-----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, GblxSgKW+QQoazJqyUxC6Cxf0GUaP89n98PC29iaKoa3SSd2jIWKjsNSE9ygMF3d +174b9n1FaWmo4GF1dCn2Q== 0000891618-99-000159.txt : 19990122 0000891618-99-000159.hdr.sgml : 19990122 ACCESSION NUMBER: 0000891618-99-000159 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19990112 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990121 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: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-20815 FILM NUMBER: 99509148 BUSINESS ADDRESS: STREET 1: 297 N BERNARDO AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 BUSINESS PHONE: 4159196500 MAIL ADDRESS: STREET 1: 297 NORTH BERNARDO AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 8-K 1 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 (Date of earliest event reported): January 12, 1999 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, CA 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 January 12, 1999, Wyeth Lederle Vaccines, a business unit of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation, and Aviron announced a worldwide collaboration for the marketing of FluMist(TM), Aviron's investigational intranasal influenza vaccine. See the Company's press releases, attached hereto as Exhibit 99.1 and Exhibit 99.2. ITEM 7. EXHIBITS. Exhibit 99.1 Press Release, dated January 12, 1999, entitled "Wyeth Lederle Vaccines and Aviron Enter Into Global Collaboration on FluMist(TM) - Agreement for Co-Promotion and International Marketing Rights." Exhibit 99.2 Press Release, dated January 12, 1999, entitled "Aviron Provides Additional Information about Global Collaboration on FluMist(TM) with Wyeth Lederle Vaccines." 1 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 20, 1999 By: /s/ J. Leighton Read, M.D. ----------------------------------------- J. Leighton Read, M.D. Chairman and Chief Executive Officer 2 4 INDEX TO EXHIBITS Exhibit 99.1 Press Release, dated January 12, 1999, entitled "Wyeth Lederle Vaccines and Aviron Enter Into Global Collaboration on FluMist(TM) - Agreement for Co-Promotion and International Marketing Rights." Exhibit 99.2 Press Release, dated January 12, 1999, entitled "Aviron Provides Additional Information about Global Collaboration on FluMist(TM) with Wyeth Lederle Vaccines." EX-99.1 2 PRESS RELEASE, "WYETH" 1 EXHIBIT 99.1 WYETH LEDERLE VACCINES AND AVIRON ENTER INTO GLOBAL COLLABORATION ON FLUMIST(TM) AGREEMENT FOR CO-PROMOTION AND INTERNATIONAL MARKETING RIGHTS ST. DAVIDS, PA AND MOUNTAIN VIEW, CA - JANUARY 12, 1999 - Wyeth Lederle Vaccines, a business unit of Wyeth-Ayerst Laboratories, (the pharmaceutical division of American Home Products Corporation - NYSE:AHP) and Aviron (Nasdaq: AVIR) today announced a worldwide collaboration for the marketing of FLUMIST(TM) - - Aviron's investigational intranasal influenza vaccine. FluMist(TM) is under development for the prevention of influenza and its associated complications and has completed pivotal phase III clinical trials. The agreement is subject to Hart-Scott-Rodino review. Under the agreement, Aviron is granting Wyeth Lederle Vaccines exclusive worldwide rights to market FLUMIST(TM). Wyeth Lederle Vaccines and Aviron will co-promote FLUMIST(TM) in the U.S., while Wyeth will have the exclusive right to market the product ex-U.S. In each case, Wyeth will hold the marketing rights for up to eleven (11) years. The collaboration excludes Korea, Australia, New Zealand and certain South Pacific countries. The companies will collaborate on the regulatory, clinical, and marketing programs for the product. "We believe Wyeth Lederle's leadership and depth of experience in the vaccine industry, together with Wyeth-Ayerst's global reach, will accelerate and broaden delivery of FLUMIST(TM) to all who may benefit from this important future influenza vaccine," says J. Leighton Read, MD, Aviron's Chairman and Chief Executive Officer. Each year, influenza affects an estimated 75 to 150 million people worldwide. In the U.S., the disease results in an estimated 150,000 hospitalizations and over 20,000 deaths annually. According to the American Lung Association, 90 million workdays were lost to the flu last year in the U.S. Children lose over 30 million school days each year due to influenza and its associated complications. "Once approved, FLUMIST(TM) will strengthen our core respiratory tract infection franchise which includes our pneumococcal vaccine, now in development - by expanding the use of flu vaccines in new patient groups," says Bernard Poussot, President, Wyeth-Ayerst Global Pharmaceuticals. Aviron is a biopharmaceutical company based in Mountain View, CA focused on prevention of disease. The company's goal is to develop products that offer cost-effective prevention of a wide range of infections that