THE WOODLANDS, Texas,
Nov. 7, 2016 /PRNewswire/
-- 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.
About Lexicon
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.
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SOURCE Lexicon Pharmaceuticals, Inc.