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July 17, 2014
05:21 EDTIPSEYIpsen Somatuline CLARINET Phase III results published in NEJM
Ipsen announced that the New England Journal of Medicine, or NEJM, has published clinical trial results showing that Somatuline Autogel/Somatuline Depot Injection 120 mg achieved statistically significant prolongation of progression free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. CLARINET, an investigational phase III randomized, double-blind, placebo-controlled study of the antiproliferative effects of Somatuline was conducted in 48 centers across 14 countries. The article titled “Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors” has been published in the July 17 edition. The data gathered from 204 GEP-NET patients over the 96-week study showed that placebo-treated patients had a median PFS of 18.0 months and 33.0% had not progressed or died at 96 weeks, whereas the median PFS for Somatuline treated patients was not reached and 65.1% had not progressed or died at 96 weeks. This represented a 53% reduction in risk of disease progression or death based on a hazard ratio of 0.47. These statistically and clinically significant antiproliferative effects of Somatuline were observed in a large population of patients with grade G1 or G2 GEP-NETs, and independent of hepatic tumor volume. Quality of life measures were not different between the Somatuline and placebo groups. Safety data generated from the study are consistent with the known safety profile of Somatuline.
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October 22, 2014
05:17 EDTIPSEYIpsen, Lexicon enter into ex-North America/Japan licensing agreement
Ipsen (IPSEY) and Lexicon Pharmaceuticals (LXRX) announced that they have entered into an exclusive licensing agreement for Ipsen to commercialize telotristat etiprate outside of North America and Japan, with a focus on the treatment of carcinoid syndrome. Lexicon retains sole rights to commercialize telotristat etiprate in the United States, Canada and Japan. Lexicon is conducting Phase 3 clinical trials of telotristat etiprate for carcinoid syndrome, a serious condition caused by symptomatic neuroendocrine tumors, which produce large amounts of serotonin. Carcinoid syndrome is characterized by severe diarrhea, flushing and, in some cases, heart valve damage. Telotristat etiprate is an oral, small-molecule inhibitor of tryptophan hydroxylase, or TPH, that reduces peripheral serotonin production without affecting brain serotonin levels. Telotristat etiprate has received fast track status and orphan drug designation from the FDA, and has received orphan drug designation from the European Medicines Agency. Under the financial terms of the agreement, Lexicon is eligible to receive up to $145M, comprising $23M upfront payment and additional payments contingent upon achievement of clinical, regulatory and commercial milestones. In addition, Lexicon is also eligible to receive royalties on net sales of telotristat etiprate in the licensed territory.
October 10, 2014
11:33 EDTIPSEYIpsen announces positive Phase III results for Decapeptyl
Ipsen announced positive results from the phase III study of Decapeptyl administered subcutaneously in patients with locally advanced or metastatic prostate cancer at the European Association of Urology 14th Central European Meeting in Cracow, Poland. The primary objective of the study was to assess the efficacy and safety profile of the sustained-release Decapeptyl formulation when administered by the subcutaneous route in men with locally advanced or metastatic prostate cancer. This objective was met with castration levels of testosterone achieved in 97.6% of men at week 4 and castration maintained in 96.6% of these men at week 26. The efficacy results and safety profile of Decapeptyl administered by the subcutaneous route are consistent with the known efficacy and safety profile of Decapeptyl administered by the intramuscular route. Based on these results, Ipsen has applied for the addition of the subcutaneous route, alongside the intramuscular route, to the label of Decapeptyl.

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