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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
April 19, 2000
Date of Report (Date of earliest event reported)
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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<S> <C>
1-1136 22-079-0350
(Commission File Number) (IRS Employer Identification No.)
345 Park Avenue, New York 10154
(Address of principal executive offices) (Zip Code)
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(212) 546-4000
(Registrant's telephone number, including area code)
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Item 5. Other Events.
Attached hereto and incorporated herein by reference as Exhibit 99.1 is
a copy of a press release issued by Bristol-Myers Squibb Company on April 19,
2000.
Item 7. Financial Statements and Exhibits.
(c) Exhibits
(99.1) Press Release, dated April 19, 2000.
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.
BRISTOL-MYERS SQUIBB COMPANY
By: /s/ Sandra Leung
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Name: Sandra Leung
Title: Secretary
Dated: April 19, 2000
EXHIBIT INDEX
(99.1) Press Release, dated April 19, 2000.
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(PRINCETON, N.J., April 19, 2000)--Bristol-Myers Squibb Company
(NYSE:BMY) is voluntarily withdrawing its current New Drug Application (NDA) for
VANLEV'TM' (omapatrilat) from the U.S. Food and Drug Administration (FDA). The
company now expects to resubmit its application early next year. Bristol-Myers
Squibb is taking this action in response to questions raised recently by the
agency regarding the comparative incidence and severity of an infrequent side
effect known as angioedema reported within the NDA database. Angioedema is a
localized swelling that generally affects the face, throat, lips or tongue that
can be triggered by food and commonly used drugs such as ACE-inhibitors,
nonsteroidal anti-inflammatory agents and some antibiotics.
The company is cooperating with the FDA to identify the additional data
needed to resolve the agency's questions. Simultaneously, prospective controlled
clinical studies in patients with hypertension and heart failure will continue.
Regulatory filing activities outside the U.S. for VANLEV are proceeding as
planned.
VANLEV is the most clinically developed member of the vasopeptidase
inhibitor class of cardiovascular compounds. VANLEV was designed to
simultaneously inhibit two key enzymes--angiotensin-converting enzyme (ACE) and
neutral endopeptidase (NEP)--which regulate blood pressure. Clinical studies
have demonstrated that VANLEV significantly reduces both systolic (top number)
and diastolic (bottom number) blood pressure.
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In January 2000, the FDA provided a priority review for VANLEV, a
status the agency grants for drugs considered to be a significant therapeutic
advance under the Prescription Drug User Fee Act (PDUFA). VANLEV became the
first antihypertensive to receive a priority review under this system.
Hypertension, or high blood pressure, affects more than 600 million
people worldwide. Three of four people with high blood pressure in the U.S. are
not at or below the recommended target goal of lower than 140/90 mmHg and remain
at higher risk for heart attack, stroke, heart failure, and kidney disease.
Bristol-Myers Squibb is committed to improving the lives of people with high
blood pressure and believes VANLEV will be a significant advance in extending
and enhancing human life.
