Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic version of Tarceva®1 (erlotinib)
tablets, 100 and 150 mg, in the U.S.
Erlotinib Tablets are a kinase inhibitor indicated for the
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors have epidermal growth factor receptor (EGFR)
exon 19 deletions or exon 21 (L858R) substitution mutations as
detected by an FDA-approved test receiving first-line, maintenance,
or second or greater line treatment after progression following at
least one prior chemotherapy regimen. Erlotinib Tablets are also
indicated for first-line treatment of patients with locally
advanced, unresectable or metastatic pancreatic cancer in
combination with gemcitabine.
“The launch of generic Tarceva® tablets marks an important
addition to our offering of oncology products,” said Brendan
O’Grady, EVP and Head of North America Commercial.
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.
Tarceva® tablets have annual sales of $202 million in the U.S.,
according to IQVIA data as of February 2019.
About Erlotinib Tablets
Erlotinib Tablets are indicated for the treatment of patients
with metastatic non-small cell lung cancer (NSCLC) whose tumors
have epidermal growth factor receptor (EGFR) exon 19 deletions or
exon 21 (L858R) substitution mutations as detected by an
FDA-approved test receiving first-line, maintenance, or second or
greater line treatment after progression following at least one
prior chemotherapy regimen. Limitations of use: Safety and efficacy of
Erlotinib Tablets have not been established in patients with NSCLC
whose tumors have other EGFR mutations. Erlotinib Tablets are not
recommended for use in combination with platinum-based
chemotherapy.
Erlotinib Tablets in combination with gemcitabine are indicated
for the first-line treatment of patients with locally advanced,
unresectable or metastatic pancreatic cancer.
IMPORTANT SAFETY INFORMATION
Cases of serious interstitial lung disease, including fatal
cases, can occur with erlotinib treatment. Hepatorenal syndrome,
severe acute renal failure including fatal cases, and renal
insufficiency can occur with erlotinib treatment. Renal failure may
arise from exacerbation of underlying baseline hepatic impairment
or severe dehydration. Hepatic failure and hepatorenal syndrome,
including fatal cases, can occur with erlotinib treatment in
patients with normal hepatic function; the risk of hepatic toxicity
is increased in patients with baseline hepatic impairment.
Gastrointestinal perforation, including fatal cases, can occur
with erlotinib treatment. Patients receiving concomitant
anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based
chemotherapy, or who have prior history of peptic ulceration or
diverticular disease may be at increased risk of perforation.
Bullous, blistering and exfoliative skin conditions, including
cases suggestive of Stevens-Johnson syndrome/toxic epidermal
necrolysis, which in some cases were fatal, can occur with
erlotinib treatment. The risk of cerebrovascular accident is
increased in patients with pancreatic cancer. The risk of
microangiopathic hemolytic anemia is increased in patients with
pancreatic cancer.
Decreased tear production, abnormal eyelash growth,
keratoconjunctivitis sicca or keratitis can occur with erlotinib
treatment and can lead to corneal perforation or ulceration. Severe
and fatal hemorrhage associated with International Normalized Ratio
(INR) elevations can occur when erlotinib and warfarin are
administered concurrently. Based on animal data and its mechanism
of action, erlotinib can cause fetal harm when administered to a
pregnant woman.
The most common adverse reactions (≥ 20%) with erlotinib from a
pooled analysis in patients with NSCLC across all approved lines of
therapy, with and without EGFR mutations, and in patients with
pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea,
cough, nausea, and vomiting.
For more information, please see accompanying Full Prescribing
Information. A copy may be requested from Teva U.S. Medical
Information at 888-TEVA-USA (888-838-2872), druginfo@tevapharm.com,
or Teva’s Public Relations or Investor Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 35,000
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. 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 Tarceva®, 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 Tarceva®,
- 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.
1 Tarceva® is a trademark of OSI Pharmaceuticals, an affiliate
of Astellas Pharma US, Inc.
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