Vivus has received FDA approval for its metered-dose topical spray Evamist (estradiol) to treat moderate to severe vasomotor symptoms due to menopause, the firm announced July 30.

The approval triggers a $140 million payment to Vivus from KV Pharmaceutical.

In May, Vivus closed on the deal with St. Louis-based KV worth upwards of $150 million, selling exclusive rights to Evamist (¹ Also see "Vivus Sells EvaMist Rights To KV For $150 Million" - Pink Sheet, 30 March, 2007.). Vivus received $10 million up front. The firm is also eligible for further payments based on sales milestones.

"[KV's] existing presence in the OB/GYN community combined with their dedicated specialty sales force of over 280 reps should allow them to make the benefits of Evamist known to patients in a timely fashion," Vivus CEO Leland F. Wilson said.

Mountain View, Calif.-based Vivus has said Evamist could differentiate itself from other estrogen replacement products because its transdermal delivery offers a better safety profile.

Even so, Evamist will compete in a crowded transdermal estradiol market, said CIBC World Markets analyst Elliot Wilbur in a July 30 research note, with the closest competitors being Esprit Pharma's Estrasorb (estradiol topical emulsion) and Ascend Therapeutics' EstroGel (estradiol gel), with annual sales of $3 million and $8.9 million, respectively.

BioSante Pharmaceuticals received FDA approval for Elestrin (estradiol transdermal gel 0.06%) in December 2006 for treatment of moderate to severe hot flashes. Elestrin (formerly Bio-E-Gel ) is approved at the lowest daily dose available for the indication, according to the firm (² Also see "BioSante To Launch Hot Flash Drug Elestrin in 2007" - Pink Sheet, 18 December, 2006.).

BioSante announced the commercial launch of Elestrin June 13. At the time of approval, the firm had noted that Fairfield, N.J.-based Bradley Pharmaceuticals would market Elestrin in the Untied States through its Kenwood Therapeutics Division with 50 sales representatives targeting mostly gynecologists.

-Pamela Taulbee (p.taulbee@elsevier.com)

Vivus Gets FDA Approval For Evamist Estradiol Spray

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