8-K 1 f74475e8-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: July 30, 2001 Date of earliest event reported: July 27, 2001 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 July 27, 2001, we issued a press release announcing that the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee on that day recommended that there are adequate data to support the efficacy of FluMist(TM) (Influenza Virus Vaccine, Trivalent, Types A & B Live, Cold Adapted) for the prevention of influenza in healthy children and healthy adults ages 1 - 64, but that the data analysis completed to date is not sufficient to support the safety of the vaccine at this time. Given the Advisory Committee's recommendation, we do not currently expect to begin commercialization of FluMist(TM) for the 2001-2002 influenza season. A copy of the press release is attached as an exhibit hereto and incorporated by reference herein in its entirety. ITEM 7. EXHIBITS. Exhibit 99.1 Press Release, dated July 27, 2001, entitled "FDA Advisory Committee Evaluates FluMist(TM) Safety & Efficacy Data" 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: July 30, 2001 By: /s/ C. Boyd Clarke ----------------------------------- C. Boyd Clarke Chairman, President and Chief Executive Officer 3 4 INDEX TO EXHIBITS Exhibit 99.1 Press Release, dated July 27, 2001, entitled "FDA Advisory Committee Evaluates FluMist(TM) Safety & Efficacy Data" 4