0000912057-01-533361.txt : 20011009
0000912057-01-533361.hdr.sgml : 20011009
ACCESSION NUMBER: 0000912057-01-533361
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20010925
ITEM INFORMATION: Other events
ITEM INFORMATION: Financial statements and exhibits
FILED AS OF DATE: 20010925
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: BRISTOL MYERS SQUIBB CO
CENTRAL INDEX KEY: 0000014272
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 220790350
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-01136
FILM NUMBER: 1744105
BUSINESS ADDRESS:
STREET 1: 345 PARK AVE
CITY: NEW YORK
STATE: NY
ZIP: 10154
BUSINESS PHONE: 2125464000
MAIL ADDRESS:
STREET 1: 345 PARK AVE
CITY: NEW YORK
STATE: NY
ZIP: 10154
FORMER COMPANY:
FORMER CONFORMED NAME: BRISTOL MYERS CO
DATE OF NAME CHANGE: 19891012
8-K
1
a2059923z8-k.txt
8-K
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
September 25, 2001
Date of Report
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
1-1136 22-079-0350
(Commission File Number) (IRS Employer Identification Number)
345 Park Avenue, New York, NY 10154
(Address of principal executive offices) (Zip Code)
(212) 546-4000
Item 5. OTHER EVENTS
Incorporated by reference in its entirety is a press release issued by
the registrant on September 25, 2001, attached as exhibit 99.1, concerning the
registrant's announcement that it expects to re-file its New Drug Application
(NDA) with the U.S. Food and Drug Administration (FDA) for VANLEV(R).
Item 7. FINANCIAL STATEMENTS AND EXHIBITS
(a) Financial Statements
Inapplicable.
(b) Pro Forma Financial Information
Inapplicable.
(c) Exhibit.
99.1 Press Release dated September 25, 2001.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
BRISTOL-MYERS SQUIBB COMPANY
By: /s/ Sandra Leung
-------------------------------
Name: Sandra Leung
Title: Corporate Secretary
EXHIBIT INDEX
Exhibit No. Description of the Exhibit
----------- --------------------------
99.1 Press Release dated September 25, 2001
EX-99.1
3
a2059923zex-99_1.txt
EXHIBIT 99.1
Exhibit 99.1
Contact: MEDIA: INVESTOR:
------ ---------
BRISTOL-MYERS SQUIBB BRISTOL-MYERS SQUIBB
Peggy Ballman Timothy Cost
(609) 252-3366 (212) 546-4103
margaret.ballman@bms.com timothy.cost@bms.com
------------------------
BRISTOL-MYERS SQUIBB TO RE-FILE VANLEV NDA
------------------------------------------
(NEW YORK, September 25, 2001) - Bristol-Myers Squibb Company
(NYSE:BMY) announced today that it expects to re-file its New Drug Application
(NDA) with the U.S. Food and Drug Administration (FDA) for VANLEV (R), its novel
medicine for the treatment of hypertension.
Peter R. Dolan, chairman and chief executive officer of Bristol-Myers
Squibb, said, "We are pleased to announce that after review and analysis of the
results of our landmark 25,000 patient OCTAVE* study of VANLEV, we expect to
make our submission for the use of VANLEV in hypertension to the FDA by the end
of 2001."
VANLEV was compared in the OCTAVE study to enalapril, one of the
widely-used class of antihypertensive drugs known as ACE inhibitors. The company
also noted that its separate clinical study known as OVERTURE**, which is
investigating VANLEV in the treatment of congestive heart failure, is expected
to be completed early next year.
The company earlier reported that, pending supportive results from the
OCTAVE study, it expected to make a decision to re-file its NDA
in the September/October timeframe. To preserve the integrity of the NDA review,
the company said it does not intend to publicly disclose OCTAVE data until the
FDA has completed is review process of the NDA submission.
This press release contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 that may be
identified by terminology such as "expects" and other words or terms of similar
expression or meaning. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties, including factors
that could delay, divert or change any of them, and could cause actual outcomes
and results to differ materially from current expectations. These factors
include, among other things, uncertainties relating to product development,
unexpected regulatory delays and government regulation generally. For further
details and a discussion of these and other risks and uncertainties, see the
company's Securities Exchange and Commission fillings, including the company's
2000 annual report on Form 10K. We undertake no obligation to publicly update
any forward-looking statement, whether as a result of new information, future
events or otherwise.
# # #
*OCTAVE (Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril)
**OVERTURE (Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing
Events)