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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 9, 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 officers, 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 it has
acquired from Wyeth Laboratories, U.K., a subsidiary of American Home Products,
rights in the U.K. and ROI to Lodine (etodolac), a selective COX-2 inhibitor.
The agreement includes Lodine SR, a patent protected once-a-day
formulation of this prescription nonsteroidal anti-inflammatory drug (NSAID).
Lodine is indicated for acute and long term use in rheumatoid and
osteoarthritis. Additionally, as a selective COX-2 inhibitor, Lodine has
demonstrated a low incidence of the gastrointestinal side effects normally
associated with prolonged use of NSAIDs.
In general, both the therapeutic benefits and gastrotoxicity of NSAIDs
have been linked to the inhibition of the cyclo-oxygenase (COX) enzyme. However,
there are two isoforms of this enzyme, COX-1 and COX-2. While the
anti-inflammatory benefits of NSAIDs have been related to the inhibition of the
COX-2 isoform, the gastrointestinal side effects, including ulcers and bleeding,
have been related to a concurrent inhibition of COX-1. In turn, there has been
much publicity recently about efforts by some pharmaceutical companies to
develop and market a product that is selective in inhibiting COX-2 while sparing
COX-1.
Etodolac, the active ingredient in Lodine, has already demonstrated
COX-2 selectivity based on several comparative and large-scale safety studies.
These studies, plus years of clinical experience, including more than 13 years
of marketing in the U.K., represent strong supportive evidence that etodolac has
an efficacy similar to NSAIDs, but with a more favorable gastrointestinal safety
profile.
Roberts said that the efficacy and safety profile of etodolac has been
demonstrated in a way that will likely take years for new agents to duplicate.
Moreover, following a recent review of supportive documentation, the UK
Medicines Control Agency allowed a variation in the product's license resulting
in a change in Lodine's data sheet to include statements about its COX-2
selectivity. To the Company's best knowledge, this is the only product in the
U.K. whose data sheet carries such statements.
Roberts also noted that, under a prior distribution agreement, its
U.K./ROI subsidiary, Monmouth Pharmaceuticals, has been marketing Lodine for the
past two years. During this period, Monmouth has accelerated the sales of Lodine
to a double-digit annual growth rate.
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The Company stated that the acquisition of Lodine reflects their
commitment to building upon Monmouth Pharmaceuticals strengths in the analgesic
market.
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 10, 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.
