Bli medlem
Bli medlem

Du är här

2016-11-18

Novartis International AG: Innovative study with three treatment switches confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

Novartis International AG / Innovative study with three treatment switches
confirms Sandoz biosimilaretanercept has equivalent efficacy to originator .
Processed and transmitted by Nasdaq Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* No clinically meaningful differences between biosimilar etanercept and the
originator product in safety and efficacy over 52 weeks[1]
* Innovative study design demonstrates switching between biosimilar
etanercept and the originator product has no impact on safety and
efficacy[1]
* Sandoz biosimilar etanercept was approved by the FDA* in August 2016 and is
currently under review by the EMA **

Holzkirchen, November 18, 2016
- Sandoz, a Novartis division, and the pioneer and global leader in
biosimilars, today announced the publication of the EGALITY study in
theBritish Journal of Dermatology
. The confirmatory clinical safety and efficacy study shows Sandoz biosimilar
etanercept is equivalent to the originator product, Enbrel®***, in more than
500 adult patients over 52 weeks[1].

The innovative design of the EGALITY study includes switched and continuous
treatment arms. Patients who switched treatments crossed over between
biosimilar etanercept and the originator product three times with no
clinically meaningful differences in safety and efficacy.

"Sandoz recognizes that clinicians need robust data on switching to
confidently prescribe biosimilars. In EGALITY the same patients received
treatment with biosimilar etanercept and the originator product in an
alternating fashion and these three treatment switches had no impact on
safety and efficacy," said Malte Peters M.D., Head Global Clinical
Development, Biopharmaceuticals, Sandoz. "This innovative study demonstrates
that Sandoz is at the frontier of building trust and confidence in
biosimilars to increase access to biologics for patients worldwide." Peters
continued.

The 52-week EGALITY study was a randomized, double-blind trial which involved
531 adult patients with moderate to severe plaque psoriasis. The study was
carried out over 12 months in 74 dermatology clinical sites across Europe and
South Africa and consisted of three treatment periods. In the first 12-week
period, patients received biosimilar etanercept or the originator product. In
the second period, patients with at least 50% improvement of psoriasis
symptoms were re-randomized into four groups; the first two groups continued
with their original treatment and other two switched to the alternate
treatment every six weeks until week 30[1]. In the third period, the patients
continued to receive their last treatment at week 30 up to week 52.

From baseline to week 52, the percentage change in Psoriasis Area and Severity
Index (PASI) score was comparable between biosimilar etanercept and the
originator product. EGALITY also confirms a comparable safety profile of the
two medicines over 52 weeks, with similar incidence rates of
treatment-emergent adverse events seen in all study arms. The primary
endpoint of achieving equivalence in PASI 75 response rates were met at week
12[2]. These data were presented at the congress of the Psoriasis
International Network (PIN), 2016.

The FDA approved Sandoz biosimilar etanercept in August 2016 for all
indications included in the label of the originator product, which is used to
treat various inflammatory conditions including rheumatoid arthritis, plaque
psoriasis and psoriatic arthritis. It is currently under regulatory review by
the EMA after the submission was accepted in the second half of 2015.

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. Sandoz has a leading
biosimilar pipeline and 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 Sandoz biosimilar etanercept

The Sandoz proposed biosimilar to Enbrel®, has been studied in a global
development program, which included a comprehensive comparison of the
biosimilar and Enbrel® at the analytical, pre-clinical, and clinical levels,
including data from four pharmacokinetic studies (GP15-101, GP15-102,
GP15-103 and GP15-104§) involving a total of 216 healthy volunteers, as well
as data from the confirmatory clinical safety and efficacy study EGALITY
(GP15-302). The development program also included five pre-clinical studies.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "under review," "committed," "pipeline," "plans,"
"launch," "well positioned," "proposed," or similar terms, or by express or
implied discussions regarding potential marketing approvals for biosimilar
etanercept or any of the other products in the Sandoz biosimilar pipeline, or
regarding potential future revenues from biosimilar etanercept 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 etanercept 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. Nor can there be any guarantee that
biosimilar etanercept 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 etanercept and such other
Sandoz biosimilar pipeline 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, including potential approval of additional versions
of biosimilar etanercept; global trends toward health care cost containment,
including government, industry and general public pricing pressures;
unexpected litigation outcomes, including intellectual property disputes or
other legal efforts to prevent or limit Sandoz from selling biosimilar
etanercept or its other biosimilar products; the particular prescribing
preferences of physicians and patients; general economic and industry
conditions; unexpected 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 worldwide 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 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.

* US Food and Drug Administration (FDA)
** European Medicines Agency (EMA)
*** Enbrel®is a registered trademark of Pfizer in Europe and Amgen in the US

§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

References
[1] Griffiths C et al. The EGALITY study: A confirmatory, randomised,
double-blind study comparing the efficacy, safety and immunogenicity of
GP2015, a proposed etanercept biosimilar, versus the originator product in
patients with moderate to severe chronic plaque-type psoriasis. Br J
Dermatol.
[2] Griffiths EMet al
. GP2015, a proposed etanercept biosimilar, has equivalent efficacy, safety
and immunogenicity to etanercept originator product in patients with chronic
plaque-type psoriasis: 12 week results from the phase 3 EGALITY study. Poster
presented at the Psoriasis 2016, 5th Congress of the Psoriasis International
Network (PIN), July 07, 2016 (e-poster P222)

###

For further information, contact:

---------------------------------------------------------------
| Eric Althoff Tara Lanigan |
| |
| |
|Novartis Global Media Relations Sandoz Global Communications |
|+41 61 324 7999 (direct) +49 (0) 172 8295 276 |
|+41 79 593 4202 (mobile) tara.lanigan@sandoz.com |
|eric.althoff@novartis.com |
| |
| |
| |
|Duncan Cantor |
| |
| |
|Sandoz Global Communications |
|+49 (0) 170 650 6067 |
|duncan.cantor@sandoz.com |
---------------------------------------------------------------
Novartis Investor Relations

Central investor relations line: +41 61 324 7944
E-mail:investor.relations@novartis.com

-----------------------------------------
| Samir Shah +41 61 324 7944 |
| Pierre-Michel Bringer +41 61 324 1065 |
| Thomas Hungerbuehler +41 61 324 8425 |
| Isabella Zinck +41 61 324 7188 |
| North America: |
| Richard Pulik +1 212 830 2448 |
| Sloan Pavsner +1 212 830 2417 |
-----------------------------------------

Media Release (PDF)
http://hugin.info/134323...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.