- Both doses of TEV-48125 demonstrated
statistically significant reduction in the number of headache hours
(primary endpoint) after just one week
- More than half of the patients in each
dose group experienced a 50% or more decrease in headache frequency
(P<0.01 for both doses vs. placebo)
- Nearly one third of patients in each
dose group had a 75% decrease in headache frequency (p < 0.05
for both doses).
- Around 15% were totally free of
headaches at month three
- By the end of the study, nearly 60% of
patients reverted from chronic (>15 headache days per month) to
episodic migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced the presentation of further data from its chronic
migraine phase 2b study evaluating the efficacy and safety, versus
placebo, of two doses of TEV-48125, an anti-calcitonin gene-related
peptide (CGRP) ligand monoclonal antibody. These data will be
presented on Friday, May 15th, 2015, as a late breaking oral
presentation at the 17th Congress of the International Headache
Society (IHC 2015).
Both assessed doses of TEV-48125 (loading of 675 followed by
monthly injections of 225 mg or 900 mg), were significantly
superior to placebo in reducing, relative to baseline, the number
of hours with headache (primary endpoint - p < 0.05 and p <
0.01). TEV-48125 also significantly decreased the number of
headache days of moderate or severe intensity in month 3 (secondary
endpoint - p < 0.05 and p < 0.05).
A priori analyses indicated that separation from placebo was
seen after a single dose of therapy, and exploratory analyses also
showed both doses of TEV-48125 separating from placebo as early as
one week post-treatment: decrease of headache hours from baseline
(primary endpoint) at week 1 was -9.1 for TEV-48125 675/225mg (p =
0.03), -11.4 for 900 mg (p = 0.003), and -2.8 for placebo. This
benefit increased progressively at 1 month, with decreases of -44.1
hours for 675/225 mg (p = 0.003), -56.82 hours for 900 mg (p <
0.001) and -18.1 hours for placebo. At three months decreases were
-59.8 for 675/225 mg (p = 0.04) -67.5 for 900 mg (p = 0.006) and
-37.1 for placebo. Similar decreases were seen for number of
moderate/severe headache days (secondary endpoint), where both
doses separated from placebo at 2 weeks, and maintained at 1 month
and 3 months.
Additionally, TEV-48125 was associated with a significant
decrease in the consumption of acute migraine medications. No
treatment-related serious adverse events were reported with use of
TEV-48125. Most common AEs were mild injection-site pain or
pruritus. No other relevant differences in the rate of
treatment-emergent adverse events occurred for those receiving
TEV-48125 doses relative to placebo. Antibodies anti-drug were the
lowest in class up to this point (1.1% for TEV-48125 in this trial,
and present before drug exposure).
Furthermore, 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.
The study was conducted amongst 264 highly severe chronic
migraine patients who suffered from a mean of approximately 162
headache hours per month (approx. 17 migraine days per month, and
around 21 days of headache per month). They had suffered from
migraines for mean period of 18 years. Amongst the most affected of
these patients (upper third), 42% reverted to episodic migraine in
the 675/225 mg arm and 43% in the 900 mg arm, vs 22% in placebo.
Overall, by the end of the study nearly 60% of patients reverted
from chronic to episodic migraine.
"Chronic migraine represents an incredibly debilitating
neurological disorder which significantly diminishes quality of
life and disables the sufferers," said Alan M. Rapoport, M.D.
President of the International Headache Society, as well as
Clinical Professor of Neurology at The David Geffen School of
Medicine at UCLA, Los Angeles, and a co-author of the study.
"Although all individuals with chronic migraine qualify for
preventive therapy, most do not receive it and a substantial
proportion of those who receive it, end up discontinuing therapy.
These data provide a basis for real hope for chronic migraine
patients. The speed and magnitude of reductions in migraine hours
and days seen in this trial may significantly, and positively,
impact the lives of these patients."
"These results with TEV-48125 have not previously been achieved
at any phase in chronic migraine. They are highly statistically
significant, and provide a solid foundation to advancing the
program into phase III", said Michael Hayden, Teva’s President of
Global R&D and Chief Scientific Officer. "Patients who
have suffered from chronic migraine for many years now have a very
good reason for hope."
About the Study
The study was a multicenter, randomized, double-blind,
double-dummy, placebo-controlled, parallel group, multi-dose study
comparing TEV-48125 with placebo. Following a 28 day run-in period,
qualifying patients (n=264) were randomized to one of three
treatment arms receiving high dose TEV-48125 (900mg), low dose
TEV-48125 (675/225 mg) or placebo, given subcutaneously once a
month for three months.
Subjects had their headache and health information captured
daily during the entire study, using an electronic headache diary
system. 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. 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. Data from a recently announced Phase
IIb study for the prevention of high frequency episodic migraine,
also demonstrated the efficacy and safety of two doses of TEV-48125
in 300 patients. Findings were consistent with the chronic migraine
data achieving highly significant reductions in mean monthly
migraine days after a single dose, establishing TEV-48125 as the
first, and only, treatment to date to meet efficacy and safety
endpoints in trials of both chronic and episodic migraine and
across multiple doses.
TEV-48125 successfully completed six Phase I trials with 118
healthy volunteers receiving active drug. 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. Most treatment-related
adverse events were mild, transient and resolved spontaneously.
About Chronic Migraine:
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.
The World Health Organization (WHO), listed chronic migraine as
4th in a table of disabling conditions. This ranked it in the same
disability class as quadriplegia, acute psychosis and dementia, and
more disabling than blindness, paraplegia, angina or rheumatoid
arthritis.**
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.
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.
Teva Pharmaceutical Industries Ltd.IR:Kevin C. Mannix,
(215) 591-8912United StatesorRan Meir, (215) 591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPR:Iris
Beck Codner, 972 (3) 926-7687IsraelorDenise Bradley,
(215) 591-8974United StatesorNancy Leone, (215)
284-0213United States
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