Lexicon Pharmaceuticals has licensed to Ipsen rights to commercialize the Phase III compound telotristat etiprate outside of North America and Japan, with a focus on the treatment of carcinoid syndrome. The deal could generate up to $145 million-plus for Lexicon, the companies said today.

“This collaboration with Ipsen provides the opportunity to create added value for Lexicon and more effectively commercialize telotristat etiprate in markets around the world,” Lonnel Coats, Lexicon’s president and CEO, said in a statement.

Lexicon retains sole rights to commercialize telotristat etiprate in the United States, Canada, and Japan under the companies’ exclusive licensing agreement. Telotristat etiprate is an oral small-molecule inhibitor of tryptophan hydroxylase (TPH) designed to reduce peripheral serotonin production without affecting brain serotonin levels.

Lexicon is conducting Phase III clinical trials of telotristat etiprate for carcinoid syndrome. Lexicon will continue to lead the global Phase III clinical program for telotristat etiprate in carcinoid syndrome, from which data are expected in 2015.

The pivotal trial will compare telotristat etiprate to placebo in the current standard-of-care of somatostatin analog (SSA) therapy in patients whose carcinoid syndrome is not adequately controlled with lanreotide or octreotide. The Phase III study is recruiting in approximately 70 centers worldwide.

Lexicon will continue to be responsible for the potential registration of telotristat etiprate in Canada, Japan, and the U.S.—where the compound has received fast track status and orphan drug designation from the FDA.

Lexicon and Ipsen will collaborate to seek regulatory approvals in Europe—where the compound has won the European Medicines Agency’s orphan drug designation—and other countries within the Ipsen licensed territory, with Ipsen assuming the lead responsibility in those markets.

In return for its commercialization rights outside of North America and Japan, Ipsen has agreed to pay Lexicon up to $145 million—including a $23 million upfront payment and additional payments tied to clinical, regulatory and commercial milestones. Lexicon is also eligible to receive royalties on net sales of telotristat etiprate in its licensed territory.

“This agreement reflects our strategy to strengthen our presence in the fields of oncology, endocrinology and neurology, which will continue to be supported by our newly signed five-year multi-currency €500 million (about $633.3 million) revolving credit facility,” Marc de Garidel, Ipsen’s chairman and CEO, said in a statement.

Ipsen already markets a product to treat carcinoid syndrome in pancreatic and gastrointestinal Neuroendocrine Tumors (NET), Somatuline® (lanreotide). During the first half of 2014, Somatuline racked up €139.3 million ($176.5 million), up 12.9% from a year earlier: “Upon approval, telotristat etiprate will enlarge our footprint in the symptomatic management of NET and offer important benefits to patients with carcinoid syndrome,” de Garidel added.








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