-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Q2audQdZdYtWsUoFDwZPnmI/x0KZBk0G9hobiEMh/jDi6j+MmX6AZQU2IP3BzX8r TNWxLH4m9BfPMTMjBNfdjA== 0000950123-02-002555.txt : 20020415 0000950123-02-002555.hdr.sgml : 20020415 ACCESSION NUMBER: 0000950123-02-002555 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020315 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: FILED AS OF DATE: 20020315 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MERCK & CO INC CENTRAL INDEX KEY: 0000064978 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221109110 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-03305 FILM NUMBER: 02576670 BUSINESS ADDRESS: STREET 1: ONE MERCK DR STREET 2: P O BOX 100 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 BUSINESS PHONE: 9084234044 MAIL ADDRESS: STREET 1: ONE MERCK DR STREET 2: PO BOX 100 WS3AB-05 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 8-K 1 y58608e8-k.txt FORM 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 Date of Report (Date of earliest event reported) MARCH 15, 2002 ------------------------- MERCK & CO., INC. ------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Its Charter) NEW JERSEY ------------------------------------------------------------------------------- (State or Other Jurisdiction of Incorporation) 1-3305 22-1109110 ----------------------------------- ------------------------------------ (Commission File Number) (I.R.S. Employer Identification No.) ONE MERCK DRIVE, PO BOX 100, WHITEHOUSE STATION, NJ 08889-0100 ------------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code (908) 423-1000 -------------- ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS --------------------------------- (c) EXHIBITS -------- Exhibit 99 Press release issued March 15, 2002 Filed with this document ITEM 9. REGULATION FD DISCLOSURE ------------------------ Incorporated by reference, and attached as Exhibit 99, is a press release issued by the Registrant on March 15, 2002. This information is not "filed" pursuant to the Securities Exchange Act and is not incorporated by reference into any Securities Act registration statements. Additionally, the submission of this report on Form 8-K is not an admission as to the materiality of any information in this report that is required to be disclosed solely by Regulation FD. 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. MERCK & CO., Inc. Date: March 15, 2002 By: /S/ DEBRA A. BOLLWAGE ------------------------ DEBRA A. BOLLWAGE Assistant Secretary EXHIBIT INDEX -------------- Exhibit NUMBER DESCRIPTION - ------- ----------- 99 Press release issued March 15, 2002 EX-99 3 y58608ex99.txt PRESS RELEASE Exhibit 99 [MERCK LOGO] News Release - ------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE Media Contacts: Greg Reaves Investor Contact: Mark Stejbach 908/423-6022 908/423-5185 Christine Fanelle 267/305-3203 MERCK PLANS TO EXPAND ARCOXIA(TM) U.S. NEW DRUG APPLICATION TO INCLUDE NEW EFFICACY DATA; WITHDRAWS ORIGINAL U.S. NDA COMPANY CONFIRMS 2002 EPS GUIDANCE AND PROVIDES INITIAL GUIDANCE FOR FIRST QUARTER WHITEHOUSE STATION, N.J., March 15, 2002 -- Merck & Co., Inc. today announced plans to submit an expanded New Drug Application (NDA) for Arcoxia(TM)(etoricoxib) to the U.S. Food and Drug Administration (FDA) in order to include new efficacy data that will better position the product to compete successfully in the coxib class, where there already are three entrants. Accordingly, Merck announced the withdrawal of the original U.S. NDA for the investigational medicine. Merck is submitting the additional efficacy data to support a new indication for ankylosing spondylitis, which is a chronic, inflammatory disorder primarily involving the spine. Merck also is seeking indications for osteoarthritis, rheumatoid arthritis, chronic pain, acute pain, dysmenorrhea (menstrual pain) and acute gouty arthritis. Merck believes the new data, along with the data previously submitted, will provide a fuller picture of the product's efficacy and safety and will position it more favorably for approval in the United States. The regulatory process for Arcoxia outside the United States continues uninterrupted. Merck also announced today that it continues to anticipate earnings per share (EPS) for 2002, on an as-reported basis, to be at the same level as 2001 results. The 2002 as-reported EPS will be affected by the benefit from the implementation of FAS 142 regarding goodwill amortization, most of which relates to Merck's 1993 acquisition of Merck-Medco, and the timing of the completion of the previously announced separation of Merck-Medco. The Company also reiterated that it would be reasonable to anticipate an EPS growth rate in the second half of 2002 moderately better than the growth rate in the first half of 2002. Merck also confirmed that it expects to deliver double-digit EPS growth in 2003. - more - ARCOXIA (TM) IS THE MERCK TRADEMARK FOR ETORICOXIB. Merck's 2002 sales guidance for its coxib franchise of $2.8 billion to $3.1 billion remains unchanged from guidance provided earlier this year. In addition, Merck provided initial guidance for its first quarter 2002 EPS. Merck is comfortable with a range of first quarter 2002 EPS estimates of $0.69 to $0.72. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Merck-Medco manages pharmacy benefits for employers, insurers and other plan sponsors, encouraging the appropriate use of medicines and providing disease management programs. This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this document should be evaluated together with the many uncertainties that affect our businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2000, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference. # # # -----END PRIVACY-ENHANCED MESSAGE-----