-----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, IQH8mbFZ1lM9pkr9jDSQ+1kLJ8QwCIYy/V9egVF+0svYqybP82N2bh4KEzHe6ntH 2/Ar4FvZpuBP9VVl6lv5JA== 0001068800-05-000599.txt : 20050922 0001068800-05-000599.hdr.sgml : 20050922 20050922141316 ACCESSION NUMBER: 0001068800-05-000599 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050921 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20050922 DATE AS OF CHANGE: 20050922 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: 051097830 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 kv0921.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 21, 2005 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 the Company has entered into a licensing agreement with Theramex SpA to market Gynazole-1(R) and Clindesse(TM) in Italy. 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. * * * -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 22, 2005 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 logo] FOR IMMEDIATE RELEASE ANOTHER PRESTIGIOUS INTERNATIONAL PARTNER IN KV'S LICENSING NETWORK FOR GYNAZOLE-1(R) AND CLINDESSE(TM) AGREEMENT SIGNED BETWEEN KV AND THERAMEX SPA FOR MARKETING IN ITALY St. Louis, MO - September 21, 2005 - KV Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has signed a licensing agreement with Theramex SpA for the marketing in Italy of two of KV's top-selling women's health products, Gynazole-1(R) and Clindesse(TM). This latest agreement adds Italy to the list of more than 50 markets worldwide in which KV has licenses in place for the sale of Gynazole-1(R), and it is the fifth international license for the more recently introduced Clindesse(TM). Theramex will market KV's proprietary Gynazole-1(R) product under the trade name Gynafem(TM). The Company expects the subject of the first launch to be Gynazole-1(R) during calendar 2006 with Clindesse(TM) to follow. Under the terms of the agreement, KV will receive licensing fees and manufacturing revenues for both products. Marc S. Hermelin, Vice Chairman of the Board and CEO of KV stated, "We are delighted to join forces with Theramex SpA to bring these innovative and market-leading products to the important Italian market. With well over 50 international markets under license, and approvals beginning to be received, it is an exciting time for these products, the first truly global products offered by our Ther-Rx subsidiary. We're looking forward to working with Theramex to bring the therapeutic benefits of Gynazole-1(R) and Clindesse(TM) to the Italian women's health marketplace as early as next fiscal year." Gynazole-1(R) (butoconazole nitrate 2% vaginal cream) is KV's proprietary prescription one-dose vaginal cream for the treatment of yeast infections caused by Candida. Clindesse(TM) (clindamycin phosphate 2% vaginal cream) is the first single-dose treatment for bacterial vaginosis (BV), the most common form of vaginitis. Both Gynazole-1(R) and Clindesse(TM) are the fastest growing products in branded market share for their categories, currently at approximately 20% and 17% of new prescriptions, respectively. Both products utilize KV's proprietary VagiSite(TM) bioadhesive drug delivery technology and are the first approved single-dose prescription cream therapies for patients suffering from vaginal yeast infections from Candida and bacterial vaginosis, the most common form of vaginitis, respectively. Theramex SpA is a joint venture of Schering SpA and Theramex SAM, an affiliate of Merck KGaA, Darmstadt, Germany. Based in Monaco, Theramex SpA was created in 2000 with the aim of being dedicated to women's health. Additional Safety Information about Gynazole-1(R) and Clindesse(TM): GYNAZOLE-1(R) (BUTOCONAZOLE NITRATE) VAGINAL CREAM 2% Gynazole-1(R) is indicated for the local treatment of vulvovaginal candidiasis. The diagnosis should be confirmed by the KOH smears and/or cultures. Gynazole-1(R) is safe and effective in non-pregnant women; however, the safety and effectiveness in pregnant women has not been established. Gynazole-1(R) is contraindicated in patients with a history of hypersensitivity to any of the components in the product. Gyanzole-1(R) contains mineral oil, which may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with Gynazole-1(R) is not recommended. Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection. If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections. CLINDESSE(TM) (CLINDAMYCIN PHOSPHATE) VAGINAL CREAM, 2% Clindesse(TM) is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream, and in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibioitic-associated" colitis. There are no adequate and well controlled studies of Clindesse(TM) in pregnant women. Clindesse(TM) contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse(TM). During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV or other sexually transmitted diseases. Pseudo membranous colitis has been reported with nearly all antibacterial agents, including clindamycin. Orally and parenterally administered clindamycin has been associated with severe colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even though there is minimal systemic absorption of clindamycin from the vagina with administration of Clindesse(TM) cream. In clinical trials totaling 368 women associated with a single dose of Clindesse(TM), 1.6% of the patients discontinued therapy due to adverse events. The most frequently reported adverse events were vaginosis fungal (14.1%), vulvovaginal pruritus (3.3%), and headache (2.7%). ABOUT THERAMEX SPA Theramex SpA has a wide portfolio of products in Gynecology including, menopause, pregnancy and vaginal infections. Theramex SpA has a very positive professional image in the Gynecology area in Italy due in part from their number 2 ranking in menopause and their very active medical educational internet activity. 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, expenditures and 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; (5) new product development and launch including but not limited to 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; (9) fluctuations in operating results; (10) the difficulty of predicting international regulatory approvals, 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-----