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 The leading web portal for pharmacy resources, news, education and careers September 22, 2017
Pharmacy Choice - Pharmaceutical News - GNW-News: Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study (english) - September 22, 2017

Pharmacy News Article

 9/14/17 - GNW-News: Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study (english)

Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study



Novartis International AG /
Sandoz proposed biosimilar adalimumab matches reference biologic in terms of 
efficacy and safety in long-term study 
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement. 

* 51-week clinical study confirms that Sandoz proposed biosimilar adalimumab

    matches reference medicine Humira()* safety and efficacy profile[1]
  * Sandoz proposed biosimilar adalimumab is currently under review by the
    European Medicines Agency for the treatment of several immunological
    diseases

* Sandoz expects that approval of biosimilar adalimumab would further improve

access to treatment for people living with immunological diseases

Holzkirchen, September 14, 2017 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announces new data on its proposed biosimilar adalimumab.


Data from a long-term study of patients continuously treated with the proposed
biosimilar or the reference medicine show that efficacy and safety profiles of
the two medicines match throughout 51 weeks of treatment in patients with
moderate-to-severe chronic plaque psoriasis[1]. Results were presented at the
26(th) Congress of the European Academy of Dermatology and Venereology (EADV) in
Geneva, Switzerland.

"Patient access to often critical and expensive biologic medicines is one of the
key challenges facing healthcare systems in developed economies today," said
Mark Levick MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz.

He added: "Biosimilars are fundamentally changing the ability of healthcare
systems to address this challenge. This clinical data supports the safety and
efficacy ofour proposed biosimilaradalimumab and offers a real alternative for
patients living with immunological diseases."

Sandoz is committed to increasing patient access to high-quality biosimilars. We
are the pioneer and global leader in biosimilars, with five biosimilars
currently marketed worldwide, as well as a leading global pipeline. We plan to
launch a total of five major oncology and immunology biosimilars between 2017
and 2020, including adalimumab, which is currently being reviewed by the
European Medicines Agency.

Sandoz is well positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.


About the study
ADACCESS (NCT02016105) is a Phase III confirmatory randomized, double-blind,
controlled, 51-week study to compare efficacy and safety between Sandoz
biosimilar adalimumab and the reference medicine. 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 biosimilar adalimumab or its reference
medicine. In the second period, patients were re-randomized into four groups;
the first two groups continued with their originally assigned treatment and the
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[1].

The Phase III confirmatory study demonstrates that Sandoz biosimilar adalimumab
matches the reference medicine in terms of efficacy and safety up to Week 51.
Psoriasis Area and Severity Index 75 (PASI 75) response rates for patients who
received biosimilar adalimumab continuously throughout the study were 75.2% at
Week 17 and 84.5% at Week 51, compared with 67.8% at Week 17 and 79.6% at Week
51 for patients who received continuous treatment with the reference
medicine[1]. PASI 75 response represents an improvement of at least 75% in the
severity of a patient's psoriasis. Investigator's Global Assessment (IGA)
response rates were also similar between the two groups in the study throughout
the 51 weeks. There were no clinically relevant differences in adverse events
between the two treatment groups, and the immunogenicity profiles were
similar[1].

Disclaimer

This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals, new indications or
labeling for the investigational or approved biosimilar products described in
this press release, or regarding potential future revenues from such products.
You should not place undue reliance on these statements. Such forward-looking
statements are based on our current beliefs and expectations 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 the investigational or approved products described in this
press release will be submitted or approved for sale or for any additional
indications or labeling in any market, or at any particular time. Neither can
there be any guarantee that, if approved, such biosimilar products will be
approved for all indications included in the reference product's label. Nor can
there be any guarantee that such products will be commercially successful in the
future. In particular, our expectations regarding such products could be
affected by, among other things, the uncertainties inherent in research and
development, including clinical trial results and additional analysis of
existing clinical data; regulatory actions or delays or government regulation
generally; the particular prescribing preferences of physicians and patients;
competition in general, including potential approval of additional biosimilar
versions of such products; global trends toward health care cost containment,
including government, payor and general public pricing and reimbursement
pressures; litigation outcomes, including intellectual property disputes or
other legal efforts to prevent or limit Sandoz from selling its products;
general economic and industry conditions, including the effects of the
persistently weak economic and financial environment in many countries; 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 phase III confirmatory study comparing GP2017 with reference adalimumab in patients with moderate-to-severe chronic plaque psoriasis: 51 week results from the ADACCESS study. Poster #P0405 presented at the 26(th) Congress of the European Academy of Dermatology and Venereology (EADV), 13-17 September 2017.


                                     # # #

For further information, contact:

Novartis Media Relations

Central media line: +41 61 324 2200

media.relations@novartis.com


 Eric Althoff                                     Tara Lanigan
 Novartis Global Media Relations                  Sandoz Global Communications
 +41 61 324 7999 (direct)                         +49 172 829 5276
 +41 79 593 4202 (mobile)                         tara.lanigan@sandoz.com
 eric.althoff@novartis.com

 Chris Lewis
 Sandoz Global Communications
 +49 174 244 9501
 chris.lewis@sandoz.com


 Novartis Investor Relations

Central investor relations line: +41 61 324 7944

investor.relations@novartis.com


  Central                                  North America

  Samir Shah              +41 61 324 7944   Richard Pulik   +1 212 830 2448

  Pierre-Michel Bringer   +41 61 324 1065   Cory Twining    +1 212 830 2417

  Thomas Hungerbuehler    +41 61 324 8425

  Isabella Zinck          +41 61 324 7188




Media release (PDF): 
http://hugin.info/134323/R/2133945/816396.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novartis International AG via GlobeNewswire

http://www.novartis.com



Copyright dpa-AFX.

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