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Lexicon and Ipsen to commercialize telotristat etiprate in Canada

US-based biopharmaceutical firm Lexicon and France's Ipsen have expanded their licensing and commercialization agreement to commercialize telotristat etiprate in Canada for the treatment of carcinoid syndrome.

Carcinoid syndrome is a serious condition caused by symptomatic neuroendocrine tumors, which produce large amounts of serotonin.

Telotristat etiprate is an oral, small-molecule inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral serotonin production without affecting brain serotonin levels.

Originally, the agreement was signed by the two firms in October 2014. As part of the expanded deal, Lexicon will retain sole rights to commercialize telotristat etiprate in the US and Japan.

The deal will see Lexicon get $5m in up-front and pre-commercial milestone payments for Canadian rights, plus royalties and sales milestones under original agreement

Lexicon executive vice-president and chief financial officer Jeffrey Wade said: "The expansion of our collaboration with Ipsen to include Canada provides the opportunity to create added value for Lexicon while adding greater focus to our own commercialization plans for telotristat etiprate in the US.

"Ipsen’s North American expansion, based on the strength of its oncology franchise, offered us the opportunity to expand our collaboration to Canada while maintaining Lexicon’s core strategy of maintaining commercialization rights in the US market."

Currently, telotristat etiprate is being evaluated by Lexicon in Phase III clinical trials as an investigational treatment for carcinoid syndrome, which is characterized by severe diarrhea, flushing and, in some cases, heart valve damage.

The company said that telotristat etiprate has secured fast track status and orphan drug designation from the US FDA as well as orphan drug status from the European Medicines Agency (EMA).

Data from the ongoing Phase III clinical program for telotristat etiprate in carcinoid syndrome will be reported in the third quarter of 2015.

The Phase III 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 SSA therapy.