EATONTOWN, N.J., July 23 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (AMEX: RPC) today announced the filing with the Food and Drug
Administration (FDA) of an Investigational New Drug Application (IND) for
LY315535, one of the new gastrointestinal (GI) compounds recently acquired
from Lilly. Roberts plans to develop the compound for the treatment of
Functional Bowel Disorders (FBD), a potentially large and unsatisfied GI
market that includes Irritable Bowel Syndrome and non-ulcer dyspepsia.
A common feature of FBD is an abnormal intestinal motility pattern which
can lead to a variety of symptoms including constipation, diarrhea,
indigestion, and abdominal pain. It has been estimated that 15%-20% of the
world population has FBD and that the worldwide market approximates
900 million days of therapy per year. Current therapies such as dietary
changes, over-the-counter medicines and prescription antispasmodics tend to
provide limited or erratic treatment response.
LY315535 is a potentially potent orally administrated drug that can act as
both a muscarinic receptor antagonist and as a serotonin (5-HT) receptor
agonist with a high degree of selectivity for the 5-HT1A receptor subtype.
Because of these two different, but synergistic modes of action on the GI
tract, the compound offers the potential to treat a broad spectrum of FBD
symptoms with a single drug.
LY315535 is one of several pipeline compounds recently acquired by Roberts
which represent potential breakthrough drugs for large cardiovascular as well
as GI markets. "As the first of these new compounds to be internally advanced
by Roberts towards clinical development, LY315535 heralds in an important new
phase in our R&D program," said Dr. David S. Tierney, Roberts Senior Vice
President of Medical and Regulatory Affairs. He continued by noting, "We are
positioning our pipeline to support long-term growth, first through the
development of niche market drugs such as the recently launched ProAmatine(R)
and Agrylin(TM), and then through the commercialization of drugs like LY315535
that address substantially larger markets."
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada, and the United Kingdom, focuses on new health care
solutions through the acquisition and development of specialty
pharmaceuticals. The Company's first pipeline product, ProAmatine, was
recently launched in the U.S. as the first FDA cleared drug to treat
orthostatic hypotension. Agrylin, Roberts' second pipeline product, has since
been launched in the U.S. as the first drug cleared to treat essential
thrombocythemia, and is currently under review in Canada and the European
Union.
This and past press releases of Roberts Pharmaceutical Corporation are
available through PR Newswire's Company News On-Call fax service at
1-800-758-5804, extension 760975 and on the internet at
http://www.prnewswire.com and http://www.robertspharm.com.
This release may contain forward-looking statements which reflect
management's current views of future events and operations. These forward-
looking statements are based on assumptions and external factors, including
assumptions relating to regulatory action and competing products. Any changes
in such assumptions or external factors could produce significantly different
results.
SOURCE Roberts Pharmaceutical Corporation
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CONTACT: Stuart Z. Levine, Ph.D., Director of Investor Relations of Roberts Pharmaceutical, 908-389-1182, ext. 3064
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