0001193125-12-367467.txt : 20120824 0001193125-12-367467.hdr.sgml : 20120824 20120824074024 ACCESSION NUMBER: 0001193125-12-367467 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120823 ITEM INFORMATION: Material Impairments ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120824 DATE AS OF CHANGE: 20120824 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: 121053172 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 d402287d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

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 (Date of earliest event reported): August 23, 2012

 

 

BRISTOL-MYERS SQUIBB COMPANY

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   1-1136   22-079-0350

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

345 Park Avenue

New York, NY, 10154

(Address of Principal Executive Office)

Registrant’s telephone number, including area code: (212) 546-4000

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.06. Material Impairments.

On August 23, 2012 Bristol-Myers Squibb Company (the “Company”) issued a press release announcing that it has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C. The decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that the Company voluntarily suspended on August 1, 2012. The Company acquired BMS-986094 when it completed its acquisition of Inhibitex, Inc. in February 2012. As a result of the termination of this development program, the Company has concluded that a non-cash, pre-tax impairment charge of $1.8 billion related to the in-process research and development intangible asset is required. This charge will be recognized in the third quarter of 2012. The Company does not expect that the impairment charge will result in future cash expenditures.

A copy of the press release is filed as Exhibit 99.1 to this report.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

99.1    Press release of Bristol-Myers Squibb Company dated August 23, 2012.


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 hereunto duly authorized.

 

    BRISTOL-MYERS SQUIBB COMPANY
Dated: August 24, 2012     By:  

/s/ Sandra Leung

    Name:   Sandra Leung
    Title:   General Counsel and Corporate Secretary


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    Press release of Bristol-Myers Squibb Company dated August 23, 2012.
EX-99.1 2 d402287dex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED AUGUST 23, 2012 Press release of Bristol-Myers Squibb Company dated August 23, 2012

Exhibit 99.1

 

LOGO

Bristol-Myers Squibb Discontinues Development of BMS-986094, an Investigational NS5B Nucleotide for the Treatment of Hepatitis C

Company will share BMS-986094 data with other companies developing similar hepatitis C drugs to inform patient safety measures

(Princeton, NJ, August 23, 2012) - Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Company has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C. This decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that the Company voluntarily suspended on August 1, 2012. The U.S. Food and Drug Administration (FDA) subsequently placed the compound on clinical hold.

The initial case of heart failure, which was the basis for halting the study, subsequently resulted in death. The Company is working in close collaboration with the FDA and clinical study investigators to conduct ongoing, comprehensive assessments and close follow-up of all BMS-986094 study patients. To date, nine patients have been hospitalized, including the initial patient; two patients remain hospitalized. While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the Company has determined that it is in the best interest of patients to halt development of BMS-986094.

“The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients,” said Elliott Sigal, M.D., Ph.D., Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb. “In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C. We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community.”


Bristol-Myers Squibb is committed to investigating this safety issue further, including studies to evaluate the potential mechanism of this toxicity. The Company will continue close monitoring and follow-up of patients who have received BMS-986094 across all studies.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

# # #

 

Media:    Sonia Choi, 609-252-5132, sonia.choi@bms.com or Cristi Barnett, 609-252-6028, cristi.barnett@bms.com
Investors:    John Elicker, 609-252-4611, john.elicker@bms.com or Timothy Power, 609-252-7509, timothy.power@bms.com

 

2

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