Lexicon Realigns Business Around Research and Development Assets, with Focus on Phase 2 LX9211 Neuropathic Pain Program
July 30 2020 - 7:15AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that
it is realigning its business around its research and development
assets, with a focus on its LX9211 neuropathic pain program, now in
Phase 2 clinical development. In that regard:
- Initiation of Phase 2 Clinical Development of
LX9211. Lexicon has initiated patient screening in
RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled,
multi-center clinical study of LX9211 for the treatment of diabetic
peripheral neuropathic pain that is expected to enroll
approximately 300 patients at 30 U.S. sites. Lexicon is preparing
for additional Phase 2 studies of LX9211, a potent oral small
molecule inhibitor of adaptor associated kinase 1 (AAK1), in other
areas of neuropathic pain based on promising results in multiple
preclinical models of neuropathic pain and a favorable Phase 1
clinical safety profile.
- Sale of XERMELO to TerSera. Lexicon entered
into an asset purchase and sale agreement with TerSera Therapeutics
LLC for the sale of Lexicon’s XERMELO®
(telotristat ethyl) product and related assets for up to $224
million in upfront and milestone payments, consisting of
approximately $159 million in cash at closing and up to $65 million
in development, regulatory and sales milestones relating to biliary
tract cancer, plus eligibility for mid-teens royalties on net sales
of XERMELO in biliary tract cancer. As part of the
transaction, TerSera has agreed to assume the currently ongoing
TELE-ABC Phase 2 clinical study of XERMELO in biliary tract cancer
patients and offer employment to at least 20 Lexicon employees
currently dedicated to XERMELO. MTS Health Partners, L.P. served as
financial advisor and WilmerHale served as legal counsel to
Lexicon.
- Debt Reduction. Lexicon will use the upfront
proceeds from the XERMELO sale to substantially reduce its debt,
including full repayment of its $150 million secured term
loan.
“We are implementing a strategic realignment of
Lexicon around some truly compelling assets, with a focus on LX9211
for neuropathic pain and other early-stage research and development
programs,” said Lonnel Coats, Lexicon’s president and chief
executive officer. “The sale of our commercial product, XERMELO, to
TerSera provides a home for an important treatment for patients
with cancer as well as a number of our employees, allows us to use
our resources more efficiently and dedicate appropriate investment
to LX9211 development, and enables a substantial reduction of our
debt.”
About the RELIEF-DPN-1
Study
RELIEF-DPN-1 is a Phase 2 randomized,
double-blind, placebo-controlled, parallel-group, multicenter study
evaluating the efficacy, safety and pharmacokinetics of LX9211 in
the treatment of diabetic peripheral neuropathic pain. The study is
designed to enroll approximately 300 patients at approximately 30
U.S. clinical sites. The primary efficacy endpoint under evaluation
is the change from baseline (Day 1) to Week 6 in Average Daily Pain
Score (ADPS), based on the 11-point numerical rating scale
(NRS).
About LX9211
LX9211 is a potent, orally delivered, selective
small molecule inhibitor of AAK1, a target discovered and
extensively characterized in an alliance with Bristol Myers Squibb.
Preclinical studies of LX9211 demonstrated central nervous system
penetration and reduction in pain behavior in models of neuropathic
pain. Lexicon holds exclusive research, development and
commercialization rights to LX9211 and additional compounds acting
through AAK1 under the alliance.
About XERMELO (telotristat
ethyl)
Discovered using Lexicon’s unique approach to
gene science, XERMELO is the first and only approved oral therapy
for carcinoid syndrome diarrhea. XERMELO targets tryptophan
hydroxylase, an enzyme that mediates the excess serotonin
production within metastatic neuroendocrine tumor (mNET) cells.
XERMELO is approved in the United States, the European Union and
certain additional countries for the treatment of carcinoid
syndrome diarrhea in combination with somatostatin analog (SSA)
therapy in adults inadequately controlled by SSA therapy. Carcinoid
syndrome is a rare condition that occurs in patients living with
mNETs and is characterized by frequent and debilitating diarrhea.
XERMELO targets the overproduction of serotonin inside mNET cells,
providing an additional treatment option for patients suffering
from carcinoid syndrome diarrhea.
Lexicon has granted Ipsen an exclusive
royalty-bearing right and license to commercialize XERMELO outside
of the United States and Japan. Lexicon is commercializing XERMELO
in the United States and Ipsen is commercializing XERMELO in
multiple countries, including the United Kingdom and Germany.
XERMELO
(telotristat ethyl) Important Safety
Information
- Warnings and
Precautions: XERMELO may cause constipation, which can be
serious. Monitor for signs and symptoms of constipation and/or
severe, persistent, or worsening abdominal pain in patients taking
XERMELO. Discontinue XERMELO if severe constipation or severe,
persistent, or worsening abdominal pain develops.
- Adverse Reactions:
The most common adverse reactions (≥5%) include nausea, headache,
increased gamma-glutamyl-transferase, depression, flatulence,
decreased appetite, peripheral edema, and pyrexia.
- Drug Interactions:
If necessary, consider increasing the dose of concomitant CYP3A4
substrates, as XERMELO may decrease their systemic exposure. If
combination treatment with XERMELO and short-acting octreotide is
needed, administer short-acting octreotide at least 30 minutes
after administering XERMELO.
For more information about XERMELO, see Full Prescribing
Information at www.xermelo.com.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives. Through its Genome5000™ program, Lexicon
scientists studied the role and function of nearly 5,000 genes and
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, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology 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 the sale of XERMELO
(telotristat ethyl) and Lexicon’s long-term outlook on its business
In addition, this press release also contains forward looking
statements relating to Lexicon’s growth and future operating
results, discovery, development and commercialization 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 Lexicon’s ability
to meet its capital requirements, successfully complete the sale of
XERMELO, successfully conduct preclinical and clinical development
and obtain necessary regulatory approvals of sotagliflozin, LX9211
and its other potential drug candidates on its anticipated
timelines, 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, 2019, 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.
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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