Teva to Present New Analyses of Fremanezumab and Country-Specific Burden of Migraine at 24th World Congress of Neurology
2019年10月24日 - 9:00PM
ビジネスワイヤ(英語)
Four oral presentations and eight posters
highlight Teva’s commitment to patients with migraine worldwide
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that 12 new analyses will be presented at the 24th World
Congress of Neurology (WCN), taking place in Dubai, United Arab
Emirates on October 27-31, 2019. Among the analyses, Teva will
present on fremanezumab’s efficacy by country in one of the three
oral presentations from the international, multicenter, randomized,
placebo-controlled Phase IIIb FOCUS study. The company will also
provide data in an oral presentation on the burden of migraine
across China, Israel, Russia, South Korea and Turkey, as well as a
poster presentation evaluating the burden of migraine across
Argentina, Brazil, Chile and Mexico.
“As the largest international study to date evaluating patients
with an inadequate response to multiple classes of preventive
migraine treatments, we are proud to be presenting the FOCUS
results to a global audience,” said Joshua M. Cohen, MD, MPH, FAHS,
Global Medical Lead for Migraine & Headache, Teva. “This broad
range of data highlights our global commitment to helping patients
with difficult to treat migraine as well as our leadership in the
CNS therapeutic area of research.”
The FOCUS 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 treatments. Additional FOCUS data
to be presented at WCN include data on reversion from chronic to
episodic migraine, data on the odds of achieving meaningful
response rates on fremanezumab as compared to placebo, and an
analysis demonstrating a significant reduction in the frequency of
migraine aura in patients treated with fremanezumab compared to
placebo.
Data to be presented include:
Oral Presentations:
- [WCN19-1409] Efficacy of fremanezumab by country in patients
with documented inadequate response to 2-4 classes of migraine
preventive medications in the multicentre, randomised,
placebo-controlled FOCUS study (October 30, 2019, 9:10
GST)
- [WCN19-1417] Burden of migraine across China, Israel,
Russia, South Korea, and Turkey: Results from a systematic
literature review (October 30, 2019, 9:20 GST)
- [WCN19-1330] Odds ratios for response to fremanezumab in
migraine patients with inadequate response to 2-4 migraine
preventive medication classes: Results of the FOCUS Phase 3b
study (October 30, 2019, 10:10 GST)
- [WCN19-1372] Reversion from chronic to episodic migraine in
patients with inadequate response to 2-4 classes of migraine
preventive treatments in the FOCUS Phase 3b study (October 30,
2019, 10:20 GST)
Poster Presentations:
- [WCN19-1351] Reduction in migraine days with aura with
fremanezumab in patients with documented inadequate response to 2-4
classes of migraine preventive medications in the FOCUS study
(October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1380] Reversion from chronic to episodic migraine and
clinically meaningful responses to fremanezumab in patients with
inadequate response to 2-4 classes of migraine preventive
medications (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1432] Burden of migraine across Argentina, Brazil,
Chile, and Mexico: Results from a systematic literature review
(October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1590] Reductions in migraine and headache days in
chronic migraine patients with and without prior migraine
preventive treatment use: Subgroup analysis of the HALO CM
study (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1043] Long-term effect of fremanezumab on the overall
number of headache hours and on the duration of remaining headaches
in patients with chronic or episodic migraine(October 30, 2019,
9:30 – 15:00 GST)
- [WCN19-1339] Fremanezumab impact on disability and MSQoL in
patients with inadequate response to 2-4 classes of preventive
medications who reverted from chronic to episodic migraine
(October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1504] Reductions in headache impact test (HIT-6)
scores with fremanezumab and erenumab among patients with episodic
migraine (EM) and 2-4 prior treatment failures: A network
meta-analysis (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1574] Reduction in acute headache medication use with
fremanezumab in chronic migraine patients by prior migraine
preventive treatment use: Subgroup analysis of the HALO CM
study (October 30, 2019, 9:30 – 15:00 GST)
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.
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 (commercialized as AJOVY®), 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 commercial success of AJOVY;
- challenges inherent in product research and development,
including obtaining regulatory approvals for additional indications
for Fremanezumab;
- 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)
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