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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
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(exact name of registrant as specified in its charter)
NEW JERSEY 1-1-432 22-2429994
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) Number)
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(Address of principal executive offices, including zip code)
Registrant's telephone number, including area code: 732-676-1200
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(Former name or former address, if changed from last report)
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Item 5. Other Events
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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
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(Registrant)
Date: March 18, 1999 /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
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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.
