity recently completed a Phase II trial of Cand5 in age-related macular degeneration and is currently conducting a Phase II trial for diabetic macular edema. Acuity is applying its drug development expertise to a growing pipeline of novel agents for ophthalmic conditions. In support of these programs, Acuity is also developing proprietary technologies for ocular drug delivery. For more information, see the company's website at http://www.acuitypharma.com .

About Pathogenics, Inc.

Pathogenics, Inc. is a biopharmaceutical company that acquires and develops new therapeutic drugs that have large sales potential and target unmet medical needs. We are currently developing two new drugs - a broad- spectrum anti-infective drug called N-Chlorotaurine, and novel formulations of the well-known drug Chloroquine for neurological disorders such as Parkinson's disease. These drugs may safely treat multiple infections and diseases - many which have very large markets, and few, if any, satisfactory drug treatments. The Company in-licenses its experimental drugs, demonstrates they work in small-scale human clinical trials, and then partners with large pharmaceutical companies who are seeking new drugs to fill their product pipelines. These partners then complete larger-scale clinical trials, obtain US FDA new drug approval, and market the drugs worldwide. This business strategy is designed to minimize fixed costs, add significant value to our experimental drugs, and accelerate the time to corporate profitability. For more information, see the company's website at http://www.pathogenics.com .

Contacts: Media: Acuity Pharmaceuticals GendeLLindheim BioCom Partners Todd Wallach Barbara Lindheim 215 966-6181 917 355-9234

Acuity Pharmaceuticals, Inc.

CONTACT: Todd Wallach of Acuity Pharmaceuticals, +1-215-966-6181; orBarbara Lindheim of GendeLLindheim BioCom Partners, +1-917-355-9234


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