The Woodlands, Texas, November 7, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has obtained exclusive research, development and commercialization rights to LX9211 (BMS-986176), a development candidate for neuropathic pain that was jointly developed by Lexicon and Bristol-Myers Squibb Company as part of their neuroscience drug discovery alliance. Additional small molecule compounds acting through the same target as LX9211 are also included in the exclusive arrangement. LX9211 is currently completing IND-enabling studies, with Phase 1 clinical trials anticipated to commence during 2017.
“In our alliance with Bristol-Myers Squibb, we jointly discovered and extensively characterized a promising new target and novel compounds for neuropathic pain, ultimately selecting LX9211 as a development candidate,” said Jeffrey L. Wade, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer. “This program demonstrates the utility of Lexicon’s science and the value that we have been able to create through our strategic alliance with Bristol-Myers Squibb. Our acquisition of full development and commercialization rights to this program furthers our strategy of developing drug candidates with the potential for changing the standard of care in areas of high unmet medical need.”
“Working together with Bristol-Myers Squibb, we have accumulated an extensive amount of data supporting the potential of LX9211 for neuropathic pain and other chronic pain indications,” said Praveen Tyle, Ph.D., Lexicon’s executive vice president of research and development. “With the nearing completion of IND-enabling studies, we are planning to advance LX9211 into the clinic next year so that patients in an area of high unmet need can benefit from this innovation.”
LX9211 is an orally-administered small molecule for the treatment of neuropathic pain. In preclinical studies, LX9211 has shown robust efficacy in models of neuropathic pain and is well-tolerated at and above efficacious doses in animals.
About the Lexicon Pharmaceuticals-Bristol-Myers Squibb Neuroscience Alliance
Lexicon and Bristol-Myers Squibb established a drug discovery alliance in December 2003 to discover, develop and commercialize small molecule drugs in the neuroscience field. Lexicon initiated the alliance with a number of neuroscience drug discovery programs at various stages of development and used its gene knockout technologies to identify additional drug targets with promise in the neuroscience field. For those targets that were validated and selected within the alliance, Lexicon and Bristol-Myers Squibb have been working together, on an exclusive basis, to discover, characterize and carry out the nonclinical development of small molecule drug candidates, and have shared equally both in the costs and in the work attributable to those efforts. Lexicon received $86 million in upfront payments and research funding under the agreement during the target discovery portion of the alliance, which expired in October 2009.
Lexicon has acquired the rights to LX9211 under an amendment to the neuroscience alliance, pursuant to which Lexicon has agreed to pay Bristol-Myers Squibb development and regulatory milestones starting with the commencement of the first Phase 2 clinical trial in the first indication. Lexicon has agreed to pay additional development and regulatory milestones for each of the second and third indications, if applicable. Finally, Lexicon has agreed to pay royalties on worldwide net sales of small molecules related to the alliance that act through the target of LX9211 as well as certain sales performance milestones.
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. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s preclinical and clinical development of LX9211 and the results of and projected timing of preclinical studies and clinical trials and the potential therapeutic and commercial potential of LX9211. 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 preclinical studies of LX9211 may not support further development, future clinical studies of LX9211 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 LX9211 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 LX9211. As a result, LX9211 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, 2015, 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.