DONA™ USA NEWS
Monza, New York, August 7, 2000
ROTTA RESEARCH LABORATORIUM ANNOUNCES AGREEMENT WITH FOREST LABORATORIES FOR LICENSE OF DEXLOXIGLUMIDE
Rotta Research Laboratorium. S.p.A, an Italian based international pharmaceutical manufacturer and marketer, today announced that it has entered into an agreement with Forest Laboratories, Inc. of New York (NYSE: FRX), for the development and marketing in the United States of its product dexloxiglumide for the treatment of patients with constipation-predominant irritable bowel syndrome (IBS).
Dexloxiglumide is a potent and selective cholecystokinin type A (CCKA) receptor antagonist as demonstrated in vitro and animal studies. Through their action on CCKA receptors in the gastrointestinal system, CCKA antagonists increase gastric emptying and intestinal motility as well as modulating intestinal sensitivity to distension. This mechanism of action differs from that of other compounds recently approved or under review by FDA for the treatment of IBS that act on serotonin receptors in the intestines. In a phase II study performed in Europe, dexloxiglumide showed evidence of improving the symptoms of IBS when constipation was the predominant symptom.
IBS is a chronic intestinal disorder characterized by recurrent abdominal pain and bloating accompanied by constipation and/or diarrhea. It is extremely common, occurring in up to 20-25% of the population in the U.S. and in Europe. Its cause is unknown but it often develops during periods of stress and anxiety. It can have a major impact on the lifestyles of those suffering from this disorder. Until recently, it was managed by diet, antidiarrheal drugs, laxatives, and antispasmodic drugs to treat the pain. Dexloxiglumide is one of a few novel compounds in development for this disorder.
It is planned that dexloxiglumide will enter phase III trials in the U.S. in the first half of 2001.
Prof. Luigi Rovati, founder, Chairman and Chief Executive Officer of Rotta, said: " It is a great pleasure for us to cooperate with Forest in developing dexloxiglumide in the U.S. We believe that this may be the beginning of a close scientific and marketing collaboration between our companies. "