THE WOODLANDS, Texas, July 31, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that it has exercised its option under its collaboration and license agreement with Sanofi to co-promote sotagliflozin, an investigational oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), for the treatment of type 1 diabetes in the U.S. The opt-in decision was based on positive data from three Phase 3 studies, inTandem1, inTandem2, and inTandem3 and is aligned to a planned regulatory filing in the U.S.
"This marks another milestone for this collaboration and is a meaningful step forward on the path to bringing a novel and first-in-class therapy to patients with type 1 diabetes. This decision allows us to play a significant role in the commercialization of sotagliflozin, if the medicine is approved by the FDA," said Jeffrey L. Wade, JD, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer. "As we near completion of the type 1 diabetes development program for sotagliflozin, we look forward to additional sotagliflozin clinical data this quarter and presentations at the upcoming EASD meeting in September."
"Sotagliflozin is an important and innovative investigational medicine for the treatment of type 1 diabetes," said Stefan Oelrich, Senior Vice President and Head, Global Diabetes Franchise, Sanofi. "People with this disease have few treatment options, and their unmet need for oral medications that can be used with insulin is high. We are pleased with Lexicon's election to exercise its option to co-promote this product in the U.S., if approved."
Sanofi intends to file applications in the first half of 2018 for the EU and U.S. regulatory reviews of sotagliflozin for the treatment of type 1 diabetes, pending the full read out of Phase 3 data.
Collaboration Background
In November 2015, Lexicon and Sanofi entered into a collaboration and license agreement for the development and commercialization of sotagliflozin. Under the terms of the agreement, Lexicon received an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating double digit percentage royalties on net sales of sotagliflozin.
Under the collaboration, Lexicon granted Sanofi an exclusive worldwide (excluding Japan) license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes. Sanofi is responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of type 2 diabetes worldwide and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's and its licensees' clinical development of and regulatory filings for sotagliflozin and the results and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin. In addition, this 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 the risk that clinical studies of sotagliflozin may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon's currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, 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. Any of these risks, uncertainties and other factors 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, 2016, 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.
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"This marks another milestone for this collaboration and is a meaningful step forward on the path to bringing a novel and first-in-class therapy to patients with type 1 diabetes. This decision allows us to play a significant role in the commercialization of sotagliflozin, if the medicine is approved by the FDA," said Jeffrey L. Wade, JD, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer. "As we near completion of the type 1 diabetes development program for sotagliflozin, we look forward to additional sotagliflozin clinical data this quarter and presentations at the upcoming EASD meeting in September."
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"Sotagliflozin is an important and innovative investigational medicine for the treatment of type 1 diabetes," said Stefan Oelrich, Senior Vice President and Head, Global Diabetes Franchise, Sanofi. "People with this disease have few treatment options, and their unmet need for oral medications that can be used with insulin is high. We are pleased with Lexicon's election to exercise its option to co-promote this product in the U.S., if approved."
Sanofi intends to file applications in the first half of 2018 for the EU and U.S. regulatory reviews of sotagliflozin for the treatment of type 1 diabetes, pending the full read out of Phase 3 data.
Collaboration Background
In November 2015, Lexicon and Sanofi entered into a collaboration and license agreement for the development and commercialization of sotagliflozin. Under the terms of the agreement, Lexicon received an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating double digit percentage royalties on net sales of sotagliflozin.
Under the collaboration, Lexicon granted Sanofi an exclusive worldwide (excluding Japan) license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes. Sanofi is responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of type 2 diabetes worldwide and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's and its licensees' clinical development of and regulatory filings for sotagliflozin and the results and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin. In addition, this 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 the risk that clinical studies of sotagliflozin may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon's currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, 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. Any of these risks, uncertainties and other factors 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, 2016, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.
