Long-term efficacy and safety data for AJOVY®
(fremanezumab-vfrm) injection for the preventive treatment of
migraine are the highlight of over 20 abstracts, including four
platform presentations
Data for AUSTEDO® (deutetrabenazine) tablets
further our understanding of treatment for tardive dyskinesia
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the Company will present data at the 71st Annual Meeting
of the American Academy of Neurology (AAN) in Philadelphia from May
4-10, 2019. The diverse selection of data to be presented includes
research across central nervous system (CNS) disorders, including
migraine, tardive dyskinesia (TD), dyskinesia in cerebral palsy
(DCP) and multiple sclerosis (MS). The research spans pediatric to
adult populations and contains long-term data across two
therapeutic areas.
“Improving the lives of patients is Teva’s driving force, and
the data being presented at this year’s AAN meeting are a testament
to that commitment,” said Hafrun Fridriksdottir, Executive Vice
President, Global R&D at Teva. “With a wide range of exciting
data on AJOVY® (fremanezumab-vfrm) injection, accompanied by
ongoing research on AUSTEDO® (deutetrabenazine) tablets, we believe
the quality and breadth of Teva’s findings reinforce the Company’s
legacy in diseases of the central nervous system and focus on
improving patient treatment.”
Among the data to be presented for AJOVY®, Teva will highlight
new analyses on the long-term efficacy and safety data from the
long-term extension of the Phase III HALO long-term study in
chronic and episodic migraine. Long-term data presentations include
analyses on efficacy and safety, quarterly dosing persistency,
reversion from a chronic to an episodic migraine classification and
quality of life results. Additional Teva data include a platform
presentation on long-term data from an open-label study of AUSTEDO®
treatment in TD and a poster presentation of the design of a Phase
III study investigating deutetrabenazine for the treatment of
DCP.
The full set of Teva-sponsored data to be presented
includes:
AJOVY®:Platform Presentations:
- [S17.005] Fremanezumab
Cardiovascular and Cerebrovascular Safety Profile: Pooled Data From
Placebo-Controlled and Long-Term Studies (Session 17, May 6,
2019, 1:44 pm ET)
- [S17.006] Long-Term Data on
Fremanezumab in Patients Who Reverted From a Chronic to an Episodic
Migraine Classification (Session 17, May 6, 2019, 1:55 pm
ET)
- [S38.001] Long-Term Data on
Fremanezumab on Response Rates: Results of a 1-Year Study
(Session 38, May 8, 2019, 1:00 pm ET)
- [S38.004] Long-Term Data on
Fremanezumab in Migraine: Results of a 1-Year Study (Session
38, May 8, 2019, 1:33 pm ET)
Poster Presentations:
- [P1.10-004] Data on Fremanezumab on
Response Rates, Migraine Days, and Acute Medication Use in Patients
with Chronic Migraine Who Have Failed at Least One Prior Migraine
Preventive Medication (Poster Session 1, May 5, 2019,11:30 am –
6:30 pm ET)
- [P1.10-005] Long-Term Data on
Response Rates, Acute Headache Medication Use, and Disability in
Patients With Episodic Migraine: Results of a 1-Year Study
(Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-006] Data on
Migraine-Specific Health-Related Quality of Life in Chronic
Migraine Patients Who Previously Used Topiramate (Poster
Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-008] Long-Term Data on
Fremanezumab in Patients With Chronic Migraine With Concomitant
Preventive Medication Use (Poster Session 1, May 5, 2019, 11:30
am – 6:30 pm ET)
- [P1.10-011] Data on Fremanezumab in
Migraine Patients Who Have Failed at Least One Prior Migraine
Preventive Medication (Poster Session 1, May 5, 2019, 11:30 am
– 6:30 pm ET)
- [P1.10-012] Data on
Migraine-Specific Health-Related Quality of Life in Chronic
Migraine Patients With Concomitant Preventive Medication Use
(Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-013] Data on Response Over
Time With Fremanezumab in Patients Who Reverted From a Chronic to
an Episodic Migraine Classification (Poster Session 1, May 5,
