|NovaBay Receives Nonproprietary Name Auriclosene for NVC-422; FDA Issues Guidance for Chelsea Therapeutics' Northera|
|By Staff and Wire Reports|
|Wednesday, 20 February 2013 20:15|
NovaBay® Pharmaceuticals, Inc. (NYSE: NBY), a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides®, announced the World Health Organization (WHO) has approved the international nonproprietary name (INN) "auriclosene" (pronounced awr-rih-CLO-zeen) for the Company's lead Aganocide® compound NVC-422. INNs facilitate the identification of active pharmaceutical ingredients, and each INN is a globally recognized unique name.
Aganocides are NovaBay's first-in-class topical antimicrobial compounds, which are active against viruses, fungi, and bacteria, including the bacteria that grow and thrive under biofilm. Testing in-vitro and in-vivo has shown that these non-systemic, non-antibiotic compounds do not give rise to bacterial or fungal resistance. Phase 2 studies for auriclosene are currently ongoing in urology, ophthalmology, and dermatology.
Dr. Ron Najafi, Chairman and Chief Executive Officer, said, "Obtaining the INN for our lead clinical compound NVC-422 confirms that our clinical development is on track, and we anticipate progression into Phase 3 development in each of our three Aganocide programs. We also intend to conduct a Phase 2a proof-of-concept study for auriclosene in an additional ophthalmic indication. NVC-422, now auriclosene, is the first of our proprietary Aganocides to receive a nonproprietary name."
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced it has received written guidance from the Director of the Office of New Drugs ("the Director") at the U.S. FDA) stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera™ (droxidopa) New Drug Application (NDA) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The guidance is in response to a formal appeal by Chelsea to the Director, and follows a meeting with the Director and top staff from the Office of Drug Evaluation I and Division of Cardiovascular and Renal Products (DCRP) at the FDA's Center for Drug Evaluation and Research.
The guidance suggests that "data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval." It further notes that any decision regarding the outcome of an FDA review, to be performed by the DCRP will be based on the strength of Study 306B and its ability to provide substantial evidence of effectiveness to support approval.
Based on this guidance, Chelsea plans to file a resubmission of the Northera NDA with the DCRP in the late second quarter of 2013. If accepted by the Division, the Company's application will be subject to a 6-month review period.
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