TIDMPRTC
PureTech Health PLC
09 November 2021
9 November 2021
PureTech Health plc
PureTech Founded Entity Karuna Therapeutics and Zai Lab Announce
Strategic Collaboration for Development, Manufacturing, and
Commercialization of KarXT in Greater China
Zai Lab obtains exclusive rights to develop and commercialize
KarXT in Greater China
Karuna to receive upfront cash payment of $35 million, up to
$152 million in potential near- and long-term development and
commercial milestones and other payments, and low-double-digit to
high-teens tiered royalties
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, noted today
that its Founded Entity, Karuna Therapeutics, Inc. (NASDAQ: KRTX)
("Karuna"), and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688),
announced their entry into an exclusive license agreement for the
development, manufacturing, and commercialization of KarXT
(xanomeline-trospium) in Greater China, including mainland China,
Hong Kong, Macau, and Taiwan.
Under the terms of the agreement, Karuna will receive a $35
million upfront payment and is eligible to receive up to an
additional $80 million in development and regulatory milestones.
Karuna is also eligible to receive up to $72 million in sales
milestones and low-double-digit to high-teens tiered royalties
based on annual net sales of KarXT in Greater China. Zai Lab will
fund substantially all development, regulatory, and
commercialization activities in Greater China. PureTech is eligible
to receive certain payments from Karuna under its license
agreement, including sublicense payments and royalties on any sales
of KarXT.
Zai Lab will also work with Karuna to design the optimal
strategy to accelerate the development and regulatory timeline of
KarXT in Greater China. KarXT is an oral, investigational
M1/M4-preferring muscarinic agonist that stimulates receptors in
the central nervous system implicated in various psychiatric
conditions. Karuna is evaluating KarXT in late-stage clinical
trials for the treatment of schizophrenia and psychosis in
Alzheimer's disease.
The full text of the announcement from Karuna is as follows:
Karuna Therapeutics and Zai Lab Announce Strategic Collaboration
for Development, Manufacturing, and Commercialization of KarXT in
Greater China
Zai Lab obtains exclusive rights to develop and commercialize
KarXT in Greater China
Karuna to receive upfront cash payment of $35 million, up to
$152 million in potential near- and long-term development and
commercial milestones and other payments, and low-double-digit to
high-teens tiered royalties
BOSTON, SHANGHAI and SAN FRANCISCO - Nov. 9, 2021 -- Karuna
Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage
biopharmaceutical company driven to create and deliver
transformative medicines for people living with psychiatric and
neurological conditions, and Zai Lab Limited (NASDAQ: ZLAB; HKEX:
9688), a patient-focused, innovative, commercial-stage, global
biopharmaceutical company, today announced their entry into an
exclusive license agreement for the development, manufacturing, and
commercialization of KarXT (xanomeline-trospium) in Greater China,
including mainland China, Hong Kong, Macau, and Taiwan.
KarXT is an oral, investigational M1/M4-preferring muscarinic
agonist that stimulates receptors in the central nervous system
implicated in various psychiatric conditions. KarXT was designed to
unlock the therapeutic potential of xanomeline, which demonstrated
significant benefits in reducing symptoms of psychosis in Phase 2
studies in schizophrenia and Alzheimer's disease, while
ameliorating side effects seen in earlier studies. In the Phase 2
EMERGENT-1 trial, KarXT demonstrated clinically meaningful and
statistically significant improvements in the primary endpoint of
Positive and Negative Syndrome Scale (PANSS) total score, and in
key secondary endpoints, including PANSS-positive subscore and
PANSS-negative subscore, at week 5, and was generally
well-tolerated.
Karuna is evaluating KarXT in late-stage clinical trials for the
treatment of schizophrenia and psychosis in Alzheimer's disease.
The EMERGENT program, the clinical program evaluating KarXT for the
treatment of schizophrenia, is underway. The EMERGENT program is
comprised of the previously completed Phase 2 EMERGENT-1 trial and
four ongoing Phase 3 trials, with data from EMERGENT-2 and
EMERGENT-3, the two Phase 3 acute efficacy and safety trials,
expected in mid-2022 and in the second half of 2022, respectively.
