INCHEON, Republic of Korea & JERUSALEM--(BUSINESS WIRE)--Jul. 31, 2017--
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
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.
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,
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
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
1. Herceptin is a registered trademark of Genentech Inc.
2. Remsima is a trademark or a registered trademark of Celltrion
3. Inflectra is a registered trademark of Hospira UK Ltd.
4. Rituxan is a registered trademark of Biogen.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
Amitai, 972 (3) 926-7656
Beck Codner, 972 (3) 926-7208
Nancy Leone, 215-284-0213
Republic of Korea
Republic of Korea
Gunhyuk Lee, 82-32-850-5168