New data demonstrate Sandoz proposed biosimilar adalimumab has equivalent efficacy to reference medicine
(Thomson Reuters ONE) -
Novartis International AG /
New data demonstrate Sandoz proposed biosimilar adalimumab has equivalent
efficacy to reference medicine
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The issuer is solely responsible for the content of this announcement.
* Sandoz proposed biosimilar adalimumab (GP2017) shown to have equivalent
efficacy and a similar safety profile as reference medicine, Humira®(*)
* Comprehensive development program show potential of GP2017 to treat
inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel
disease and plaque psoriasis
* Study reinforces strength of Sandoz pipeline and its key role in the broader
Novartis immunology portfolio
Holzkirchen, 6 March 2017 - Sandoz, a Novartis division, and the pioneer and
global leader in biosimilars, today presented data for its proposed biosimilar
adalimumab (GP2017). The Phase 3 confirmatory efficacy, safety and
immunogenicity study met its primary endpoint demonstrating GP2017 has
equivalent efficacy to the reference medicine, Humira(®)[1]. Results were
presented at the American Academy of Dermatology (AAD) in Orlando, Florida.
The primary endpoint of the study was the proportion of patients who achieved a
75% improvement at Week 16, as measured by the Psoriasis Area and Severity Index
(PASI). Data from the study confirmed equivalent efficacy by demonstrating PASI
75 response rates of 67% for proposed biosimilar adalimumab and 65% for the
reference medicine in patients with moderate to severe, chronic plaque
psoriasis.
"Currently, it is estimated that as few as five percent of eligible psoriasis
patients get the biologics they need" said Mark Levick, MD PhD, Global Head of
Development, Biopharmaceuticals, Sandoz. "We are pleased the data reinforce the
potential of our biosimilar adalimumab, if approved, to be another treatment
option for moderate-to-severe chronic plaque psoriasis and other inflammatory
diseases" Levick continued.
Results at week 17 demonstrated similar safety and immunogenicity between GP2017
and the reference medicine. Reported adverse events and the presence of anti-
drug antibodies were similar across both treatment groups. Observed adverse
events were in line with the reference medicine's known safety profile.
Sandoz is committed to increasing patient access to high-quality, life-enhancing
biosimilars. It is the pioneer and global leader in biosimilars and currently
markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline,
with plans to file biosimilar adalimumab with the EMA and the FDA in 2017.
Sandoz also plans to launch five biosimilars of major oncology and immunology
biologics across key geographies by 2020. As a division 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 the study
The study (NCT02016105) is a Phase 3 randomized, double-blind, controlled, 51-
week study to compare efficacy, safety and immunogenicity between GP2017 and
Humira(®). The study consists of three treatment periods. During the first 17-
week treatment period, eligible patients with active, but clinically stable,
moderate to severe chronic plaque psoriasis were randomized to receive either
GP2017 or Humira(®). In the second period, patients were re-randomized into four
groups; the first two groups continued with their originally assigned treatment
and other two switched to alternating treatment every six weeks until week
35. In the third period, patients received their initially assigned treatment up
to week 51.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "proposed," "potential," "pipeline," "portfolio," "committed,"
"plans," "launch," "well-positioned," or similar terms, or by express or implied
discussions regarding potential marketing approvals or labeling for biosimilar
adalimumab or any of the other products in the Sandoz biosimilar pipeline, or
regarding potential future revenues from biosimilar adalimumab and the other
products in the Sandoz biosimilar pipeline. You should not place undue reliance
on these statements. Such forward-looking statements are based on the current
beliefs and expectations of management regarding future events, and are subject
to significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that biosimilar adalimumab
or any of the other products 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, if approved, biosimilar adalimumab will be approved for
all indications included in the reference product's label. Nor can there be any
guarantee that biosimilar adalimumab or any of the other products in the Sandoz
biosimilar pipeline will be commercially successful in the future. In
particular, management's expectations regarding biosimilar adalimumab and such
other Sandoz biosimilar pipeline products could be affected by, among other
things, regulatory actions or delays or government regulation generally; the
uncertainties inherent in research and development, including clinical trial
results and additional analysis of existing clinical data; competition in
general, including potential approval of additional versions of biosimilar
adalimumab; global trends toward health care cost containment, including
government, industry and general public pricing pressures; litigation outcomes,
including intellectual property disputes or other legal efforts to prevent or
limit Sandoz from selling biosimilar adalimumab or its other biosimilar
products; the particular prescribing preferences of physicians and patients;
general economic and industry conditions; safety, quality or manufacturing
issues, 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 approximately 1000 molecules,
covering all major therapeutic areas, accounted for 2016 sales of USD 10.1
billion. In 2016, our products reached well over 500 million patients and we
aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in
Germany's Greater Munich area.
*Humira(®) is a registered trademark of AbbVie Biotechnology Ltd.
References
[1] Blauvelt A et al. A randomized, double-blind, multicenter study to compare
the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar
(GP2017) with originator adalimumab Poster #5224 presented at the 2017 American
Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
media.relations(at)novartis.com
Eric Althoff Duncan Cantor
Novartis Global Media Relations Sandoz Global Communications
+41 61 324 7999 (direct) +49 170 650 6067
+41 79 593 4202 (mobile) duncan.cantor(at)sandoz.com
eric.althoff(at)novartis.com
Chris Lewis Michelle Bauman
Sandoz Global Communications Communications Director, Biopharma
+49 174 244 9501 +1 609 720 6699
chris.lewis(at)sandoz.com michelle.bauman(at)sandoz.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2085000/786132.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.03.2017 - 07:10 Uhr
Sprache: Deutsch
News-ID 528172
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