Teva launches generic Tarceva (erlotinib) tablets in the United States

May 10, 2019 Off By BusinessWire

JERUSALEM–(BUSINESS WIRE)–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), [email protected],
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.