IMPORTANT NEW DATA FROM TEVAS TEV-48125 PHASE 2b MIGRAINE PROGRAM PUBLISHED IN LANCET
NEUROLOGY IN BACK-TO-BACK ARTICLES
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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, September 30th, 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.
Tevas 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 worlds 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. Tevas
net revenues in 2014 amounted to $20.3 billion. For more information, visit
www.tevapharm.com.
Tevas Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on managements 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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