0001095811-01-503476.txt : 20011018 0001095811-01-503476.hdr.sgml : 20011018 ACCESSION NUMBER: 0001095811-01-503476 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20010727 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20010730 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: 1934 Act SEC FILE NUMBER: 000-20815 FILM NUMBER: 1693044 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 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 EX-99.1 3 f74475ex99-1.txt EXHIBIT 99.1 1 Exhibit 99.1 FOR IMMEDIATE RELEASE FDA ADVISORY COMMITTEE EVALUATES FLUMIST(TM) SAFETY & EFFICACY DATA MOUNTAIN VIEW, CA AND MADISON, NJ, JULY 27, 2001 - The U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) today 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. The committee also recommended that the data analysis completed to date is not sufficient to support the safety of the vaccine at this time. In closing this discussion, Dr. Robert S. Daum, Chairman of VRBPAC, indicated that the committee would welcome the opportunity to evaluate the safety data when the analyses are complete. Aviron (Nasdaq: AVIR) is continuing to work with the FDA as they complete the analysis of the safety data supporting the license application. The Biologics License Application for FLUMIST(TM) is currently under review by the FDA, which will ultimately decide whether to approve the license application. If licensed by the FDA, FLUMIST(TM) would be the first influenza vaccine delivered as a nasal mist to be commercially available in the United States. FLUMIST(TM) would be marketed by Aviron and Wyeth Lederle Vaccines, a business unit of American Home Products (NYSE:AHP). Delivered as a nasal mist, FLUMIST(TM) could offer an important new approach to help protect people from influenza. Each year in the U.S., influenza infects 35-50 million Americans, resulting in 20,000 deaths (predominantly in the elderly) and as much as $12 billion in direct and indirect costs, including 70 million lost work days and 38 million lost school days. Influenza vaccination may be particularly significant for children, who are between two and three times more likely than adults to contract influenza and who remain infectious longer. "Delivering a flu vaccine via a nasal mist makes good clinical sense since influenza is an airborne virus that typically enters the body through the nose," said Robert B. Belshe, MD, professor of Internal Medicine, Pediatrics, Molecular Microbiology and Immunology at Saint Louis University. "There is a tremendous public health need to increase influenza vaccination rates. New influenza vaccines could help meet that need," said C. Boyd Clarke, chairman and chief executive officer of Aviron. "Together with Wyeth Lederle Vaccines, Aviron looks forward to working with the FDA as it completes its review of FLUMIST(TM)." "Wyeth has a strong heritage rooted in the development of innovative vaccines, particularly those directed at protecting the health of children," said Kevin Reilly, president of Wyeth 5 2 Lederle Vaccines. "There's excitement at both companies to be on the cutting edge of technology in influenza prevention." ABOUT AVIRON AND WYETH LEDERLE VACCINES Aviron is a biopharmaceutical company headquartered in Mountain View, California, focused on the prevention of disease through innovative vaccine technologies. Wyeth Lederle Vaccines is a business unit of Wyeth-Ayerst Pharmaceuticals, the pharmaceutical division of American Home Products Corporation. Wyeth-Ayerst is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, 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 Aviron's license application for its nasal influenza vaccine is 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 both companies' SEC filings, including their Annual Reports on Form 10-K. MEDIA INQUIRIES ON FRIDAY, JULY 27 SHOULD BE DIRECTED TO 301-721-0162 Media: John Bluth, Aviron 650-919-3716 Asha Jennings, Aviron 650-919-1429 Natalie de Vane, Wyeth-Ayerst Laboratories 610-999-8756 Lowell Weiner, American Home Products 973-660-5013 Investors: Justin R. Victoria, American Home Products 973-660-5340 John Bluth, Aviron 650-919-3716 Fred Kurland, Aviron 650-919-6666
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