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Novartis International AG: Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA

Novartis International AG / Sandoz strengthens its biosimilars portfolio with
acquisition of Pfizer'sbiosimilar infliximab in EEA . Processed and
transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* Sandoz acquires rights to PF-06438179 (biosimilar infliximab) in the
European Economic Area (EEA)*
* Sandoz plans to complete Phase III development program and file for
registration in the EU
* Deal strengthens Novartis immunology portfolio which includes
investigational biosimilars adalimumab, etanercept and rituximab

Holzkirchen, February 12, 2016
- Sandoz, a Novartis company and a global leader in biosimilars, announced
today that it has acquired from Pfizer the rights for the development and
commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries
that form the European Economic Area (EEA)*. Infliximab is a tumor necrosis
factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune
diseases including rheumatoid arthritis (RA) and psoriasis.

"Infliximab is one of the most important biologic therapy options for people
living with severe autoimmune diseases such as rheumatoid arthritis" said
Richard Francis, Global Head of Sandoz. "We intend to complete the
development and registration of PF-06438179 and make it available to patients
across Europe as part of our robust portfolio of immunology treatments"
Francis continued.

Under the terms of the deal, Sandoz plans to complete the clinical study
program and submit the biosimilar infliximab to the European Medicines Agency
(EMA) for regulatory approval and registration with the European Commission.
Included in the program is a global phase III trial - REFLECTIONS (B537-02)
investigating the safety and efficacy of PF-06438179 and infliximab in
combination with methotrexate in subjects with active rheumatoid arthritis
who have had an inadequate response to methotrexate. Sandoz acquired the
rights to infliximab, following Pfizer's commitments to the European
Commission in connection with the acquisition of Hospira, Inc. to divest the

Sandoz is committed to increasing patient access to high-quality biosimilars.
It is the pioneer and global market leader in biosimilars and was the first
to launch biosimilars in the United States, Europe and Japan. Sandoz has a
leading biosimilar pipeline with programs in various stages of development
and regulatory filing including biosimilars adalimumab and etanercept that,
like infliximab, are anti-tumor necrosis factor alpha (TNF-alpha) medicines.
The company plans to make 10 regulatory filings over a three year period
(2015-2017) having already announced

*Pfizer retains commercialization and manufacturing rights to infliximab in
countries outside of the EEA.

five, which include biosimilar etanercept filed with both the EMA and the US
Food and Drug Administration. As part of the Novartis Group, Sandoz is
well-positioned to lead the biosimilars industry based on its deep experience
and capabilities in development, manufacturing and commercialization.


The foregoing release contains forward-looking statements that can be
identified by words such as "plans," "investigational," "will," "commitment,"
"pipeline," "well-positioned to lead," or similar terms, or by express or
implied discussions regarding potential marketing approvals for PF-06438179,
or regarding potential future revenues from PF-06438179. 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 PF-06438179 will be submitted or approved for
sale in any market, or at any particular time. Nor can there be any guarantee
that PF-06438179 will be commercially successful in the future. In
particular, management's expectations regarding PF-06438179 could be affected
by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; unexpected regulatory actions or delays
or government regulation generally; competition in general, including
potential approval of additional versions of biosimilar infliximab;
unexpected litigation outcomes, including intellectual property disputes or
other legal efforts to prevent or limit Sandoz from selling biosimilar
infliximab; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
safety issues; unexpected manufacturing or quality 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, a Novartis company, is a global leader in generic pharmaceuticals and
biosimilars, driving sustainable access to high-quality healthcare. Sandoz
supplies a broad range of affordable, primarily off-patent products to
patients and customers around the globe. The Sandoz portfolio comprises
approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2
billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich
area. The company holds leading global positions in biosimilars as well as in
generic anti-infectives, ophthalmics and transplantation medicines.

# # #

For further information:

| |
| Eric Althoff Sreejit Mohan |
| |
| |
|Novartis Global Media Relations Sandoz Global Communications |
|+41-61-324-7999 +49 (0) 162 429 7971 |
|+41-79-593-4202 sreejit.mohan@sandoz.com |
|eric.althoff@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@novartis.com |
©2015 Sandoz Inc. All rights reserved.

Media release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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


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