Celltrion & Teva Announce FDA Oncologic Drugs Advisory Committee Recommends Approval of Celltrion BLA for CT-P10, a Proposed ...
2018年10月11日 - 1:30AM
ビジネスワイヤ(英語)
If approved, CT-P10, a proposed biosimilar to
Rituxan® (rituximab), will be the first rituximab biosimilar to be
approved in the United States
Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries
Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug
Administration (FDA) Oncologic Drugs Advisory Committee voted
unanimously 16-0 to recommend approval of CT-P10, a proposed
monoclonal antibody (mAb) biosimilar to Rituxan®1 (rituximab) for
the treatment of adult patients in three proposed indications. The
proposed indications are: (1) relapsed or refractory, low-grade or
follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a
single agent; (2) 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; and (3) non-progressing (including stable
disease), low-grade, CD20-positive, B-cell NHL as a single agent
after first-line cyclophosphamide, vincristine, and prednisone
chemotherapy.
The FDA will take the Committee’s recommendation into
consideration before taking action on the Biologics License
Application (BLA) for the proposed Rituxan® biosimilar.
The Committee based its recommendation on a review of a
comprehensive data package inclusive of foundational analytical
biosimilarity data, nonclinical data, clinical pharmacology,
immunogenicity and clinical efficacy and safety data. The results
of the clinical development program for CT-P10 demonstrated that
there were no clinically meaningful differences between CT-P10 and
Rituxan® in terms of the safety, purity and potency of the product
for the three proposed indications.
“We welcome the Oncologic Drugs Advisory Committee’s
recommendation. If approved by the FDA, CT-P10, a proposed
biosimilar to Rituxan®, will be the first rituximab biosimilar to
be approved in the United States for the three proposed
indications,” said Woosung Kee, Chief Executive Officer of
Celltrion. “The development of biosimilars is of great importance
in the field of oncology, and has the potential to increase
accessibility to therapies for patients.”
“If approved, Teva is well positioned to successfully
commercialize CT-P10, given our unique portfolio of branded and
generic medications, as well as patient support experience,” said
Brendan O’Grady, Executive Vice President and Head of North America
Commercial at Teva. “We are encouraged by the outcome of today’s
meeting, which emphasizes the growing importance of biosimilars and
the potential value to be introduced into our health systems.”
Celltrion and Teva Pharmaceutical Industries Ltd. entered into
an exclusive partnership in October 2016 to commercialize CT-P10 in
the U.S. and Canada.
1 Rituxan® is a registered trademark of Biogen and Genentech
USA, Inc.
About CT-P10
Celltrion’s CT-P10, a proposed biosimilar to Biogen and
Genentech USA, Inc.’s Rituxan®, is currently approved in 47
countries across the globe. CT-P10 is the world’s first monoclonal
antibody (mAb) biosimilar approved by the European Commission (EC)
for the treatment of oncology and was first launched in Europe in
2017. The active substance in CT-P10, has been designed to bind
specifically to the transmembrane protein CD20 found on both
malignant and normal B cells.
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 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:
- challenges inherent in product research
and development, including uncertainty of obtaining regulatory
approvals for CT-P10;
- expected delay between FDA approval and
commercialization of CT-P10;
- 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181010005787/en/
Celltrion, Inc.IR Contacts:Josh
Hwang, +82 32 850 5171Josh.Hwang@celltrion.comorPR Contacts:Gunn Lee, +82 32 850
5168Gunhyuk.lee@celltrion.comorHeewon Park, +82 32 850
5356Heewon.park@celltrion.comorTeva Pharmaceutical Industries
Ltd.IR Contacts:Kevin C. Mannix,
215-591-8912orRan Meir, 972 (3) 926-7516orPR
Contacts:United StatesDoris Saltkill,
913-777-3343orIsraelYonatan Beker, 972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 6 2024 まで 7 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 7 2023 まで 7 2024