JERUSALEM–(BUSINESS WIRE)–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.
Contacts
IR Contacts
United States
Kevin C. Mannix
(215)
591-8912
Israel
Ran Meir
972 (3) 926-7516
PR Contacts
United States
Kelley Dougherty
(973)
658-0237
Israel
Yonatan Beker
972 (54) 888 5898