REG - PureTech Health PLC - KarXT/Cobenfy Approved by FDA; PRTC Receives $29M

Puretech HealthAnnouncement

27/09/2024 07:00

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RNS Number : 9409F  PureTech Health PLC  27 September 2024

27 September 2024

PureTech Health plc

 

PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval
for the Treatment of Schizophrenia in Adults

 

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 Cobenfy(TM 1 )

 

Cobenfy is the first new drug mechanism approved in over 50 years for the
treatment of schizophrenia in adults

 

PureTech Health plc (https://puretechhealth.com/) (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
(https://news.puretechhealth.com/news-releases/news-release-details/prtc-gets-500m-rprx-karxt-royalty)
and PureTech's Founded Entity, Karuna Therapeutics, which was acquired by
(https://news.puretechhealth.com/news-releases/news-release-details/14b-acquisition-prtcs-karuna-bms-completed)
Bristol Myers Squibb (NYSE: BMY) ("BMS")
(https://news.puretechhealth.com/news-releases/news-release-details/14b-acquisition-prtcs-karuna-bms-completed)
 in March of 2024
(https://news.puretechhealth.com/news-releases/news-release-details/14b-acquisition-prtcs-karuna-bms-completed)
. 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 Glyph(TM)
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 (³5% 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
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpackageinserts.bms.com%2Fpi%2Fpi_cobenfy.pdf&esheet=54127503&newsitemid=20240925382351&lan=en-US&anchor=U.S.+Full+Prescribing+Information&index=5&md5=95337607e4fc453b81beb2ab5211b922)
 
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpackageinserts.bms.com%2Fpi%2Fpi_cobenfy.pdf&esheet=54127503&newsitemid=20240925382351&lan=en-US&anchor=U.S.+Full+Prescribing+Information&index=5&md5=95337607e4fc453b81beb2ab5211b922)
, including Patient Information
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpackageinserts.bms.com%2Fppi%2Fppi_cobenfy.pdf&esheet=54127503&newsitemid=20240925382351&lan=en-US&anchor=Patient+Information&index=6&md5=04e6e750d56cf599740b02002dad8b5b)
 
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpackageinserts.bms.com%2Fppi%2Fppi_cobenfy.pdf&esheet=54127503&newsitemid=20240925382351&lan=en-US&anchor=Patient+Information&index=6&md5=04e6e750d56cf599740b02002dad8b5b)
.

 

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
(http://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,
PureTechÕs 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.

 

Contact:

PureTech

Public Relations

publicrelations@puretechhealth.com (mailto:publicrelations@puretechhealth.com)

Investor Relations

 

UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com (mailto:puretech@fticonsulting.com)

 

US Media

Nichole Bobbyn

+1 774 278 8273

nichole@tenbridgecommunications.com
(mailto:nichole@tenbridgecommunications.com)

 

 1  Cobenfy is a trademark of Bristol Myers Squibb.

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