-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UDJ9f144xYTbalUhEvMjIMprhzmE5ABhDoQJeCr9QR8/+id/3BxLTc44JhWtZwX0 R6s5zUFDIq6S6s7Y286rHg== 0001068800-06-000957.txt : 20060912 0001068800-06-000957.hdr.sgml : 20060912 20060912172255 ACCESSION NUMBER: 0001068800-06-000957 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060912 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20060912 DATE AS OF CHANGE: 20060912 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KV PHARMACEUTICAL CO /DE/ CENTRAL INDEX KEY: 0000057055 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 430618919 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09601 FILM NUMBER: 061087091 BUSINESS ADDRESS: STREET 1: 2503 S HANLEY RD CITY: ST LOUIS STATE: MO ZIP: 63144 BUSINESS PHONE: 3146456600 MAIL ADDRESS: STREET 1: 2503 S HANLEY RD CITY: ST LOUIS STATE: MO ZIP: 63144 8-K 1 kv8k.txt ============================================================================== UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ---------------------------------- FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 1-9601 Date of Report (date of earliest event reported): September 12, 2006 K-V PHARMACEUTICAL COMPANY (Exact name of registrant as specified in its charter) DELAWARE 43-0618919 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 2503 SOUTH HANLEY ROAD ST. LOUIS, MISSOURI 63144 (Address of principal executive offices) (Zip Code) (314) 645-6600 (Registrant's telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: / / Written communications pursuant to Rule 425 under the Securities Act. / / Soliciting material pursuant to Rule 14a-12 under the Exchange Act. / / Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. / / Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. ============================================================================== SECTION 7 - REGULATION FD ITEM 7.01 REGULATION FD DISCLOSURE Attached and incorporated herein by reference as Exhibit 99 is a press release issued by K-V Pharmaceutical Company (the "Company") announcing that it has received notification of approval from the United States Food and Drug Administration to market six dosages of a product. The information in this Form 8-K, including Exhibit 99 attached hereto, is being furnished under Regulation FD and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. The Company has posted this Form 8-K on its internet website at www.kvpharmaceutical.com. A copy of the press release is attached hereto as Exhibit 99. * * * -2- SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: September 12, 2006 K-V PHARMACEUTICAL COMPANY By: /s/ Richard H. Chibnall ------------------------- Richard H. Chibnall Vice President, Finance -3- EX-99 2 ex99.txt EXHIBIT 99 KV PHARMACEUTICAL COMPANY CONTACT: CATHERINE M. BIFFIGNANI VICE PRESIDENT, INVESTOR RELATIONS 314-645-6600 [KV PHARMACEUTICAL logo] FOR IMMEDIATE RELEASE KV PHARMACEUTICAL COMPANY RECEIVES ANDA APPROVAL FROM U.S. FDA FOR SIX STRENGTHS OF DILTIAZEM HCl ER CAPSULES 6-MONTH EXCLUSIVITY ON 420MG DILTIAZEM STRENGTH; FIRST COMPANY WITH FULL LINE OF DOSAGE STRENGTHS WHICH ARE AB RATED TO TIAZAC(R) St. Louis, MO, September 12, 2006 - KV Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received approval from the U.S. Food and Drug Administration to market six strengths of Diltiazem HCl ER Capsules (AB rated to Tiazac(R) from Forest Pharmaceuticals, Inc.) through its wholly-owned generic/non-branded subsidiary, ETHEX Corporation. ETHEX will begin shipments of all six strengths immediately. The launch of the six strengths of Diltiazem (120mg, 180mg, 240mg, 300mg, 360mg and 420mg) will complement ETHEX's highly regarded cardiovascular family of products and will make KV the first generic company that will have a full line of product AB-rated to Tiazac(R). KV also believes it is the first generic company to receive approval of the 420mg strength dosage, and thus expects to have six months exclusivity on this strength. However, it is also expected that the brand manufacturer may launch an "authorized generic" version. Total market sales for this product are approximately $160 million. Tiazac(R) is indicated for the treatment of hypertension (high blood pressure) and angina (chest pain). Tiazac(R) belongs to a class of drugs known as calcium channel blockers (CCBs) that lower blood pressure by blocking calcium influx into the smooth muscle cells of the blood vessels. CCBs may be used to treat high blood pressure, angina and some arrhythmias. Approximately 50 million people in the U.S. have hypertension, however, approximately 52% are not on therapy and only 21% are on adequate control which controls their hypertension. Hypertension is a lifelong condition and can remain asymptomatic for many years. It is very important to reach one's blood pressure goal and maintain that goal throughout one's life. Marc S. Hermelin, Chairman of the Board and Chief Executive Officer stated, "We are delighted to be extending ETHEX's cardiovascular expertise into the CCB segment with a complete line of AB-rated equivalents to an outstanding product like Tiazac(R). The approval extends ETHEX's line-up of quality ANDA products across multiple therapeutic categories, with several more important opportunities in our pipeline. We are pleased to be able to offer a full line of this important product to our customers and patients." ABOUT KV PHARMACEUTICAL COMPANY KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures and 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 emerging branded drug subsidiary. KV has consistently ranked as one of America's fastest growing small companies, most recently by Forbes in its November 2004 issue. For further information about KV Pharmaceutical Company, please visit the Company's corporate website at 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", "anticipate", "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 Company's strategy for growth, product development, 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, 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; (8) the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in operating results; (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; and (14) 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 report. -----END PRIVACY-ENHANCED MESSAGE-----