Teva Receives Positive Committee for Medicinal Products for Human Use (CHMP) Opinion for AJOVY® (fremanezumab) for the Proph...
2019年2月1日 - 8:50PM
ビジネスワイヤ(英語)
If Approved, AJOVY will be the First and Only
Anti-CGRP Treatment with Quarterly and Monthly Dosing Options in
the European Union
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has recommended
granting a marketing authorization for AJOVY® (fremanezumab) 225 mg
solution for injection in pre-filled syringe for the prophylaxis of
migraine in adults who have at least four migraine days per month.
If approved by the European Commission (EC), AJOVY, a humanized
monoclonal antibody that binds to the calcitonin gene-related
peptide (CGRP) ligand and blocks its binding to the receptor, will
be the first and only anti-CGRP treatment in the European Union
(EU) with both quarterly and monthly dosing options.
Migraine is a disabling neurological disease often accompanied
by nausea, vomiting, photophobia, phonophobia and changes in
vision.1 Globally, there are approximately one billion people
affected by migraine2, with more than 50 million people suffering
from the disease across Europe.3 It is estimated that the total
annual cost of migraine in Europe is €111 billion.4
“We are very pleased to report a positive opinion by the CHMP,”
said Richard Daniell, Executive Vice President, European Commercial
at Teva. “This is another important milestone for us and the
migraine community as a whole. We hope to expand the availability
of AJOVY to the EU so that eligible patients can potentially
benefit from the flexibility AJOVY offers through quarterly and
monthly dosing options.”
The positive CHMP opinion is based on the review of a Marketing
Authorization Application (MAA) that included efficacy and safety
data from the HALO clinical development program. The program
evaluated fremanezumab in two pivotal Phase III clinical trials
that enrolled patients with disabling migraine and studied
fremanezumab as a prophylaxis of migraine in adults. In these
trials, patients treated with fremanezumab had a significantly
greater reduction in migraine days compared to placebo. Adverse
drug reactions (ADRs) observed with AJOVY were mostly mild to
moderate, short-lasting skin reactions around the injection area:
pain, hardening, redness, itching and rash at the injection
site.
“Migraine is the most prevalent disabling neurological disease
in Europe,” said Professor Peter J. Goadsby, MD, PhD, Professor of
Neurology at King's College, London. “It is the second most common
cause of years lost to disability in the world, interrupting
patients during their most active and productive years. Migraine
disrupts their work and family lives at a time when others rely on
them the most. Many patients have to live in fear of their next
attack; the most disabled have chronic migraine, experiencing 15 or
more days of illness per month. Fremanezumab is an anti-CGRP
monoclonal antibody (mAb) specifically developed for migraine, and
if approved for use in the EU, it will offer an additional
treatment option for patients and more flexibility in managing
their condition.”
The positive CHMP opinion is a formal recommendation to grant
the marketing authorization for AJOVY in the EU. The recommendation
will now be reviewed by the EC, which has authority to approve
medicines for use in the 28 countries of the EU. A final decision
is expected in the first half of 2019.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global leader in generic medicines, with innovative treatments in
select areas, including CNS, pain and respiratory. We deliver
high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an
established presence in generics, specialty, OTC and API, building
on more than a century-old legacy, with a fully integrated R&D
function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at www.tevapharm.com.
Teva 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 in the United States 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 uncertainty of obtaining regulatory
approval for AJOVY in the EU;
- the uncertainty of commercial success
of AJOVY;
- 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, 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 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.
1 IHS classification – Migraine classification criteria.
2 Migraine Facts, Migraine Research Foundation. Available at
https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed January 2019.
3 Headache. EAN. Available at:
https://www.ean.org/index.php?id=2796. Accessed January 2019.
4 Linde M1 Gustavsson A, Stovner LJ et al. 2011. The cost of
headache disorders in Europe: the Eurolight project. [Online]
Available from:
https://www.ncbi.nlm.nih.gov/pubmed/22136117. Accessed January 2019.
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