ST. LOUIS, Oct. 20 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it was advised by Hologic, Inc., the holder of the New Drug Application (NDA) for Gestiva(TM), that the U.S. Food and Drug Administration (FDA) has extended the PDUFA date on Gestiva(TM) for ninety days from October 24, 2008 to January 25, 2009. The ninety-day extension is in line with the FDA's standard operating procedure when it receives updated data from the applicant seeking the NDA.
Under the terms of the previously announced agreement, KV will acquire ownership of the Gestiva(TM) NDA from Hologic upon payment of KV's final milestone payment of $72.5 million that will become due upon FDA marketing approval for the product and KV's receipt of adequate commercial launch quantities.
KV reiterates that the revised PDUFA date is not expected to impact KV's plans regarding the timing of the launch of Gestiva(TM) during the second half of fiscal 2009.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its branded drug subsidiary.
For further information about KV Pharmaceutical Company, please visit the company's corporate website at http://www.kvpharmaceutical.com/.
Safe Harbor
The information in this release may contain various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 ("PSLRA") and which may be based on or include assumptions concerning KV's operations, future results and prospects. Such statements may be identified by the use of words like "plans", "expect", "aim", "believe", "projects", "anticipates", "commit", "intend", "estimate", "will", "should", "could" and other expressions that indicate future events and trends.
All statements that address expectations or projections about the future, including without limitation, product development, product launches, regulatory approvals, market position, acquisitions, revenues, expenditures and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the "safe harbor" provisions, KV provides the following cautionary statements identifying important economic, political and technology factors, which among others, 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) changes in the current and future business environment, including interest rates and capital and consumer spending; (2) the difficulty of predicting FDA approvals such as the Gestiva(TM) NDA discussed above, including timing, and that any period of exclusivity may not be realized; (3) acceptance and demand for new pharmaceutical products; (4) the introduction and impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (5) new product development and launch, including the planned launch of Gestiva(TM), including the possibility that any product launch, including such launch of Gestiva(TM), may be delayed or that product acceptance may be less than anticipated; (6) reliance on key strategic alliances; (7) the availability of raw materials and/or products manufactured for the Company under contract manufacturing arrangements with third parties; (8) the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in revenues; (10) the difficulty of predicting international regulatory approval, including timing; (11) the difficulty of predicting the pattern of inventory movements by the Company's customers; (12) the impact of competitive response to the Company's sales, marketing and strategic efforts, including the introduction or potential introduction of generic or competing products against products sold by the Company and its subsidiaries; (13) risks that the Company may not ultimately prevail in litigation, including challenges to our intellectual property rights by actual or potential competitors or to our ability to market generic products due to brand company patents and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company or its subsidiaries including without limitation the litigation and claims referred to in Note 16 of the Notes to the Consolidated Financial Statements in the Company's Form 10-Q for the quarter ended June 30, 2008; (14) actions by the Internal Revenue Service with respect to the Company's stock option grants and accounting practices; (15) the possibility that KV's current estimates of the financial effect of certain previously announced product recalls could prove to be incorrect; (16) whether any product recalls or product introductions results in litigation, agency action or material damages; (17) the possibility that the findings of the Audit Committee inquiry referenced in the Company's Form 10-Q for the quarter ended June 30, 2008, could have a material impact on the Company's financial results; (18) the satisfaction or waiver of the other closing conditions in the Gestiva(TM) acquisition agreement in addition to those noted above; and (19) the risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. This discussion is by no means exhaustive, but is designed to highlight important factors that may impact the Company's outlook. We are under no obligation to update any of the forward-looking statements after the date of this release.
