Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of EXJADE®1 (deferasirox)
Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, in the
U.S.
Deferasirox Tablets for Oral Suspension are an iron chelator
indicated for the treatment of chronic iron overload due to blood
transfusions in patients two years of age and older.
“We’re proud to offer an affordable generic treatment option
with the launch of Deferasirox Tablets for Oral Suspension in the
U.S.,” said Brendan O’Grady, EVP and Head of North America
Commercial. “We continue striving to enable access to medicines for
people living with chronic, complex conditions.”
With nearly 500 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 eight
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
EXJADE® had annual sales of $134 million in the U.S., according
to IQVIA data as of December 2018.
About Deferasirox Tablets for Oral Suspension
Deferasirox Tablets for Oral Suspension are indicated for the
treatment of chronic iron overload due to blood transfusions
(transfusional hemosiderosis) in patients 2 years of age and
older.
Limitations of Use: Controlled
clinical trials of deferasirox with myelodysplastic syndromes (MDS)
and chronic iron overload due to blood transfusions have not been
performed. The safety and efficacy of deferasirox when administered
with other iron chelation therapy have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: Renal Failure, Hepatic Failure, and Gastrointestinal
Hemorrhage. Deferasirox can cause acute renal failure and
death, particularly in patients with comorbidities and those who
are in the advanced stages of their hematologic disorders.
Deferasirox can cause hepatic injury including hepatic failure
and death. Deferasirox can cause gastrointestinal (GI)
hemorrhages, which may be fatal, especially in elderly patients who
have advanced hematologic malignancies and/or low platelet
counts.
Deferasirox is contraindicated in patients with: estimated GFR
less than 40 mL/min/1.73m2; poor performance status; high-risk
myelodysplastic syndromes; advanced malignancies; platelet counts
less than 50 x 109/L; or known hypersensitivity to deferasirox or
any component of deferasirox tablets for oral suspension.
Nonfatal upper GI irritation, ulceration and hemorrhage have
also been reported in patients, including children and adolescents,
receiving deferasirox. The risk of gastrointestinal hemorrhage may
be increased when administering deferasirox in combination with
drugs that have ulcerogenic or hemorrhagic potential, such as
nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids,
oral bisphosphonates, or anticoagulants. There have been reports of
ulcers complicated with gastrointestinal perforation (including
fatal outcome). Neutropenia, agranulocytosis, worsening anemia, and
thrombocytopenia, including fatal events, have been reported in
patients treated with deferasirox. Preexisting hematologic
disorders may increase this risk.
Deferasirox has been associated with serious and fatal adverse
reactions in the postmarketing setting among adults, predominantly
in elderly patients. Deferasirox has been associated with serious
and fatal adverse reactions in pediatric patients in the
postmarketing setting. Deferasirox may cause serious
hypersensitivity reactions (such as anaphylaxis and angioedema),
with the onset of the reaction usually occurring within the first
month of treatment. Severe cutaneous adverse reactions (SCARs)
including Stevens-Johnson syndrome (SJS), toxic epidermal
necrolysis (TEN), and drug reaction with eosinophilia and systemic
symptoms (DRESS) which could be life-threatening or fatal have been
reported during deferasirox therapy. Cases of erythema multiforme
have been observed. Rashes may occur during deferasirox
treatment.
Auditory disturbances (high frequency hearing loss, decreased
hearing), and ocular disturbances (lens opacities, cataracts,
elevations in intraocular pressure, and retinal disorders) were
reported at a frequency of less than 1% with deferasirox therapy in
the clinical studies. The frequency of auditory adverse events
irrespective of causality was increased among pediatric patients
who received deferasirox doses greater than 25 mg/kg/day when serum
ferritin was less than 1,000 mcg/L.
In clinical trials of patients with transfusional iron overload,
the most frequently occurring (greater than 5%) adverse reactions
for deferasirox were diarrhea, vomiting, nausea, abdominal pain,
skin rashes, and increases in serum creatinine.
For more information, please see accompanying Full Prescribing
Information, including the Boxed Warning. A copy may be requested
from Teva US Medical Information at 888-TEVA-USA (888-838-2872),
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
1 EXJADE® is a registered trademark of Novartis Pharmaceuticals
Corporation
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 43,000
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 the launch and potential benefits of the generic version
of EXJADE®, 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 EXJADE;
- 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® or 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190322005444/en/
IR ContactsUnited StatesKevin C. Mannix(215)
591-8912
IsraelRan Meir972 (3) 926-7516
PR ContactsUnited StatesKelley Dougherty(973)
658-0237
IsraelYonatan Beker972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024