KV Pharmaceutical Company Announces Acquisition of Rights to G...( Potential NDA Approval for Gestiv...),Health

Potential NDA Approval for Gestiva(TM) Anticipated in Calendar 2008 Gestiva(TM), is Designated as an Orphan Drug by the FDA for the Prevention

of Preterm Birth in Singleton Pregnancies

ST. LOUIS, Jan. 22 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb), a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology-differentiated branded and generic/non-branded prescription pharmaceutical products, announced today that it has entered into a definitive purchase agreement that gives KV full U.S. and worldwide rights to Gestiva(TM) (17-alpha hydroxyprogesterone caproate) upon approval of the pending Gestiva(TM) New Drug Application ("NDA").

The NDA for Gestiva(TM) is currently before the FDA, pending approval for use in the prevention of preterm birth in certain categories of pregnant women. The proposed indication is for to women with a history of at least one spontaneous preterm delivery (i.e., less than 37 weeks), who are pregnant with a single fetus. The FDA issued an "approvable" letter for Gestiva(TM) in October 2006, and a final approval is anticipated in late 2008. The FDA has granted an Orphan Drug Designation for Gestiva(TM).

KV is acquiring Gestiva(TM) from Massachusetts-based Hologic, Inc. for $82 million in cash, $7.5 million of which is payable at closing. The balance is payable upon final FDA approval and the production of launch quantities of Gestiva(TM). KV expects Gestiva(TM) to be additive to KV's earnings per share in the first 12 months following its launch.

"Gestiva(TM) marks an exciting and important extension to Ther-Rx's growing women's health franchise," said Marc S. Hermelin, Chairman of the Board and Chief Executive Officer of KV. "Our commitment to women's health is second-to-none in the industry and we believe the acquisition of Gestiva(TM), following the acquisition of our approved and soon-to-be-launched Evamist(TM)
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