# Forest Labs Announces Agreement With Rotta Research For License Of Dexloxiglumide



## Jeffrey Roberts (Apr 15, 1987)

NEW YORK, Aug. 7 /PRNewswire/ -- Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that it had entered into an agreement with Rotta Research Laboratorium S.p.A. of Monza, Italy, for the development and marketing in the United States of dexloxiglumide for the treatment of patients with constipation-prone irritable bowel syndrome (IBS). 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 an estimated 30 million people in the U.S. 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. Currently, constipation-prone IBS is managed by diet, laxatives, and antispasmodic drugs to treat the pain. Dexloxiglumide is one of a few novel compounds in development for this disorder. Dexloxiglumide is a potent and selective cholecystokinin type A (CCKA) receptor antagonist as demonstrated in in vitro and animal studies. Through their action in 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. It is planned that dexloxiglumide will enter phase III trials in the U.S. in the first half of 2001. Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "We believe that dexloxiglumide is a useful drug which will be very helpful for many people suffering from irritable bowel syndrome. We are delighted to be entering into this relationship with Rotta Research, which is a highly regarded privately held company which has a history of gastrointestinal disease research programs particularly in the field of CCK antagonists. We expect our relationship with Rotta, which has many of the ingredients of our highly successful collaboration with other mid-sized European companies, to be long term and highly beneficial to both parties, combining Rotta's proven innovative research and development and marketing expertise with Forest's development, regulatory and marketing skills in the United States." Prof. Luigi Rovati, Chairman, President, 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." Rotta Research Laboratorium is among the most important Italian-based pharmaceutical companies with a strong market presence in Europe, the Far East and Latin America. Rotta has a long history of expertise in gastrointestinal as well as other research and was the first company to synthesize and develop the CCK receptor antagonists.


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## JudyW (Jul 14, 2000)

This is great news, Jeff.....thanks for posting. IBS-C people are finally getting some attention. I wonder if this med will be the competition for Zelmac when it comes out?------------------Judy (IBS-C)


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## JeanG (Oct 20, 1999)

Thanks for posting this, Jeff. So, unlike Zelmac which works on the serotonin receptors in the intestines, this works by, "increase[(ing) jeang] gastric emptying and intestinal motility as well as modulating intestinal sensitivity to distension"? The sensitivty to distension must mean the dreaded bloat!







JeanG[This message has been edited by JeanG (edited 08-12-2000).]


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## JudyW (Jul 14, 2000)

Good question JeanG.------------------Judy (IBS-C)


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## Pete (Jan 20, 2000)

Jeff,Do you know if this is available in Europe?


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