Aviron Zulassung ist durch!!! - 500 Beiträge pro Seite

[cupsieger]

Aviron seeks OK for FluMist nasal influenza vaccine
TUESDAY, OCTOBER 31, 2000 7:20 PM
- Reuters

MOUNTAIN VIEW, Calif., Oct 31 (Reuters) - Pharmaceutical company Aviron (NASDAQ NM:AVIR) and American Home Products Corp.(NYSE:AHP) said on Tuesday they have filed for U.S. FDA approval of Aviron`s FluMist, an investigational intranasal influenza vaccine to be used in children and adults.

The filing "marks an important milestone in our progress toward bringing a new influenza vaccine to physicians and patients in the United States," Aviron Chief Executive Boyd Clarke said in a statement.

FluMist is delivered as a nasal mist.

In 1999, Aviron and American Home division Wyeth Lederle Vaccines agreed to collaborate on the drug`s development and possible distribution on a worldwide basis.

Rtr 19:20 10-31-00

Selector Code: reuco

Copyright 2000, Reuters News Service

[cupsieger]

Aviron Submits Biologics License Application for FluMist(TM)
TUESDAY, OCTOBER 31, 2000 6:31 PM
- PRNewswire

MOUNTAIN VIEW, Calif. and MADISON, N.J., Oct 31, 2000 /PRNewswire via COMTEX/ -- Aviron (Nasdaq: AVIR) and American Home Products Corporation (NYSE: AHP) today announced that a Biologics License Application (BLA) for FluMist(TM), an investigational intranasal influenza vaccine, has been submitted to the U.S. Food and Drug Administration (FDA). Aviron is seeking U.S. licensure of FluMist(TM) to prevent influenza in children and adults.

(Photo: http://www.newscom.com/cgi-bin/prnh/20001031/SFTU109 )

"Today`s BLA submission marks an important milestone in our progress toward bringing a new influenza vaccine to physicians and patients in the U.S.," said C. Boyd Clarke, Aviron president and chief executive officer. "We look forward to continuing to work closely with the FDA throughout the regulatory process."

According to the Centers for Disease Control and Prevention, influenza is a highly infectious respiratory illness that can cause disease in all age groups. Annual influenza epidemics in the United States typically affect 10-20 percent of the general population and cause 20,000 deaths. FluMist(TM), which is delivered as a gentle nasal mist, could be an important new way to protect people from the flu. FluMist(TM) may be particularly significant for children, who suffer high influenza attack rates and are thought to be important in the spread of influenza.

"The impact of influenza has been a long-standing problem in the United States," said Kevin Reilly, president, Wyeth Lederle Vaccines, the vaccine division of American Home Products Corporation. "We hope this new approach can become an important tool in the fight against a common infectious disease."

In 1999, Aviron and Wyeth Lederle Vaccines announced a global collaboration agreement for FluMist(TM).

Aviron is a biopharmaceutical company based in Mountain View, California, focused on the prevention of disease through innovative vaccine technology.

Wyeth Lederle Vaccines is the vaccine business of Wyeth-Ayerst Laboratories. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women`s health care, cardiovascular therapies, central nervous system drugs, anti-inflammatory agents, infectious disease, hemophilia, oncology, vaccines, and generic pharmaceuticals. American Home Products Corporation is one of the world`s largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, and animal health care.

Actual results may differ materially from the forward-looking statements contained in this release. Factors that could cause actual results to differ include, but are not limited to, the assessment by regulatory agencies that the company`s license applications for its nasal influenza vaccine are incomplete or inadequate to approve the product for marketing to one or more target populations. Additional information concerning factors that could cause such a difference is contained in Aviron`s SEC filings, including its S-3 Registration Statement and Annual Report on Form 10-K for the year ended December 31, 1999.

To receive an index and copies of recent press releases, call Aviron`s News-On-Call toll-free fax service, 800-758-5804, extension 114000. Additional information about the company can be located at http://www.aviron.com.

In conjunction with this news release, Aviron will host a conference call that will be broadcast live over the Internet. The conference call will take place on Wednesday, November 1, beginning at 8:30 a.m. EST. To access the webcast, visit the Aviron Web site at http://www.aviron.com and log-on to the audio feed as instructed. If you are unable to participate during the live webcast, the call will be archived at http://www.aviron.com. The information provided on the conference call and on the webcast is only accurate at the time of the call, and Aviron will take no responsibility for providing updated information.

SOURCE Aviron

CONTACT: Media, John Bluth, 650-919-3716, or Asha Jennings,
650-919-1429, both of Aviron; or Douglas Petkus, 610-902-7336, or
Lowell Weiner, 973-660-5013, both of American Home Products Corporation; or
Investors, Fred Kurland, 650-919-6666, or John Bluth, 650-919-3716, both of
Aviron; or Thomas Cavanagh of American Home Products Corporation,
973-660-5706
/Company News On-Call: http://www.prnewswire.com/comp/044235.html" target="_blank" rel="nofollow ugc noopener">http://www.prnewswire.com/comp/044235.html or fax,
800-758-5804, ext. 044235
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001031/SFTU109
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 201-369-3467

URL: http://www.aviron.com
http://www.prnewswire.com

(C) 2000 PR Newswire. All rights reserved.