Karuna plans to initiate the Phase 3 ARISE trial evaluating KarXT
as an adjunctive treatment for schizophrenia in adults who
inadequately respond to atypical antipsychotics in the fourth
quarter of 2021. Additionally, Karuna also plans to initiate a
Phase 3 program evaluating KarXT for the treatment of psychosis in
Alzheimer's disease in mid-2022 following encouraging results from
the completed Phase 1b healthy elderly volunteer trial, which
suggest that potentially therapeutic doses of KarXT can be
administered to elderly adults while maintaining a favorable
tolerability profile. Zai Lab will work with Karuna to design the
optimal strategy to accelerate the development and regulatory
timeline of KarXT in Greater China.
Under the terms of the agreement, Karuna will receive a $35
million upfront payment and is eligible to receive up to an
additional $80 million in development and regulatory milestones.
Karuna is also eligible to receive up to $72 million in sales
milestones and low-double-digit to high-teens tiered royalties
based on annual net sales of KarXT in Greater China. Zai Lab will
fund substantially all development, regulatory, and
commercialization activities in Greater China.
"We are thrilled to collaborate with Zai Lab, who shares our
commitment to bringing transformative medicines to people living
with psychiatric conditions globally," said Steve Paul, M.D., chief
executive officer, president, and chairman of Karuna Therapeutics.
"With their proven record of successfully developing and
commercializing novel therapies in Greater China, we believe that
Zai Lab is the ideal partner to expand the global footprint for
KarXT alongside our ongoing efforts in the U.S., with the goal of
providing meaningful treatments to millions of people living with
mental illness globally."
"Our collaboration with Karuna is a significant milestone for
Zai Lab, marking the expansion and diversification of our
development and commercial portfolio into neuroscience, our fourth
therapeutic area," said Samantha Du, Ph.D., founder, chairperson
and chief executive officer of Zai Lab. "KarXT is well positioned
to serve as the anchor asset in our new neuroscience franchise. Zai
Lab's mission is to deliver innovative medicines to address unmet
medical needs of patients, and we look forward to working with
Karuna to bring KarXT to patients in need in Greater China as soon
as possible."
"There is a significant need for new and more effective
therapies with improved safety to treat serious psychiatric
conditions in Greater China," said Gang Wang, M.D., Director of
National Clinical Research Center for Mental Disorders, Dean of
Beijing Anding Hospital, Capital Medical University. "Currently,
more than 8 million people in Greater China are living with
schizophrenia, yet fewer than half are receiving treatment, and
even fewer are obtaining adequate symptom improvement from current
treatment. We believe KarXT has the potential to provide a
meaningful new treatment option for many patients living with
schizophrenia and other conditions with disabling symptoms of
psychosis."
Goldman Sachs & Co. LLC is acting as financial advisor to
Karuna Therapeutics.
About KarXT
KarXT (xanomeline-trospium) is an oral, investigational
M1/M4-preferring muscarinic acetylcholine receptor agonist in
development for the treatment of psychiatric and neurological
conditions, including schizophrenia and dementia-related psychosis.
KarXT preferentially stimulates muscarinic receptors in the central
nervous system implicated in these conditions, as opposed to
current antipsychotic medicines, which bind to the D2 dopamine
receptor. KarXT has the potential to usher in a new class of
treatment for schizophrenia and dementia-related psychosis based on
its differentiated mechanism of action.
About Karuna Therapeutics
Karuna Therapeutics is a clinical-stage biopharmaceutical
company driven to create and deliver transformative medicines for
people living with psychiatric and neurological conditions. At
Karuna, we understand there is a need for differentiated and more
effective treatments that can help patients navigate the challenges
presented by these severe and disabling disorders. Utilizing our
extensive knowledge of neuroscience, we are harnessing the untapped
potential of the brain in pursuit of novel pathways to develop
medicines that make meaningful differences in peoples' lives. For
more information, please visit www.karunatx.com.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused,
innovative, commercial-stage, global biopharmaceutical company
focused on developing and commercializing therapies that address
medical conditions with unmet needs in oncology, autoimmune
disorders, infectious diseases, and neuroscience. To that end, our
experienced team has secured partnerships with leading global
biopharmaceutical companies in order to generate a broad pipeline
of innovative marketed products and product candidates. We have
also built an in-house team with strong product discovery and
translational research capabilities and are establishing a pipeline
of proprietary product candidates with global rights. Our vision is
to become a leading global biopharmaceutical company, discovering,
developing, manufacturing and commercializing our portfolio in
order to impact human health worldwide.
