(2) risks associated with the introduction and growth strategy related to the Company's Makena® product, including:
(a) 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, on the Company's sales, marketing, product pricing, product access and strategic efforts;
(b) the possibility that the benefit of any period of exclusivity resulting from the designation of Makena® as an orphan drug may not be realized as a result of U.S. Food and Drug Administration (the "FDA")'s decision to decline to take enforcement action with regards to compounded alternatives;
(c) the Center for Medicare and Medicaid Services' ("CMS") policy regarding Medicaid reimbursement for Makena®, and the resulting coverage decisions for Makena® by various state Medicaid and commercial payors;
(d) the satisfaction or waiver of the terms and conditions for our continued ownership of the full U.S. and worldwide rights to Makena® set forth in the previously disclosed Makena® acquisition agreement, as amended, including a $107.5 million scheduled payment by us for those rights; and
(e) the number of preterm births for which Makena® may be prescribed, its safety and side effects profiles and acceptance of pricing;
(3) the possibility of delay or inability to obtain FDA approvals of Clindesse® and Gynazole-1® and the possibility that any product relaunch may be delayed or unsuccessful;
(4) risks related to compliance with various agreements and settlements with governmental entities which are discussed in Part I, Item 2— "
|SOURCE K-V Pharmaceutical Company|
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