TRUXIMA Available Week of November 11
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Celltrion,
Inc., (KRX KRX:068270) and Celltrion Healthcare, Co., Ltd. (KRX
KOSDAQ:091990), today announced that TRUXIMA® (rituximab-abbs)
injection is the first biosimilar to the reference product
Rituxan®1 (rituximab) now available in the United States with a
full oncology label. TRUXIMA is currently indicated for the
treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and
Chronic Lymphocytic Leukemia (CLL):
- Non-Hodgkin’s Lymphoma (NHL)
- Relapsed or refractory, low grade or follicular, CD20-positive
B-cell NHLas a single agent
- Previously untreated follicular, CD20-positive, B-cell NHL in
combination with first line chemotherapy and, in patients achieving
a complete or partial response to a rituximab product in
combination with chemotherapy, as single-agent maintenance
therapy
- Non-progressing (including stable disease), low-grade,
CD20positive, B-cell NHL as a single agent after first-line
cyclophosphamide, vincristine, and prednisone (CVP)
chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in
combination with (cyclophosphamide, doxorubicin, vincristine, and
prednisone) (CHOP) or other anthracycline-based chemotherapy
regimens
- Chronic Lymphocytic Leukemia (CLL)
- In combination with fludarabine and cyclophosphamide (FC), for
the treatment of adult patients with previously untreated and
previously treated CD20-positive CLL
“We are excited about the first FDA-approved biosimilar to
rituximab in the U.S.,” stated Brendan O’Grady, Executive Vice
President and Head of North America Commercial at Teva. “Teva’s
commitment to biosimilars is focused on the potential to create
lower healthcare costs and increased price competition. This focus
is consistent with Teva’s mission of making accessible medications
to help improve the lives of patients.”
TRUXIMA was approved by the U.S. Food and Drug Administration
(FDA) as the first rituximab biosimilar. The approval was based on
a review of a comprehensive data package inclusive of foundational
and extensive analytical characterization, nonclinical data,
clinical pharmacology, immunogenicity, clinical efficacy, and
safety data. In May 2019, the FDA approved TRUXIMA to match all of
the reference product’s oncology indications for NHL and CLL. In
light of a patent settlement with Genentech, Celltrion and Teva
have a pending FDA submission for rheumatoid arthritis (RA),
granulomatosis with polyangiitis (GPA), and microscopic
polyangiitis (MPA), and a license from Genentech to expand the
TRUXIMA label to include these indications in Q2 2020.
“We are pleased to announce the launch of the first rituximab
biosimilar, TRUXIMA, with our marketing partner Teva in the U.S.”
said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We
believe that the introduction of TRUXIMA into the U.S. market will
contribute to addressing unmet needs of U.S. patients as well.”
The Wholesale Acquisition Cost (WAC or “list price”) for TRUXIMA
will be 10 percent lower than the reference product. TRUXIMA is
being made available through primary wholesalers at a WAC of
$845.55 for 100mg vial and $4227.75 for 500mg vial. Actual costs to
individual patients and providers for TRUXIMA are anticipated to be
lower than WAC because WAC does not account for additional rebates
and discounts that may apply. Savings on out-of-pocket costs may
vary depending on the patient’s insurance payer and eligibility for
participation in the assistance program.
Dedicated patient support services are also available from Teva
through the Comprehensive Oncology Reimbursement Expertise (CORE)
program. CORE is available to help eligible patients, caregivers
and healthcare professionals navigate the reimbursement process.
CORE offers a range of services, including benefits verification
and coverage determination, support for precertification and prior
authorization, assistance with coverage guidelines and claims
investigation, and support through the claims and appeals process.
A savings program is also available for eligible commercially
insured patients. To learn more, please visit TevaCORE.com. For
healthcare professionals seeking additional information, there is
also a dedicated site at TRUXIMAhcp.com.
Celltrion and Teva Pharmaceutical Industries Ltd. entered into
an exclusive partnership in October 2016 to commercialize TRUXIMA
in the U.S. and Canada.
Please see the Important Safety Information below including the
Boxed Warning regarding fatal infusion-related reactions, severe
mucocutaneous reactions, hepatitis B virus reactivation and
progressive multifocal leukoencephalopathy. For more information,
please visit the full prescribing information.
Important Safety Information
WARNING: FATAL
INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS,
HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY
Infusion-Related Reactions -
Administration of rituximab products, including TRUXIMA, can result
in serious, including fatal, infusion-related reactions. Deaths
within 24 hours of rituximab infusion have occurred. Approximately
80% of fatal infusion-related reactions occurred in association
with the first infusion. Monitor patients closely. Discontinue
TRUXIMA infusion for severe reactions and provide medical treatment
for Grade 3 or 4 infusion-related reactions
Severe Mucocutaneous Reactions -
Severe, including fatal, mucocutaneous reactions can occur in
patients receiving rituximab products
Hepatitis B Virus (HBV) Reactivation
- HBV reactivation can occur
in patients treated with rituximab products, in some cases
resulting in fulminant hepatitis, hepatic failure, and death.
