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.
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(Exact name of registrant as specified in charter)
Canada 1-10451 98-0121241
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(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation identification No.)
12103 Indian Creek Court, Beltsville, Maryland 20705
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: 301/419-8400
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Exhibit Index appears on page 4
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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
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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
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Sharon Mates, Ph.D.
President
Dated: January 12, 1998
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EXHIBIT INDEX
ITEM NO.
99.1 Press Release, dated January 9, 1998
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[ 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.
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12103 Indian Creek Court . Beltsville, MD 20705 . Phone 301-419-8400 . Fax 301-419-0167
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