Milestone triggers payments to PureTech
totaling $29 million under agreements with Royalty Pharma and
PureTech’s Founded Entity, Karuna Therapeutics, which was acquired
by Bristol Myers Squibb in March 2024, and unlocks potential future
payments related to additional milestones and royalties
Bristol Myers Squibb to market KarXT as
CobenfyTM1
Cobenfy is the first new drug mechanism
approved in over 50 years for the treatment of schizophrenia in
adults
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
changing the lives of patients with devastating diseases, today
announced that KarXT (xanomeline and trospium chloride), which was
initially invented and advanced by PureTech, has received U.S. Food
and Drug Administration (“FDA”) approval for the treatment of
schizophrenia in adults. The FDA approval triggers two separate
milestone payments to PureTech totaling $29 million under
agreements with Royalty Pharma and PureTech’s Founded Entity,
Karuna Therapeutics, which was acquired by Bristol Myers Squibb
(NYSE: BMY) (“BMS”) in March of 2024. Under these agreements,
PureTech is also entitled to potential future payments related to
additional milestones as well as approximately 2% royalties on net
annual sales over $2 billion. Following the acquisition of Karuna,
KarXT is now under the stewardship of BMS and will be marketed as
Cobenfy.
Cobenfy was invented at PureTech by combining two biologically
active molecules – xanomeline and trospium chloride – to address a
tolerability challenge that had held back a potential new class of
medicines for the treatment of neuropsychiatric conditions, such as
schizophrenia. Consistent with its unique model of drug
development, PureTech advanced Cobenfy by founding Karuna
Therapeutics, which later became a publicly traded company on
Nasdaq.
Eric Elenko, PhD, Co-founder and President of PureTech said:
“The FDA approval of Cobenfy is a significant milestone in our
mission to transform the lives of patients with devastating
diseases. Our initial hypothesis was that we could overcome the
tolerability issues that had hindered the development of an
otherwise promising drug, xanomeline, and we were able to test and
validate this concept early on. We are immensely proud that our
dedication to this program has led to the first major innovation in
decades for those living with schizophrenia, and I am equally
pleased that our unique approach to R&D has delivered yet
another novel therapeutic to patients. Congratulations to the teams
at Karuna and BMS on this historic accomplishment.”
The FDA approval of Cobenfy is further validation of PureTech’s
model and a hallmark of how it creates value both clinically and
financially. PureTech’s monetization of equity holdings in Karuna,
including gross proceeds from the BMS acquisition of Karuna, and a
strategic royalty agreement with Royalty Pharma have enabled
PureTech to generate approximately $1.1 billion to date after
directing $18.5 million toward Karuna’s founding and Cobenfy’s
development. PureTech’s business model is designed to repeat and
scale this type of outcome, and proceeds from the success of
Cobenfy have enabled PureTech to self-fund the advancement of
several programs – including LYT-100 (deupirfenidone), LYT-200
(anti-galectin-9 mAb), and the GlyphTM platform supporting the
pipeline of Seaport Therapeutics.
Bharatt Chowrira, PhD, JD, Chief Executive Officer of PureTech
said: “Congratulations to the Karuna and BMS teams for delivering a
groundbreaking treatment to people with schizophrenia. The FDA
approval of Cobenfy is a testament to our unique R&D engine,
which has now produced three FDA approved therapeutics. We've
applied this approach across our portfolio, from our late-stage
Internal Program LYT-100 (deupirfenidone) to our newly launched
Founded Entity, Seaport Therapeutics, and we will continue to
leverage this successful drug development model as we enter our
next phase of innovation.”
PureTech’s next wave of innovation continues to focus on
validated biologic and small molecule modalities with human
clinical data in diseases with significant unmet need. LYT-100
(deupirfenidone) is PureTech’s wholly-owned program in development
for the treatment of idiopathic pulmonary fibrosis (IPF), a rare
progressive lung disease with no cure. The LYT-100 program
leverages extensive prior clinical data and follows the same
blueprint used with Cobenfy to unlock the full therapeutic
potential of an efficacious but poorly tolerated medicine. PureTech
anticipates topline data from the Phase 2b clinical trial of
LYT-100 in patients with IPF by the end of the year, as well as
additional readouts from its oncology program, LYT-200
(anti-galectin-9 monoclonal antibody).
