THE WOODLANDS, Texas,
Oct. 5, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced that it has entered into an agreement to buy out its
remaining obligations under its clinical development financing
arrangement with Symphony Icon Holdings LLC upon regulatory
approval in the United States for
the marketing and sale of telotristat ethyl.
"In light of progress in the process of regulatory review of
telotristat ethyl for carcinoid syndrome, we felt this would be an
opportune time to reach a favorable settlement of the remaining
financial obligations under our collaboration with Symphony Icon,"
said Jeffrey L. Wade, Lexicon's
executive vice president, corporate and administrative affairs and
chief financial officer. "The buyout arrangement will reduce
the overall amount of our payment obligations and eliminate the
sharing of future milestone payment and other license proceeds
relating to telotristat ethyl."
Under the buyout arrangement, Lexicon will make a single payment
to Symphony Icon of $21.013 million
upon U.S. regulatory approval of telotristat ethyl. The
buyout will replace and eliminate the remaining contingent payments
of up to $29.550 million for which
Lexicon was obligated under the terms of the Symphony collaboration
in effect prior to the buyout agreement. Consistent with the
terms of the Symphony collaboration previously in effect, the
buyout payment may be payable in cash or a combination of cash and
up to 50% in Lexicon common stock, at Lexicon's option.
About Telotristat Ethyl
Discovered using Lexicon's unique approach to gene science,
telotristat ethyl is the first investigational drug in clinical
studies to target tryptophan hydroxylase, an enzyme that triggers
the excess serotonin production within mNET cells that is a key
driver of carcinoid syndrome. While existing treatments for
carcinoid syndrome work to reduce the release of serotonin outside
tumor cells, telotristat ethyl works at the source to reduce
serotonin production within the tumor cells. By specifically
inhibiting serotonin production, telotristat ethyl seeks to control
this important driver of carcinoid syndrome and, in combination
with SSA therapy, the current standard of care, to provide patients
with more control over their disease.
Telotristat ethyl has received Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration and has been
granted priority review by the FDA with a Prescription Drug User
Fee Act (PDUFA) target action date of February 28, 2017.
Lexicon retains rights to market telotristat ethyl in the U.S.
and Japan, and is building the
in-house commercial infrastructure to serve the U.S. market.
Lexicon has a license and collaboration agreement with Ipsen to
commercialize telotristat ethyl in Europe and other countries outside the U.S.
and Japan.
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 clinical development of
telotristat ethyl (formerly referred to as telotristat etiprate and
LX1032) and the results of and projected timing of clinical trials
and the potential therapeutic and commercial potential of
telotristat ethyl. 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 telotristat ethyl 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 telotristat ethyl 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 telotristat ethyl. As a
result, telotristat ethyl 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.