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)