KV buys premature birth treatment drug for $82 million

KV Pharmaceutical Co., based in Brentwood, said today it is paying $82 million for exclusive worldwide rights to sell Gestiva, a preventive treatment for premature birth that is awaiting regulatory approval.

KV said it is paying Bedford, Mass.-based Hologic Inc. $7.5 million as the deal closes. It will pay the remaining $74.5 million if the drug is approved by the Food and Drug Administration.

KV said it expects FDA approval late this year. If that comes, Gestiva sales will add to the company’s earnings per share in the first year following launch.

Gestiva, the brand name for 17-alpha hydroxyprogesterone caproate, can help prevent birth at less than 37 weeks of gestation in certain women who are pregnant with a single fetus and have had at least one prior spontaneous premature delivery, KV said.

Gestiva adds to a line of branded women’s health products sold by KV’s Ther-Rx Corp. unit. These include PrimaCare prenatal vitamins, Clindesse vaginal anti-infective products; and Evamist, the first FDA-approved transdermal spray for the treatment of menopause symptoms, that is expected to launch early this year and have peak annual sales of $125 million.