- Telotristat etiprate, a Phase 3 compound for the treatment of carcinoid syndrome
- Lexicon to potentially receive $145 million in upfront and milestone payments, plus royalties
PARIS, France & THE WOODLANDS, TX, USA I October 22, 2014 I Ipsen (Euronext: IPN; ADR: IPSEY) and Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today 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 (TPH) that reduces peripheral serotonin production without affecting brain serotonin levels. 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.
“This collaboration with Ipsen provides the opportunity to create added value for Lexicon and more effectively commercialize telotristat etiprate in markets around the world,” said Lonnel Coats, Lexicon’s President and Chief Executive Officer. “Ipsen is a leader in the treatment of carcinoid syndrome and neuroendocrine tumors with Somatuline® (lanreotide). Lexicon will benefit commercially from Ipsen’s substantial market presence in Europe and other countries in the licensed territory, and will benefit globally from coordination with Ipsen on medical and scientific matters. This agreement represents an important achievement for Lexicon as we continue to execute on a strategy to translate our discoveries into life-changing products for patients in important areas of unmet medical need.”
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: “Ipsen is delighted to enter into a partnership with Lexicon in Europe and other countries. The CLARINET® study with Somatuline® (lanreotide) paved the way for a change in the treatment paradigm for pancreatic and gastro intestinal NET patients. Upon approval, telotristat etiprate will enlarge our footprint in the symptomatic management of NET and offer important benefits to patients with carcinoid syndrome.” Marc de Garideladded: “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 revolving credit facility.”
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.
About carcinoid syndrome
Neuroendocrine neoplasms are tumors arising from the diffuse neuroendocrine system most often along the gastrointestinal tract. They are rare but their incidence is increasing (approximately 2.5 to 4.5 new cases diagnosed per 100,000 persons per year). They constitute a heterogeneous group of tumors with location of the primary tumor in the gastric mucosa, pancreas, small and large intestine. As a result of their origin, they are capable of releasing a variety of hormones and neuroamines, most commonly serotonin, which, when released into the systemic circulation, can cause distinct clinical symptoms, such as the carcinoid syndrome associating diarrhea and flushing, with often abdominal pain. In some cases, digestive disorders and flushing are associated with heart failure (wheezing, edema of the lower limbs, irregular heartbeats) indicator of carcinoid valvular heart disease.
Lexicon Conference Call
Lexicon management will hold a conference call at 8:30 a.m. Eastern Time on October 22, 2014. The dial-in number for the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international). The conference ID for all callers is 11632. Investors can access a live webcast of the call at www.lexpharma.com. An archived version of the webcast will be available on the website through November 22, 2014.
About Lexicon
Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease. Lexicon has clinical-stage drug programs for diabetes, carcinoid syndrome, and other indications, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2013, R&D expenditure totaled close to €260 million, representing more than 21% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has close to 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
SOURCE: Ipsen
