Celltrion & Teva Announce FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER...
2018年12月15日 - 8:31AM
ビジネスワイヤ(英語)
Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries
Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and
Drug Administration (FDA) has approved HERZUMA® (trastuzumab-pkrb),
a HER2/neu receptor antagonist biosimilar to HERCEPTIN®1
(trastuzumab) for the following indications:
- Adjuvant Breast Cancer of HER2
overexpressing node positive or node negative (ER/PR negative or
with one high risk feature) breast cancer
- as part of a treatment regimen
consisting of doxorubicin, cyclophosphamide, and either paclitaxel
or docetaxel
- as part of a treatment regimen with
docetaxel and carboplatin
- Metastatic Breast Cancer
- in combination with paclitaxel for
first-line treatment of HER2-overexpressing metastatic breast
cancer
- as a single agent for treatment of
HER2-overexpressing breast cancer in patients who have received one
or more chemotherapy regimens for metastatic disease.
- In these indications, patients should
be selected for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product
“Biosimilars are of growing importance to the oncology community
and the approval of HERZUMA may provide more patients access to
this important therapy,” stated Woosung Kee, Chief Executive
Officer of Celltrion. “This is our second oncology biosimilar
approval in the United States in the past month, which reinforces
the goal for all of our approved products -- providing broader
treatment options for patients and the providers who treat
them.”
HERZUMA meets the FDA’s rigorous standards as a biosimilar to
the reference product for the approved indications based on a
totality of evidence. The FDA approval is based on a review of a
comprehensive data package inclusive of foundational analytical
similarity data, nonclinical data, clinical pharmacology,
immunogenicity, clinical efficacy and safety data. The results of
the clinical development program for HERZUMA demonstrated that
there were no clinically meaningful differences in purity, potency
and safety between HERZUMA and HERCEPTIN for the treatment of
HER2-overexpressing breast cancer for the approved indications.
“We are excited about building Teva’s presence in biosimilars,”
said Brendan O’Grady, Executive Vice President and Head of North
America Commercial at Teva. “The addition of HERZUMA to our
biosimilars portfolio will allow us to leverage our strengths from
Oncology and Generics.”
Trastuzumab products have a Boxed Warning which states that
treatment with trastuzumab may be associated with cardiomyopathy,
infusion reactions, pulmonary toxicity and embryo-fetal toxicity.
Please see the full Boxed Warning and additional Important Safety
Information in this release and accompanying Prescribing
Information.
Celltrion and Teva Pharmaceutical Industries Ltd. entered into
an exclusive partnership in October 2016 to commercialize HERZUMA
in the U.S. and Canada.
Important Safety Information and Boxed Warnings
WARNING: CARDIOMYOPATHY, INFUSION
REACTIONS, EMBRYO-FETAL TOXICITY, AND PULMONARY TOXICITY
Cardiomyopathy - Administration of
trastuzumab products can result in sub-clinical and clinical
cardiac failure. The incidence and severity was highest in patients
receiving trastuzumab with anthracycline- containing chemotherapy
regimens.
Evaluate left ventricular function in all
patients prior to and during treatment with HERZUMA. Discontinue
HERZUMA treatment in patients receiving adjuvant therapy and
withhold HERZUMA in patients with metastatic disease for clinically
significant decrease in left ventricular function.
Infusion Reactions; Pulmonary Toxicity
- Administration of trastuzumab products can result in serious
and fatal infusion reactions and pulmonary toxicity. Symptoms
usually occur during or within 24 hours of HERZUMA administration.
Interrupt HERZUMA infusion for dyspnea or clinically significant
hypotension. Monitor patients until symptoms completely resolve.
Discontinue HERZUMA for anaphylaxis, angioedema, interstitial
pneumonitis, or acute respiratory distress syndrome.
Embryo Fetal Toxicity - Exposure to
trastuzumab products during pregnancy can result in oligohydramnios
and oligohydramnios sequence manifesting as pulmonary hypoplasia,
skeletal abnormalities, and neonatal death. Advise patients of
these risks and the need for effective contraception.
Cardiomyopathy
- Trastuzumab products can cause left
ventricular cardiac dysfunction, arrhythmias, hypertension,
disabling cardiac failure, cardiomyopathy, and cardiac death.
Trastuzumab products can also cause asymptomatic decline in left
ventricular ejection fraction (LVEF).
- There is a 4–6-fold increase in the
incidence of symptomatic myocardial dysfunction among patients
receiving trastuzumab products as a single agent or in combination
therapy compared with those not receiving trastuzumab products. The
highest absolute incidence occurs when a trastuzumab product is
administered with an anthracycline.
- Withhold HERZUMA for ≥ 16% absolute
decrease in LVEF from pre-treatment values or an LVEF value below
institutional limits of normal and ≥ 10% absolute decrease in LVEF
from pretreatment values. The safety of continuation or resumption
of HERZUMA in patients with trastuzumab product-induced left
ventricular cardiac dysfunction has not been studied.
- Patients who receive anthracycline
after stopping HERZUMA may also be at increased risk of cardiac
dysfunction.
Cardiac Monitoring
- Conduct thorough cardiac assessment,
including history, physical examination, and determination of LVEF
by echocardiogram or MUGA scan. The following schedule is
recommended:
- Baseline LVEF measurement immediately
prior to initiation of HERZUMA.
