-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, EQZbtVRGkmBJMsQF08bZYdLRdSRE0BF9jmHqCn9u0bFtNn7WXuOTzXS8/PHYaUC/ z0m5shVQPt0hBz7hbYTsSw== 0001095811-01-000056.txt : 20010122 0001095811-01-000056.hdr.sgml : 20010122 ACCESSION NUMBER: 0001095811-01-000056 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20001228 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20010104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVIRON CENTRAL INDEX KEY: 0000949173 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 770309686 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-20815 FILM NUMBER: 1501664 BUSINESS ADDRESS: STREET 1: 297 N BERNARDO AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 BUSINESS PHONE: 6509196500 MAIL ADDRESS: STREET 1: 297 NORTH BERNARDO AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 8-K 1 f68329e8-k.txt FORM 8-K 1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report: January 4, 2001 Date of earliest event reported: December 28, 2000 AVIRON (Exact name of registrant as specified in its charter) DELAWARE (State or other jurisdiction of incorporation) 0-20815 77-0309686 (Commission File No.) (IRS Employer Identification No.)
297 N. BERNARDO AVENUE MOUNTAIN VIEW CALIFORNIA 94043 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (650) 919-6500 2 ITEM 5. OTHER EVENTS. On December 28, 2000, the U.S. Food and Drug Administration accepted for filing Aviron's Biologics License Application for its investigational intranasal influenza vaccine, FluMist(TM). On December 29, 2000, Aviron announced the acceptance for filing in a press release, a copy of which is attached as an exhibit to this Form 8-K and is incorporated by reference in its entirety. ITEM 7. EXHIBITS. Exhibit 99.1 Press Release, dated December 29, 2000, entitled "FDA accepts FluMist(TM) Biologics License Application (BLA) for review --- Triggers $15.5 million payment from American Home Products." 2 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. AVIRON Dated: January 4, 2001 By: /s/ C. Boyd Clarke ------------------------------------- C. Boyd Clarke President and Chief Executive Officer 3 4 INDEX TO EXHIBITS Exhibit 99.1 Press Release, dated December 29, 2000, entitled "FDA accepts FluMist(TM) Biologics License Application (BLA) for review --- Triggers $15.5 million payment from American Home Products."
4 EX-99.1 2 f68329ex99-1.txt EXHIBIT 99.1 1 Exhibit 99.1 FDA ACCEPTS FluMist(TM)BIOLOGICS LICENSE APPLICATION (BLA) FOR REVIEW --Triggers $15.5 million payment from American Home Products-- Mountain View, CA, December 29, 2000 - Aviron (Nasdaq: AVIR) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for FluMist(TM), an investigational intranasal influenza vaccine. On October 31, 2000, Aviron submitted a BLA to the FDA seeking U.S. licensure of FluMist(TM) to prevent influenza in healthy children and healthy adults. Today's decision by the FDA to accept the submission for review was the next step in the regulatory process. If approved, FluMist(TM) would be the first flu vaccine delivered as a nasal mist to be commercially available in the U.S. The BLA acceptance triggers a $15.5 million payment to Aviron from American Home Products Corporation (NYSE:AHP) as part of an ongoing global collaboration agreement for the development and marketing of FluMist(TM). The payment will appear as revenue in Aviron's fourth quarter 2000 financial statements. Annual influenza epidemics in the United States typically affect 10 to 20 percent of the general population and cause approximately 20,000 deaths. FluMist(TM), which is delivered as a 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. Aviron is a biopharmaceutical company based in Mountain View, California, focused on the prevention of disease through innovative vaccine technology. 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. For information, please contact: 2 Media: John Bluth, Aviron 650-919-3716 Asha Jennings, Aviron 650-919-1429 Camela Stuby, Fleishman-Hillard 212-453-2000 Investors: John Bluth, Aviron 650-919-3716 Fred Kurland, Aviron 650-919-6666 Asha Jennings, Aviron 650-919-1429
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