To: 5,17,37,5,101,... who wrote (343 ) 12/26/1997 3:13:00 PM From: flickerful Respond to of 756
okokok...so they're not skulking exactly : Friday December 26, 1:47 pm Eastern Time Company Press Release SOURCE: IVAX Corporation FDA Responds to IVAX's Paxene(R) Application MIAMI, Dec. 26 /PRNewswire/ -- IVAX Corporation (Amex: IVX - news) announced today that its subsidiary, Baker Norton Pharmaceuticals, Inc., received a tentative approval from the United States Food and Drug Administration of its New Drug Application for Paxene(R) to treat Kaposi's sarcoma after failure of first line or subsequent systemic chemotherapy. In granting the tentative approval, the FDA concluded that Paxene(R) is safe and effective for this indication. Paxene(R) is Baker Norton's registered trademark for the compound paclitaxel (referred to in some scientific and medical literature as taxol*). Earlier this year, Bristol-Myers Squibb Company (NYSE: BMY - news) received approval to market its version of paclitaxel, called Taxol(R), for a related indication for which Taxol(R) received seven years of market exclusivity under the provisions of the Orphan Drug Act. That act provides for market exclusivity for drug products approved to treat diseases or conditions affecting fewer than 200,000 persons in the United States. The FDA has indicated that, in view of Taxol(R)'s orphan drug exclusivity for a related indication, the application by Baker Norton may not be finally approved until August 4, 2004. Baker Norton anticipated that obtaining marketing approval of Paxene(R) for this indication would be a difficult challenge and is exploring alternative strategies to market Paxene(R) for Kaposi's sarcoma in advance of the expiration of Taxol(R)'s orphan drug exclusivity. Baker Norton noted that Taxol(R)'s market exclusivity does not apply to the use of paclitaxel to treat other indications or to Abbreviated New Drug Applications. Baker Norton has conducted clinical studies of Paxene(R) for other indications, and intends to file an application for the use of Paxene(R) to treat one or more of such other indications. IVAX Corporation, headquartered in Miami, Florida, is a holding company with core subsidiaries engaged primarily in the research, development, manufacture and marketing of generic and branded pharmaceuticals. Except for the historical matters contained herein, statements in this press release are forward looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Investors are cautioned that forward looking statements involve risks and uncertainties which may affect IVAX's business and prospects, including the risk that IVAX may not obtain regulatory approval for or successfully commercialize Paxene(R) and certain economic, competitive, governmental, technological and other factors discussed in IVAX's filings with the Securities and Exchange Commission. * Taxol(R) is a registered trademark of Bristol-Myers Squibb Company for an anti-cancer preparation containing paclitaxel. SOURCE: IVAX Corporation ------------------------------------------------------------------------ More Quotes and News: Bristol-Myers Squibb Co (NYSE:BMY - news)Ivax Corp (AMEX:IVX - news) Related News Categories: biotech, medical/pharmaceutical ------------------------------------------------------------------------ Help ------------------------------------------------------------------------ Copyright c 1997 PRNewswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Important Disclaimers and Legal Information Questions or Comments?