Important Safety Information
CONTRAINDICATIONS
COBENFY is contraindicated in patients with:
- urinary retention
- moderate (Child-Pugh Class B) or severe (Child-Pugh Class C)
hepatic impairment
- gastric retention
- history of hypersensitivity to COBENFY or trospium chloride.
Angioedema has been reported with COBENFY and trospium
chloride.
- untreated narrow-angle glaucoma
WARNINGS AND PRECAUTIONS
Risk of Urinary Retention: COBENFY can cause urinary
retention. Geriatric patients and patients with clinically
significant bladder outlet obstruction and incomplete bladder
emptying (e.g., patients with benign prostatic hyperplasia (BPH),
diabetic cystopathy) may be at increased risk of urinary retention.
COBENFY is contraindicated in patients with pre-existing urinary
retention and is not recommended in patients with moderate or
severe renal impairment.
In patients taking COBENFY, monitor for symptoms of urinary
retention, including urinary hesitancy, weak stream, incomplete
bladder emptying, and dysuria. Instruct patients to be aware of the
risk and promptly report symptoms of urinary retention to their
healthcare provider. Urinary retention is a known risk factor for
urinary tract infections. In patients with symptoms of urinary
retention, consider reducing the dose of COBENFY, discontinuing
COBENFY, or referring patients for urologic evaluation as
clinically indicated.
Risk of Use in Patients with Hepatic Impairment: Patients
with hepatic impairment have higher systemic exposures of
xanomeline, a component of COBENFY, compared to patients with
normal hepatic function, which may result in increased incidence of
COBENFY-related adverse reactions.
COBENFY is contraindicated in patients with moderate or severe
hepatic impairment. COBENFY is not recommended in patients with
mild hepatic impairment.
Assess liver enzymes prior to initiating COBENFY and as
clinically indicated during treatment.
Risk of Use in Patients with Biliary Disease: In clinical
studies with COBENFY, transient increases in liver enzymes with
rapid decline occurred, consistent with transient biliary
obstruction due to biliary contraction and possible gallstone
passage.
COBENFY is not recommended for patients with active biliary
disease such as symptomatic gallstones. Assess liver enzymes and
bilirubin prior to initiating COBENFY and as clinically indicated
during treatment. The occurrence of symptoms such as dyspepsia,
nausea, vomiting, or upper abdominal pain should prompt assessment
for gallbladder disorders, biliary disorders, and pancreatitis, as
clinically indicated.
Discontinue COBENFY in the presence of signs or symptoms of
substantial liver injury such as jaundice, pruritus, or alanine
aminotransferase levels more than five times the upper limit of
normal or five times baseline values.
Decreased Gastrointestinal Motility: COBENFY contains
trospium chloride. Trospium chloride, like other antimuscarinic
agents, may decrease gastrointestinal motility. Administer COBENFY
with caution in patients with gastrointestinal obstructive
disorders because of the risk of gastric retention. Use COBENFY
with caution in patients with conditions such as ulcerative
colitis, intestinal atony, and myasthenia gravis.
Risk of Angioedema: Angioedema of the face, lips, tongue,
and/or larynx has been reported with COBENFY and trospium chloride,
a component of COBENFY. In one case, angioedema occurred after the
first dose of trospium chloride. Angioedema associated with upper
airway swelling may be life-threatening. If involvement of the
tongue, hypopharynx, or larynx occurs, discontinue COBENFY and
initiate appropriate therapy and/or measures necessary to ensure a
patent airway. COBENFY is contraindicated in patients with a
history of hypersensitivity to trospium chloride.
Risk of Use in Patients with Narrow-angle Glaucoma:
Pupillary dilation may occur due to the anticholinergic effects of
COBENFY. This may trigger an acute angle closure attack in patients
with anatomically narrow angles. In patients known to have
anatomically narrow angles, COBENFY should only be used if the
potential benefits outweigh the risks and with careful
monitoring.
