First bulleted paragraph, second sentence of release dated May
15, 2018 should contain the numbers 4.9, 5.3 and 6.5 (instead of
4.6, 4.9 and 5.9, respectively). Third bulleted paragraph,
second sentence, the first number should read 4.4 (instead of 4.5),
and the final number should read 5.8 (instead of 5.4). Fourth
paragraph, third sentence should read ...38.0, 41.7, and 37.3...
(instead of ...38.3, 39.2, and 37.1...). Fourth paragraph,
fourth sentence should read ...14.6 points for quarterly...
(instead of ...14.5 points for quarterly...). Also fourth
paragraph, fourth sentence should read ...19.4 points for placebo.
(instead of ...19.7 points for placebo.)
The corrected release reads:
TEVA ANNOUNCES PUBLICATION OF PHASE III
TRIAL DATA OF FREMANEZUMAB FOR THE PREVENTIVE TREATMENT OF EPISODIC
MIGRAINE IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the publication of data from the Phase III HALO study
evaluating the efficacy, safety, and tolerability of both quarterly
(every three months) and monthly subcutaneous dosing regimens of
fremanezumab for the prevention of episodic migraine (EM). These
pivotal data were published online today by The Journal of the
American Medical Association (JAMA). Fremanezumab is a monoclonal
antibody that selectively targets CGRP (calcitonin gene-related
peptide), a neuropeptide involved in the pathophysiology of
migraine. The study evaluated the use of both quarterly and monthly
dosing regimens of subcutaneous fremanezumab, compared with placebo
in patients with EM (defined as 14 migraine headache days or less
per month) who had previously failed multiple medication
classes.
“The results of the HALO study are encouraging and provide
insight into the effect of targeting the underlying biological
mechanisms of migraine,” said Tushar Shah, M.D., Senior Vice
President, Head of Specialty Clinical Development at Teva. “Acute
migraine treatments were permitted in this study, and a subset of
patients were allowed to continue treatment with existing
preventive migraine therapies while using fremanezumab. Results
from this trial may offer insight into helping patients achieve
their treatment goals including those patients who continue to
experience disabling migraine.”
The HALO EM trial met its primary endpoint demonstrating that
fremanezumab significantly reduced monthly migraine days for both
quarterly and monthly dosing regimens:
- The baseline mean number of monthly
migraine days was 8.9, 9.2, and 9.1 days in the monthly dosing,
quarterly dosing, and placebo groups, respectively. During the
12-week period after the first dose, fremanezumab treatment
significantly reduced monthly migraine days to 4.9 days for monthly
(P < 0.001) and 5.3 days for quarterly (P < 0.001) dosing
compared with 6.5 days for placebo.
- Response rates of ≥50% reduction in
monthly average number of migraine days were also significantly
greater in monthly (47.7%, P < 0.001) and quarterly (44.4%, P
< 0.001) dosing compared with placebo (27.9%).
- Additionally, the baseline mean number
of monthly days of any acute headache medication use was 7.7, 7.9,
and 7.7 days in the monthly, quarterly, and placebo groups,
respectively. Fremanezumab significantly reduced monthly days of
any acute headache medication use to 4.4 days for monthly (P <
0.001) and 4.6 days for quarterly (P < 0.001) dosing compared
with 5.8 days for placebo.
The mean change in the Migraine Disability Assessment (MIDAS)
score was also measured. The MIDAS questionnaire assesses
headache-related disability based on lost days of activity over the
previous three months, with scores of 0–5 (little or no
disability), 6–10 (mild disability), 11–20 (moderate disability),
and ≥21 (severe disability). Baseline mean MIDAS scores were 38.0,
41.7, and 37.3 points in the monthly, quarterly, and placebo
groups, respectively. MIDAS scores improved with fremanezumab to
12.6 points for monthly (P < 0.001) and 14.6 points for
quarterly (P = 0.002) dosing compared with 19.4 points for placebo.
The multicenter, randomized, double-blind, placebo-controlled,
parallel-group study enrolled 875 patients and consisted of a
screening visit, 28-day pre-treatment period, 12-week treatment
period, and final evaluation at week 12. The most common adverse
events in patients treated with fremanezumab were injection site
pain, induration, and erythema.
“With this publication in JAMA, all Phase II and Phase III
studies of fremanezumab have now been published in prominent
peer-reviewed medical journals which highlights the importance of
these data for the migraine community,” said Daniel McBryan, M.D.,
Head of Global Medical Affairs at Teva. “With millions of people
suffering from migraine headaches that are often debilitating,
these results demonstrate the potential of fremanezumab as another
treatment option for patients in need.”
About Fremanezumab
Fremanezumab is an investigational therapy currently under
review by the U.S. Food and Drug Administration (FDA) as a
quarterly or monthly injection for the preventive treatment of
migraine in adults.
Fremanezumab is a monoclonal antibody targeting the CGRP
(calcitonin gene-related peptide) ligand, currently being
investigated as a preventive treatment for migraine. With limited
availability of preventive treatment options, fremanezumab
represents a potential new option to address a significant unmet
medical need.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicenter,
randomized, double-blind, placebo-controlled, parallel-group
studies to compare the safety, tolerability, and efficacy of four
dose regimens 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 randomized 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
randomized (around 376 patients per treatment group). Patients were
randomized 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 Migraine
Migraine is an unpredictable neurological condition with
symptoms such as severe head pain and physical impairment that can
impact quality of life and productivity. There are two clinical
manifestations of migraine – chronic, where patients suffer 15 or
more headache days per month, and episodic, where patients have 14
or less headache days per month. Worldwide, approximately 90% of
people diagnosed with migraine have episodic migraine and 10% have
chronic migraine.
With more than 1 billion people affected worldwide, migraine is
the third most prevalent illness in the world and the 6th most
disabling illness in the world. In the U.S., EU5 and Japan, nearly
75 million people suffer from episodic and chronic migraine – more
than 38 million in the U.S. alone. Of the approximately 40% of
patients suffering from migraine for whom prevention is
appropriate, only 13% are currently receiving therapy. There
remains a significant medical need for treatments designed
specifically to prevent migraine. According to recent analysis, the
economic burden for migraine patients reaches approximately $78
billion per year in the U.S.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,800 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 2017 were $22.4 billion. For
more information, visit 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; 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 substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and 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 the restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new 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; 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; governmental investigations
into sales 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 Annual Report on Form 10-K
for the year ended December 31, 2017, including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180515005694/en/
IR ContactsUnited StatesKevin C. Mannix,
215-591-8912Ran Meir, 972 (3) 926-7516IsraelTomer Amitai,
972 (3) 926 7656orPR ContactsUnited StatesDoris
Saltkill, 913-777-3343IsraelYonatan Beker, 972 (54) 888
5898
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