Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection at the American Headache Society’s 61st Annual Scientific...
2019年7月10日 - 10:17PM
ビジネスワイヤ(英語)
Three late breakers, one oral presentation and
27 posters showcase AJOVY as a preventive treatment for
migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the Company will present 31 scientific abstracts for
AJOVY® (fremanezumab-vfrm) injection at the 61st Annual Scientific
Meeting of the American Headache Society, taking place in
Philadelphia from July 11-14, 2019. AJOVY is indicated for the
preventive treatment of migraine in adults.
“Migraine continues to be a difficult to treat disease and as
the migraine treatment landscape evolves, we remain committed to
improving the lives of patients,” said Hafrun Fridriksdottir,
Executive Vice President, Global R&D at Teva. “We are pleased
to be presenting 31 posters and presentations at AHS this year, and
our presence underscores Teva’s ongoing focus on addressing the
treatment challenges that migraine patients face.”
The data to be presented include findings from the FOCUS study,
a multicenter, randomized, double-blind, parallel-group,
placebo-controlled study that evaluated the efficacy and safety of
quarterly and monthly treatment with AJOVY, compared to placebo.
The FOCUS study is the largest study to date in patients who
inadequately responded to 2-4 classes of preventive migraine
treatments, and is the first study of its type to be conducted in
chronic as well as episodic migraine patients. Of note, this year’s
AHS meeting is the first time that FOCUS data will be presented at
a U.S. meeting.
Additionally, two late-breaking poster presentations will detail
findings from a web-based patient survey following completion of an
AJOVY 1-year extension study.
Teva-sponsored data to be presented includes:
Oral Presentation:
- [IOR08] Clinically Meaningful Responses to Fremanezumab in
Patients With Migraine and Documented Inadequate Response to 2-4
Classes Of Migraine Preventive Medications in the Multicenter,
Randomized, Placebo-Controlled FOCUS Study
Late-Breaking Poster Presentations:
- [P272LB] Data on Patient Satisfaction With Fremanezumab
Treatment for Chronic or Episodic Migraine: Results From a
Web-Based, Patient Survey Following Completion of a 1-Year
Extension Study
- [P274LB] Data on Patient Preference for Dosing Regimen and
Perception of Dosing Flexibility With Fremanezumab for Chronic or
Episodic Migraine: Results From A Web-Based, Patient Survey
Following Completion of a 1-Year Extension Study
- [P273LB] Simulated Use of a Fremanezumab Autoinjector: Use
as Intended, Ease of Use, and Comfort With Using the
Autoinjector
Poster Presentations:
- [P128] The Impact of Fremanezumab on the Maximum Number of
Consecutive Days Without Headaches of at Least Moderate Severity in
Patients with Chronic Migraine
- [P139] The Impact of Fremanezumab on the Maximum Number of
Consecutive Days Without Migraine in Patients with Episodic
Migraine
- [P129] Long-term Efficacy of Fremanezumab in Migraine
Patients With and Without Concomitant Oral Preventive Medication
Use: Results of a 1-Year Study
- [P130] Long-Term Impact of Fremanezumab on Migraine-Specific
Health-Related Quality of Life in Migraine Patients With
Concomitant Preventive Medication Use: Results of a 1-Year
Study
- [P110] Long-term Response Rates in Chronic and Episodic
Migraine Patients With Concomitant Preventive Medication Use:
Results from 1-Year Study
- [P107] Long-Term Efficacy of Fremanezumab in Chronic and
Episodic Migraine Patients With Acute Medication Overuse at
Baseline: Results of a 1-Year Study
- [P140] Long-Term Impact of Fremanezumab on Response Rate,
Acute Headache Medication Use, and Disability in Chronic Migraine
Patients With Acute Medication Overuse at Baseline: Results of a
1-Year Study
- [P141] Long-Term Impact of Fremanezumab on Response Rate,
Acute Headache Medication Use, and Disability in Episodic Migraine
Patients With Acute Medication Overuse at Baseline: Results of a
1-Year Study
- [P151] Long-Term Efficacy of Fremanezumab in Chronic and
Episodic Migraine Patients Who Failed at Least One Prior Migraine
Preventive Medication: Results of a 1-Year Study
- [P152] Long-Term Impact of Fremanezumab on Response Rates,
Acute Headache Medication Use, and Disability in Patients With
Chronic Migraine Who Have Failed at Least One Prior Preventive
Migraine Medication: Results of a 1-Year Study
- [P153] Long-Term Impact of Fremanezumab on Response Rates,
Acute Headache Medication Use, and Disability in Patients With
Episodic Migraine Who Have Failed at Least One Prior Preventive
Migraine Medication: Results of a 1-Year Study
- [P105] Efficacy and Safety Of Fremanezumab in Patients With
Migraine And Documented Inadequate Response to 2-4 Classes Of
Migraine Preventive Medications: Results of the Multicenter,
Randomized, Placebo-Controlled FOCUS Study
- [P136] Improvement in Headache-Related Disability With
Fremanezumab in Patients With Migraine and Documented Inadequate
Response to 2-4 Migraine Preventive Medication Classes in the
International, Multicenter, Randomized FOCUS Study
- [P148] Safety and Tolerability Outcomes of the Multicenter,
Randomized, Placebo-Controlled FOCUS Study of Fremanezumab in
Patients With Migraine and Documented Inadequate Response to 2-4
Classes of Migraine Preventive Medications
About AJOVY®
AJOVY is indicated for the preventive treatment of migraine in
adults. 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 office by a healthcare professional or
at home by a patient or caregiver. No starting dose is required to
begin treatment.
Important Safety Information about AJOVY®
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 Prescribing Information for AJOVY®
(fremanezumab-vfrm) injection.
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 35,000
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 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 AJOVY® and 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.
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