Date: 2014-10-22
Type of information: Licensing agreement
Compound: telotristat etiprate
Company: Ipsen (France) Lexicon Pharmaceuticals (USA - TX)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: licensing
Action mechanism: enzyme inhibitor. Telotristat etiprate is an oral, small-molecule inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral serotonin production without affecting brain serotonin levels.
Disease: carcinoid syndrome
Details: * On October 22, 2014, Ipsen and Lexicon Pharmaceuticals 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 has received fast track status and orphan drug designation from the Food and Drug Administration in the United States, and has received orphan drug designation from the European Medicines Agency.
Lexicon will continue to lead the global Phase 3 clinical program for telotristat etiprate in carcinoid syndrome, from which data are expected in 2015. The pivotal Phase 3 trial is comparing telotristat etiprate to placebo on a background of somatostatin analog (SSA) therapy, the current standard of care, in patients whose carcinoid syndrome is not adequately controlled with lanreotide or octreotide. The clinical Phase 3 study is recruiting in approximately 70 centers worldwide. Lexicon will continue to be responsible for the potential registration of telotristat etiprate in the U.S., Canada and Japan, while Lexicon and Ipsen will collaborate to seek regulatory approvals in Europe and other countries within the Ipsen licensed territory, with Ipsen assuming the lead responsibility in those markets.
Financial terms: Under the financial terms of the agreement, Lexicon is eligible to receive up to $145 million, comprising $23 million 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.
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