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The NDA for Gestiva(TM) is currently before the FDA, pending approval foruse in the prevention of preterm birth in certain categories of pregnantwomen. The proposed indication is for to women with a history of at least onespontaneous preterm delivery (i.e., less than 37 weeks), who are pregnant witha single fetus. The FDA issued an "approvable" letter for Gestiva(TM) inOctober 2006, and a final approval is anticipated in late 2008. The FDA hasgranted an Orphan Drug Designation for Gestiva(TM).
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KV is acquiring Gestiva(TM) from Massachusetts-based Hologic, Inc. for $82million in cash, $7.5 million of which is payable at closing. The balance ispayable upon final FDA approval and the production of launch quantities ofGestiva(TM). KV expects Gestiva(TM) to be additive to KV's earnings per sharein the first 12 months following its launch.
"Gestiva(TM) marks an exciting and important extension to Ther-Rx'sgrowing women's health franchise," said Marc S. Hermelin, Chairman of theBoard and Chief Executive Officer of KV. "Our commitment to women's health issecond-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)product and the continued growth of Ther-Rx's current women's health suite ofproducts, charts a course for sustained growth and profitability for ourbranded business."
KV -- through its wholly-owned branded subsidiary, Ther-Rx Corporation --has built an emerging leadership position in selected women's healththerapies. Gestiva(TM) will join a product roster that includes:
The acquisition of Gestiva(TM) is intended to allow Ther-Rx to capitalizeon the already strong relationships built over the past seven years betweenTher-Rx's 300-member sales force and Obstetrician/Gynecologists. KV believesGestiva(TM) is a perfect fit for Ther-Rx's sale force where it will be able tocontinue to expand its focus on women and their babies as a complement toTher-Rx's leading selling line of branded prenatal vitamins.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceuticalcompany that develops, manufactures, markets and acquirestechnology-distinguished branded and generic/non-branded prescriptionpharmaceutical products. The Company markets its technology-distinguishedproducts through ETHEX Corporation, a national leader in pharmaceuticals thatcompete with branded products, and Ther-Rx Corporation, its brandedprescription pharmaceutical subsidiary.
For further information about KV Pharmaceutical Company, please visit theCompany's corporate website at www.kvpharmaceutical.com.
Safe Harbor
The information in this release may contain various forward-lookingstatements within the meaning of the United States Private SecuritiesLitigation Reform Act of 1995 ("PSLRA") and which may be based on or includeassumptions concerning KV's operations, future results and prospects. Suchstatements may be identified by the use of words like "plans," "expect,""aim," "believe," "projects," "anticipates," "commit," "intend," "estimate,""will," "should," "could" and other expressions that indicate future eventsand trends.
All statements that address expectations or projections about the future,including without limitation, statements about the Company's strategy forgrowth, product develop
