-----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, KSsCKHPUGGNb5hnj8FRp498DCDmWHbTglsJ8DXZDf3/8hyOk6a7fo/k4Xjl+q/WF JO8QUnGMPWOMIg1BCJpqgg== 0000950130-99-001512.txt : 19990319 0000950130-99-001512.hdr.sgml : 19990319 ACCESSION NUMBER: 0000950130-99-001512 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19990316 ITEM INFORMATION: FILED AS OF DATE: 19990318 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ROBERTS PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0000853022 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222429994 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 001-10432 FILM NUMBER: 99567618 BUSINESS ADDRESS: STREET 1: MERIDIAN CENTER II STREET 2: 4 INDUSTRIAL WAY W CITY: EATONTOWN STATE: NJ ZIP: 07724 BUSINESS PHONE: 7326761200 MAIL ADDRESS: STREET 1: 4 INDUSTRIAL WAY WEST STREET 2: 4 INDUSTRIAL WAY WEST CITY: EATONTOWN STATE: NJ ZIP: 07755 8-K 1 FORM 8-K FORM 8-K SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 16, 1999 ROBERTS PHARMACEUTICAL CORPORATION - -------------------------------------------------------------------------------- (exact name of registrant as specified in its charter) NEW JERSEY 1-1-432 22-2429994 - -------------------- ------------------ ---------------------- (State or other (Commission (IRS Employer jurisdiction of File Number) Identification incorporation) Number) Meridian Center II 4 Industrial Way West Eatontown, New Jersey 07724 - -------------------------------------------------------------------------------- (Address of principal executive offices, including zip code) Registrant's telephone number, including area code: 732-676-1200 - -------------------------------------------------------------------------------- (Former name or former address, if changed from last report) -2- Item 5. Other Events ------------ Roberts Pharmaceutical Corporation announced today that a preliminary review of data from Phase III post-operative dental pain study indicate strong analgesic potency for Dirame (propiram). Dirame is an orally administered, centrally acting, opioid receptor agonist/antagonist being developed by Roberts for the treatment of moderate to severe pain. Phase III clinical trials of the compound involve ongoing osteoarthritis and the now completed post-operative dental pain model. Roberts said these models are reliable indicators of analgesic effects. This recently concluded post-operative pain study involved 350 patients with extractions of 2 or more third molars. The clinical trial was designed as a single-dose, randomized, double blind, and placebo-controlled study of Dirame at 25mg, 50mg, 100mg and 150mg. The study also included, as an active comparator, 100mg Ultram(R) (tramadol), the maximum recommended single-dose for this approved and market leading opioid analgesic. Primary endpoints focused on differences in pain intensity from baseline over a period of several hours. The results of these studies demonstrated that Dirame produced significant analgesic effect at doses of 50mg and above. Moreover, at the 50mg and higher doses, Dirame's efficacy proved to be statistically significant in comparison to 100mg tramadol as well as placebo. The Company stated that pain is still not particularly well managed and there is increasing acceptance within the medical community that many patients are suffering unnecessarily. This creates a significant opportunity for a new drug that can demonstrate advantages over existing products. To date, the clinical evidence regarding the analgesic potency of Dirame has been very encouraging. 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. ROBERTS PHARMACEUTICAL CORPORATION ---------------------------------- (Registrant) Date: March 18, 1999 /s/ Anthony A. Rascio --------------------------------- Anthony A. Rascio Vice President -3- FORWARD LOOKING STATEMENTS Certain statements included in Item 5 of this form 8-K are intended to be, and are hereby identified as, forward looking statements for purposes of the safe harbor provided by Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. The Registrant cautions readers that forward looking statements, including, without limitation, those relating to the Registrant's future business prospects, revenues, cost of sales, intangible dispositions and write-offs, continuing operations and discontinued operations, and liquidity and capital resources, are subject to certain risks and uncertainties, including, without limitation, the ability of the Registrant to secure regulatory approval in the United States and in foreign jurisdictions for the Registrant's developmental pipeline drugs, the efforts of the Registrant's competitors and the introduction of rival pharmaceutical products which may prove to be more effective than the Registrant's products, general market conditions, the availability of capital, and the uncertainty over the future direction of the healthcare industry, that could cause actual results to differ materially from those indicated in the forward looking statements. -----END PRIVACY-ENHANCED MESSAGE-----