Vivus has sold its rights to the Phase III topical estradiol spray EvaMist to KV Phamaceutical in a deal worth up to $150 million, the firms announced March 30.

EvaMist, which is used to treat vasomotor symptoms (hot flashes) associated with menopause, is currently before the FDA with a user fee date of July 29.

Under the terms of the deal, St. Louis-based KV will make a $10 million upfront payment, followed by an additional $140 million payment if the NDA is approved. Vivus could receive other bonuses if sales milestones are met.

Vivus Chief Executive Officer Leland Wilson told "The Pink Sheet" DAILY that the Mountain View, Calif., firm had initially planned to market EvaMist on its own, but will use some of the proceeds of the sale to fund a Phase III trial of its obesity candidate, Qnexa , a combination of the appetite suppressant phentermine and topiramate (Johnson & Johnson's Topamax and generics), which is used in epilepsy and migraine. The trial is expected to commence in the second half of 2007.

If approved, EvaMist will be sold by KV's Ther-Rx division, which already has a women's health care product line, and detailed by its 285 sales reps.

KV estimated that peak sales of EvaMist could reach $125 million annually, adding that the estrogen replacement market reached sales of $1.3 billion in 2006.

Vivus has said that EvaMist could differentiate itself from other estrogen replacement products because it has a better safety profile as a result of its transdermal mode of delivery (¹ Also see "Vivus Submits NDA For Skin Spray To Treat Hot Flashs" - Pink Sheet, 2 October, 2006.).

- Jonathan M. Block (j.block@elsevier.com)

Vivus Sells EvaMist Rights To KV For $150 Million

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