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Alcon Inc. (NSYE: ACL) Launches Phase II Clinical Trial of NovaBay’s NVC-422

NovaBay’s New Compound to Treat Viral Conjunctivitis

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Swiss-based Alcon Inc. (NYSE: ACL) and partner NovaBay Pharmaceuticals (NYSE-AMEX: NBY) of Emeryville, Calif., jointly announced Alcon has begun the phase II clinical trial of NovaBay’s patented lead Aganocide compound, NVC-422, to treat viral conjunctivitis, commonly referred to as “pink eye” or “Madras eye.”  Conjunctivitis is a common ocular disease, described by an inflammation of the conjunctiva (inner surface of the eyelids).  The disease is contagiously transmitted from person to person.

The various causes of conjunctivitis are mostly due to an allergic reaction or an infection, either viral or bacterial, and is responsible for more than 4 million visits to a doctor or hospital in the United States each year.  Millions of other cases go unreported.

The world’s leading eye care company Alcon and drug developer NovaBay Pharmaceuticals partnered in the licensing and research of Alcon’s Aganocide(R) compounds.  These compounds are expected to be used in the eye, ear and sinus, as well as in contact lens solutions.

NovaBay’s Aganocide is a proprietary synthetic analog of the same molecules contained in white blood cells, which are the cells the body naturally uses to attack viruses and bacteria.  NovaBay said Aganocide compounds offer a solution to the problem of rising resistance of microbes the body triggers to fight traditional antibiotics.

Aganocide just successfully completed its phase I study to show safety and tolerability, with the demonstration  of 120 healthy volunteers experiencing no serious adverse effects.

“We are pleased to be entering mid-stage clinical testing for viral conjunctivitis,” said Ron Najafi, Ph.D., chairman and CEO of NovaBay. “This is the first step in the ophthalmic clinical development program for NVC-422, which has the immediate goal of developing the first effective product to address viral conjunctivitis for which there are limited treatment options.”

Phase II will be a multi-center, randomized, placebo-controlled trial to show safety and efficacy of NVC-422 with patients with viral conjunctivitis.  The study will involve 250 patients at more than 30 medical centers.

“This study is an important step forward with the clinical program for this potentially dual-acting therapy to address the multiple causes of conjunctivitis. Dual action against viral and bacterial conjunctivitis is important because when an infection is diagnosed it is difficult, time-consuming and expensive to determine the underlying cause of the infection and treat it properly,” said Dr. Sabri Markabi, M.D., Alcon’s senior vice president of research and development and chief medical officer.

Alcon Laboratories Inc. (NYSE: ACL)
Founded in 1945, Alcon Laboratories Inc. traces its roots back to two pharmacists, Robert Alexander and William Conner, who opened a small pharmacy in Fort Worth, Texas, and combined the first syllables of their last names to create the name Alcon.

Majority owned by Nestlé S.A. and incorporated in Hünenberg, Switzerland with U.S. operations based in Fort Worth, Texas, the company team of over 15,000 dedicated employees worldwide develops, manufactures, and distributes hundreds of eye care products in more than 180 countries.

In March 2002, Alcon conducted a partial initial public offering (IPO) on the New York Stock Exchange (NYSE). Nestlé still owns approximately 75% of the company.

Alcon’s core business is centered on three key divisions – Surgical, Pharmaceutical and Consumer Vision Care. As of 2008, sales reached US$6.3 billion.

Alcon conducts business at offices located in 75 countries around the world in regions including Canada and the Far East; Europe, Middle East and Africa; Latin America and the Caribbean; and the United States.

NovaBay Pharmaceuticals (NYSE-AMEX: NBY)

NovaBay is focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and community environments. Many of these infections have become increasingly difficult to treat because of the rapid increase in infectious microbes that have become resistant to current drugs.
NovaBay’s in vitro and in vivo tests have demonstrated our compounds kill a wide range of bacteria, viruses and other infection causing microbes, including those that are resistant to multiple antibiotics.

It is developing hospital indications and have partnered certain other indications with Alcon, the world’s leading eye care company, and with Galderma S.A., a global leading pharmaceutical company dedicated exclusively to the field of dermatology.

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