Zoek in het archief
 
terug

Check the original
News breaking: 2017-09-10

Teva Showcases Data Demonstrating Potential of Fremanezumab to Addre..


Previous Article
Teva Announces Exclusive Launch of Gen...
Teva Showcases Data Demonstrating Potential of Fremanezumab to Address Significant Unmet Need in Patients with Chronic and Episodic Migraine

Late-Breaking Data Presented at IHC Highlight Primary and Secondary
Outcome Measure Results from Chronic and Episodic Migraine Phase III
Clinical Trials

JERUSALEM--(BUSINESS WIRE)--Sep. 9, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) has presented
new data evaluating fremanezumab, an investigational treatment for the
prevention of migraine, at the 18th Congress of the
International Headache Society (IHC) in Vancouver, Canada. Data
presented across two platform presentations and five late-breaking
abstracts featured detailed, positive efficacy results from pivotal
Phase III HALO studies of fremanezumab in chronic (CM) and episodic
migraine (EM), as well as data from patient-reported outcomes tools in
the chronic migraine trial.
“We developed a clinical program for fremanezumab that was
patient-centered, and closely mimicked the real-world experience of
people living with the debilitating effects of migraine,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific
Officer at Teva. “We are very proud to be a leader in the development of
this new type of preventive treatment for migraine, which we believe
holds tremendous potential to make a meaningful difference in the lives
of the millions of people around the world suffering from migraine.”
“The statistically significant results from the CM and EM trials across
multiple measures of migraine burden, including improvement in quality
of life and disability, highlight the potential of fremanezumab to
provide patients with meaningful relief,” said Marcelo Bigal, M.D.,
Ph.D., Chief Medical Officer & Head of Specialty Clinical Development at
Teva. “After validating the target for CM and EM in the Phase II
clinical trials, we are thrilled to present these results to the
migraine community, providing a deeper view into the pivotal trial
design and full results of the HALO program.”
Across the Phase III HALO studies in chronic and episodic migraine,
fremanezumab achieved statistically significant and clinically
meaningful results for all 25 primary and secondary analyses in both
monthly and quarterly dosing regimens. In the chronic migraine study,
endpoint analyses presented at IHC include:
Significant reduction in the number of monthly headache days of at
least moderate severity during the 12-week period after 1st dose for
both dosing regimens [monthly (-4.6 days) and quarterly (-4.3 days)
versus placebo (-2.5 days); p<0.0001]
Statistically significant reduction in the number of monthly migraine
days during the 12-week period after the 1st dose, for both dosing
regimens [monthly (-5.0 days from a baseline of 16.0 days) and
quarterly (-4.9 days from a baseline of 16.2 days) versus placebo
(-3.2 days from a baseline of 16.3 days); p<0.0001], and during the
4-week period after 1st dose, for both dosing regimens (p<0.0001)
Improvement in Migraine-Specific Quality of Life scores for both
dosing regimens [least-squares mean ± standard error differences
versus placebo: monthly (6.3±1.4) and quarterly (5.6±1.4); p<0.0001]
Improvement in overall health status as measured by the EuroQol
5-dimension 5 response level (EQ-5D-5L) questionnaire for both dosing
regimens [quarterly (4.6±1.1; p=0.0402) and monthly (4.8±1.1;
p=0.0291) versus placebo (2.2±1.1)]
Significant reduction in the weekly number of headache days of at
least moderate severity at week 1 (-1.1 days; p<0.0001) versus placebo
(-0.5 days)
Larger reductions from baseline in overall work productivity loss
(composite of absenteeism and impairment while working [presenteeism])
compared with placebo (–16.6%±2.09% [quarterly] and –15.9%±2.02%
[monthly] vs –9.1%±2.02% [placebo]), resulting in significant
treatment differences for each fremanezumab treatment arm versus
placebo (quarterly: –7.5%±2.24%, P=0.0009; monthly: –6.8%±2.26%,
P=0.0026) in patients with CM
Significant reduction in impairment of activity outside of work in the
quarterly dosing arm of the study compared with placebo (–15.0%±1.70%
vs –11.0%±1.7%; treatment difference of –4.0%±1.85%, P=0.0311) in
patients with CM
Reduction in the number of monthly days of acute headache medication
use for both dosing regimens [monthly (-4.2 days) and quarterly (-3.7
days) versus placebo (-1.9 days); p<0.0001]
Improvement of a >50% reduction in monthly average number of headache
days of at least moderate severity with both dosing regimens [monthly
(40.8%) and quarterly (37.6%) versus placebo (18.1%); p<0.0001]
Improvement in disability as measured by the 6-item Headache Impact
Test (HIT-6) with both dosing regimens [monthly (-6.8; p<0.0001) and
quarterly (-6.4; p=0.0001) versus placebo (-4.5)]
In episodic migraine, endpoint analyses presented at IHC include:
Reduction in the number of monthly migraine days during the 12-week
period for both dosing regimens [monthly (-3.7 days from a baseline of
9.2 days) and quarterly (-3.4 days from a baseline of 8.9 days) versus
placebo (-2.2 days from a baseline of 9.1 days); p<0.0001] and during
the 4-week period after 1st dose, for both dosing regimens
Reduction in the number of monthly headache days of at least moderate
severity during the 12-week period for both dosing regimens [monthly
(-2.9 days) and quarterly (-3.0 days); vs placebo (-1.5 days);
p<0.0001)] and during the 4-week period after 1st dose, for both
dosing regimens (p<0.0001)
Significant reduction in the number of monthly days of acute headache
medication use for both [monthly (-3.0 days) and quarterly (-2.9 days
versus placebo (-1.6 days) ); p<0.0001]
A ≥50% reduction in monthly average number of migraine days of least
moderate severity for both dosing regimens [monthly (47.7%) and
quarterly (44.4%) versus placebo (27.9%); p<0.0001]
Improvement in disability as measured by the Migraine Disability
Assessment (MIDAS) for both dosing regimens [monthly (-24.6; p=0.0021)
and quarterly (-23.0; p=0.0023) versus placebo (-17.5)]