2019, 11:30 am – 6:30 pm ET)
- [P1.10-015] Long-Term Data on
Fremanezumab: Results of a 1-Year Study (Poster Session 1, May
5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-022] Long-Term Data on
Fremanezumab on Headache-Related Disability and Quality of Life in
Patients Who Reverted From a Chronic to an Episodic Migraine
Classification (Poster Session 1, May 5, 2019, 11:30 am – 6:30
pm ET)
- [P1.10-024] Long-Term Data on
Fremanezumab in Patients With Chronic Migraine and Comorbid
Moderate to Severe Depression (Poster Session 1, May 5, 2019,
11:30 am – 6:30 pm ET)
- [P1.10-026] Data on Medication
Overuse in Patients With Chronic Migraine (Poster Session 1,
May 5, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-001] Data on Response Rates,
Acute Medication Use, and Disability in Patients With Episodic
Migraine Who Have Failed at Least One Prior Migraine Preventive
Medication (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm
ET)
- [P2.10-002] Data on the Severity of
Headache in Patients With Chronic and Episodic Migraine With
Fremanezumab Treatment (Poster Session 2, May 6, 2019, 11:30 am
– 6:30 pm ET)
- [P2.10-008] Data on the Number of
Headache Hours in Chronic and Episodic Migraine With
Fremanezumab (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm
ET)
- [P2.10-013] Data on Quarterly
Administration of Fremanezumab During Third Month After
Injection (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm
ET)
- [P2.10-015] Long-Term Data on
Response Rates, Acute Headache Medication Use, and Disability in
Patients With Chronic Migraine: Results of a 1-Year Study
(Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-023] Long-Term Data on
Fremanezumab on Headache-Related Disability, Quality of Life, and
Patient Satisfaction in Episodic Migraine and Chronic Migraine
(Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P3.10-013] Data on Offering Monthly
and Quarterly Dosing Options for a Class of Migraine Preventive
Therapy on Likelihood of Acceptance and Adherence in Adults With
Migraine (Poster Session 3, May 7, 2019, 11:30 am – 6:30 pm
ET)
AUSTEDO®:Platform Presentation:
- [S4.009] Long-Term Treatment With
Deutetrabenazine in Tardive Dyskinesia (TD): Data From an
Open-Label Extension Study (Session 4, May 5, 2019, 2:28 pm
ET)
Deutetrabenazine (DCP):Poster Presentation:
- [P4.8-036] RECLAIM-DCP: A
Randomized, Double-Blind, Placebo-Controlled Study of
Deutetrabenazine for the Treatment of Dyskinesia in Cerebral Palsy
in Children and Adolescents (Poster Session 4, May 8, 2019,
11:30 am – 6:30 pm ET)
COPAXONE®:Poster Presentation:
- [P4.2-096] Pregnancy Outcomes In
Patients With Multiple Sclerosis And Exposure To Branded Glatiramer
Acetate (Poster Session 4, May 8, 2019, 11:30 am – 6:30 pm
ET)
Other Teva data:Poster Presentations:
- [P2.1-014] Impact of Antipsychotic
Treatment Switching in Patients With Schizophrenia, Bipolar
Disorder, And Major Depressive Disorder (Poster Session 2, May
6, 2019, 11:30 am – 6:30 pm ET)
- [P3.8-027] Hospital Utilization
Rates Following Antipsychotic Dose Reductions Among Patients With
Bipolar And Major Depressive Disorders (Poster Session 3, May
7, 2019, 11:30am – 6:30 pm ET)
- [P3.2-099] Real-World Switching
Patterns Among US Generic Glatiramer Acetate Multiple Sclerosis
Patients (Poster Session 3, May 7, 2019, 11:30 am – 6:30 pm
ET)
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 AUSTEDO®/deutetrabenazine
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease. Safety and
effectiveness in pediatric patients have not been established.
The use of deutetrabenazine for the treatment of dyskinesia in
cerebral palsy is investigational and not currently approved by the
U.S. Food and Drug Administration or any other country’s regulatory
agency for this use.
Important Safety Information about AUSTEDO®
AUSTEDO® can increase the risk of depression
and suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Anyone considering the use of
AUSTEDO® must balance the risks of depression and
suicidality with the clinical need for treatment of chorea.
