Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases
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Sandoz biosimilar etanercept recommended by FDA advisory committee for approval
to treat multiple inflammatory diseases
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* Committee votes unanimously in favor of the Sandoz proposed biosimilar
etanercept for all approved indications of the reference product
* Committee's recommendation based on totality of evidence from global
development program showing biosimilar etanercept is highly similar to
Enbrel(®)*
Holzkirchen, 13 July, 2016. Sandoz, a Novartis division and leader in
biosimilars, announced today that the US Food and Drug Administration (FDA)
Arthritis Advisory Committee recommended approval of its proposed biosimilar
etanercept. The committee voted unanimously (20-0), in support of biosimilar
etanercept for all five indications of the reference product, including
rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic psoriasis (PsA),
ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis
(JIA).
"We are encouraged by today's favorable advisory committee recommendation for
our proposed biosimilar etanercept," said Mark McCamish, M.D., Ph.D., Head of
Global Biopharmaceutical Development, Sandoz. "As a global market leader in
biosimilars, we are pleased to move one step closer toward our goal of expanding
patient access with our proposed biosimilar etanercept, and look forward to
continuing to work with the FDA as they complete their review of our
application."
The recommendation was provided after the presentation of data from a global
development program including analytical, pre-clinical and clinical studies of
the Sandoz biosimilar etanercept, which demonstrated biosimilarity to the
reference product. Clinical studies included four comparative pharmacokinetic
(PK) studies in 216 healthy volunteers(**) and a confirmatory efficacy and
safety similarity study in 531 patients with chronic plaque psoriasis.
The FDA frequently seeks the advice of its advisory committees as it reviews and
decides whether to approve applications, although the agency does not always
follow their recommendations.
In December 2015, the European Medicines Agency (EMA) accepted Sandoz Marketing
Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed
Enbrel(®), which seeks approval for the same indications as the reference
product.
Sandoz is committed to providing patient access to high-quality, life-enhancing
biosimilars. It is the pioneer and global market leader and currently markets
three biosimilars worldwide. Sandoz has a leading pipeline with several
biosimilars in late stage development, including assets in immunology and
oncology. As part of the Novartis Group, Sandoz is well-positioned to lead the
biosimilars industry based on its experience and capabilities in development,
manufacturing and commercialization.
About GP2015
GP2015, the Sandoz proposed biosimilar of Enbrel(®), has been studied in a
global development program, which included a comprehensive comparison of GP2015
and Enbrel(® )at the analytical, non-clinical, and clinical levels, including
data from four pharmacokinetic (PK) studies (GP15-101, GP15-102, GP15-103 and
GP15-104(**)) involving a total of 216 healthy volunteers, as well as data from
a confirmatory efficacy and safety study of 531 patients with moderate-to-severe
chronic plaque psoriasis (PsO) (GP15-302). The development program also included
five non-clinical studies. The proposed indications for GP2015 are identical to
the indications for Enbrel(®) in rheumatoid arthritis (RA), PsO, psoriatic
psoriasis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile
idiopathic arthritis (JIA).
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "recommended," "proposed," "recommendation," "encouraged,"
"goal," "look forward to," "committed," "pipeline," "late stage development,"
"well-positioned," or similar terms, or by express or implied discussions
regarding potential marketing approvals for biosimilar etanercept, or potential
marketing approvals for other products in the Sandoz biosimilar pipeline, or
regarding potential future revenues from biosimilar etanercept and other
products in the Sandoz biosimilar portfolio. Such forward-looking statements
reflect the current views of the Group regarding future events, and involve
known and unknown risks, uncertainties and other factors that may cause actual
results to be materially different from any future results expressed or implied
by such statements. There can be no guarantee that biosimilar etanercept will be
approved for sale in any market where it has been submitted, or submitted for
sale in any additional markets, or at any particular time. Neither can there be
any guarantee that, if approved, biosimilar etanercept will be approved for all
indications included in the reference product label. Nor can there be any
guarantee that any other product in the Sandoz biosimilar pipeline will be
submitted or approved for sale in any market, or at any particular time. Neither
can there be any guarantee that biosimilar etanercept or any other product in
the Sandoz biosimilar portfolio will be commercially successful in the future.
In particular, management's expectations regarding biosimilar etanercept and
such other biosimilar portfolio products could be affected by, among other
things, unexpected regulatory actions or delays or government regulation
generally; the uncertainties inherent in research and development, including
unexpected clinical trial results and additional analysis of existing clinical
data; competition in general; global trends toward health care cost containment,
including government, industry and general public pricing pressures; unexpected
litigation outcomes; unexpected safety, quality or manufacturing issues; general
economic and industry conditions, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a
division of the Novartis Group, our purpose is to discover new ways to improve
and extend people's lives. We contribute to society's ability to support growing
healthcare needs by pioneering novel approaches to help people around the world
access high- quality medicine. Our portfolio of more than 1000 molecules,
covering all major therapeutic areas, accounted for 2015 sales of USD 10.1
billion. In 2015, our products reached more than 500 million patients and we
aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in
Germany's Greater Munich area.
* Enbrel(®) is a registered trademark of Immunex Corporation.
(** )GP15-104, one of the four PK studies that intended to demonstrate
bioequivalence between GP2015 and EU-licensed Enbrel, was submitted as an
amendment to the initial Biologics License Agreement at the request of European
authorities
For further information:
Eric Althoff Tara Lanigan
Novartis Global Media Relations Sandoz Global Communications
+41-61-324-7999 +49 (0) 172 8295 276
+41-79-593-4202 tara.lanigan(at)sandoz.com
eric.althoff(at)novartis.com
Elizabeth Renz Duncan Cantor
Sandoz US Communications Sandoz Global Communications
+1 609-627-8558 +49 (0) 170 650 6067
+1 856-625-3959 duncan.cantor(at)sandoz.com
Elizabeth.renz(at)novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944 North America:
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/2028522/754147.pdf
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originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
[HUG#2028522]
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Datum: 13.07.2016 - 21:42 Uhr
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