The most commonly-reported adverse event in the episodic and chronic
migraine trials was injection site pain, with similar rates in the
placebo and active groups.
“The results we have presented at IHC are truly exciting and reflect
Teva’s commitment to developing and delivering medicines to meet the
needs of patients around the world living with chronic diseases,” said
Ernesto Aycardi, M.D., Vice President & Therapeutic Area Head, R&D,
Migraine and Headache at Teva. “With our full CM and EM pivotal results
presented to the migraine community, we now look forward to filing a BLA
in the U.S. later this year, bringing us one step closer to potentially
bringing a new, preventive migraine treatment option to patients.”
About Fremanezumab (TEV-48125)
Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP
ligand, a well-validated target in migraine. With limited availability
of preventive treatment options, fremanezumab represents a potential new
option to address a significant unmet medical need.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies are 16-week, multicenter,
randomized, double-blind, placebo-controlled, parallel-group studies to
compare the safety, tolerability, and efficacy of four dose regimens of
subcutaneous fremanezumab compared to placebo in adults with episodic
and chronic migraine. The studies consist of a screening visit, a 28-day
run-in period, and a 12-week (84-day) treatment period, including a
final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks
[28 days] after the final dose of study drug).
In the EM study, 875 patients were enrolled (294, 291, 290 patients in
the placebo, quarterly, and monthly dose groups, respectively).
Patients were randomized in a 1:1:1 ratio to receive subcutaneous
injections of fremanezumab at 225 mg (monthly dose regimen) for three
months, fremanezumab at 675 mg at initiation followed by placebo for
two months (quarterly dose regimen), or three monthly doses of
matching placebo. The primary efficacy endpoint of the EM study was
the mean change from baseline (28-day run-in period) in the monthly
average number of migraine days during the 12-week period after the
first dose of fremanezumab.
In the CM study, 1,130 patients were randomized (around 376 patients
per treatment group). Patients were randomized in a 1:1:1 ratio to
receive subcutaneous injections of fremanezumab at 675 mg at
initiation followed by monthly 225 mg for two months (monthly dose
regimen), fremanezumab at 675 mg at initiation followed by placebo for
two months (quarterly dose regimen), or three monthly doses of
matching placebo. The primary efficacy endpoint of the CM study was
the mean change from baseline (28-day run-in period) in the monthly
average number of headache days of at least moderate severity during
the 12-week period after the first dose of fremanezumab.
About Migraine
Migraine is an unpredictable neurological condition with symptoms such
as severe head pain and physical impairment that can impact quality of
life and productivity. There are two clinical manifestations of migraine
– chronic, where patients suffer 15 or more headache days per month, and
episodic, where patients have 14 or less headache days per month.
Worldwide, approximately 90% percent of people diagnosed with migraine
have episodic migraine and 10% have chronic migraine.
With more than 1 billion people affected worldwide, migraine is the
third most prevalent illness in the world and the 6th most disabling
illness in the world. In the U.S., EU5 and Japan, nearly 75 million
people suffer from episodic and chronic migraine – more than 38 million
in the U.S. alone. Of the approximately 40% of patients suffering from
migraine for whom prevention is appropriate, only 13% are currently
receiving therapy. There remains a significant medical need for
treatments designed specifically to prevent migraine. According to
recent analysis, the economic burden for migraine patients reaches
approximately $78 billion per year in the U.S.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200 million
patients over 60 markets every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its portfolio of
more than 1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Statements Regarding Forward-Looking Information:
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the potential benefits and commercialization of Fremanezumab,
which are based on management’s current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and unknown,
that could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
the uncertainty of commercial success of Fremanezumab;
challenges inherent in product research and development, including
uncertainty of obtaining regulatory approvals;
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our leading medicine, which
faces competition from existing and potential additional generic
versions and orally-administered alternatives; our ability to achieve
expected results from investments in our product pipeline; competition
from companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
our business and operations in general, including: our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our or third party
information technology systems or breaches of our data security; the
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products;
compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
government scrutiny of our patent settlement agreements; failure to
comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F for
the year ended December 31, 2016 (“Annual Report”), including in the
section captioned “Risk Factors,” and in our other filings with the
U.S. Securities and Exchange Commission, which are available at www.sec.gov
and www.tevapharm.com.
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 statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these forward-looking
statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170909005003/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
MannixUnited States(215) 591-8912orRan
MeirUnited States(215) 591-3033orTomer
AmitaiIsrael972 (3) 926-7656orPR Contacts:Iris
Beck CodnerIsrael972 (3) 926-7208orDenise
BradleyUnited States(215) 591-8974
Share on FacebookShare on LinkedIn