KV Pharmaceutical Company ( KVa/KVb) today announced it has entered into an amendment to the existing asset purchase agreement with Hologic, Inc. to secure the full U.S. and worldwide rights to Gestiva(TM), subject to the terms and conditions set forth in the amendment. Upon approval by the U.S. Food and Drug Administration (the "FDA"), Gestiva(TM) will be the first and only FDA-approved treatment for the prevention of preterm birth in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past. A description of certain material terms and conditions of the amendment to the existing asset purchase agreement with Hologic, Inc. is set forth in the Current Report on Form 8-K filed by the Company today with the SEC.
David Van Vliet, interim CEO at KV Pharmaceutical Company, said, "While our highest priority is to demonstrate cGMP compliance so we can return our approved products to market, we believe Gestiva(TM) will be an important addition to our women's health franchise and are pleased we could reach this agreement with Hologic. We will continue to assist Hologic in completing the steps to obtain FDA approval of this socially valuable product."
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KV Pharmaceutical Company
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