Increases in Heart Rate: COBENFY can increase heart rate.
Assess heart rate at baseline and as clinically indicated during
treatment with COBENFY.
Anticholinergic Adverse Reactions in Patients with Renal
Impairment: Trospium chloride, a component of COBENFY, is
substantially excreted by the kidney. COBENFY is not recommended in
patients with moderate or severe renal impairment (estimated
glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure
of trospium chloride is higher in patients with moderate and severe
renal impairment. Therefore, anticholinergic adverse reactions
(including dry mouth, constipation, dyspepsia, urinary tract
infection, and urinary retention) are expected to be greater in
patients with moderate and severe renal impairment.
Central Nervous System Effects: Trospium chloride, a
component of COBENFY, is associated with anticholinergic central
nervous system (CNS) effects. A variety of CNS anticholinergic
effects have been reported with trospium chloride, including
dizziness, confusion, hallucinations, and somnolence. Monitor
patients for signs of anticholinergic CNS effects, particularly
after beginning treatment or increasing the dose. Advise patients
not to drive or operate heavy machinery until they know how COBENFY
affects them. If a patient experiences anticholinergic CNS effects,
consider dose reduction or drug discontinuation.
Most Common Adverse Reactions (≥5% and at least twice
placebo): nausea, dyspepsia, constipation, vomiting,
hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and
gastroesophageal reflux disease.
Use in Specific Populations:
- Moderate or Severe Renal Impairment: Not recommended
- Mild Hepatic Impairment: Not recommended
COBENFY (xanomeline and trospium chloride) is available in
50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.
Please see U.S. Full Prescribing Information,
including Patient Information.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to giving life to new classes of medicine to change the lives of
patients with devastating diseases. The Company has created a broad
and deep pipeline through its experienced research and development
team and its extensive network of scientists, clinicians and
industry leaders that is being advanced both internally and through
its Founded Entities. PureTech's R&D engine has resulted in the
development of 29 therapeutics and therapeutic candidates,
including three that have been approved by the U.S. Food and Drug
Administration. A number of these programs are being advanced by
PureTech or its Founded Entities in various indications and stages
of clinical development, including registration enabling studies.
All of the underlying programs and platforms that resulted in this
pipeline of therapeutic candidates were initially identified or
discovered and then advanced by the PureTech team through key
validation points.
For more information, visit www.puretechhealth.com or connect
with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation those related to additional milestones or
royalties potentially due to PureTech in relation to KarXT/Cobenfy,
PureTech’s development plans and the timing of data readouts,
including as related to LYT-100 and LYT-200, and our future
prospects, developments and strategies. The forward-looking
statements are based on current expectations and are subject to
known and unknown risks, uncertainties and other important factors
that could cause actual results, performance and achievements to
differ materially from current expectations, including, but not
limited to, those risks, uncertainties and other important factors
described under the caption "Risk Factors" in our Annual Report on
Form 20-F for the year ended December 31, 2023, filed with the SEC
and in our other regulatory filings. These forward-looking
statements are based on assumptions regarding the present and
future business strategies of the Company and the environment in
which it will operate in the future. Each forward-looking statement
speaks only as at the date of this press release. Except as
required by law and regulatory requirements, we disclaim any
obligation to update or revise these forward-looking statements,
whether as a result of new information, future events or
otherwise.
_____________________________ 1 Cobenfy is a trademark of
Bristol Myers Squibb.
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version on businesswire.com: https://www.businesswire.com/news/home/20240926084146/en/
PureTech Public Relations
publicrelations@puretechhealth.com Investor Relations
UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
puretech@fticonsulting.com
US Media Nichole Bobbyn +1 774 278 8273
nichole@tenbridgecommunications.com
PureTech Health (NASDAQ:PRTC)
過去 株価チャート
から 11 2024 まで 12 2024
PureTech Health (NASDAQ:PRTC)
過去 株価チャート
から 12 2023 まで 12 2024