- LVEF measurements every 3 months during
and upon completion of HERZUMA.
- Repeat LVEF measurement at 4 week
intervals if HERZUMA is withheld for significant left ventricular
cardiac dysfunction.
- LVEF measurements every 6 months for at
least 2 years following completion of HERZUMA as a component of
adjuvant therapy.
Infusion Reactions
- Infusion reactions consist of a symptom
complex characterized by fever and chills, and on occasion included
nausea, vomiting, pain (in some cases at tumor sites), headache,
dizziness, dyspnea, hypotension, rash, and asthenia.
- In post-marketing reports, serious and
fatal infusion reactions have been reported. Severe reactions,
which include bronchospasm, anaphylaxis, angioedema, hypoxia, and
severe hypotension, were usually reported during or immediately
following the initial infusion. However, the onset and clinical
course were variable, including progressive worsening, initial
improvement followed by clinical deterioration, or delayed
post-infusion events with rapid clinical deterioration. For fatal
events, death occurred within hours to days following a serious
infusion reaction.
- Interrupt HERZUMA infusion in all
patients experiencing dyspnea, clinically significant hypotension,
and intervention of medical therapy administered (which may include
epinephrine, corticosteroids, diphenhydramine, bronchodilators, and
oxygen). Patients should be evaluated and carefully monitored until
complete resolution of signs and symptoms. Permanent
discontinuation should be strongly considered in all patients with
severe infusion reactions.
- There are no data regarding the most
appropriate method of identification of patients who may safely be
retreated with trastuzumab products after experiencing a severe
infusion reaction. Prior to resumption of trastuzumab infusion, the
majority of patients who experienced a severe infusion reaction
were pre-medicated with antihistamines and/or corticosteroids.
While some patients tolerated trastuzumab infusions, others had
recurrent severe infusion reactions despite pre-medications.
Embryo-Fetal Toxicity
- Trastuzumab products can cause fetal
harm when administered to a pregnant woman. In post marketing
reports, use of trastuzumab during pregnancy resulted in cases of
oligohydramnios and oligohydramnios sequence manifesting as
pulmonary hypoplasia, skeletal abnormalities, and neonatal
death.
- Verify the pregnancy status of females
of reproductive potential prior to the initiation of HERZUMA.
Advise pregnant women and females of reproductive potential that
exposure to HERZUMA during pregnancy or within 7 months prior to
conception can result in fetal harm. Advise females of reproductive
potential to use effective contraception during treatment and for 7
months following the last dose of HERZUMA.
Pulmonary Toxicity
- Trastuzumab product use can result in
serious and fatal pulmonary toxicity. Pulmonary toxicity includes
dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural
effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency
and hypoxia, acute respiratory distress syndrome, and pulmonary
fibrosis. Such events can occur as sequelae of infusion
reactions.
- Patients with symptomatic intrinsic
lung disease or with extensive tumor involvement of the lungs,
resulting in dyspnea at rest, appear to have more severe
toxicity.
Exacerbation of Chemotherapy-Induced Neutropenia
- In randomized, controlled clinical
trials, the per-patient incidences of NCI-CTC Grade 3 to 4
neutropenia and of febrile neutropenia were higher in patients
receiving trastuzumab in combination with myelosuppressive
chemotherapy as compared to those who received chemotherapy alone.
The incidence of septic death was similar among patients who
received trastuzumab and those who did not.
Adverse Reactions
- Adjuvant Breast Cancer - Most
common adverse reactions (≥5%) are headache, diarrhea, nausea, and
chills.
- Metastatic Breast Cancer- Most
common adverse reactions (≥ 10%) are fever, chills, headache,
infection, congestive heart failure, insomnia, cough, and
rash.
Please click here for full Prescribing Information for
HERZUMA.
1 HERCEPTIN® is a registered trademark of Genentech, Inc.
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 and EC’s approval for Inflectra® and Remsima®,
respectively, which is the world’s first mAb biosimilar to receive
approval from a regulatory agency in a developed country. For more
information, visit www.celltrion.com.
About Teva
Teva Pharmaceutical Industries Ltd. 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 45,000 professionals, committed to
improving the lives of millions of patients. Learn more at
www.tevapharm.com.
Teva 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 HERZUMA®, 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 commercial success
of HERZUMA, including the successful launch of the product;
- Our ability to successfully challenge
third party's intellectual property that may apply to HERZUMA;
- 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; 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 substantially increased
indebtedness and significantly decreased cash on hand, 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 sales 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, 2017,
including in the section captioned “Risk Factors,” and in our other
filings with the U.S. Securities and Exchange Commission, which are
available at www.sec.gov and www.tevapharm.com. 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.
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Celltrion, Inc.IR
Contacts:Josh Hwang, +82 32 850 5171 /
Josh.hwang@celltrion.com
PR Contacts:Gunn Lee, +82 32 850
5168 / Gunhyuk.lee@celltrion.comHeewon Park, +82 32 850 5356 /
Heewon.park@celltrion.com
Teva Pharmaceutical Industries
Ltd.IR Contacts:Kevin C.
Mannix, (215) 591-8912Ran Meir, 972 (3) 926-7516
PR Contacts:United States, Doris
Saltkill, 913-777-3343Israel, Yonatan Beker, 972 (54) 888 5898
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