Noven Pharmaceuticals is projecting 2012 sales in excess of $400 million for Mesafem , a non-hormone treatment for menopausal vasomotor symptoms it would gain in a $125 million cash deal to acquire the specialty pharma JDS, Noven CEO Robert C. Strauss said during a July 10 conference call announcing the planned acquisition.

"If approved ... this product alone could transform our company" from its current focus on transdermal drug delivery to becoming a "broader based, fully integrated specialty pharmaceutical company," Strauss said. The deal "provides Noven an established psychiatry sales force, three products in the psychiatry pipeline, and a potential large market opportunity in women's health," the exec told "The Pink Sheet" DAILY.

While Strauss noted that Noven's core area of expertise is women's health, the firm is also well-known for developing Shire's Daytrana (methylphenidate transdermal system), whose April 2006 approval made it the first transdermal treatment for attention deficit hyperactivity disorder (¹ Also see "Shire/Noven Daytrana Patch To Carry Similar Warnings To Other ADHD Drugs, FDA Says" - Pink Sheet, 6 April, 2006.).

Mesafem should enter Phase III studies in the first half of 2008 with an NDA filing possible in 2009, Noven VP-Marketing and Sales Neil Jones predicted. The potential hot flash therapy is a low-dose form of JDS' branded selective serotonin re-uptake inhibitor Pexeva (paroxetine mesylate). In contrast, the active ingredient in GlaxoSmithKline's now-generic Paxil is paroxetine hydrochloride.

"We believe there are five to six million symptomatic women seeking proven alternatives to hormones, and Mesafem would help fill that need," Jones said. He estimated the value of the new market segment at over $3 billion.

Noven is engaged in an ongoing women's health joint venture with Novartis, called Novogyne, through which it markets transdermal estradiol products, including the venture's leading product Vivelle-Dot .

The company plans to apply "intelligence gained" from the Novogyne venture to leverage the marketing and sales infrastructure it will assume from JDS to launch and promote Mesafem, the company told "The Pink Sheet" DAILY. The current approximately 55-member sales force will support new and existing JDS psychiatric products, as well as Mesafem, Noven said.

"Through our success with hormone patches and with our Novogyne joint venture we know the menopause therapy market as well as anyone," said Jones.

Competitors in that space could include Wyeth's investigational SNRI Pristiq (desvenlafaxine), which has a July FDA action date and would be the first non-hormone product to market with a vasomotor indication (² Also see "Wyeth Suggests Pristiq Could Surpass Effexor XR In Depression Market" - Pink Sheet, 13 June, 2007.). Another potential competitor is Depomed, which is studying its extended-release, gastric-retained gabapentin formulation in a Phase II trial for that indication (³ Also see "Depomed’s Gabapentin GR Fails Phase III Postherpetic Neuralgia Study" - Pink Sheet, 10 July, 2007.).

In addition to the $125 million payment, Miami-based Noven plans to assume $10 million of the New York firm's net liabilities. The deal was expected to close by early August.

Along with Mesafem, Noven gains a late-stage pipeline of psychiatric therapies that gives the firm "the potential to launch one new product a year for ... the next four years," Sr VP-Strategic Alliances Jeffrey Eisenberg noted.

Psychiatric hopefuls include Stavzor (valproic acid softgel), a delayed release capsule for bipolar disorder, migraine and epilepsy, for which an NDA is pending at FDA with an October action date. JDS licensed Stavzor, which would compete with Abbott's Depakote (divalproex), from Banner Pharmacaps.

Lithium QD , a once-daily formulation of lithium for bipolar disorder, is entering Phase III this month, and Stavzor ER (extended-release valproic acid softgel) is in preclinical development by Banner.

- Shirley Haley (s.haley@elsevier.com)

Noven Gains Phase III Vasomotor Symptoms Candidate With JDS Acquisition

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