EATONTOWN, N.J., Nov. 10 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) today announced the successful completion of a
Phase 1a study of LY315535, a gastrointestinal (GI) compound acquired from
Lilly. The compound is being developed by Roberts for the treatment of
Functional Bowel Disorders, including Irritable Bowel Syndrome and non-ulcer
dyspepsia.
The Phase 1a single rising dose study in human volunteers was conducted
for Roberts by PPD Pharmaco (Austin, Texas). The objectives of the placebo-
controlled study were to 1) show safety across a range of doses and 2)
establish a maximum tolerated dose. The study demonstrated a favorable safety
profile with LY315535 being well-tolerated across a broad range of doses.
Given the positive outcome of this study, the next stage of Phase I testing in
humans is scheduled to commence shortly.
"We are excited about this advancement in the clinical development of
LY315535," said John T. Spitznagel, Roberts President and CEO. "This is a
novel compound which acts 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. It is a potentially potent orally administrated drug
to address the needs of a large and generally unsatisfied GI market."
LY315535 is one of four compounds Roberts acquired from Lilly in late 1996
which target different gastrointestinal disorders. These compounds are at
various stages of development, ranging from pre-clinical to Phase II.
Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada, and the United Kingdom, focuses on licensing,
acquiring, developing and commercializing innovative pharmaceuticals in
selected therapeutic categories. The Company's first pipeline product,
ProAmatine(R) was recently launched in the US as the first FDA cleared drug to
treat orthostatic hypotension. Agrylin(TM), Roberts second pipeline product,
has since been launched in the US as the first drug cleared to treat essential
thrombocythemia and is currently under review for approval 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 Pharmaceuticals Corporation
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CONTACT: Stuart Z. Levine, Ph.D., Director of Investor Relations, 732-389-1182, ext. 3064
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