[puhvogel]

Tut mir echt leid, Deine Freude dämpfen zu müssen, aber übersetzt bedeutet dies, dass die einen Antrag auf Marktzulassung gestellt haben.

[korkut]

Biotech Stocks
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Biotech stocks turn around, move up


By Ted Griffith, CBS.MarketWatch.com
Last Update: 12:21 PM ET Nov 1, 2000

Newswatch
Latest Headlines


NEW YORK (CBS.MW) -- Biotechnology stocks shrugged off early weakness Wednesday and moved higher, with shares of Aviron among the gainers following an announcement that it had filed for approval to sell a flu vaccine.
The Amex Biotechnology Index ($BTK: news, msgs) gained 2.2 percent and the Nasdaq Biotechnology Index ($IXBT: news, msgs) added 2.9 percent.

Shares of Aviron (AVIR: news, msgs) were up $3.75 to $69.13 in recent action, having touched a 52-week high of $70.61 earlier in the session.

Mountain View, Calif.-based Aviron said late Tuesday that it filed for Food and Drug Administration approval to sell its nasal flu vaccine, called FluMist. If approved, the product is expected to be marketed by Aviron partner American Home Products (AHP: news, msgs) , whose shares were off 31 cents to $63.19 in recent action.

Excitement over nasal flu vaccine

In a note to clients Wednesday, SG Cowen analyst Eric Schmidt estimated worldwide sales of FluMist could total $80 million next year on the way to $639 million by 2003.

"FluMist could be one of the largest biotech products launched next year," Schmidt wrote. "The product has generated excellent clinical data in the hard-to-vaccinate child population, serves a large unmet medical need, and will be marketed by a worldwide leader in vaccines."

[Predo]

Hi Aviron Aktionäre!

Hier die News vom 01.11.00 ins deutsche übersetzt!

Aviron Verkündet $8 Million Finanzierend Fotorezeptor Newswire Mittwoch November 1 7:00am Mountain View, Calif., November 1 / PRNewswire / -- Aviron (Nasdaq: AVIR) verkündete heute, daß es 153.448 Anteile seiner Stammaktien verkauft hat, unter seiner Ausrichtung Anweisung auf Formular S-3 (Nr. 333-87185), zur nordamerikanischen Kapital Billigkeit Acqua Wellington, Ltd. (Acqua Wellington) für einen gesamten Preis von $8.000.000 oder von $52,13 pro Anteil registriert. Der Kaufpreis wurde gründete auf dem Datenträger belasteten durchschnittlichen Marktpreise während einer handelnden Periode 18-day, die an Oktober 27 beendete, 2000 festgestellt. Die Firma zahlte keine Gebühren oder anderen Ausgleich in Zusammenhang mit dieser Verhandlung. Netzerträge vom Verkauf werden verwendet, um Betriebskosten, Kapitalaufwand und Arbeitskapitalnotwendigkeiten zu finanzieren, dessen Kosten FluMist(TM) der regelnden Archivierungen und der Herstellung und Kommerzialisierung FluMist(TM) in seiner aktuellen Formulierung umfassen kann; Entwicklung einer der zweiten Generationformulierung von FluMist(TM), der Forschung und der Entwicklung anderer Rohrleitungprodukte; Entwicklung der Infrastrukturs notwendig, diese Aktivitäten zu unterstützen; und anderer allgemeiner Gegenstand des Unternehmens. FluMist(TM) ist intranasaler Grippeuntersuchungsimpfstoff Aviron. Aviron ist eine biopharmaceutical Firma, die im Mountain View, Kalifornien gegründet wird, das auf die Verhinderung der Krankheit durch erfinderische vaccine Technologie gerichtet wird. Tatsächliche Resultate können von den Vorwärts-forward-looking Anweisungen materiell sich unterscheiden, die in dieser Freigabe enthalten werden. Faktoren, denen veranlassen konnten tatsächliche Resultate sich zu unterscheiden umfassen, aber werden begrenzt zu, Störung der klinischen Versuche, Sicherheit und Wirksamkeit zu demonstrieren, Unfähigkeit, die Impfstoffe der Firma herzustellen und Einschätzung nicht durch Aufsichtsbehörden, daß die Lizenzanwendungen der Firma für seine Impfstoffe unvollständig oder unzulänglich sind, das Produkt für Marketing zu einer oder mehr Zielbevölkerungen zu genehmigen. Die zusätzlichen Informationen hinsichtlich sind der Faktoren, die solch einen Unterschied verursachen konnten, werden enthalten in den Archivierungen Aviron sek, einschließlich seiner Anweisungen der Ausrichtung S-3 und jährlichen Repor

Gruß Predo