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FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
Date:2/4/2011

riage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (i.e. low amniotic fluid levels; 3.6% vs. 1.3%).

The most common adverse reactions reported in ≥ 2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35%], swelling [17%], pruritus [6%], and nodule[5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%).

Asset Purchase AgreementUnder the terms of an existing asset purchase agreement between Hologic, Inc. and K-V, worldwide rights to Makena will be transferred to K-V subject to the satisfaction of certain terms and conditions, all of which K-V anticipates will be satisfied within 5 business days.  Following the asset transfer from Hologic to K-V, Makena will be marketed by K-V's branded drug subsidiary, Ther-Rx Corporation.  After a short stock-in period, Makena will be available through specialty pharmacies and distributors by prescription only and is subject to all U.S. guidelines applicable to dispensing an FDA-approved prescription product.  In conjunction with the approval of Makena, Ther-Rx Corporation is launching the Makena Care Connection™, a comprehensive program for patients and healthcare providers that provides administrative, financial, and treatment support for Makena in one single point of contact.  More information about the Makena Care Connection™ will be available soon at www.makena.com.   To view the Makena Prescribing Information, please visit http://www.kvpharmaceutical.com/pdf/Makena_PI.pdf.

Conference Call InformationK-V Pharmaceutical will host an investor conference call on Monday, February 14, 2011 at 10:00 a.m. EST to discuss the FDA app
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SOURCE K-V Pharmaceutical Company
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