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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.
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
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
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
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
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 firstname.lastname@example.org,
or Teva’s Public Relations or Investor Relations contacts.
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
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
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
1 ADCIRCA® is a registered trademark of Eli Lilly
2 CIALIS® is a registered trademark of Eli Lilly
View source version on businesswire.com:
IR ContactsUnited StatesKevin C. Mannix(215) 591-8912
IsraelRan Meir972 (3) 9267516
PR ContactsUnited StatesKelley Dougherty(973) 658-0237Elizabeth
IsraelYonatan Beker972 (54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.