IMPAX erhält FDA-Zulassung für Generikum - 500 Beiträge pro Seite | Diskussion im Forum

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Das Pharma-Unternehmen IMPAX Laboratories Inc. erhielt von der U.S. Food and Drug Administration die zeitweilige Zulassung für eine generische Version von Schering-Ploughs Allergie-Medikament Claritin.

IMPAX hat die Wirkung der Tabletten auf 24 Stunden verlängert. Claritin hat jährliche Umsätze von etwa 3,0 Mrd. Dollar, das sind rund ein Drittel vom Umsatz der Schering-Plough Corp.

Ende April empfahl der Beraterstab der FDA die erweiterte Zulassung des Medikaments für die Behandlung von Hautausschlag. Würde die Zulassung tatsächlich erteilt, würde dies den Markteintritt von Generika erschweren.

Die Aktien von IMPAX schlossen an der NASDAQ bei 7,90 Dollar.

Wertpapiere des Arkikels:
IMPAX LABORATORIES DL-,01


Autor: (© wallstreet:online AG / SmartHouse Media GmbH),13:57 29.05.2002

[Mattek]

mmmh, vorbörslich bereits auf 8,80 $.

Hochinteressanter Chart, schreit förmlich nach gap-schließung aus März auf 10 $.

Infos und aussichten angenehm.

So long,
mattek

[Mattek]

Schade, dass scheinbar kein Interesse an Impax vorhanden ist:

Meldung von heute, 31.05.02:

IMPAX to Present at UBS Warburg Global Specialty Pharmaceuticals Conference
Company Presentation Thursday, June 6, at 11:00 a.m. EDT
HAYWARD, Calif.--(BW HealthWire)--May 31, 2002--IMPAX Laboratories, Inc. (Nasdaq:IPXL - News) today announced that management will present at the UBS Warburg Global Specialty Pharmaceuticals Conference on Thursday, June 6, 2002, at 11:00 a.m. EDT.

The conference will be held at The Grand Hyatt New York in New York City and attendees will include institutional money managers and analysts.

IMPAX`s presentation will be webcast and accessible to the investors on-line at http://mediaondemand.com/ubs/20020605. Replays will be available the following business day for 30 days after the presentation at the same web site address or by visiting the investor relations section of IMPAX`s Website at http://www.impaxlabs.com/invest and following the link to the Company`s presentation.

IMPAX currently has 15 ANDA filings pending at the FDA that address more than $8 billion in U.S. branded product sales. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments and three of these now have tentative approval from the FDA.

IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and niche generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company`s Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation

Reform Act:

To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company`s filings with the Securities and Exchange Commission.



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Contact:

IMPAX Laboratories, Inc.
Barry R. Edwards, 215/289-2220 Ext. 371
Larry Hsu, Ph.D., 510/476-2000 Ext. 1111
Cornel C. Spiegler, 215/289-2220 Ext. 306
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212/838-3777
[e-mail]
Bruce Voss, 310/691-7100
[e-mail]
www.lhai.com