Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of ALYQ™, a generic version of ADCIRCA®1
(tadalafil) tablets, 20 mg in the U.S.
ALYQ™ is a phosphodiesterase 5 (PDE5) inhibitor indicated for
the treatment of pulmonary arterial hypertension (PAH) (WHO Group
1) to improve exercise ability. PAH is high blood pressure in the
blood vessels of the lungs.
Brendan O’Grady, EVP and Head of North America Commercial at
Teva said, “This launch is an important addition to our portfolio
of generic medicines that treat complex conditions and we’re proud
to offer an affordable treatment option for this rare disease.”
With over 550 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products on the market and holds
the leading position in first-to-file opportunities, with over 100
pending first-to-files in the U.S. Currently, one in seven generic
prescriptions dispensed in the U.S. is filled with a Teva generic
product.
ADCIRCA® had annual total sales of approximately $490 million in
the U.S., according to IQVIA data as of November 2018.
About ALYQ™
ALYQ™ is indicated for the treatment of pulmonary arterial
hypertension (PAH) (WHO Group 1) to improve exercise ability.
Studies establishing effectiveness included predominately patients
with NYHA Functional Class II – III symptoms and etiologies of
idiopathic or heritable PAH (61%) or PAH associated with connective
tissue diseases (23%).
IMPORTANT SAFETY INFORMATION
Do not use ALYQ™ in patients who are using any form of organic
nitrate, either regularly or intermittently. ALYQ™ potentiates the
hypotensive effect of nitrates. Do not use ALYQ™ in patients who
are using a guanylate cyclase (GC) stimulator, such as riociguat.
ALYQ™ may potentiate the hypotensive effects of GC stimulators.
ALYQ™ is contraindicated in patients with a known serious
hypersensitivity to tadalafil. Hypersensitivity reactions have been
reported, including Stevens-Johnson syndrome and exfoliative
dermatitis.
Patients who experience anginal chest pain after taking ALYQ™
should seek immediate medical attention. PDE5 inhibitors, including
tadalafil, have mild systemic vasodilatory properties that may
result in transient decreases in blood pressure. Patients with
severely impaired autonomic control of blood pressure or with left
ventricular outflow obstruction may be particularly sensitive to
the actions of vasodilators, including PDE5 inhibitors. Pulmonary
vasodilators may significantly worsen the cardiovascular status of
patients with pulmonary veno-occlusive disease (PVOD).
PDE5 inhibitors, including ALYQ™, and alpha-adrenergic blocking
agents are vasodilators with blood pressure-lowering effects. When
vasodilators are used in combination, an additive effect on blood
pressure may be anticipated. Safety of combined use of PDE5
inhibitors and alpha blockers may be affected by other variables,
including intravascular volume depletion and use of other
antihypertensive drugs. Both alcohol and tadalafil are mild
vasodilators. When mild vasodilators are taken in combination,
blood pressure-lowering effects are increased.
Use of ALYQ™ in patients taking ritonavir requires dosage
adjustment. Avoid use of ALYQ™ in patients taking potent inhibitors
of CYP3A such as ketoconazole and itraconazole, and in patients
chronically taking potent inducers of CYP3A, such as rifampin. A
lower starting dose of ALYQ™ should be used in patients with mild
or moderate renal or hepatic impairment. Avoid use of ALYQ™ in
patients with severe renal or hepatic impairment.
Patients should seek immediate medical attention in the event of
a sudden loss of vision in one or both eyes. Such an event may be a
sign of non-arteritic anterior ischemic optic neuropathy (NAION), a
cause of decreased vision, including permanent loss of vision.
Patients should seek immediate medical attention in the event of
sudden decrease or loss of hearing.
Tadalafil is also marketed as CIALIS®2. The safety and efficacy
of taking ALYQ™ together with CIALIS® or other PDE5 inhibitors have
not been studied. Patients taking ALYQ™ should not take CIALIS® or
other PDE5 inhibitors. There have been rare reports of prolonged
erections greater than 4 hours and priapism for this class of
compounds. Patients who have an erection lasting greater than 4
hours, whether painful or not, should seek emergency medical
attention.
In a placebo-controlled clinical study, the most common adverse
events (reported by ≥9% of patients in the tadalafil tablets 40 mg
group and more frequent than placebo by 2%) were: headache,
myalgia, nasopharyngitis, flushing, respiratory tract infection,
extremity pain, nausea, back pain, dyspepsia, and nasal
congestion.
For more information, please see accompanying Full Prescribing
Information. A copy may be requested from Teva US Medical
Information at 888-TEVA-USA (888-838-2872) or
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
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.
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 Teva's tadalafil tablets, 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 the commercial
success of our generic version of Adcirca®;
- 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.
1 ADCIRCA® is a registered trademark of Eli Lilly and
Company.
2 CIALIS® is a registered trademark of Eli Lilly and
Company.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190205006038/en/
IR ContactsUnited StatesKevin C. Mannix(215) 591-8912
IsraelRan Meir972 (3) 9267516
PR ContactsUnited StatesKelley Dougherty(973) 658-0237Elizabeth
DeLuca(267) 468-4329
IsraelYonatan Beker972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 6 2024 まで 7 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 7 2023 まで 7 2024