For additional information about the company, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
Karuna Therapeutics Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding the potential benefits and
results that may be achieved through our collaboration with Zai
Lab, our ongoing and planned clinical trials and regulatory
filings, our goals to develop and commercialize our product
candidates, and other statements identified by words such as
"could," "expects," "intends," "may," "plans," "potential,"
"should," "will," "would," or similar expressions and the negatives
of those terms. Forward-looking statements are not promises or
guarantees of future performance and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
which could cause actual results to differ materially from those
contemplated in such forward-looking statements. These factors
include risks related to our limited operating history, our ability
to obtain necessary funding, our ability to generate positive
clinical trial results for our product candidates and other risks
inherent in clinical development, the timing and scope of
regulatory approvals, changes in laws and regulations to which we
are subject, competitive pressures, risks relating to business
interruptions resulting from the coronavirus (COVID-19) pandemic,
and other risks set forth under the heading "Risk Factors" of our
Annual Report on Form 10-K for the year ended December 31, 2020.
Our actual results could differ materially from the results
described in or implied by such forward-looking statements.
Forward-looking statements speak only as of the date hereof, and,
except as required by law, we undertake no obligation to update or
revise these forward-looking statements.
Zai Lab Forward-Looking Statements
This press release contains statements about future
expectations, plans and prospects, including, without limitation,
statements relating to the potential, benefits, safety and efficacy
of KarXT; the clinical development of KarXT; the potential
treatment of schizophrenia and dementia-related psychosis; the
potential of Zai Lab's commercial business and pipeline programs;
the anticipated benefits and potential of Zai Lab's collaboration
arrangement with Karuna Therapeutics, Inc. and other risks and
uncertainties associated with drug development and
commercialization. These forward-looking statements may contain
words such as "aim," "anticipate, " "believe," "could," "estimate,"
"expect," "forecast," "goal," "intend," "may," "plan," "possible,"
"potential, " "will," "would" and other similar expressions. Such
statements constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are not statements of historical fact
nor are they guarantees or assurances of future performance.
Forward-looking statements are based on our expectations and
assumptions as of the date of this press release and are subject to
inherent uncertainties, risks and changes in circumstances that may
differ materially from those contemplated by the forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including but not limited to (1) our ability to
successfully commercialize and generate revenue from our approved
products; (2) our ability to finance our operations and business
initiatives and obtain funding for such activities, (3) our results
of clinical and pre-clinical development of our product candidates,
(4) the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approvals of our
product candidates, (5) the effects of the novel coronavirus
(COVID-19) pandemic on our business and general economic,
regulatory and political conditions and (6) the risk factors
identified in our most recent annual or quarterly report and in
other reports we have filed with the U.S. Securities and Exchange
Commission. We anticipate that subsequent events and developments
will cause our expectations and assumptions to change, and we
undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required by law. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders. This pipeline,
which is being advanced both internally and through PureTech's
Founded Entities, is comprised of 25 therapeutics and therapeutic
candidates, including two that have received both U.S. FDA
clearance and European marketing authorization, as of the date of
PureTech's most recently filed Half Year Report and corresponding
Form 6-K. 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 based on the Company's unique
insights into the biology of the brain, immune and gut, or BIG,
systems and the interface between those systems, referred to as the
BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains 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 statements
regarding PureTech's eligibility to receive potential payments,
including sublicense payments and royalties on any sales of KarXT,
under its patent license agreement with Karuna, the potential
therapeutic benefits of Karuna's KarXT, expectations regarding the
benefits of Karuna's strategic collaboration with Zai Lab,
including the development, manufacturing, and commercialization of
KarXT in Greater China, including mainland China, Hong Kong, Macau,
and Taiwan, or matters related thereto, as well as Karuna's future
prospects, development plans, 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, 2020 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:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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