New Study Published in Cephalalgia Identifies Mechanistic Differences Among CGRP Migraine Treatments
2021年2月26日 - 10:00PM
ビジネスワイヤ(英語)
In vitro findings suggest specific
classifications for calcitonin gene-related peptide (CGRP)
pathway-based therapeutics based on mechanisms
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
highlights results from the in vitro study “Migraine Therapeutics Differentially Modulate the CGRP
Pathway,” which were published online by Cephalalgia, a
monthly journal published on behalf of the International Headache
Society. These results will also be featured in a future print
issue of the journal. This study demonstrated marked differences in
the mechanism of blocking the calcitonin gene-related peptide
(CGRP) ligand versus the CGRP receptor.
This newly-published study evaluates three distinct mechanistic
classes of drugs based on receptor binding, signaling and drug
internalization: (1) Monoclonal antibodies against the CGRP ligand,
(2) The monoclonal antibody against the CGRP receptor and (3)
‘Gepants’, small molecule inhibitors of the CGRP receptor.
“This in vitro study explored these mechanistic differences by
comparing the tested compounds in the same experimental analyses,
and found that the different ways to target the CGRP pathway may
have a different biologic impact,” said Steffen Nock, Senior Vice
President of Global Biologics, Teva. “For instance, fremanezumab in
particular, as a monoclonal antibody against the CGRP ligand, is
targeted and specific in its mechanism.”
AJOVY® (fremanezumab-vfrm) injection is a fully humanized IgG2ΔA
monoclonal antibody that specifically and solely targets CGRP, a
key neuropeptide involved in the pathophysiology of migraine. Since
2018, multiple CGRP pathway-based therapeutics have been approved
by the U.S. Food and Drug Administration (FDA). These in vitro
study data indicate that CGRP receptor targeting therapeutics bind
at multiple receptors and prevent the subsequent signaling of
several peptides, while AJOVY selectively binds to only CGRP,
suggesting that its mechanism is specific while other receptor
targeting treatments have potential for an off-target binding.
Importantly, this in vitro research found that an agent that
targets the CGRP receptor versus the ligand, also bind to the human
amylin AMY1 receptor, affecting signaling and undergoing
internalization at both receptors suggesting a potential difference
in their biologic function.
Clinical implications of these findings are unknown, but the in
vitro studies provide insights into potential mechanistic
differences. This study was supported by Teva, and all authors are
full-time Teva employees.
AJOVY is the first and only long-acting anti-CGRP subcutaneous
injection approved in the U.S. and EU for the preventive treatment
of migraine in adults that offers both quarterly and monthly dosing
options.1+±
U.S. Important Safety Information about AJOVY
(fremanezumab-vfrm) injection Contraindications: AJOVY
is contraindicated in patients with serious hypersensitivity to
fremanezumab-vfrm or to any of the excipients.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, pruritus, drug hypersensitivity, and urticaria were
reported with AJOVY in clinical trials. Most reactions were mild to
moderate, but some led to discontinuation or required
corticosteroid treatment. Most reactions were reported from within
hours to one month after administration. If a hypersensitivity
reaction occurs, consider discontinuing AJOVY and institute
appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5%
and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for
AJOVY (fremanezumab-vfrm) injection.
Information for Europe about AJOVY▼ can be found
here.
▼Adverse events should be reported.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events.
Reporting forms and information can be found at
https://www.hpra.ie. Adverse events should also be reported to Teva
– please refer to local numbers.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
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
regarding AJOVY, which are based on management’s current beliefs
and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- the commercial success of AJOVY;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” Forward-looking statements speak only as of
the date on which they are made, and we assume no obligation to
update or revise any forward-looking statements or other
information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
References
- AJOVY (fremanezumab-vfrm) injection, for subcutaneous use
[prescribing information]. Teva Pharmaceuticals USA, Inc.: North
Wales, PA; 2020. + “Long-acting” defined as efficacy measured over
a 12-week period following a 675 mg (225 mg x 3) SC dose. ± 225 mg
monthly administered as one subcutaneous injection, or 675 mg every
three months (quarterly), which is administered as three
subcutaneous injections.
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IR Contacts United States Kevin C. Mannix (215)
591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Li (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
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