FDA Issues Approvable Letter for Stavzor(TM) Delayed Release Valproic Acid Capsules
Noven/JDS Sales Force Expected to Launch Stavzor™ in 2008
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Stavzor™ (delayed release valproic acid capsules) in 125mg, 250mg and 500mg strengths. The approvable letter relates to the use of Stavzor™ in the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
The FDA states in the letter that it has completed its review of the Stavzor™ NDA and that it is approvable. The FDA has requested certain non-clinical information, including additional in vitro dissolution data, as a condition to final approval. The FDA has not requested additional human studies or clinical data.
Because the NDA for Stavzor™, submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories’ Depakote® product, final approval is also subject to the expiration of any applicable exclusivity periods benefiting Depakote®. Based on receipt of the approvable letter, interaction with Banner Pharmacaps Inc. (the NDA holder and developer of the product), and its understanding of Depakote® exclusivity, Noven continues to expect Stavzor™ final approval, at the latest, by the end of July 2008.
Stavzor™ was developed using Banner’s patent-pending EnteriCare™ enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor™ in the U.S. as part of Noven’s acquisition of JDS Pharmaceuticals in August 2007. Stavzor™ will be a branded product; it is not expected to be AB-rated to or generically substitutable for Depakote®, nor will Depakote® or any Depakote® generics be substitutable for Stavzor™. Promotion of the Stavzor™ brand will target primarily high-prescribing physicians through the Noven/JDS sales force.
“We are very pleased to announce that the FDA has issued an approvable letter for Stavzor™, and we offer our congratulations to the Banner and JDS teams for this successful result,” said Robert C. Strauss, Noven’s President, CEO & Chairman. “We are now working with Banner to satisfy the conditions to final approval as expeditiously as possible. Banner has advised that it expects to respond to the FDA’s requests in the coming weeks. Concurrently, the Noven/JDS team has begun launch and production planning in anticipation of a 2008 launch of Stavzor™.”
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatin capsules.
EnteriCare™ is a trademark of Banner; Depakote® is a registered trademark of Abbott Laboratories or its affiliates.
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, has established itself as a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Its commercialized transdermal products include Vivelle-Dot® (estradiol transdermal system), the most prescribed estrogen patch in the U.S., and Daytrana™ (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD.
With the acquisition of JDS Pharmaceuticals in August 2007, Noven has become a broader-based specialty pharmaceutical company with the infrastructure, products and category expertise to market and sell products itself, and with a substantially enhanced late-stage product pipeline.
Products currently marketed through the JDS psychiatry sales infrastructure include Pexeva® (paroxetine mesylate) and Lithobid® (lithium carbonate). Pipeline products in psychiatry consist of Stavzor™ (delayed release valproic acid capsule), Lithium QD (once-daily lithium carbonate), and Stavzor™ ER (extended release valproic acid capsule). Pipeline products in women’s health consist of Mesafem™ (low-dose paroxetine mesylate), a non-hormonal product entering Phase 3 clinical trials for vasomotor symptoms (hot flashes). See www.noven.com for additional information.
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