Hologic sells rights to preterm birth drug

KV Pharmaceutical Co. said today that it is buying the rights to Hologic Inc.'s Gestiva drug for the prevention of preterm birth, in an $82 million cash deal.

Gestiva is pending approval from the Food and Drug Administration. The drug's proposed indication is for women with a history of at least one spontaneous preterm delivery who are pregnant with a single fetus.

The FDA issued an "approvable" letter for Gestiva in October 2006, and final approval is expected in late 2008.

The FDA has granted Gestiva an orphan drug designation, given to drugs that treat underserved diseases and conditions. Companies generally receive tax breaks, clinical-trial help and years of marketing exclusivity if approved.

St. Louis-based KV Pharma develops, acquires, makes and markets branded and generic prescription drugs. Bedford, Mass.-based Hologic makes diagnostic and medical imaging systems. (AP)