-----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, BhEReKeqf+8RkNy/Cl0/QiUYrt+e/4pl8A1mHUP2iUCDT+tOhm/+JMBGV2oOZEgw 0hi1pDs9kFLH/UkeOlbixg== 0000200406-04-000140.txt : 20041202 0000200406-04-000140.hdr.sgml : 20041202 20041202160835 ACCESSION NUMBER: 0000200406-04-000140 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041201 ITEM INFORMATION: Other Events FILED AS OF DATE: 20041202 DATE AS OF CHANGE: 20041202 FILER: COMPANY DATA: COMPANY CONFORMED NAME: JOHNSON & JOHNSON CENTRAL INDEX KEY: 0000200406 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221024240 STATE OF INCORPORATION: NJ FISCAL YEAR END: 0103 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-03215 FILM NUMBER: 041180815 BUSINESS ADDRESS: STREET 1: ONE JOHNSON & JOHNSON PLZ CITY: NEW BRUNSWICK STATE: NJ ZIP: 08933 BUSINESS PHONE: 7325242454 8-K 1 cover.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8K Current Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 1,2004 JOHNSON & JOHNSON (Exact name of registrant as specified in its charter) New Jersey 1-3215 22-1024240 (State or other (Commission (I.R.S. Employer jurisdiction File Number) Identification No.) of incorporation) One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933 (Address of principal executive offices) (zip code) Registrant's telephone number including area code: (732) 524-0400 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: [ ] 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 8.01. Other Events On December 1, 2004, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., a Johnson & Johnson company, issued a press release indicating that it is discontinuing its current clinical development program for its controlled release formulation of topiramate in obesity and type 2 diabetes. Item 9.01. Financial Statements and Exhibits 9.01(c) Exhibits: Exhibit Number 99.17: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Press Release dated December 1, 2004. 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. JOHNSON & JOHNSON Date: December 2, 2004 By: /s/ Michael H. Ullmann Michael H. Ullmann Corporate Secretary EX-99.17 (AS APPROP) 2 article.txt JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. DISCONTINUES CLINICAL DEVELOPMENT PROGRAM FOR CONTROLLED RELEASE FORMULATION OF TOPIRAMATE IN OBESITY AND DIABETES RARITAN, N.J., Dec 1, 2004 /PRNewswire-FirstCall via COMTEX/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), a Johnson & Johnson company, announced today that it is discontinuing the current clinical development program for its controlled release formulation of topiramate in obesity and type 2 diabetes. A controlled release formulation of topiramate was specifically developed for study in obese individuals with type 2 diabetes to potentially simplify dosing and enhance the compound's profile in order to create a better treatment option for patients. Data from a recently completed phase II clinical study with the controlled release formulation of topiramate showed that the controlled release formulation did not provide significant advantages in this population compared to previously conducted studies using the immediate release formulation. This decision is not based on any new safety information and does not impact the use of topiramate, marketed as TOPAMAX(R) (topiramate / topiramate capsules), in any currently-approved indications or clinical development programs underway. J&JPRD remains committed to developing innovative medicines for the treatment of metabolic disease. TOPAMAX(R) is marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company, and is approved to treat various types of epileptic seizures in more than 95 countries, and for the prevention of migraine headaches in more than 28 countries. For more information on TOPAMAX(R), please see full prescribing information or visit http://www.ortho- mcneil.com. Based in Raritan, New Jersey, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) conducts pharmaceutical research and development for the pharmaceutical companies of Johnson & Johnson. (This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2003. Copies of this Form 10-K are available online at http://www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.) -----END PRIVACY-ENHANCED MESSAGE-----