-- Lexicon eligible for an additional $5 million in up-front and pre-commercial milestone payments for Canadian rights, plus royalties and sales milestones under original agreement
-- Lexicon retains all commercialization rights in the U.S. and Japan
THE WOODLANDS, Texas and BASKING RIDGE, N.J., March 18, 2015 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) and Ipsen S.A. (Euronext: IPN; ADR: IPSEY) today announced that they have entered into an agreement for Ipsen, upon regulatory approval, to commercialize telotristat etiprate in Canada, with a focus on the treatment of carcinoid syndrome. This agreement represents an expansion of the licensing agreement previously entered into by Ipsen and Lexicon in October 2014. Under the expanded alliance, Lexicon retains sole rights to commercialize telotristat etiprate in the United States and Japan.
Lexicon is conducting Phase 3 clinical trials of telotristat etiprate, an investigational treatment 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 the third quarter of 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 SSA therapy. Lexicon recently announced the completion of enrollment in the pivotal trial. Lexicon will continue to be responsible for the potential registration of telotristat etiprate in the U.S. and Japan, while Lexicon and Ipsen will collaborate to seek regulatory approvals in Europe, Canada and other countries within the Ipsen licensed territory, with Ipsen assuming the lead responsibility in those markets.
"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 United States," said Jeffrey Wade, Lexicon's Executive Vice President and Chief Financial Officer. "Ipsen is a leader in the treatment of neuroendocrine tumors, including carcinoid syndrome. 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 U.S. market. The license expansion is a testament to the strength of the collaboration between Lexicon and Ipsen, and to the value both companies place on telotristat etiprate for carcinoid syndrome."
Cynthia Schwalm, President and Chief Executive Officer of Ipsen Biopharmaceuticals stated: "This amendment to Ipsen's previously announced agreement with Lexicon will further our goal of becoming a leading specialty pharmaceutical company in North America." Cynthia Schwalm added: "The agreement also builds on our expertise in, and commitment to, oncology and the treatment of neuroendocrine and carcinoid tumors where there remains a tremendous need for additional therapeutic options for patients and their healthcare providers."
Under the financial terms of the agreement, Lexicon is eligible to receive up to $5 million in upfront and pre-commercialization milestones. Net sales in Canada will be aggregated with those in Europe and other territories licensed to Ipsen for purposes of the royalties and sales milestones to be paid to Lexicon under the agreement.
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.
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2014. 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 urology-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 2014, R&D expenditure totaled close to €187 million, representing about 15% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has more than 4,500 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 Reglement Differe" ("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.
Lexicon Forward Looking Statements
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of telotristat etiprate, characterizations of the results of and projected timing of clinical trials of telotristat etiprate, and the potential therapeutic and commercial potential of telotristat etiprate. The press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to meet its capital requirements, successfully conduct clinical development of telotristat etiprate and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Ipsen Forward Looking Statements
The forward-looking statements, objectives and targets contained herein are based on the Group's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favourable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group's activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group's partners could generate lower revenues than expected. Such situations could have a negative impact on the Group's business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group's business is subject to the risk factors outlined in its registration documents filed with the French Autorite des Marches Financiers.
SOURCE Lexicon Pharmaceuticals, Inc.
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