The FOCUS study looked at patients who
previously experienced inadequate response to two to four migraine
preventive medication classes. Treatment with fremanezumab
was shown to be effective versus placebo.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that results from the Phase IIIb FOCUS study, which
examined fremanezumab versus placebo in adult migraine patients who
previously experienced inadequate responses to two to four classes
of preventive treatments, were published online ahead of print in
The Lancet. The study found fremanezumab was superior versus
placebo across all primary and secondary endpoints. The primary
outcome measure of the trial was mean change from baseline in the
monthly average number of migraine days during the 12-week
treatment period following the first dose. Treatment resulted in
statistically significant reductions in monthly average number of
migraine days in participants who received either monthly or
quarterly dosing with fremanezumab during the study.
“As a physician, it is extremely rewarding to see that patients
with very difficult-to-treat migraine experienced clinically
significant improvement with fremanezumab,” said Professor Michel
D. Ferrari, MD, PhD, lead author and Chair Leiden Centre for
Translational Neuroscience, Leiden University Medical Centre,
Leiden, The Netherlands. “More than a third of patients achieved a
clinically meaningful 50% reduction in monthly migraine days within
just four weeks of initiating treatment.”
Fremanezumab is approved in the U.S. and Europe for the
preventive treatment of migraine in adults. The FOCUS study, a
randomized, double-blind, parallel-group, placebo controlled study,
evaluated the efficacy of two dosing regimens of fremanezumab (675
mg quarterly or 225 mg monthly) in a large population of adult
patients (aged 18-70) with episodic or chronic migraine who had
documented prior inadequate response* within the past ten years to
two-to-four pharmacological classes of migraine preventive
medications: beta blockers, anticonvulsants, tricyclic
antidepressants (amitriptyline), calcium channel blockers
(flunarizine), angiotensin II receptor antagonists (candesartan),
onabotulinumtoxinA, or valproic acid.
Between November 2017 and July 2018, 838 patients with episodic
(39 percent) or chronic (61 percent) migraine were randomized
(1:1:1) by electronic interactive response technology (IRT) at 104
sites in 14 countries to placebo (n=279), quarterly fremanezumab
(n=276), or monthly fremanezumab (n=283). Both patients with and
without overuse of acute headache medication were included.
Reductions from baseline in monthly days with migraine, moderate to
severe headache, or use of acute headache medications were about
3.5 days (30 percentage points) greater with fremanezumab than with
placebo (p<0.0001). The odds relative to placebo for achieving a
≥50 percent reduction in migraine days as early as four weeks after
starting study treatment were approximately six-fold higher with
fremanezumab (p<0.0001). Patients treated with fremanezumab had
3.1- to 3.8-day greater reductions in migraine days (from 9.4 to
17.1 days at baseline) across dosing and migraine classification
subgroups than patients receiving placebo (p<0.0001),
representing a therapeutic gain of 26 to 39 percentage points.
“Migraine can be debilitating for patients – and frustrating for
those who have failed multiple preventive treatments,” said Joshua
M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine &
Headache at Teva. “We continue our clinical trial efforts in the
area of migraine research and we are very pleased with the FOCUS
results. Fremanezumab shows promise for patients with migraine, and
being published in the Lancet, a very prestigious medical journal,
demonstrates the value of the clinical work being done at Teva to
support and elevate the need for migraine education and
treatment.”
The most common adverse reactions in the study were injection
site reactions. Less than 1 percent of patients in the fremanezumab
group experienced an adverse event leading to discontinuation.
Patients with major comorbid diseases, including major
cardiovascular disease, were excluded from participation in this
study.
*Inadequate response was defined as no clinically meaningful
improvement after at least three months of therapy at a stable
dose, per the treating physician’s judgement; discontinuation due
to adverse events that made treatment intolerable; or the treatment
was contraindicated or unsuitable for the preventive treatment of
migraine for the patient. Documentation of prior failure to
migraine preventive medication was generally based on the patient’s
medical record, with the medication name, treatment duration, dose
level and reason for discontinuation. If obtaining the medical
record was not possible, the treating physician could provide an
affidavit confirming prior treatment failures according to the
protocol definition.
About Fremanezumab
Fremanezumab is available as a 225 mg/1.5mL single dose
injection in a prefilled syringe with two dosing options – 225 mg
monthly administered as one subcutaneous injection, or 675 mg every
three months (quarterly), administered as three subcutaneous
injections. Fremanezumab can be administered in office by a
healthcare professional or at home by a patient or caregiver. No
starting dose is required to begin treatment. Fremanezumab is
marketed in the United States as AJOVY® (fremanezumab-vfrm)
injection and as AJOVY®■ in Europe.
U. S. Important Safety Information about AJOVY
AJOVY is indicated for the preventive treatment of migraine in
adults.
Contraindications: AJOVY is contraindicated in patients
with serious hypersensitivity to fremanezumab-vfrm or to any of the
excipients.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, pruritus, drug hypersensitivity, and urticaria were
reported with AJOVY in clinical trials. Most reactions were mild to
moderate, but some led to discontinuation or required
corticosteroid treatment. Most reactions were reported from within
hours to one month after administration. If a hypersensitivity
reaction occurs, consider discontinuing AJOVY and institute
appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5%
and greater than placebo) were injection site reactions.
Please click here for full U. S. Prescribing Information for
AJOVY® (fremanezumab-vfrm) injection.
Information for Europe about AJOVY■ can be found
here.
AJOVY is indicated to prevent migraine in adults who have at
least four migraine days a month.
■Adverse events should be reported.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events.
Reporting forms and information can be found at https://
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. Adverse events should also be
reported to Teva – please refer to local numbers.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding 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:
- challenges inherent in product research and development,
including uncertainty of clinical success and obtaining regulatory
approvals;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; competition for our specialty products, especially
COPAXONE®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AJOVY® or AUSTEDO®; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: failure to
effectively execute our restructuring plan announced in December
2017; uncertainties related to, and failure to achieve, the
potential benefits and success of our senior management team and
organizational structure; harm to our pipeline of future products
due to the ongoing review of our R&D programs; our ability to
develop and commercialize additional pharmaceutical products;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; compliance with
sanctions and other trade control laws; 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 failure to
recruit or retain key personnel; variations in intellectual
property laws that may adversely affect our ability to manufacture
our products; challenges associated with conducting business
globally, including adverse effects of political or economic
instability, major hostilities or terrorism; significant sales to a
limited number of customers in our U.S. market; our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions;
implementation of a new enterprise resource planning system that,
if deficient, could materially and adversely affect our operations
and/or the effectiveness of our internal controls; and our
prospects and opportunities for growth if we sell assets;
- 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; increased legal and regulatory action in connection
with public concern over the abuse of opioid medications in the
U.S.; governmental investigations into selling and marketing
practices; potential liability for patent infringement; 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;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and 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;
and other factors discussed in our Quarterly Reports on Form
10-Q for the first and second quarter of 2019 and in our Annual
Report on Form 10-K for the year ended December 31, 2018, including
in the sections captioned "Risk Factors” and “Forward Looking
Statements.” 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.
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IR Contacts United States Kevin C. Mannix
(215) 591-8912 Ran Meir 972 (3) 926-7516
PR Contacts United States Doris
Saltkill (913) 777-3343 Israel Yonatan Beker 972
(54) 888 5898
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