Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults
April 1, 2019-
In clinical trials, many patients on AJOVY experienced significant
reductions of at least 50% in the number of monthly migraine
days with reduction observed as early as week one1,2 -
Migraine is the most prevalent neurological disorder affecting more
than 50 million people in Europe and 1 billion worldwide3,4
JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the European Commission (EC) has granted the 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. AJOVY is a
humanized monoclonal antibody (mAb) that binds to the calcitonin
gene-related peptide (CGRP) ligand and blocks its binding to the
receptor. AJOVY is the first and only anti-CGRP drug approved in the
European Union (EU) and the United States (US) that is designed for the
prevention of migraine that offers both quarterly and monthly dosing
options for the phrophylatic treatment of migraine.
Elena Ruiz de la Torre, Executive Director, European Migraine & Headache
Alliance (EMHA) said: “Migraine is not just a headache, it is an
unpredictable neurological disease which can frequently go undiagnosed
and undertreated. After decades of migraine patients feeling left
behind, we are delighted to see the progression of preventive treatments
which offer patients new hope in managing their condition. The
availability of a new treatment, which is specifically designed for the
prevention of migraine, is another positive step forward for the
migraine community and we welcome the fact that Europe’s more than 50
million patients will now have greater choice over their treatment
options and more days uninterrupted by migraine.”
AJOVY was evaluated in two pivotal Phase III clinical trials that
enrolled patients with disabling migraine and studied fremanezumab as a
prophylactic treatment for 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 fremanezumab were mostly mild to moderate, short-lasting
skin reactions around the injection area: pain, hardening, redness,
itching and rash at the injection site.
Messoud Ashina, Professor of Neurology in the Faculty of Health and
Medical Sciences, University of Copenhagen, Denmark, stated: “Migraine
is a debilitating neurological disease which can have a substantial
impact on quality of life. The disease is most common between the ages
of 25 and 55 meaning that it strikes during the most productive years,
disrupting patients’ personal and professional lives. The approval of
fremanezumab in the EU will provide European physicians with an
important new treatment option offering patients greater flexibility
through monthly and quarterly dosing options and, most importantly, a
significant reduction in the number of migraine days.”
Richard Daniell, Executive Vice President, European Commercial at Teva
said: “Migraine can have a significant impact on the day-to-day life of
patients with some experiencing 15 headache days per month. It is our
hope that AJOVY® will provide patients and European
healthcare professionals with a preventive treatment which offers
patients more migraine free days as well as greater flexibility in
managing this unpredictable disease. The approval of fremanezumab is
also an important step in our focus on biopharmaceuticals, the next
generation of innovative medicines, coupled with our ongoing commitment
to developing treatments for disorders of the central nervous system
(CNS).”
The EC decision is applicable to all 28 EU member states plus Iceland,
Norway and Liechtenstein after transposition into legally binding acts
in these countries. AJOVY received U.S. FDA approval for the preventive
treatment of migraine in adults on 14 September 2018. Additional
regulatory filings are underway with other health authorities worldwide.
About AJOVY®
AJOVY (fremanezumab) is indicated for the prophylaxis of migraine in
adults who have at least four migraine days per month. AJOVY 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. AJOVY can be administered
in by a healthcare professional or at home by a patient or caregiver if
instructed by a healthcare professional in subcutaneous self-injection
technique.
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 43,000
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 EU approval of 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 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; the
uncertainty of commercial success of 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 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 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 Annual Report on Form 10-K for the year ended
December 31, 2018, including the sections thereof captioned “Risk
Factors.” -
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 Dodick DW et al. JAMA 2018; 319(19): 1999–2008
2 Silberstein SD et al. N Engl J Med 2017; 377(22): 2113–2122
3 Headache. EAN. Available at: https://www.ean.org/index.php?id=2796
Accessed: 22 February 2019
4 Migraine Research Foundation, Migraine Facts. Available at: http://migraineresearchfoundation.org/about-migraine/migraine-facts/
Accessed: 22 February 2019
Contacts
IR Contacts
United States
Kevin C. Mannix
(215)
591-8912
Israel
Ran Meir
972 (3) 926-7516
PR Contacts
Europe
Fiona Cohen
+31 620082545
United States
Doris Saltkill
+1 (913) 777-3343
Israel
Yonatan Beker
972 (54) 888 5898