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In both Phase 2b studies, TEV-48125:
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Significantly reduced average monthly migraine days, headache
days and hours relative to baseline.
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Demonstrated consistent clinical improvement as early as one
month after treatment initiation.
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Was associated with a significant decrease in the consumption
of acute migraine medications.
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Was well tolerated with no treatment-related serious
adverse events reported and no treatment-related emergent
Anti-Drug Antibodies (ADA) response observed.
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Teva is expected to commence Phase III studies
JERUSALEM--(BUSINESS WIRE)--Sep. 30, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that Lancet
Neurology published online, as back-to-back articles, the results
from two Phase 2b studies of TEV-48125, a monoclonal anti-calcitonin
gene-related peptide (CGRP) antibody investigational treatment for the
prevention of chronic migraine and high frequency episodic migraine
(HFEM). The Lancet Neurology ranks first among 194 journals in
the clinical neurology category (2013 Journal Citation Reports®,
Thomson Reuters 2014).
The Phase 2b clinical development program consistently met all primary
and secondary efficacy and safety endpoints for TEV-48125 in 564
patients and across multiple doses. Clinical improvements were exhibited
after a single administration of all tested doses of TEV-48125 in both
episodic and chronic migraine studies.
These results were achieved in the presence of patients being allowed to
remain on existing migraine prevention therapy and the results
demonstrated significant separation in favor of TEV-48125 even in
patients considered to be failing current optimal therapy.
The studies are available online at:
HFEM: http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00249-5/abstract
CM: http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00245-8/abstract
The papers under strict embargo until 6:30pm [NY time] Tuesday, 29
September, 2015.
"These findings constitute an exciting landmark in the development of
migraine prevention treatment options," said Marcelo E. Bigal, MD.,
PhD., Senior Vice President of Clinical Operations & Innovation and
Headaches Therapeutic Area Lead at Teva. "We are delighted with the
publication in Lancet Neurology, a journal that recognizes
the rigor of these studies; we foresee the potential of this drug in
treating a very prominent unmet medical need."
“It is critical to understand the importance of the data published in
these two studies. The positive impact of this novel treatment approach
should dramatically improve the lives of migraineurs”, said Alan M.
Rapoport, MD., Immediate Past-President of the International Headache
Society, Clinical Professor of Neurology at The David Geffen School of
Medicine at UCLA, Los Angeles, and a co-author of both
studies. “Patients with chronic or frequent episodic migraine are
often in extreme pain and severely disabled, sometimes unable to leave
home for 2-3 days at a time. I hope that treating physicians will
digest these studies with the same level of excitement and hope that I
have. In my opinion, we are on a path to dramatic and
unprecedented progress in the management of this incapacitating
condition.”
The Chronic Migraine Study, (ClinicalTrials.gov Identifier:
NCT02021773)
Both assessed doses of TEV-48125 (loading of 675mg followed by monthly
injections of 225mg or 900mg), were significantly superior to placebo in
reducing, relative to baseline, the number of headache-hours (primary
endpoint: p = 0.038 and p = 0.0057) and the number of headache days of
moderate or severe intensity in month 3 (secondary endpoint: p < 0.0345
and p =0.0237). Consistent clinical improvements were evident as early
as one month after treatment initiation, demonstrating a rapid onset of
relief. Post-hoc analysis indicated that over half of the patients in
both dose groups experienced a 50% or more decrease in headache
frequency (p<0.01 for both doses vs. placebo), nearly one third of
patients in both dose groups had a 75% decrease in headache frequency (p
< 0.05 for both doses) and around 15% were totally free of headaches at
month three.
Treatment with TEV-48125 was also associated with statistically
significant decreases in acute drug consumption in parallel. These
results were achieved amongst highly severe chronic migraine patients
(suffered from migraines for a mean period of 18 years, with
approximately 17 migraine days per month), who were allowed to remain on
other migraine prevention therapies.
The High Frequency Episodic Migraine (HFEM) Study
(ClinicalTrials.gov Identifier: NCT02025556)
This is the first study to report on more than one dose of a monoclonal
anti-CGRP antibody for the preventive treatment of HFEM, and the study
was highly positive, especially considering the severity of the
disorder. Participants had migraine for nearly two decades, with a mean
of 11.4 migraine-days per month, and 12.5 headache-days per month.
Following 12 weeks, both doses of TEV-48125 (225 mg and 675 mg) exceeded
primary and secondary endpoints, achieving statistically significant and
clinically meaningful reductions in mean monthly migraine days and
monthly headache days as well as significantly diminished number of days
and hours of headaches of at least moderate severity.
A decrease of at least 50% of migraine days for the duration of the
study were seen in 53% (p = 0.0005) and 59% (p<0.0001) of the
individuals given 225mg and 675mg correspondingly versus 28% of those
receiving placebo. A decrease of at least 75% in episodic migraine days
was observed in 11%, 34% (p = 0.0001) and in 31% (p = 0.0008) of the
individuals given placebo, 225mg and 675mg respectively. Design and
analyses also had the same rigor of a phase 3 trial.
In both studies no treatment-related serious adverse events were
reported with use of TEV-48125. No relevant differences in the rate of
treatment-emergent adverse events occurred for those receiving TEV-48125
doses relative to placebo. Anti-drug antibodies (1% for TEV-48125, and
present before drug exposure) detected an optimized assay of regulatory
quality and much lower than detected with other monoclonal anti-CGRP
antibodies.
About TEV-48125
TEV-48125 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, thus 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, administered as a once-monthly subcutaneous injection, is
being developed for both chronic migraine and high frequency episodic
migraine.
About Migraine
Global prevalence of migraine is estimated to
be almost 15%. Migraine was ranked seventh highest among specific causes
of disability globally, responsible for 2.9% of all Years Lost to
Disability (YLDs). Migraine is, by a wide margin, the leading cause of
disability among neurological disorders, accounting for over half of all
YLDs attributed to these (J Headache Pain. 2013; 14(1): (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606966/).
In the United Kingdom, for example, some 25 million working- or
school-days are lost every year because of migraine alone (http://www.who.int/mediacentre/factsheets/fs277/en/).
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.
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.
Episodic Migraine impacts up to 14% of the population, and approximately
20% of women, globally. High frequency episodic migraine substantially
impacts the individual, their family, and society. Episodic migraine is
the most common neurological condition, more prevalent than diabetes,
epilepsy and asthma combined.
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.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
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 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
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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.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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