Late breaking data examines 10-year cost
effectiveness of fremanezumab, while one oral presentation and 29
posters highlight FOCUS Phase IIIb study data in adult patients
with migraine and documented inadequate response to 2-4 classes of
prior preventive treatments, along with patient survey results and
post hoc efficacy results following the 1-year Phase III HALO
long-term study
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the Company will present more than 30 analyses on
fremanezumab, at the 19th Congress of the International Headache
Society (IHC), taking place in Dublin, Ireland on September 5-8,
2019. Teva will present late-breaking data evaluating the 10-year
cost effectiveness of fremanezumab and post hoc subgroup analyses
as well as secondary and exploratory endpoint data from the
international, multicentre, randomised, placebo-controlled Phase
IIIb FOCUS study. This study evaluated the efficacy and safety of
quarterly and monthly treatment with fremanezumab compared to
placebo in adult patients with migraine and documented inadequate
response to 2-4 classes of prior preventive migraine treatments.
Also being presented are five posters based on a patient survey
following the one-year Phase III HALO long-term study that examined
the impact of fremanezumab on functioning and productivity in
migraine patients. The presentation of data at this congress
follows the publication of FOCUS study data in The Lancet last
month.
“Migraine is one of the most prevalent diseases in the world,
with more than 1 billion people living with it globally,”1 said
Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine
& Headache, Teva. “We are committed to studying this burdensome
disease and strive to lead the way in migraine research. We are
proud to share a broad range of new fremanezumab data at this
year’s IHC from, amongst others, the largest study to date in
patients who have responded inadequately to 2-4 classes of prior
preventive migraine treatments.”
The FOCUS data analyses at IHC evaluated onset of action,
medication overuse, depression, quality of life, and reversion from
chronic to episodic migraine, and demonstrated a significant
reduction in the number of headache hours and days, and migraine
days, suffered by difficult-to-treat patients with migraine when
treated with monthly or quarterly fremanezumab, compared to
placebo. The most common adverse events included injection site
reactions. A patient survey following the one-year Phase III HALO
long-term study evaluated patient satisfaction with fremanezumab
treatment, and impact on quality of life, and patient preferences
for dosing regimens in the preventive treatment of migraine.
Below is a selection of accepted abstracts being presented at
IHC 2019:
Later Breaking Data:
- [IHC-LB-006] Burden of comorbid depression and anxiety on
migraine-specific health-related quality of life in adult migraine
patients in the United States (September 6, 2019, 11 – 12pm
IST)
- [IHC-LB-030] 10-year cost-effectiveness analyses of
response-based fremanezumab use in migraine patients with
inadequate response to prior preventive treatments (September
6, 2019, 11 – 12pm IST)
- [IHC-LB-037] 10-year cost-effectiveness analyses of
fremanezumab compared to erenumab as preventive treatment in
episodic migraine for patients with inadequate response to prior
preventive treatments (September 6, 2019, 11 – 12pm IST)
- [IHC-OR-040] (de novo): Efficacy and safety of fremanezumab
for the prevention of episodic cluster headache: results of a
randomized, double-blind, placebo-controlled, phase 3 study
(September 8, 2019, 8:20am IST)
Oral Presentation:
- [IHC-OR-012] Very early onset* of action of fremanezumab in
patients with migraine and documented inadequate response to 2-4
classes of migraine preventive treatments: results of the
international, multicentre, randomised, placebo-controlled FOCUS
study (September 7, 2019, 10:30am IST)
Poster Presentations:
- [IHC-PO-138] Efficacy with fremanezumab in migraine patients
with comorbid moderate to severe depression and documented
inadequate response to 2-4 classes of migraine preventive
treatments: subgroup analysis of the randomised, placebo-controlled
FOCUS study(September 6, 2019, 11 – 12pm IST)
- [IHC-PO-137] Early onset* of response to fremanezumab in
migraine patients with moderate to severe depression and documented
inadequate response to 2-4 classes of migraine preventive
treatments: subgroup analysis of the randomised, placebo-controlled
FOCUS study (September 6, 2019, 11 – 12pm IST)
- [IHC-PO-156] Efficacy of fremanezumab in migraine patients
with medication overuse and documented inadequate response to 2-4
migraine preventive medications: subgroup analysis of the
randomised, placebo-controlled FOCUS study (September 6, 2019,
11 – 12pm IST)
- [IHC-PO-148] Impact of fremanezumab on disability in
migraine patients with medication overuse and documented inadequate
response to 2-4 classes of preventive treatments: subgroup analysis
of the randomised, double-blind FOCUS study (September 6, 2019,
