After recently announced positive results in
chronic migraine, TEV-48125 becomes the first treatment to meet
efficacy endpoints in trials of both chronic and episodic migraine
and across multiple doses
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (“Teva”)
announced today the successful completion of its Phase IIb migraine
prevention program with positive top-line results from a Phase IIb
study evaluating the efficacy, safety and tolerability of two doses
of subcutaneous TEV-48125 for the prevention of high frequency
episodic migraine (characterized by 8-14 days of headache per
month).
TEV-48125 is a novel investigational anti-calcitonin
gene-related peptide (CGRP) monoclonal antibody, and these data,
together with the recent results achieved in the difficult to treat
chronic migraine setting, make this the first therapy to
successfully meet efficacy endpoints in the prevention of both
chronic and episodic migraine, and at multiple doses, in advanced
clinical trials.
Initial analysis of results demonstrated that both doses of
TEV-48125 met primary and secondary endpoints achieving significant
reductions in mean monthly migraine days and monthly headache days
relative to baseline. These are considered as validated endpoints
to assess benefits of new migraine treatments.
Additionally, a single administration of both tested doses of
TEV-48125 resulted in a statistically significant separation from
placebo. Data confirm that treatment with TEV-48125 resulted in
separation for both primary and secondary endpoints, at all months
of therapy, in both the chronic and episodic migraine clinical
trials.
Furthermore, these results were achieved in the presence of
patients being allowed to remain on existing migraine prevention
therapy, and without limitation on the amount of acute migraine
treatment used. This was an attribute of the TEV-48125 phase IIb
studies not seen in other reported anti-CGRP studies, and the
results demonstrated separation in favor of TEV-48125 even in
patients considered to be on optimal current therapy. Overall, four
different doses across two indications studied in a total of 561
patients met all study endpoints establishing clinical proof of
concept for anti-CGRP ligand therapy.
“The collective data from this phase II program have validated
the concept of targeting the anti-CGRP ligand with TEV-48125 with a
level of confidence that we did not foresee. We now have reason to
believe that we have developed an approach that gives us the
foundation, with identified doses, to progress to a Phase III
program that we hope will take TEV-48125 a step closer to
potentially making a significant difference to patients’ lives”
stated Marcelo E. Bigal, Teva’s Head of Global Clinical Development
for Migraine and Headaches.
The study compared two active arms of high and low dose
TEV-48125, administered as a subcutaneous injection, once a month
for three months, against placebo. In this study no important
safety or tolerability concerns were identified. The adverse event
profile for TEV-48125 appeared similar to placebo for most
parameters and supportive of previous Phase I and II 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 serious adverse
events were seen.
"Migraine is a truly debilitating disorder. Up to 15% of the
global population is affected by migraine. It causes highly
disabling pain and other symptoms that disrupt the life of the
patient and their families," said Michael Hayden, Teva’s President
of Global R&D and Chief Scientific Officer. "Our phase II
results are striking in their clarity. They provide a quality of
insight rarely seen at this stage of development and offer the
prospect of a new chapter in the lives of patients who have been
suffering the blight of recurrent migraine for many years. "
Full results from the study will be presented at a forthcoming
scientific meeting and will be submitted to a peer-reviewed journal
for publication.
About the HFEM Study
The study was a multicenter, randomized, double-blind,
placebo-controlled, parallel-group, study comparing the efficacy
and safety of two doses of subcutaneous TEV -48125 with placebo for
the preventive treatment of high frequency episodic migraine in 297
patients.
Multiple doses were selected for testing to define dose-response
and allow selection of doses for a Phase 3 study.
Treatment was administered once every 28 days (i.e.; once
monthly) over a 3-month period. 300 patients were enrolled and
randomized to one of three treatment arms receiving high dose
TEV-48125, low dose TEV-48125 or placebo, administered
subcutaneously once a month. 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, which may avoid the potential, unknown,
effects of a long-term total disruption to the normal physiological
functions of the CGRP system. TEV-48125 is being developed for two
distinct migraine indications; chronic migraine and high frequency
episodic migraine. Positive results from the Phase IIb chronic
migraine study were announced in February 2015, demonstrating a
significant reduction in both the number of monthly cumulative
headache hours, and the number of headache days of at least
moderate severity, relative to baseline, and for the first time
validating the target in chronic migraine.
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.
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
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.
IR Contacts:Kevin C. MannixUnited States(215)
591-8912orRan MeirUnited States(215) 591-3033orTomer
AmitaiIsrael972 (3) 926-7656orPR Contacts:Iris Beck
CodnerIsrael972 (3) 926-7687orDenise BradleyUnited
States(215) 591-8974
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