To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FEMSTAT One Cleared by FDA URL: http://www.pslgroup.com/dg/1E6DE.htm Doctor's Guide February 13, 1997
NUTLEY, N.J., and ST. LOUIS, Feb. 13, 1997-- Roche Laboratories, the prescription pharmaceuticals marketing and sales subsidiary of Hoffmann-La Roche Inc. (Roche), announced today that it has received FDA clearance to market FEMSTAT One, for the local treatment of vulvovaginal infections caused by Candida albicans. The product, which contains the active ingredient butoconazole nitrate, and utilizes KV's SITE RELEASE(R) technology, will be manufactured, in part, by KV Pharmaceutical Company (AMEX: KVA KVB) under an agreement with Roche Holding Ltd. of Basel, Switzerland. The current U.S. market for vaginal antifungal prescriptions is approximately $150 million annually. It is estimated that 75% of women will experience a vaginal yeast infection at least once in their lifetime. Under the agreement, KV will receive manufacturing and royalty revenues on the sales of FEMSTAT One in North America and will have semi-exclusive marketing rights in North America and exclusive marketing and licensing rights in the rest of the world. FEMSTAT One, is one of five products covered under the agreement with Roche, three of which will be developed by KV for Roche utilizing KV's proprietary technologies, and that are expected to be marketed by Roche and/or its affiliates. F. Hoffmann-La Roche Ltd. with headquarters in Basel, Switzerland, and Hoffmann-La Roche Inc., with headquarters in Nutley, N.J., are members of the Roche Group, a world leader in research-based health care with major businesses in pharmaceuticals, diagnostics, vitamins and fine chemicals, and fragrances and flavors. Roche has a long tradition of innovative breakthroughs in drug development and is a pioneer in medical applications of genetic engineering. KV Pharmaceutical is a leader in the research, development, manufacturing and marketing of controlled-release, site-specific and tastemasked forms of drug product using proprietary drug delivery and tastemasking technologies. Safe Harbor statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty in acceptance and demand for pharmaceutical products, the impact of competitive products and pricing, new product development and launch, fluctuations in operating results and other risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.