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K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P
Date:10/13/2011

and uncertainties. In connection with the PSLRA's "safe harbor" provisions, the Company provides the following cautionary statements identifying important economic, competitive, political, regulatory and technological factors, among others, that could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.

Such factors include (but are not limited to) the following:

  1. our ability to continue as a going concern;
  2. 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™, 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;
  3. the possibility of not obtaining the U.S. Food and Drug Administration (the "FDA") approvals or delay in obtaining FDA approvals;
  4. the impact of: (i) the FDA's decision to decline to take enforcement action with regards to compounded alternatives to the Company's Makena ™ product 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, includ
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SOURCE K-V Pharmaceutical Company
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