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K-V Pharmaceutical Company Announces the Completion of the Sale of Nesher Pharmaceuticals, Inc. its Generic Pharmaceutical Business
Date:8/8/2011

ed to) the following:

(1) the Company's ability to continue as a going concern;

(2) compliance by the Company and the Buyer with their respective related contractual obligations under the definitive Asset Purchase Agreement, dated June 17, 2011 for the sale of Nesher assets, the Company's generic products business and Nesher subsidiary;  

(3) the impact of competitive, commercial, payor, governmental (including Medicaid program), physician, patient, public or political responses and reactions, and responses and reactions by medical professional associations and advocacy groups, to the Company's sales, marketing, product pricing, product access and strategic efforts with respect to Makena™, (hydroxyprogesterone caproate injection), and its other products, including introduction or potential introduction of generic or competing products, or competition from unapproved therapies or compounded drugs, against products sold by the Company and its subsidiaries, including Makena™, and including competitive or responsive pricing changes;

(4) the impact of: (i) the U.S. Food and Drug Administration (FDA) decision to decline to take enforcement action with regards to compounded alternatives to Makena™, despite the Company's orphan drug exclusivity; (ii) CMS policy permitting Medicaid program reimbursement of such products; and (iii) resulting coverage decisions by various state Medicaid and commercial payors, on the Company's sales revenues for Makena™ and the resulting impact on the Company's operations and financial results, including, without limitation, its ability to continue as a going concern;

(5) new product development and launch, including the possibility that any product launch may be delayed or unsuccessful, including with respect to Makena™;

(6) acceptance of and demand for the Company's new pharmaceutical products, including Makena™, and
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SOURCE K-V Pharmaceutical Company
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