Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the exclusive first-to-file launch of a generic version
of Cialis®1 (tadalafil) tablets (2.5 mg, 5 mg, 10 mg, 20 mg) in the
U.S.
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor
indicated for the treatment of erectile dysfunction (ED), the signs
and symptoms of benign prostatic hyperplasia (BPH), and both ED and
the signs and symptoms of BPH (ED/BPH).
Teva’s EVP and Head of Global R&D, Hafrun Fridriksdottir
said, “We’re proud to offer an affordable treatment option for the
estimated 30 million men affected by ED, many of whom will also
have symptomatic BPH which is estimated to affect 15 million men in
the United States.”
Brendan O’Grady, EVP and Head of North America Commercial at
Teva added, “This launch represents an important addition to our
generics portfolio, building on our exclusive launch of a generic
version of Viagra® (sildenafil) tablets last year. We’re
committed to ensuring that patients are able to access this
medicine.”
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.
Cialis® had annual sales of nearly $1.93 billion in the U.S.,
according to IQVIA data as of July 2018.
About Tadalafil Tablets
Tadalafil tablets are indicated for the treatment of erectile
dysfunction (ED), the signs and symptoms of benign prostatic
hyperplasia (BPH), and ED and the signs and symptoms of BPH
(ED/BPH). If tadalafil tablets are used with finasteride to
initiate BPH treatment, such use is recommended for up to 26
weeks.
IMPORTANT SAFETY INFORMATION
Nitrates: Tadalafil tablets are contraindicated in
patients using any form of organic nitrate, either regularly and/or
intermittently. In clinical pharmacology studies, tadalafil was
shown to potentiate the hypotensive effect of nitrates.
Hypersensitivity Reactions: Tadalafil tablets are
contraindicated in patients with a known serious hypersensitivity
to tadalafil (or ADCIRCA®). Hypersensitivity reactions have been
reported, including Stevens-Johnson syndrome and exfoliative
dermatitis.
Concomitant Guanylate Cyclase (GC) Stimulators: Do not
use tadalafil in patients who are using a GC stimulator, such as
riociguat. Phosphodiesterase 5 (PDE5) inhibitors, including
tadalafil, may potentiate the hypotensive effects of GC
stimulators.
Cardiovascular: Physicians should consider the
cardiovascular status of their patients, since there is a degree of
cardiac risk associated with sexual activity. Therefore, treatments
for erectile dysfunction, including tadalafil, should not be used
in men for whom sexual activity is inadvisable as a result of their
underlying cardiovascular status. Patients who experience symptoms
upon initiation of sexual activity should be advised to refrain
from further sexual activity and seek immediate medical
attention.
PDE5 inhibitors, including tadalafil tablets, are mild systemic
vasodilators. While this effect should not be of consequence in
most patients, physicians should consider this potential when
prescribing tadalafil tablets.
Patients with left ventricular outflow obstruction, (e.g.,
aortic stenosis and idiopathic hypertrophic subaortic stenosis) can
be sensitive to the action of vasodilators, including PDE5
inhibitors.
Patients with certain types of cardiovascular disease were not
included in clinical safety and efficacy trials for tadalafil, and
therefore tadalafil is not recommended for the following groups of
patients:
- Myocardial infarction within the last
90 days
- Unstable angina or angina occurring
during sexual intercourse
- New York Heart Association Class 2 or
greater heart failure in the last 6 months
- Uncontrolled arrhythmias, hypotension
(<90/50 mm Hg), or uncontrolled hypertension
- Stroke within the last 6 months
Potential for Drug Interactions When Taking Tadalafil Tablets
for Once Daily Use: Tadalafil tablets for once daily use
provides continuous plasma tadalafil levels which physician’s
should consider when evaluating the potential for interactions with
medications (e.g., nitrates, alpha-blockers, anti-hypertensives and
potent inhibitors of CYP3A4) and with substantial consumption of
alcohol.
Prolonged Erection: There have been rare reports of
prolonged erections greater than 4 hours and priapism (painful
erections greater than 6 hours in duration) for this class of
compounds. Priapism, if not treated promptly, can result in
irreversible damage to the erectile tissue. Patients who have an
erection lasting greater than 4 hours, whether painful or not,
should seek emergency medical attention. Tadalafil should be used
with caution in patients who have conditions that might predispose
them to priapism (such as sickle cell anemia, multiple myeloma, or
leukemia), or in patients with anatomical deformation of the penis
(such as angulation, cavernosal fibrosis, or Peyronie’s
disease).
Effects on the Eye: Physicians should advise patients to
stop use of all PDE5 inhibitors, including tadalafil, and seek
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 rare condition and a cause of
decreased vision, including permanent loss of vision. Physicians
should consider whether their patients with underlying NAION risk
factors could be adversely affected by use of PDE5 inhibitors.
