- In both Phase 2b studies, TEV-48125:
- Significantly reduced average monthly
migraine days, headache days and hours relative to baseline.
- Demonstrated consistent clinical
improvement as early as one month after treatment initiation.
- Was associated with a significant
decrease in the consumption of acute migraine medications.
- Was well tolerated with no
treatment-related serious adverse events reported and no
treatment-related emergent Anti-Drug Antibodies (ADA) response
observed.
- Teva is expected to commence Phase III
studies
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-48125TEV-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 MigraineGlobal 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 TevaTeva 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
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150930005770/en/
Teva Pharmaceutical Industries Ltd.IR::United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
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