-----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, UPTiiYlYPxgaoUX9q8URdTWxM7NkLL1DOw/Zo0D2YTZs9wX+T0iEFdCwYX/pUWn1 aRId1nHUEpr7EuEuYHUwlw== 0000898432-98-000027.txt : 19980114 0000898432-98-000027.hdr.sgml : 19980114 ACCESSION NUMBER: 0000898432-98-000027 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19980109 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19980113 SROS: AMEX FILER: COMPANY DATA: COMPANY CONFORMED NAME: NORTH AMERICAN VACCINE INC CENTRAL INDEX KEY: 0000856573 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 980121241 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 001-10451 FILM NUMBER: 98505459 BUSINESS ADDRESS: STREET 1: 12103 INDIAN CREEK CT CITY: BELTSVILLE STATE: MD ZIP: 20705 BUSINESS PHONE: 3014706100 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 9, 1998 North American Vaccine, Inc. -------------------------------------------------- (Exact name of registrant as specified in charter) Canada 1-10451 98-0121241 - ---------------------------- ------------------------ -------------------- (State or other jurisdiction (Commission File Number) (IRS Employer of incorporation identification No.) 12103 Indian Creek Court, Beltsville, Maryland 20705 ------------------------------------------------ ---------- (Address of principal executive offices) (Zip Code) Registrant's telephone number including area code: 301/419-8400 ------------ Exhibit Index appears on page 4 - ------------------------------- Item 5. Other Events On January 9, 1998, North American Vaccine, Inc. (the "Company") issued a press release containing information that the Company deems of importance to its security holders. The press release, which is attached hereto as Exhibit 99.1, is incorporated herein by reference. Item 7. Financial Statements and Exhibits Exhibit 99.1 Press Release, dated January 9, 1998 -2- SIGNATURES 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 hereto duly authorized. NORTH AMERICAN VACCINE, INC. /s/ Sharon Mates -------------------------------- Sharon Mates, Ph.D. President Dated: January 12, 1998 -3- EXHIBIT INDEX ITEM NO. 99.1 Press Release, dated January 9, 1998 -4- EX-99.1 2 [ LOGO ] NORTH AMERICAN VACCINE, INC. Contacts: Lisa Burns (investor inquiries) Sharon Mates, President John Nugent North American Vaccine, Inc. Justin Jackson (media inquiries) Tel: 301-419-8400 Burns & McClellan Tel: 212-213-0006 FOR IMMEDIATE RELEASE NORTH AMERICAN VACCINE ADVISED BY FDA THAT CERTIVA[TRADEMARK] IS ON TRACK FOR COMPLETING FINAL STEPS FOR LICENSURE Beltsville, Maryland, January 9, 1998, North American Vaccine (AMEX:NVX) announced today that it has been advised by the U.S. Food and Drug Administration (FDA) that CERTIVA[TRADEMARK] is on track for completing the final steps for licensure. CERTIVA[TRADEMARK] is the Company's investigational vaccine against diphtheria, tetanus and pertussis disease. This information was conveyed to the Company at a meeting held with FDA officials this week. At that meeting the FDA expressed its objective of promptly completing the review process for CERTIVA[TRADEMARK]. Towards this end, the FDA has requested additional information which the Company intends to submit shortly. Based on its meeting with FDA, the Company anticipates that the regulatory review process could be completed during the first quarter of 1998 or shortly thereafter. This is a forward looking statement and the factors which may affect its outcome include the ability of the Company to timely provide the information it intends to submit, the acceptability of the information being submitted, the time it takes for the FDA to complete its review process, and the acceptability of the Company's applications in their entirety, among other factors. There can be no assurances given as to the final FDA determinations or that CERTIVA[TRADEMARK] will receive regulatory approval in the anticipated timeline. The regulatory review of a vaccine product is an ongoing, interactive process. Accordingly, the Company does not intend to continuously issue periodic updates until CERTIVA[TRADEMARK] completes it regulatory review. North American Vaccine, Inc. is engaged in the research, development and production of vaccines for the prevention of human infectious diseases. North American Vaccine news releases are available on the company's web site at http://www.nava.com. THIS PRESS RELEASE CONTAINS CERTAIN FORWARD LOOKING STATEMENTS, WHICH ARE MADE PURSUANT TO THE SAFE HARBOR PROVISIONS OF THE SECURITIES LITIGATION REFORM ACT OF 1995. INVESTORS ARE CAUTIONED THAT FORWARD LOOKING STATEMENTS INVOLVE RISKS AND UNCERTAINTIES WHICH MAY AFFECT THE COMPANY'S BUSINESS AND PROSPECTS, INCLUDING WITHOUT LIMITATION THE REQUIREMENT FOR REGULATORY APPROVAL OF PRODUCTS BY THE FDA, NATURE OF COMPETITION, EFFECTIVE MARKETING, AND UNCERTAINTIES RELATING TO CLINICAL TRIALS ALL AS DISCUSSED IN THE COMPANY'S FILINGS WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION, INCLUDING ITS ANNUAL REPORTS ON FORM 10-K, QUARTERLY REPORTS ON FORM 10-Q AND CURRENT REPORTS ON FORM 8-K.
12103 Indian Creek Court . Beltsville, MD 20705 . Phone 301-419-8400 . Fax 301-419-0167
-----END PRIVACY-ENHANCED MESSAGE-----