Teva to Present New Fremanezumab Data, Including Long-Term Data, at the American Headache Society’s 60th Annual Scientific ...
June 28 2018 - 8:00AM
Business Wire
One late breaker, three platform presentations
and 23 posters showcase fremanezumab as an investigational
treatment for the prevention of migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced 23 abstracts, one late-breaking poster and three oral
presentations of fremanezumab for the preventive treatment of
migraine which will be presented at the American Headache Society’s
(AHS) 60th Annual Scientific Meeting in San Francisco from June
28-July 1, 2018. This is the first time that one-year analyses of
fremanezumab are being presented. The new data include long-term
response rates, acute headache medication use, and disability.
Additional data presentations from clinical trials of fremanezumab
examine efficacy, safety, quality-of-life impact, and reversion of
patients from chronic to episodic migraine. 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.
“Migraine remains a challenging disease with considerable unmet
need, due to availability of few therapeutic innovations over the
past 25 years,” said Tushar Shah, M.D., Senior Vice President, Head
of Global Specialty Clinical Development at Teva. “Teva is
committed to developing novel treatments for patients with migraine
headaches. We are excited to share additional data at the meeting
on fremanezumab, particularly over the long-term, which is critical
to patients.”
Antibodies targeting calcitonin gene-related peptides
(anti-CGRPs), such as fremanezumab, are a new class of therapies
developed for the prevention of migraine in adults.
Teva-sponsored abstracts at the AHS Annual Scientific Meeting
include:
Late-Breaking Poster
Presentation:
- Response Over Time with Fremanezumab in
the Treatment of Chronic and Episodic Migraine (Poster PF111)
- Friday, June 29, poster Q&A, 1:15 -
2:15 pm PT
Platform Presentations:
- The Impact of Fremanezumab on
Medication Overuse in Patients with Chronic Migraine (IOR07)
- Saturday, June 30, 8:00 am - 10:00 am
PT
- Presentation time: 9:00 am - 9:10 am
PT
- Response with Fremanezumab in the
Treatment of Chronic Migraine (IOR11)
- Saturday, June 30, 8:00 am - 10:00 am
PT
- Presentation time: 9:40 am - 9:50 am
PT
- Reversion of Patients with Chronic
Migraine to an Episodic Migraine Classification with Fremanezumab
Treatment (OR15)
- Saturday, June 30, 2:15 pm - 3:45 pm
PT
- Presentation time: 2:15 pm - 2:25 pm
PT
Long-Term Impact of Fremanezumab Posters
(Yerba Buena Ballroom in the San Francisco Marriott
Marquis):
- Long-Term Impact of Fremanezumab on
Response Rates, Acute Headache Medication Use, and Disability in
Patients with Chronic Migraine: Interim Results of a One-Year Study
(Poster PF14)
- Friday, June 29, 1:15 - 2:15 pm PT
- Fremanezumab Long-Term Efficacy and
Safety: Interim Results of a One-Year Study (Poster PS30)
- Saturday, June 30, 1:15 - 2:15 pm
PT
- Long-Term Impact of Fremanezumab on
Response Rates, Acute Headache Medication Use, and Disability in
Patients with Episodic Migraine: Interim Results of a One-Year
Study (Poster PS35)
- Saturday, June 30, 1:15 - 2:15 pm
PT
Friday, June 29 Poster Sessions (Yerba
Buena Ballroom in the San Francisco Marriott Marquis);
presentations between 1:15 - 2:15 pm PT
- Impact of Fremanezumab on the Number of
Days with Use of Acute Headache Medications in Chronic Migraine
(Poster PF08)
- Efficacy of Fremanezumab in Patients
with Chronic Migraine Who Had Prior Use of Topiramate or
OnabotulinumtoxinA (Poster PF09)
- The Impact of Fremanezumab on
Headache-related Disability in Patients with Chronic Migraine Using
the Headache Impact Test (HIT-6) (Poster PF12)
- The Impact of Fremanezumab on Symptoms
Associated with Migraine in Patients with Chronic Migraine (Poster
PF15)
- Onset of Action with Fremanezumab
versus Placebo for the Preventive Treatment of Chronic Migraine
(Poster PF19)
- The Impact of Fremanezumab on
Migraine-specific Health-related Quality of Life and Overall Health
Status in Chronic Migraine (Poster PF23)
- Efficacy of Fremanezumab on Migraine
Frequency and Depression in Patients with Chronic Migraine and
Comorbid Moderate to Moderately Severe Depression (Poster
PF24)
- The Impact of Fremanezumab on Work
Productivity and Activity Impairment in Patients with Chronic
Migraine (Poster PF33)
- Onset of Action with Fremanezumab
versus Placebo for the Preventive Treatment of Episodic Migraine
(Poster PF43)
- Impact of Fremanezumab on the Number of
Days with Use of Acute Headache Medications in Episodic Migraine
(Poster PF44)
- Burden of Illness Among Treated
Migraine Patients with ≥4 Headache Days in the past Month (Poster
PF79)
- The Impact of Fremanezumab on
Headache-related Disability in Patients with Episodic Migraine
Using the Migraine Disability Assessment (Poster PF82)
- The Impact of Fremanezumab on
Migraine-Specific Health-Related Quality of Life in Episodic
Migraine (Poster PF87)
Saturday, June 30 Poster Sessions; (Yerba
Buena Ballroom in the San Francisco Marriott Marquis);
presentations between 1:00 - 2:15 pm PT
- Relationship Between Fremanezumab
Exposure and Efficacy in Preventive Therapy of Chronic Migraine in
Adults (Poster PS31)
- Relationship Between Fremanezumab
Exposure and Efficacy in Preventive Therapy of Episodic Migraine in
Adults (Poster PS32)
- Efficacy of Fremanezumab in Patients
with Episodic Migraine Who Had Prior Use of Topiramate or
OnabotulinumtoxinA (Poster PS34)
- Overview of Fremanezumab Pooled Safety
Data from Placebo-Controlled Phase 2 and 3 Studies (Poster
PS40)
- Fremanezumab Cardiovascular Safety
Profile: Pooled Data from Placebo-controlled and Long-term Studies
(Poster PS41)
- Lack of Relationship Between
Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2
and 3 Data Including Chronic and Episodic Migraine Patients (Poster
PS47)
- The Impact of Fremanezumab on Symptoms
Associated with Migraine in Patients with Episodic Migraine (Poster
PS59)
About Fremanezumab
Fremanezumab is an investigational therapy currently under
review by the 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 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:
- the uncertainty of obtaining regulatory
approvals for Fremanezumab;
- the uncertainty of commercial success
of 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; 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.
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Teva Pharmaceutical Industries Ltd.IR ContactsUnited
StatesKevin C. Mannix, 215-591-8912Ran Meir, 972 (3)
926-7516orIsraelTomer Amitai, 972 (3) 926 7656orPR
ContactsUnited StatesDoris Saltkill,
913-777-3343orIsraelYonatan Beker, 972 (54) 888 5898
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