Individuals who have already experienced NAION are at increased
risk of NAION recurrence. PDE5 inhibitors, including tadalafil,
should be used with caution in these patients and only when the
anticipated benefits outweigh the risks. Individuals with “crowded”
optic disc are also considered at greater risk for NAION compared
to the general population. Patients with known hereditary
degenerative retinal disorders, including retinitis pigmentosa,
were not included in the clinical trials, and use in these patients
is not recommended.
Sudden Hearing Loss: Sudden decrease or loss in hearing,
sometimes with tinnitus and dizziness has also been reported in men
taking PDE5 inhibitors, including tadalafil. It is not possible to
determine whether these hearing events are related directly to the
use of PDE5 inhibitors or to other factors.
Alpha-blockers and Antihypertensives: Physicians should
discuss with patients the potential for tadalafil to augment the
blood-pressure-lowering effect of alpha-blockers and
antihypertensive medications. Caution is advised when PDE5
inhibitors are coadministered with alpha-blockers. PDE5 inhibitors,
including tadalafil, and alpha-adrenergic blocking agents are both
vasodilators with blood-pressure-lowering effects. When
vasodilators are used in combination, an additive effect on blood
pressure may be anticipated. In some patients, concomitant use of
these two drug classes can lower blood pressure significantly,
which may lead to symptomatic hypotension (e.g., fainting).
Renal Impairment: Creatinine
clearance less than 30 mL/min or on hemodialysis: Tadalafil
tablets for daily use is not recommended; tadalafil tablets for use
as needed—5 mg not more than once every 72 hours. Creatinine clearance 30 to 50 mL/min: For
tadalafil tablets for daily use treatment of BPH or ED/BPH, start
dosing at 2.5 mg and increase to 5 mg based upon individual
response. Tadalafil tablets for use as needed, start dosing at 5 mg
not more than once per day with a maximum dose of 10 mg not more
than once every 48 hours.
Hepatic Impairment: In patients with mild or moderate
hepatic impairment, the dose of tadalafil should not exceed 10 mg.
Because of insufficient information in patients with severe hepatic
impairment, use of tadalafil in this group is not recommended.
Tadalafil for once daily use has not been extensively evaluated in
patients with mild or moderate hepatic impairment. Therefore,
caution is advised if tadalafil for once daily use is prescribed to
these patients. Because of insufficient information in patients
with severe hepatic impairment, use of tadalafil in this group is
not recommended.
Alcohol: Physicians should inform patients that
substantial consumption of alcohol (e.g., 5 units or greater) in
combination with tadalafil can increase the potential for
orthostatic signs and symptoms, including increase in heart rate,
decrease in standing blood pressure, dizziness, and headache.
Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4
(CYP3A4): For patients taking potent inhibitors of CYP3A4 such
as ritonavir, ketoconazole, and itraconazole, the dose of tadalafil
tablets should be limited to 10 mg no more than once every 72
hours. If once daily use is prescribed the maximum recommended dose
is 2.5 mg.
Combination With Other PDE5 Inhibitors or Erectile
Dysfunction Therapies: The safety and efficacy of combinations
of tadalafil and other PDE5 inhibitors or treatments for erectile
dysfunction have not been studied. Inform patients not to take
tadalafil with other PDE5 inhibitors, including ADCIRCA®.
Effects on Bleeding: Tadalafil has not been administered
to patients with bleeding disorders or significant active peptic
ulceration. Although tadalafil has not been shown to increase
bleeding times in healthy subjects, use in patients with bleeding
disorders or significant active peptic ulceration should be based
upon a careful risk-benefit assessment and caution.
Counseling Patients About Sexually Transmitted Diseases:
The use of tadalafil offers no protection against sexually
transmitted diseases. Counseling patients about the protective
measures necessary to guard against sexually transmitted diseases,
including Human Immunodeficiency Virus (HIV) should be
considered.
Consideration of Other Urological Conditions Prior to
Initiating Treatment for BPH: Prior to initiating treatment
with tadalafil for BPH, consideration should be given to other
urological conditions that may cause similar symptoms. In addition,
prostate cancer and BPH may coexist.
Common Adverse Reactions: The most common adverse
reactions reported in clinical trials (≥ 2%) were headache,
flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in
limb, naspharyngitis, upper respiratory tract infection, cough,
diarrhea, urinary tract infection, gastroesophageal reflux disease,
abdominal pain, gastroenteritis, and hypertension.
For more information, please see accompanying Full
Prescribing Information. A copy may be requested from
Teva US Medical Information at 888-4-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 tadalafil, including due to a
potential launch of an Authorized Generic version;
- 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 Cialis® is a registered trademark of Eli Lilly and
Company.
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version on businesswire.com: https://www.businesswire.com/news/home/20180927005757/en/
Teva Pharmaceutical Industries Ltd.IR ContactsUnited
StatesKevin C. Mannix, 215-591-8912orIsraelRan Meir,
215-591-3033orPR ContactsUnited StatesElizabeth
DeLuca, 267-468-4329orIsraelYonatan Beker, 972 (54) 888
5898
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