EATONTOWN, N.J., March 9 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) 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 of time, Monmouth has accelerated the
sales of Lodine to a double-digit annual growth rate.
John T. Spitznagel, Roberts' President and CEO said, "Lodine fits
strategically with Monmouth's product portfolio which includes Meptid(R)
(meptazinol), a successfully marketed analgesic for moderate to severe pain."
He further noted, "Today's announced acquisition of Lodine reflects our
commitment to building upon Monmouth's strengths in the analgesic market."
"Moreover, a strong overseas franchise in analgesics is consistent with
our strategic plans for Dirame(R), a potent opioid analgesic in Phase III
development for which we own worldwide rights," concluded Mr. Spitznagel.
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada and the United Kingdom, focuses on value-added specialty
pharmaceuticals in the therapeutic categories of gastroenterology, urology,
oncology/hematology, and cardiology/neurology. Roberts actively pursues its
strategy of Search & Develop to identify and acquire novel post-discovery drug
candidates to advance through late-stage clinical development while also
pursuing opportunities to acquire and enhance the potential of commercially
available specialty medicines.
This and past press releases of Roberts Pharmaceutical Corporation are
available through the Internet at the Roberts' home page at
http://www.robertspharm.com.
This release contains forward looking statements which are based on
assumptions and external factors, including assumptions relating to, but not
limited to regulatory action, product pricing, competitive market conditions,
unaudited financial data, new product development and other risks or
uncertainties detailed from time to time in Roberts filings with the
Securities and Exchange Commission. These forward-looking statements
represent the Company's judgment as of the date of this release and any
changes in the assumptions or external factors could produce significantly
different results.
SOURCE Roberts Pharmaceuticals Corporation
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Related links:
http://www.robertspharm.com
(RPC)
CONTACT:
Janet Browning of Roberts Pharmaceuticals
Corporation, 732-676-1200, ext. 3077
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