While preparing to launch EvaMist (transdermal estradiol spray) for hot flashes associated with menopause, KV Pharmaceutical Co. bolstered its women's health franchise by licensing Gestiva (17-alpha hydroxyprogesterone caproate) from Hologic Inc.

Gestiva, a long-acting formulation of progesterone, is under FDA review for the prevention of preterm birth in women with a history of spontaneous preterm delivery who are pregnant with a single fetus. Specialty pharmaceutical player KV Pharma agreed to pay diagnostics company Hologic $82 million in cash for worldwide rights to the drug, with $7.5 million due at closing and the remaining $74.5 million due upon FDA approval and production of launch quantities of the drug.

Gestiva originally was submitted to the FDA in May 2006 by women's health company Adeza Biomedical Corp. Adeza based its 505(b)(2) filing on a clinical trial conducted several years earlier by the NIH's National Institute of Child Health and Human Development. The double-blind, placebo-controlled trial randomized 463 patients to receive 17-alpha hydroxyprogesterone caproate or placebo weekly starting between weeks 16 and 21 of pregnancy and continuing until delivery or week 37. The drug reduced overall preterm birth by 34 percent while decreasing associated complications in preterm infants.

In August 2006, the FDA's Reproductive Drugs Advisory Committee recommended approval of Gestiva, but a few months later the FDA delivered an approvable letter requesting additional animal data.

Adeza began to push forward, but in early 2007, its plans were sidetracked thanks to a $450 million acquisition by Cytyc Corp.

As a specialist in women's health diagnostics, Cytyc acquired Adeza primarily for its sales force, which marketed FDA-approved diagnostics for preterm birth risk. Yet on a conference call, Cytyc executives called Gestiva a "great fit" that could bring in worldwide annual revenues of "$100 million plus."

Gestiva began to move forward, but again its progress was derailed, this time by Cytyc's $6.2 billion merger with Hologic in mid-2007. Hologic viewed Gestiva as noncore to its women's health diagnostic and device pipeline.

But for KV Pharma, Gestiva was a good fit. KV Pharma's wholly owned subsidiary Ther-Rx Corp. already markets branded prescription prenatal vitamins and vaginal anti-infectives, and last year it licensed EvaMist from Vivus Inc. for $180 million. (See BioWorld Today, April 2, 2007.)

KV Pharma expects final approval of the Gestiva NDA later this year. Weekly progesterone injections are recommended by the American College of Obstetricians and Gynecologists for women at high risk for preterm labor. Yet early last year, a Phase III trial of Columbia Laboratories Inc.'s Prochieve (progesterone gel) failed to outperform placebo in preventing preterm birth.

Prochieve and Crinone, another progesterone gel, are approved as part of an infertility regimen in women with progesterone deficiency and to support pregnancies in the first trimester. Prochieve also is approved for secondary amenorrhea. Together, they generated $5 million in revenues for Columbia in the third quarter of 2007.

If approved, Gestiva would be launched by Ther-Rx's 300-member women's health specialty sales force.

Shares of St. Louis-based KV Pharma (NYSE:KV-A) fell 35 cents to close at $27.85 on Tuesday, while shares of Bedford, Mass.-based Hologic (NASDAQ:HOLX) fell $1.17 to close at $63.01. Neither company returned calls seeking comment.