11 – 12pm IST)
- [IHC-PO-149] Impact of fremanezumab on migraine-specific
quality of life in patients with medication overuse and documented
inadequate response to 2-4 classes of migraine preventive
treatments: subgroup analysis of the international, multicentre,
randomised, double-blind FOCUS study (September 6, 2019, 11 –
12pm IST)
- [IHC-PO-150] Early onset* of efficacy with fremanezumab in
patients with medication overuse and documented inadequate response
to 2-4 classes of migraine preventive treatments: subgroup analysis
of the randomised, double-blind FOCUS study (September 6, 2019,
11 – 12pm IST)
- [IHC-PO-157] Clinically meaningful responses to fremanezumab
in migraine patients with medication overuse and documented
inadequate response to 2-4 migraine preventive medications in the
randomised, placebo-controlled FOCUS study (September 6, 2019,
11 – 12pm IST)
- [IHC-PO-171] A pharmacokinetic bioequivalence study of
fremanezumab administered subcutaneously using an autoinjector and
a prefilled syringe (September 6, 2019, 11 – 12pm IST)
- [IHC-PO-172] Impact of fremanezumab on any acute headache
medication use in migraine patients with medication overuse and
documented inadequate response to 2-4 migraine preventive
medications in the multicentre, randomised, placebo-controlled
FOCUS study(September 6, 2019, 11 – 12pm IST)
- [IHC-PO-151] Reversion from chronic to episodic migraine in
patients with documented inadequate response to 2-4 classes of
migraine preventive treatments: results of the randomised,
placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm
IST)
- [IHC-PO-384] Efficacy of fremanezumab in male patients with
migraine and documented inadequate response to 2-4 classes of
migraine preventive treatments: results of the randomised,
placebo-controlled FOCUS study (September 7, 14:45 – 15:45pm
IST)
- [IHC-PO-404] Patient preference and satisfaction following
completion of a 1-year extension study (September 7, 14:45 –
15:45pm IST)
- [IHC-PO-388] Functioning and productivity impact of
fremanezumab in migraine patients: a patient survey study following
completion of a 1-year extension study (September 7, 14:45 –
15:45pm IST)
*Early onset of efficacy (efficacy measures: reduction in
migraine days, reduction in headache days, response rate) is
defined as week one following treatment initiation.
About FOCUS
The Phase IIIb FOCUS study is a multicentre, randomised,
double-blind, parallel-group, placebo-controlled study that
evaluated the efficacy, safety, and tolerability of quarterly and
monthly treatment with fremanezumab, compared to placebo. Adult
patients with chronic migraine or episodic migraine who have
responded inadequately to 2-4 classes of prior preventive
treatments were enrolled in the study.
Inadequate response is defined as: lack of efficacy after at
least three months of therapy at a stable dose; or the patient
cannot tolerate the drug; or the drug is contraindicated; or the
drug is not suitable for the patient. The classes of prior
preventive medications include: beta-blockers, anticonvulsants,
tricyclics, calcium channel blockers, angiotensin II receptor
antagonists, onabotulinumtoxinA, and valproic acid.
In the study, chronic migraine and episodic migraine patients
were randomised in blinded-fashion 1:1:1 into one of three
treatment groups – a quarterly dosing regimen, a monthly dosing
regimen or matching placebo. An open-label extension of three
months (weeks 13-24) followed the placebo-controlled portion of the
study.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicentre,
randomised, double-blind, placebo-controlled, parallel-group
studies to compare the safety, tolerability, and efficacy of four
dose regimens (two for EM [quarterly and monthly] and two for CM
[quarterly and monthly]), of subcutaneous fremanezumab compared to
placebo in adults with episodic and chronic migraine. The studies
consisted 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 randomised in a 1:1:1 ratio to receive
subcutaneous injections of fremanezumab at 225 mg for three 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 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 randomised (375, 376, 379
patients in the placebo, quarterly, and monthly groups,
respectively). Patients were randomised 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.
U.S. Important Safety Information about AJOVY®
(fremanezumab)
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.
In the EU, AJOVY is indicated for prophylaxis of migraine in
adults who have at least 4 migraine days per 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.hpra.ie. 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 2,400
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.
References
- GBD 2016 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 328 diseases and
injuries for 195 countries, 1990‐2016: a systematic analysis for
the Global Burden of Disease Study 2016. Lancet.
2017;390:1211‐1259
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