affect the general population. The majority of Aviron's products under development are live vaccines against viral infections. FLUMIST(TM) is the company's lead vaccine candidate. Aviron plans to submit its license application for FLUMIST(TM) to the FDA later in 1999. Wyeth Lederle Vaccines is a business unit of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation (NYSE:AHP). Wyeth-Ayerst is a major research-oriented pharmaceutical company with leading products in the areas of women's health 2 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, agricultural products, and animal health care. The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, and the impact of competitive products and patents. Factors relating to Aviron that could cause actual results to differ materially include, but are not limited to failure to receive regulatory approval for the marketing of FLUMIST(TM) or to receive payments under collaborative agreements that are contingent upon future events that may or may not occur. Sales of FLUMIST(TM) and future payments to Aviron are dependent upon the successful development, manufacturing, supply, sale and distribution of the product by Aviron, its third party suppliers and Wyeth Lederle. Risks and uncertainties also include those detailed from time to time in AHP's and Aviron's periodic reports filed with the Securities and Exchange Commission including Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K and Form 20-F. Actual results may differ from the forward-looking statements. EX-99.2 3 PRESS RELEASE, "AVIRON" 1 Exhibit 99.2 AVIRON PROVIDES ADDITIONAL INFORMATION ABOUT GLOBAL COLLABORATION ON FLUMIST(TM) WITH WYETH LEDERLE VACCINES MOUNTAIN VIEW, CA - JANUARY 12, 1999 - Aviron (Nasdaq: AVIR) is providing additional information regarding the transaction announced earlier today between the company and Wyeth Lederle Vaccines for the marketing of FLUMIST(TM) -- Aviron's investigational intranasal influenza vaccine. As consideration under the agreement, which is subject to Hart-Scott-Rodino review, Aviron will receive cash payments of $15 million for the initial license, $15 million upon acceptance for filing with the U.S. Food and Drug Administration (FDA), and $20 million upon FDA marketing approval for FLUMIST(TM). Compensation for achieving additional development and regulatory milestones is included in the agreement terms. The granting of certain other rights under the license would trigger additional payments in excess of $140 million to Aviron. Consideration for the license also includes a commitment to provide up to $40 million in future financing to Aviron from Wyeth-Ayerst Laboratories, a portion of which is contingent upon regulatory approval of the product, with the remaining amount to come from participation in future Aviron securities offerings. The total potential value for the license fees, milestones and financing support that Aviron could receive under the collaboration exceeds $400 million. Wyeth will distribute the product and record all revenues. In addition to the payments mentioned above, Aviron anticipates that it will receive in the range of 40 percent of product revenues from Wyeth, in the form of product transfer payments and royalties, which increase at higher sales levels. Aviron will incur expenses to supply and co-promote the product. Further commercial terms have not been disclosed. Aviron is a biopharmaceutical company based in Mountain View, CA focused on prevention of disease. The company's goal is to develop products that offer cost-effective prevention of a wide range of infections that affect the general population. The majority of Aviron's products under development are live vaccines against viral infections. FLUMIST(TM) is the company's lead vaccine candidate. Aviron plans to submit its license application for FLUMIST(TM) to the FDA later in 1999. The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, and the impact of competitive products and patents. Factors relating to Aviron that could cause actual results to differ materially include, but are not limited to failure to receive regulatory approval for the marketing of FLUMIST(TM) or to receive payments under collaborative agreements that are contingent upon future events that may or may not occur. Sales of FLUMIST(TM) and future payments to Aviron are dependent upon the successful development, manufacturing, supply, sale 2 and distribution of the product by Aviron, its third party suppliers and Wyeth Lederle. Risks and uncertainties also include those detailed from time to time in Aviron's periodic reports filed with the Securities and Exchange Commission including Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Actual results may differ from the forward-looking statements. -----END PRIVACY-ENHANCED MESSAGE-----