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


To: 5,17,37,5,101,... who wrote (343)12/26/1997 2:57:00 PM
From: flickerful  Respond to of 756
 
i have to confess i am positively sick to death of
hearing about that _______yew tree.....enough already.



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
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Bristol-Myers Squibb Co (NYSE:BMY - news)Ivax Corp (AMEX:IVX - news)

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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.
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To: 5,17,37,5,101,... who wrote (343)12/26/1997 3:15:00 PM
From: flickerful  Respond to of 756
 
not skulking, just passing the buck. nothing like
a little distance, huh. what style and grace...really they are something else.( it's all news to them, you know.)

Friday December 26, 2:14 pm Eastern Time

FDA gives NaPro tentative okay for Paxene

BOULDER, Colo., Dec 26 (Reuters) - NaPro BioTherapeutics Inc said Friday the U.S. Food and Drug Administration has given tentative approval of its new drug application for Paxene.

The drug, used to treat Kaposi's sarcoma, is marketed by Baker Norton Pharmaceuticals Inc, a wholly owned subsidiary of IVAX Corp (AMEX:IVX - news).

Paxene is Baker Norton's registered trade mark for its formulation of the drug substance paclitaxel, which is manufactured in bulk form by NaPro, the company said in a statement.

NaPro said Bristol-Myers Squibb Co (NYSE:BMY - news) was granted seven years of marketing exclusivity earlier this year for its version of paclitaxel, called TAXOL, for a related indication.

NaPro said because of this exclusivity, the Paxene application may not be finally approved for marketing until Aug. 4, 2004.

NaPro said it will work with IVAX to continue to seek marketing authority for Paxene for Kaposi's sarcoma and other indications.

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More Quotes
and News:

Bristol-Myers Squibb Co (NYSE:BMY - news)Ivax Corp (AMEX:IVX - news)Napro Biotherapeutics Inc (Nasdaq:NPRO - news)

Related News Categories: biotech, health, medical/pharmaceutical
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Copyright c 1997 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters 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?



To: 5,17,37,5,101,... who wrote (343)12/26/1997 3:29:00 PM
From: flickerful  Respond to of 756
 
my last yew post for the day... you hear?

<<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. >>

so yes, i agree about the bright side.

but how come they weren't bright enough to do that in the beginning since << 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. >>

well, anyway, now we can move on. and IVAX has been moving
so nicely....



To: 5,17,37,5,101,... who wrote (343)12/26/1997 3:51:00 PM
From: flickerful  Respond to of 756
 
jackson: can you confirm the fact that middle management
seems to be buying "as much stock as they can".
this, from the dubious yahoo thread, indicates such a pattern.
so, i understand if you choose to dismiss it out of hand....this post
replies to another requesting a source for the insider buying, beyond
directors, i imagine...

<<- Previous Message 17 of 17ÿÿÿÿ Reply ÿÿÿÿÿ Subj: Resource
By: Denkim
Date: Dec 26 1997 8:44 A.M PST
Reply To: Msg. 16 by tlee4

The company I work for does business with Ivax. We have been told by "friends" from within, that many in middle management are buying as much stock as they can afford. No one will tell us why. Is it something that goes on at the end of the year or is there another reason? And what was that nonsense about a poison pill? In any case I bought Ivax last week figuring that the stock won't go much lower- and it appears that it hasn't. >>