Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?

To: flickerful who wrote (336)	12/26/1997 12:27:00 PM
From: John McCarthy	Read Replies (1) \| Respond to of 756

Randy - They are saying on NPRO thread that trading was halted. Is there trading in Ivx. Please tell Jackson. Regards, John

To: flickerful who wrote (336)	12/26/1997 2:25:00 PM
From: flickerful	Respond to of 756

Friday December 26, 1:40 pm Eastern Time Company Press Release FDA Responds To IVAX/NaPro Paxene Application BOULDER, Co.--(BW HealthWire)--Dec. 26, 1997--NaPro BioTherapeutics Inc. (Nasdaq:NPRO - news) announced today that its marketing and development partner Baker Norton Pharmaceuticals Inc., a wholly owned subsidiary of IVAX Corp., has received a tentative approval from the United States Food and Drug Administration (the FDA) of its New Drug Application for Paxene(R) to treat Kaposi's sarcoma. Paxene(R) is Baker Norton's registered trade mark for its formulation of the drug substance paclitaxel which is manufactured in bulk form by NaPro. Earlier this year Bristol-Myers Squibb Co. [NYSE:BMY - news] received approval to market its version of paclitaxel, called TAXOL(R), for a related indication and Bristol-Myers Squibb was granted seven years of marketing exclusivity for TAXOL(R) for this indication under the provisions of the Orphan Drug Act. Because of the Orphan exclusivity granted to Bristol-Myers Squibb's product TAXOL(R), the application for Paxene(R) may not be finally approved for marketing under the Federal Food Drug and Cosmetic Act until Aug. 4, 2004. While NaPro and IVAX are disappointed with FDA's decision, they are pleased that the FDA has determined Paxene(R) to be safe and effective for use in Kaposi's sarcoma and plan to continue to seek marketing authority for Paxene(R) for Kaposi's sarcoma and other indications. NaPro paclitaxel is currently being sold commercially in nine countries outside of the United States through IVAX in South America and through F.H. Faulding Co. LTD in Australia, the Middle East and Southeast Asia. NaPro BioTherapeutics Inc., headquartered in Boulder, with additional manufacturing and plantation operations in British Columbia, Canada, is a biopharmaceutical company focused on the development, production and licensing of complex natural-product 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. Such forward looking statements may include statements regarding completion of clinical trials and regulatory filings, and prospects for and timing of FDA regulatory approvals. Investors are cautioned that forward looking statements involve risks and uncertainties which may affect NaPro's business and prospects, including the risk that IVAX may not obtain regulatory approval or successfully commercialize Paxene(R) (IVAX's formulation of NaPro paclitaxel) and certain economic, competitive, governmental, technological and other factors discussed in NaPro's filings with the Securities and Exchange Commission. ------------------------------------------------------------------------ Contact: NaPro BioTherapeutics Inc. Gordon Link 303/530-3891 or Burns McClellan Inc. Ruth Markowitz (Investors) Lisa Burns (Media) 212/213-0006 ------------------------------------------------------------------------ More Quotes and News: Bristol-Myers Squibb Co (NYSE:BMY - news)Napro Biotherapeutics Inc (Nasdaq:NPRO - news) Related News Categories: biotech, medical/pharmaceutical ------------------------------------------------------------------------ Help ------------------------------------------------------------------------ Copyright c 1997 Business Wire. All rights reserved. All the news releases provided by Business Wire are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving ina public database, redistributing via a computer network or in a printed form. Important Disclaimers and Legal Information Questions or Comments?