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RESEARCH PROGRAMS

In the field of pituitary disorders, Ipsen is conducting several research programs, mainly in pituitary adenomas. Work initiated by the Group in the field of enzyme 11ßHSD inhibitors is continuing in order to develop a therapeutic treatment of metabolic syndromes associated with high cardiovascular risk among obese patients. Ipsen is continuing to pursue preclinical research to develop sustained release formulations of growth hormone antagonists to replace daily injections of growth hormone in both children and adults.

GIP is a peptide which enhances the secretion of insulin only when glucose levels are high. GIP can also restore the function of pancreatic beta cells in diabetes and could be used in the treatment of the final prediabetic condition.

PRECLINICAL DEVELOPMENT PROGRAMS LICENSED TO PARTNERS

MSH/MC4 and ghrelin

In March 2010, Ipsen granted Rhythm Pharmaceuticals exclusive worldwide rights to the research, development and marketing of its drug candidates, MC4 and ghrelin agonists, targeting obesity, metabolic disorders and gastrointestinal problems.

DEVELOPMENT PROGRAMS

Somatuline® Autogel® and Somatuline® Depot®

Ipsen is pursuing the following developments:

• a phase III clinical trial of Somatuline^® Autogel^® for the treatment of neuroendocrine tumors is in progress in Europe and the US;
• additional phase III clinical trials for the treatment of neuroendocrine tumor symptoms in order to register Somatuline^® Depot^® (the equivalent of Somatuline^® Autogel^® in the US) were launched in 2009;
• a phase III clinical trial for Somatuline^® Autogel^®  in acromegaly has been completed, and its results should be published in 2010;
• in Japan, the Group’s partner Teijin entered phase III with Somatuline^® Autogel^® for the treatment of acromegaly in January 2010.

BIM 23A760

Ipsen has synthesized a chimeric molecule (which simultaneously exercises several pharmacological activities) combining a somatostatin analog and a dopamine agonist to achieve synergistic therapeutic effects in diseases such as acromegaly and neuroendocrine tumors. Clinical phase I and phase IIa studies in acromegaly have demonstrated encouraging signs of efficacy on bioactivity markers such as the IGF-1 growth hormone and prolactin. BIM 23A760 entered phase IIb in multiple doses as well as phase II in neuroendocrine tumors.

Co-administration of rhGH and rhIGF-1

Ipsen is studying the co-administration of rhGH and rhIGF-1; a phase II clinical study will be completed in 2010. In September 2009, Ipsen published encouraging preliminary results evaluating the co-administration of recombinant human growth hormone and recombinant type 1 human insulin growth factor in two separate injections as a potential treatment for children with short stature associated with low levels of IGF-1.

Taspoglutide (BIM 51077)

Taspoglutide, currently in phase III, is a peptide hormone GLP-1 analog which is the subject of a partnership agreement with Roche. In Japan, Teijin is conducting a phase II study with this new peptide.