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INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE)--Jun. 29, 2017--
Celltrion, Inc., a global biopharmaceutical company, 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-P10, a proposed
Monoclonal Antibody (mAb) biosimilar to Rituxan®1
(rituximab), which is used to treat patients with non-Hodgkin’s lymphoma
(NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA),
granulomatosis with polyangiitis and microscopic polyangiitis.
“As the global leader in biosimilars who brought Inflectra, the world’s
first mAb biosimilar approved by the FDA, to the U.S., we are pleased
and honored to have this opportunity to once again work with the FDA on
CT-P10,” said Woo Sung Kee, Chief Executive Officer of Celltrion.
“CT-P10, which has been approved in the EU, is continuing to build a
solid track record since its launch there earlier this year and has
provided patients with access to a high quality treatment option and has
offered great savings in healthcare costs. I am hopeful that CT-P10 will
bring similar benefits to the U.S. when approved.”
The BLA for CT-P10 includes data for CT-P10 and reference rituximab in
terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and
pharmacokinetics (PK). These trials were conducted in over 600 patients
and include up to 104 weeks of data. CT-P10 was approved by the European
Commission in February 20172 and has launched in the U.K.,
Germany, Netherlands, Spain and the Republic of Korea.
“Teva is pleased to announce this important milestone today, with our
partner Celltrion, bringing us one step closer to making additional
biosimilar treatment options available to patients in the U.S.,” said
Paul Rittman, Senior Vice President and General Manager, Teva Oncology.
“We look forward to leveraging Teva’s unique cross-functional
capabilities across both specialty and generic medicines to continue our
commitment to serving those dealing with cancer, rheumatoid arthritis,
and other serious diseases.”
Celltrion and Teva entered into an exclusive partnership to
commercialize CT-P10 and CT-P6, a biosimilar to Herceptin (trastuzumab),
in the U.S. and Canada in October 2016. As part of the agreement, Teva
is responsible for all commercial activities in the U.S. and Canada,
pending regulatory approvals for both products. Celltrion has
responsibility for completing all clinical development and regulatory
The BLA for CT-P10 has been accepted for filing by the FDA for standard
review, with FDA Regulatory Action expected during the first quarter of
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 biosimilar mAb to receive approval from a regulatory agency in a
developed country. For more information, visit www.celltion.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 hematological cancers
Hematological cancers begin in blood-forming tissue or cells of the
immune system. There are three common types of hematological cancers:
lymphoma, leukemia and myeloma. There are many types of NHL, the most
common group is B cell lymphomas, of which follicular lymphoma and
diffuse large B cell lymphoma are the most common. CLL is a type of
leukemia and is characterized by accumulation of monoclonal B cells (a
type of white blood cell).
About rheumatoid arthritis
Rheumatoid Arthritis (RA) is estimated to affect as much as 1% of the
worldwide population. On average, every third person with RA becomes
work disabled and up to 40 percent leave work completely within 5 years
of diagnosis. Although there is no cure for RA, there are many
treatments that can reduce inflammation and ease pain. As with all
rheumatic diseases early diagnosis and intervention is key.
About CT-P10 (biosimilar rituximab)
CT-P10 is an investigational mAb designed to target CD20, a protein
found on the surface of most B cells. Overactive B cells can stimulate
attack of healthy cells in immune-related diseases such as RA. B cells
are also implicated in some types of hematological cancer including NHL
and CLL. B cells express CD20 at many stages of their development making
the protein a good target for treatments.
CT-P10 is approved in the EU for the treatment of people with NHL, CLL,
RA, granulomatosis with polyangiitis and microscopic polyangiitis.
Further details of the approved indications and safety information for
CT-P10 are available in the summary of product characteristics (SmPC2).
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-P10 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:
1 Rituxan® is a registered trademark of Biogen2
European Commission. Community register of medicinal products for human
use. Available at http://ec.europa.eu/health/documents/community-register/html/h1167.htm.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170629005580/en/
Source: Teva Pharmaceutical Industries Ltd. and Celltrion, Inc.
Teva Pharmaceutical Industries Ltd.IR Contacts:United StatesKevin
C. Mannix, 215-591-8912orRan Meir, 215-591-3033orIsraelTomer
Amitai, 972 (3) 926-7656orPR Contacts:IsraelIris
Beck Codner, 972 (3) 926-7687orUnited StatesDenise
Bradley, 215-591-8974orNancy Leone, 215-284-0213orCelltrion