Screen all patients for HBV infection before treatment initiation,
and monitor patients during and after treatment with TRUXIMA.
Discontinue TRUXIMA and concomitant medications in the event of HBV
reactivation
Progressive Multifocal
Leukoencephalopathy (PML), including fatal PML, can occur in
patients receiving rituximab products
Warnings and Precautions
Infusion-Related Reactions - Rituximab products can cause
severe, including fatal, infusion-related reactions. Severe
reactions typically occurred during the first infusion with time to
onset of 30-120 minutes. Rituximab product-induced infusion-related
reactions and sequelae include urticaria, hypotension, angioedema,
hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory
distress syndrome, myocardial infarction, ventricular fibrillation,
cardiogenic shock, anaphylactoid events, or death.
Premedicate patients with an antihistamine and acetaminophen
prior to dosing. Institute medical management (e.g.
glucocorticoids, epinephrine, bronchodilators, or oxygen) for
infusion-related reactions as needed. Depending on the severity of
the infusion-related reaction and the required interventions,
temporarily or permanently discontinue TRUXIMA. Resume infusion at
a minimum 50% reduction in rate after symptoms have resolved.
Closely monitor the following patients: those with pre-existing
cardiac or pulmonary conditions, those who experienced prior
cardiopulmonary adverse reactions, and those with high numbers of
circulating malignant cells (>25,000/mm3)
Severe Mucocutaneous Reactions - Mucocutaneous reactions,
some with fatal outcome, can occur in patients treated with
rituximab products. These reactions include paraneoplastic
pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis,
vesiculobullous dermatitis, and toxic epidermal necrolysis. The
onset of these reactions has been variable and includes reports
with onset on the first day of rituximab exposure. Discontinue
TRUXIMA in patients who experience a severe mucocutaneous reaction.
The safety of re-administration of rituximab products to patients
with severe mucocutaneous reactions has not been determined.
Hepatitis B Virus Reactivation - Hepatitis B virus (HBV)
reactivation, in some cases resulting in fulminant hepatitis,
hepatic failure and death, can occur in patients treated with drugs
classified as CD20-directed cytolytic antibodies, including
rituximab products. Cases have been reported in patients who are
hepatitis B surface antigen (HBsAg) positive and also in patients
who are HBsAg negative but are hepatitis B core antibody (anti-HBc)
positive. Reactivation also has occurred in patients who appear to
have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc
positive and hepatitis B surface antibody [anti-HBs] positive).
HBV reactivation is defined as an abrupt increase in HBV
replication manifesting as a rapid increase in serum HBV DNA levels
or detection of HBsAg in a person who was previously HBsAg negative
and anti-HBc positive. Reactivation of HBV replication is often
followed by hepatitis, i.e., increase in transaminase levels. In
severe cases increase in bilirubin levels, liver failure, and death
can occur.
Screen all patients for HBV infection by measuring HBsAg and
anti-HBc before initiating treatment with TRUXIMA. For patients who
show evidence of prior hepatitis B infection (HBsAg positive
[regardless of antibody status] or HBsAg negative but anti-HBc
positive), consult with physicians with expertise in managing
hepatitis B regarding monitoring and consideration for HBV
antiviral therapy before and/or during TRUXIMA treatment.
Monitor patients with evidence of current or prior HBV infection
for clinical and laboratory signs of hepatitis or HBV reactivation
during and for several months following TRUXIMA therapy. HBV
reactivation has been reported up to 24 months following completion
of rituximab therapy.
In patients who develop reactivation of HBV while on TRUXIMA,
immediately discontinue TRUXIMA and any concomitant chemotherapy,
and institute appropriate treatment. Insufficient data exist
regarding the safety of resuming TRUXIMA treatment in patients who
develop HBV reactivation. Resumption of TRUXIMA treatment in
patients whose HBV reactivation resolves should be discussed with
physicians with expertise in managing HBV.
Progressive Multifocal Leukoencephalopathy (PML) - JC
virus infection resulting in PML and death can occur in rituximab
product-treated patients with hematologic malignancies. The
majority of patients with hematologic malignancies diagnosed with
PML received rituximab in combination with chemotherapy or as part
of a hematopoietic stem cell transplant. Most cases of PML were
diagnosed within 12 months of their last infusion of rituximab.
Consider the diagnosis of PML in any patient presenting with
new-onset neurologic manifestations. Evaluation of PML includes,
but is not limited to, consultation with a neurologist, brain MRI,
and lumbar puncture.
Discontinue TRUXIMA and consider discontinuation or reduction of
any concomitant chemotherapy or immunosuppressive therapy in
patients who develop PML.
Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia,
hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis,
sometimes fatal, can occur within 12-24 hours after the first
infusion of rituximab products in patients with NHL. A high number
of circulating malignant cells (>25,000/mm3) or high tumor burden, confers a
greater risk of TLS.
Administer aggressive intravenous hydration and
anti-hyperuricemic therapy in patients at high risk for TLS.
