Celltrion & Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Herceptin® (trastu...
31 Juillet 2017 - 2:00PM
Business Wire
Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE
and TASE: TEVA) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the Biologics License
Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb)
biosimilar to Herceptin®1 (INN: trastuzumab) which is used for the
treatment of Human Epidermal growth factor Receptor 2
(HER2)-overexpressing breast cancer and metastatic gastric
cancer.
“Following on the heels of our global success with Remsima®2
(Inflectra®3), our infliximab biosimilar, which has brought
affordable and effective biologic treatment to many patients around
the world with proven similarity of quality, efficacy and safety to
the reference product, we are confident to submit a comprehensive
package of quality, nonclinical and clinical data of CT-P6 for FDA
review,” said Woo Sung Kee, Chief Executive Officer of Celltrion.
“If approved, CT-P6 will expand patient access to this important
biosimilar treatment option in the U.S.”
The BLA for CT-P6 includes data for CT-P6 and reference
trastuzumab in terms of efficacy, safety, immunogenicity,
pharmacodynamics (PD) and pharmacokinetics (PK). These trials were
conducted in over 500 patients in 22 countries.
CT-P6 has been approved by the Korean Ministry of Food and Drug
Safety. Celltrion also filed marketing authorization applications
for CT-P6 to the European Medicines Agency in October 2016.
“As Celltrion’s North American commercial partner for CT-P6 and
CT-P10, a proposed mAb biosimilar to Rituxin®2 (rituximab), we look
forward to the opportunity to leverage Teva’s strong legacy and
U.S. commercial presence in Oncology to bring additional biosimilar
treatment options to patients,” said Paul Rittman, Senior Vice
President and General Manager, Teva Oncology. “With today’s
announcement, we are one-step closer to doing so in the U.S. We are
very pleased to acknowledge the positive progress in our
partnership with Celltrion to help provide these additional
options, if approved, to patients living with cancer and other
serious diseases.”
Celltrion and Teva entered into an exclusive partnership to
commercialize CT-P6 and CT-P10 in the U.S. and Canada in October
2016. FDA also accepted for review the Biologics License
Application (BLA) for CT-P10, a proposed mAb biosimilar to Rituxan®
(rituximab) in June 2017.
The BLAs for both CT-P6 and CT-P10 have been accepted for filing
by the FDA for standard review, with FDA Regulatory Action expected
during the first half of 2018.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading
biopharmaceutical company, specializing in research, development
and manufacture 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 EMA 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. Celltrion
also received EMA approval for Truxima® (CT-P10, a proposed mAb
biosimilar to Rituxan® (rituximab)) in February 2017. For more
information, visit www.celltrion.com.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in 100 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging
its portfolio of more than 1,800 molecules to produce a wide range
of generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
www.tevapharm.com.
About CT-P6 (A proposed biosimilar trastuzumab)
CT-P6 is being investigated in the US as a proposed biosimilar
to trastuzumab which is a monoclonal antibody (mAb), a protein
designed to recognize and bind to a specific structure or antigen
in the body. Celltrion has carried out extensive studies between
CT-P6 and reference trastuzumab to submit for FDA review.
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 CT-P6 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:
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals of CT-P6;
- the uncertainty of commercial success
of CT-P6;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; 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 restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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; and other factors discussed
in our Annual Report on Form 20-F for the year ended December
31, 2016 (“Annual Report”), 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.
###
1. Herceptin is a registered trademark of Genentech Inc.
2. Remsima is a trademark or a registered trademark of Celltrion
Inc.
3. Inflectra is a registered trademark of Hospira UK Ltd.
4. Rituxan is a registered trademark of Biogen.
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version on businesswire.com: http://www.businesswire.com/news/home/20170731005433/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, 215-591-8974Nancy Leone,
215-284-0213orCelltrion, Inc.IR Contact:Republic of KoreaJosh
Hwang, 82-32-850-5171Josh.Hwang@celltrion.comorPR
Contact:Republic of KoreaGunhyuk Lee,
82-32-850-5168Gunhyuk.Lee@celltrion.com
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