Full Description

Noven Pharmaceuticals, Inc. (Noven), incorporated in 1987, is a specialty pharmaceutical company engaged in the research, development, manufacturing, licensing, marketing and sale of prescription pharmaceutical products. Its business is focused in three segments: Noven Transdermals, its transdermal drug delivery segment; Novogyne Pharmaceuticals (Novogyne), its women’s health joint venture with Novartis Pharmaceuticals Corporation (Novartis), and Noven Therapeutics, its specialty pharmaceutical segment. The Company’s primary commercialized products include prescription transdermal patches utilizing its proprietary transdermal drug delivery technology for use in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and in menopausal hormone therapy (HT), as well as oral prescription products for use in the treatment of certain psychiatric conditions. Its developmental pipeline includes products in the women’s health and central nervous system (CNS) categories. In August 2009, Hisamitsu Pharmaceutical Co., Ltd. and Hisamitsu U.S., Inc. announced the completion of their acquisition of Noven, pursuant to a short form merger of Northstar Merger Sub, Inc., a wholly owned subsidiary of Hisamitsu U.S., Inc., with and into Noven. As a result of the transaction, Noven became a wholly owned subsidiary of Hisamitsu U.S., Inc.

Noven Transdermals

The Company’s Noven Transdermals segment is engaged in the manufacturing, licensing and sale of advanced transdermal patches utilizing its proprietary drug delivery technologies. Its principal commercialized transdermal products are prescription patches for use in the treatment of ADHD and in HT. These products include Daytrana, has been approved by the United States Food and Drug Administration (FDA) for the treatment of ADHD; Vivelle-Dot, which is a transdermal estrogen therapy product marketed primarily under the brand name outside the United States, and CombiPatch, the first combination estrogen/progestin transdermal patch approved by the FDA. This product is marketed primarily under the brand name Estalis outside the United States. Patches incorporating the Company’s DOT Matrix technology, such as Daytrana, Vivelle-Dot and CombiPatch, are diffusion-based patches that use a blend of silicone adhesive, acrylic adhesive and drug.

Novogyne Pharmaceuticals

The Company’s HT products are marketed and sold in the United States through Vivelle Ventures LLC (doing business as Novogyne Pharmaceuticals) (Novogyne), a joint venture that it established with Novartis to market and sell women’s prescription healthcare products. These products include its transdermal hormone therapy product delivery systems marketed under the brand names Vivelle-Dot and CombiPatch. It holds a 49% equity interest in Novogyne, and Novartis holds the remaining 51% equity interest.

Noven Therapeutics

In August 2007, the Company acquired Noven Therapeutics, which consists of its specialty pharmaceutical operations. Noven Therapeutics markets and sells three branded prescription psychiatry products. Stavzor is a valproic acid delayed release product utilizing an enteric-coated soft gelatin capsule delivery system. In July 2008, the FDA granted final approval for the product, which is indicated for use in the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches. Stavzor was commercially launched in August 2008. Pexeva is a selective serotonin re-uptake inhibitor (SSRI) antidepressant indicated for major depressive disorder, panic disorder, obsessive compulsive disorder and generalized anxiety disorder. Lithobid is an extended release lithium product indicated for the maintenance of bipolar disorder and the treatment of related manic episodes. The Company’s products under development include Vivelle-Dot, CombiPatch, Testosterone Patch and DentiPatch.

The Company competes with Lilly, GlaxoSmithKline, Pfizer Inc. and AstraZeneca PLC.