Correct electrolyte abnormalities, monitor renal function and fluid
balance, and administer supportive care, including dialysis as
indicated.
Infections - Serious, including fatal, bacterial, fungal,
and new or reactivated viral infections can occur during and
following the completion of rituximab product-based therapy.
Infections have been reported in some patients with prolonged
hypogammaglobulinemia (defined as hypogammaglobulinemia >11
months after rituximab exposure). New or reactivated viral
infections included cytomegalovirus, herpes simplex virus,
parvovirus B19, varicella zoster virus, West Nile virus, and
hepatitis B and C. Discontinue TRUXIMA for serious infections and
institute appropriate anti-infective therapy. TRUXIMA is not
recommended for use in patients with severe, active infections.
Cardiovascular Adverse Reactions - Cardiac adverse reactions, including
ventricular fibrillation, myocardial infarction, and cardiogenic
shock may occur in patients receiving rituximab products.
Discontinue infusions for serious or life-threatening cardiac
arrhythmias. Perform cardiac monitoring during and after all
infusions of TRUXIMA for patients who develop clinically
significant arrhythmias, or who have a history of arrhythmia or
angina.
Renal Toxicity - Severe, including fatal, renal toxicity can
occur after rituximab product administration in patients with NHL.
Renal toxicity has occurred in patients who experience tumor lysis
syndrome and in patients with NHL administered concomitant
cisplatin therapy during clinical trials. The combination of
cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs
of renal failure and discontinue TRUXIMA in patients with a rising
serum creatinine or oliguria.
Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and
perforation, in some cases leading to death, can occur in patients
receiving rituximab in combination with chemotherapy. In
postmarketing reports, the mean time to documented gastrointestinal
perforation was 6 (range 1-77) days in patients with NHL. Evaluate
if symptoms of obstruction such as abdominal pain or repeated
vomiting occur.
Immunization - The
safety of immunization with live viral vaccines following rituximab
product therapy has not been studied and vaccination with live
virus vaccines is not recommended before or during
treatment.
Embryo-Fetal Toxicity - Based on human data, rituximab products can
cause fetal harm due to B-cell lymphocytopenia in infants exposed
to rituximab in-utero. Advise pregnant women of the risk to a
fetus. Females of childbearing potential should use effective
contraception while receiving TRUXIMA and for 12 months following
the last dose of TRUXIMA.
Most common adverse reactions in clinical trials of NHL
(>25%) were: infusion-related reactions, fever,
lymphopenia, chills, infection, and asthenia
Most common adverse reactions in clinical trials of CLL
(>25%) were: infusion-related reactions and
neutropenia
Nursing Mothers - There are no data on the presence of
rituximab in human milk, the effect on the breastfed child, or the
effect on milk production. Since many drugs including antibodies
are present in human milk, advise a lactating woman not to
breastfeed during treatment and for at least 6 months after the
last dose of TRUXIMA due to the potential for serious adverse
reactions in breastfed infants.
About TRUXIMA®
TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration
(FDA)-approved biosimilar to RITUXAN® (rituximab) for the treatment
of adult patients with CD20-positive, B-cell NHL to be used as a
single agent or in combination with chemotherapy or CLL in
combination with fludarabine and cyclophosphamide (FC).
TRUXIMA has the same mechanism of action as Rituxan and has
demonstrated biosimilarity to Rituxan through a totality of
evidence.
About Celltrion Healthcare, Co. Ltd.
Celltrion Healthcare conducts the worldwide marketing, sales and
distribution of biological medicines developed by Celltrion, Inc.
through an extensive global network that spans more than 120
different countries. Celltrion Healthcare’s products are
manufactured at state-of-the-art mammalian cell culture facilities,
designed and built to comply with the US Food and Drug
Administration (FDA) cGMP guidelines and the EU GMP guidelines.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading
biopharmaceutical company, specializing in research, development
and manufacturing of biosimilar and innovative drugs. Celltrion
strives to provide more affordable biosimilar mAbs to patients who
previously had limited access to advanced therapeutics. Celltrion
received FDA approval for TRUXIMA® (rituximab-abbs) and HERZUMA®
(trastuzumab-pkrb) in 2018.
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 3,500
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.
Teva's 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 TRUXIMA®, 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 commercial success of TRUXIMA;
- challenges inherent in product research and development,
including obtaining regulatory approvals for additional indications
for TRUXIMA;
- 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 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;
implementation of a new enterprise resource planning system that,
if deficient, could materially and adversely affect our operations
and/or the effectiveness of our internal controls; 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; increased legal and regulatory action in connection
with public concern over the abuse of opioid medications in the
U.S.; 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 Quarterly Reports on Form
10-Q for the first and second quarter of 2019 and in our Annual
Report on Form 10-K for the year ended December 31, 2018, including
in the sections captioned "Risk Factors” and “Forward Looking
Statements.” 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 RITUXAN is a registered trademark of Genentech and Biogen.
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IR United States Kevin C. Mannix (215) 591-8912
Ran Meir 972 (3) 926-7516
PR United States Doris Li (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
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