AUSTEDO® is contraindicated in patients with
Huntington’s disease who are suicidal, or have untreated or
inadequately treated depression.
AUSTEDO® is also contraindicated in: patients with hepatic
impairment; patients taking reserpine or within 20 days of
discontinuing reserpine; patients taking monoamine oxidase
inhibitors (MAOIs), or within 14 days of discontinuing MAOI
therapy; and patients taking tetrabenazine (Xenazine®) or
valbenazine (Ingrezza®).
AUSTEDO® may cause a worsening in mood, cognition, rigidity, and
functional capacity in patients with Huntington’s disease.
Tetrabenazine (a closely related VMAT2 inhibitor) causes an
increase in the corrected QT (QTc) interval. A clinically relevant
QT prolongation may occur in some patients treated with AUSTEDO®
who are CYP2D6 poor metabolizers or are co-administered a strong
CYP2D6 inhibitor or other drugs that are known to prolong QTc.
Neuroleptic Malignant Syndrome has been observed in patients
receiving tetrabenazine. AUSTEDO® may increase the risk of
akathisia, agitation, and restlessness. AUSTEDO® may cause
parkinsonism in patients with Huntington’s disease. Sedation is a
common dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated
patients and greater than placebo) in controlled clinical studies
of patients with tardive dyskinesia were nasopharyngitis and
insomnia. The most common adverse reactions (>8% of
AUSTEDO®-treated patients and greater than placebo) in a controlled
clinical study of patients with chorea associated with Huntington’s
disease were somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information,
including Boxed Warning.
About COPAXONE®
COPAXONE® is indicated for the treatment of patients with
relapsing forms of multiple sclerosis.
Important Safety Information about COPAXONE®
COPAXONE® is contraindicated in patients with known
hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per mL
compared to 4% of those on placebo, and approximately 2% of
patients exposed to COPAXONE® 40 mg per mL compared to none on
placebo experienced a constellation of symptoms that may occur
immediately (within seconds to minutes, with the majority of
symptoms observed within 1 hour) after injection and included at
least 2 of the following: flushing, chest pain, palpitations,
tachycardia, anxiety, dyspnea, throat constriction, and urticaria.
In general, these symptoms have their onset several months after
the initiation of treatment, although they may occur earlier, and a
given patient may experience 1 or several episodes of these
symptoms. Typically, the symptoms were transient and self-limited
and did not require treatment; however, there have been reports of
patients with similar symptoms who received emergency medical
care.
Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL
patients compared to 6% of placebo patients, and approximately 2%
of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While
some episodes of chest pain occurred in the context of the
immediate post-injection reaction described above, many did not.
The temporal relationship of this chest pain to an injection was
not always known. The pain was usually transient, often
unassociated with other symptoms, and appeared to have no clinical
sequelae. Some patients experienced more than 1 such episode, and
episodes usually began at least 1 month after the initiation of
treatment.
At injection sites, localized lipoatrophy and, rarely, injection
site skin necrosis may occur. Lipoatrophy may occur at various
times after treatment onset (sometimes after several months) and is
thought to be permanent. There is no known therapy for
lipoatrophy.
Because COPAXONE® can modify immune response, it may interfere
with immune functions. For example, treatment with COPAXONE® may
interfere with recognition of foreign antigens in a way that would
undermine the body’s tumor surveillance and its defenses against
infection. There is no evidence that COPAXONE® does this, but there
has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most common
adverse reactions with COPAXONE® vs placebo were injection site
reactions (ISRs), such as erythema (43% vs 10%); vasodilatation
(20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain
(13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most common
adverse reactions with COPAXONE® vs placebo were ISRs, such as
erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to
discontinuation of COPAXONE®. ISRs, such as erythema, pain,
pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy,
occurred at a higher rate with COPAXONE® than placebo.
Please click here for Full Prescribing Information.
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, 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:
- 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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IR ContactsUnited StatesKevin C. Mannix, (215)
591-8912Ran Meir, 972 (3) 926-7516
PR ContactsUnited StatesDoris Saltkill, (913)
777-3343IsraelYonatan Beker, 972 (54) 888 5898
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