Lexicon Pharmaceuticals Enters Into Agreement With TerSera Therapeutics for the Sale of XERMELO
July 30 2020 - 7:10AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) and TerSera
Therapeutics LLC announced today that they have entered into an
asset purchase and sale agreement for the sale to TerSera of
Lexicon’s rights, title and interest in XERMELO
®
(telotristat ethyl).
Pursuant to the terms of the agreement, TerSera
will pay Lexicon approximately $159 million in cash at closing,
which includes a $155 million upfront payment and approximately $4
million for existing inventory. Lexicon may receive
additional development, regulatory and sales milestone payments of
up to an aggregate of $65 million for the development and
commercialization of telotristat ethyl in patients with biliary
tract cancer. Additionally, Lexicon will be eligible to
receive 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.
The transaction is expected to close in the third quarter of 2020,
subject to customary closing conditions.
“This agreement allows us to focus Lexicon
around LX9211 for neuropathic pain and other early-stage research
and development programs, enabling efficient use of our resources
and substantially reducing our debt,” said Lonnel Coats, Lexicon’s
president and chief executive officer. “TerSera’s dedicated
oncology focus will provide physicians and patients continued
access to this important medicine for carcinoid syndrome diarrhea
and continue its ongoing development for people suffering with
biliary tract cancer.”
“XERMELO continues to gain an increasingly
important role in carcinoid syndrome diarrhea with a potential
future role in other cancers,” said Ed Fiorentino, Chairman &
CEO of TerSera. “We are very excited to add XERMELO to our existing
oncology portfolio.”
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.
About TerSera Therapeutics
TerSera Therapeutics acquires, develops and
markets specialty pharmaceutical products with a focus on oncology
and non-opioid pain. Its mission is to provide products which
truly make a difference for patients. For more information
about TerSera Therapeutics, please visit www.tersera.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
TerSera Therapeutics LLC Contact: Mark Leonard
+1 847 651 9682 or mark@reachthenextlevel.com
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