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NovaBay Pharmaceuticals, Inc.

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Msg  12 of 12  at  1/8/2014 12:26:44 PM  by


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NovaBay Pharma provides business unit update; Reported positive Phase 2 clinical study results of auriclosene to reduce urinary catheter blockage and encrustation (NBY) : provided a business update highlighting recent accomplishments and outlook for 2014. Dr. Ron Najafi, NovaBay Chairman and Chief Executive Officer, commented, "2013 was a year of progress and discovery at NovaBay and we look forward to continuing our clinical and commercial progress in 2014. We remain dedicated to our mission of addressing the large unmet therapeutic needs of the global topical anti-infective market.

The positive, statistically-significant data from the Phase 2 clinical study of auriclosene to reduce UCBE confirms our belief that treating catheters with auriclosene can make a substantial difference in the lives of patients requiring chronic indwelling urinary catheters, including those with spinal cord injuries. We are excited to see that auriclosene may dramatically reduce the problems of unpredictable early catheter blockage."

Business Overview:

Urology: Statistically-significant and clinically-meaningful results from a Phase 2 clinical study of Auriclosene (NVC-422) Irrigation Solution to reduce urinary catheter blockage and encrustation were announced on September 16, 2013. Study CL1001 achieved the study's primary endpoints and showed clear benefits for patients with long-term indwelling catheters
Ophthalmology: The ongoing global clinical trial for auriclosene in conjunctivitis is expected to complete and results available in the middle of 2014. The launch of i-Lid Cleanser (being developed for use in ophthalmological applications) is expected in selected markets in 2014.
Dermatology: In November 2013, the Phase 2b clinical study of impetigo, conducted by our partner Galderma, was completed. While the study showed that auriclosene is safe and well tolerated, it did not meet its primary clinical endpoint. NovaBay plans to reinitiate a Phase 2b clinical trial of auriclosene for impetigo in 2014. Knowledge gained from the two previous impetigo studies is expected to lead to the use of an optimized formulation of auriclosene for this upcoming clinical trial. NovaBay will be responsible for the planning and execution of the upcoming trial. An exclusive licensing agreement provides Galderma with the right to commercialize impetigo products and an option to license auriclosene for use in other dermatological indications
Chronic Wounds: With a mechanism of action distinct from Aganocides, NovaBay believes that the US FDA 510(k)-cleared NeutroPhase is the only available patented pure hypochlorous acid solution available which has the potential to be best suited product on the market to treat the 6 million patients in the U.S. who suffer from chronic wounds, such as pressure, venous stasis and diabetic ulcers.

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