Both high and low dose TEV-48125 demonstrated
significant reduction in number of headache hours and headache days
in patients.
Data establishes proof of concept as the first
anti-CGRP study in chronic migraine patients to report.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (“Teva”)
announced today positive results from a Phase IIb study evaluating
the efficacy, safety and tolerability of two doses of subcutaneous
TEV-48125, an investigational anti-calcitonin gene-related peptide
(CGRP) monoclonal antibody for the prevention of chronic migraine
(migraine with headaches on at least 15 days per month).
The study compared two active arms of different doses of
TEV-48125, administered as a subcutaneous injection, once a month
for three months, against placebo. Results demonstrated that both
tested doses of TEV-48125 achieved the primary and secondary
efficacy endpoints of the study at one and three months. The data
revealed a significant and clinically relevant reduction in both
the number of monthly cumulative headache hours, and the number of
headache days of at least moderate severity, relative to
baseline.
In this study no important safety or tolerability concerns were
identified. The adverse event profile for TEV-48125 appeared
similar to placebo and supportive of previous Phase I safety data.
Of the adverse events reported, mild, transient injection site
discomfort and redness was infrequent but higher than that observed
in the placebo group. No serious treatment-related adverse events
were seen.
“For the first time in chronic migraine, there is clinical data
on the positive role of calcitonin gene-related peptide signaling
disruption using a monoclonal antibody” said Marcelo E. Bigal,
Teva’s Head of Global Clinical Development for Migraine and
Headaches.
“Chronic migraine is a challenging, complex and highly
debilitating condition that desperately needs effective new
treatment options” said Michael Hayden, Teva’s President of Global
R&D and Chief Scientific Officer. “These results in support of
TEV-48125 take us a step closer to realizing the potential of the
anti-CGRP ligand-based approach for millions of women and men who
suffer from chronic migraine.”
Full results from the study will be presented at a forthcoming
meeting and will be submitted to a peer-reviewed journal for
publication.
About the Study
The study was a multicenter, randomized, double-blind,
double-dummy, placebo-controlled, parallel group, multi-dose study
comparing TEV-48125 with placebo. Following a 28 day run-in period,
qualifying patients were randomized to one of three treatment arms
receiving high dose TEV-48125, low dose TEV-48125 or placebo, given
subcutaneously once a month for three months. 261 patients were
included in the trial, 172 receiving TEV-48125
Subjects had their headache and health information captured
daily during the entire study, using an electronic headache diary
system. The study was conducted in approximately 60 centers in the
USA.
About TEV-48125
TEV -48125 (formerly LBR-101/ RN-307) is a monoclonal antibody
that binds to calcitonin gene-related peptide (CGRP), a
well-validated target in migraine. CGRP signaling may be disrupted
by targeting the ligand itself or its receptor.
Teva's approach targets the ligand, allowing for some CGRP
signaling during therapy. This avoids the potential effects of a
long-term total disruption to the normal physiological functions of
the CGRP system – which are unknown.
TEV-48125 is being developed for two distinct migraine
indications; chronic migraine and high frequency episodic migraine.
Data from a Phase IIb study, evaluating TEV-48125 in the preventive
treatment of high frequency episodic migraine, is expected to
report in the second quarter of 2015.
TEV-48125 successfully completed five Phase I trials with 94
healthy volunteers. Results were published in Cephalalgia, the
official journal of the International Headache Society, in December
2013, and presented at the 2014 annual meeting of the American
Academy of Neurology. Most treatment-related adverse events were
mild, transient and resolved spontaneously.
About Chronic Migraine:
Approximately 3.2 million Americans, mostly women, suffer from
Chronic Migraine*. Chronic migraine is characterized by headaches
on at least 15 days per month. Chronic migraine patients are often
referred to as the ‘invisible population’ due to the isolating
nature of the condition, where patients are left, in many cases,
effectively house-bound.
The World Health Organization (WHO), listed chronic migraine as
4th in a table of disabling conditions. This ranked it in the same
disability class as quadriplegia, acute psychosis and dementia, and
more disabling than blindness, paraplegia, angina or rheumatoid
arthritis.**
Chronic migraine imposes a considerable burden on patients,
magnified by the paucity of approved treatment options for this
condition. More than one in four of all migraineurs are candidates
for preventive therapy, and a substantial proportion of those who
might benefit from prevention do not receive it.* Consequently, the
prophylactic treatment of chronic migraine continues to present
considerable challenges, and there remains a significant medical
need for new, safe and effective migraine prophylaxis options.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Cautionary Notice Regarding Forward-Looking
Statements
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our innovative
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents) and our ability to migrate users to
our new 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality
production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions
as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices, particularly for our specialty
pharmaceutical products; adverse effects of political or economic
instability, major hostilities or acts of terrorism on our
significant worldwide operations; interruptions in our supply chain
or problems with internal or third-party information technology
systems that adversely affect our complex manufacturing processes;
significant disruptions of our information technology systems or
breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; the impact of continuing consolidation
of our distributors and customers; decreased opportunities to
obtain U.S. market exclusivity for significant new generic
products; potential liability in the U.S., Europe and other markets
for sales of generic products prior to a final resolution of
outstanding patent litigation; our potential exposure to product
liability claims that are not covered by insurance; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare
and Medicaid reporting and payment obligations; significant
impairment charges relating to intangible assets, goodwill and
property, plant and equipment; the effects of increased leverage
and our resulting reliance on access to the capital markets;
potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2014 and
in our other filings with the U.S. Securities and Exchange
Commission. 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 statement, whether as a result of new
information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
Mannix, (215) 591-8912United StatesorRan Meir, (215)
591-3033United StatesorTomer Amitai, 972 (3)
926-7656IsraelorPR:Iris Beck Codner, 972 (3)
926-7687IsraelorDenise Bradley, (215) 591-8974United
States
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