Both high and low dose TEV-48125 demonstrated significant reduction
in number of headache hours and headache days in patients.
Data establishes proof of concept as the first anti-CGRP study in
chronic migraine patients to report.
JERUSALEM--(BUSINESS WIRE)--Feb. 24, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (“Teva”) announced today
positive results from a Phase IIb study evaluating the efficacy, safety
and tolerability of two doses of subcutaneous TEV-48125, an
investigational anti-calcitonin gene-related peptide (CGRP) monoclonal
antibody for the prevention of chronic migraine (migraine with headaches
on at least 15 days per month).
The study compared two active arms of different doses of TEV-48125,
administered as a subcutaneous injection, once a month for three months,
against placebo. Results demonstrated that both tested doses of
TEV-48125 achieved the primary and secondary efficacy endpoints of the
study at one and three months. The data revealed a significant and
clinically relevant reduction in both the number of monthly cumulative
headache hours, and the number of headache days of at least moderate
severity, relative to baseline.
In this study no important safety or tolerability concerns were
identified. The adverse event profile for TEV-48125 appeared similar to
placebo and supportive of previous Phase I 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 adverse events were seen.
“For the first time in chronic migraine, there is clinical data on the
positive role of calcitonin gene-related peptide signaling disruption
using a monoclonal antibody” said Marcelo E. Bigal, Teva’s Head of
Global Clinical Development for Migraine and Headaches.
“Chronic migraine is a challenging, complex and highly debilitating
condition that desperately needs effective new treatment options” said
Michael Hayden, Teva’s President of Global R&D and Chief Scientific
Officer. “These results in support of TEV-48125 take us a step closer to
realizing the potential of the anti-CGRP ligand-based approach for
millions of women and men who suffer from chronic migraine.”
Full results from the study will be presented at a forthcoming meeting
and will be submitted to a peer-reviewed journal for publication.
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 were
randomized to one of three treatment arms receiving high dose TEV-48125,
low dose TEV-48125 or placebo, given subcutaneously once a month for
three months. 261 patients were included in the trial, 172 receiving
TEV-48125
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 is being developed for two distinct migraine indications;
chronic migraine and high frequency episodic migraine. Data from a Phase
IIb study, evaluating TEV-48125 in the preventive treatment of high
frequency episodic migraine, is expected to report in the second quarter
of 2015.
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. 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.
Cautionary Notice Regarding Forward-Looking Statements
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 new 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C.
Mannix, (215) 591-8912
United States
or
Ran Meir,
(215) 591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
PR:
Iris Beck Codner,
972 (3) 926-7687
Israel
or
Denise Bradley, (215)
591-8974
United States