ST. LOUIS, July 29 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb), today reported that it is set to dispose of its inventory of certain drug products -- principally cough/cold products -- previously sold by ETHEX Corporation. The inventory disposal will signal the conclusion of previously disclosed discussions with the FDA regarding the agency's guidance on products containing guaifenesin that were marketed by ETHEX as well as other pharmaceutical companies for a number of years based on long-standing FDA compliance policies.
KV, in the financial statements contained in its fiscal 2008 Form 10-K filed in June 2008, already had written off the value of all the affected products and recognized the financial impact of its decision not to resume the manufacture or sale of those products. Therefore, there will be no further financial impact to KV related to the products to be destroyed.
The final step to resolve the guaifenesin matter is the physical disposal of remaining inventory. In this regard, we have now been informed that the FDA will initially assume control of the inventory for the purpose of supervising its disposition, procedurally implemented as a "seizure", and then either destroy the products or assign the products back to KV for actual physical destruction. KV will continue its cooperation with the FDA in bringing this matter to final resolution.
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 prescription pharmaceutical subsidiary.
For further information about KV Pharmaceutical Company, please visit the Company's corporate website at http://www.kvpharmaceutical.com.
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, statements about the future impact pertaining to the products subject to the referenced product hold, or the Company's strategy for growth, product development, product launches, regulatory filings or approvals, market position, market share increases, 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, competitive, judicial, 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, including timing, and that any period of exclusivity may not be realized; (3) acceptance and demand for new pharmaceutical products; (4) the impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (5) new product development and launch, including the possibility that any product launch 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; (13) risks that the Company may not ultimately prevail in litigation, including challenges to our intellectual property rights by actual or potential competitors; (14) actions by the Securities and Exchange Commission and the Internal Revenue Service with respect to the Company's stock option grants and accounting practices; (15) the Company's success in litigation with Lannett Company Inc. concerning its prenatal vitamin product; (16) the Company's expectation that the resolution of regulatory developments with respect to products containing guaifenesin formerly marketed by its ETHEX subsidiary will not have future material adverse financial effect may not prove to be correct; and (17) 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.
|SOURCE KV Pharmaceutical Company|
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