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Novartis International AG: Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

Novartis International AG / Sandoz advances its biosimilars program with EMA
acceptance of regulatorysubmission for biosimilar pegfilgrastim . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* Sandoz' late-stage biosimilar pipeline gains momentum with sustained
investment - five of 10 planned regulatory filings achieved
* Sandoz believes that the totality of evidence in its submission, including
three pivotal clinical studies, demonstrates that the proposed biosimilar
is highly similar to the reference product.
* Sandoz is the European market leader in both the daily G-CSF class and for
biosimilar filgrastim.

Holzkirchen, 11 February, 2016
- Sandoz, a Novartis company and the global leader in biosimilars, announced
today that the European Medicines Agency (EMA) has accepted their Marketing
Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed
Neulasta®*(pegfilgrastim) - a long-acting recombinant human granulocyte
colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same
indication as the reference product.

Commenting on today's milestone, Richard Francis, Division Head and CEO Sandoz
said, "Securing five major regulatory file acceptances in five months
demonstrates substantial progress on our long-term biosimilars investment
strategy. Further advancing our biosimilars pipeline is an important priority
for us this year and we'll continue to invest significantly in bringing our
pipeline to patients."

Pegfilgrastim is a prescription medicine used in cancer patients (except those
with chronic myeloid leukemia and myelodysplastic syndromes) to help with
some of the side effects of their treatment. It reduces the duration of
neutropenia (low levels of neutrophils, a type of white blood cell that
fights infections) and the incidence of febrile neutropenia (neutropenia with
fever) that are a result of their chemotherapy treatment. The incidence of
febrile neutropenia (FN) occurring with common chemotherapy regimens is 25 to
40% of treatment-naive patients.[1]

"Sandoz is the leading provider of daily G-CSF in Europe and the regulatory
filing of our biosimilar pegfilgrastim further cements our commitment to
patients undergoing cancer treatment" said Mark McCamish, M.D., Ph.D., and
Head of Global Biopharmaceutical&Oncology Injectables Development at Sandoz.
"If approved, physicians in the EU will have another high-quality Sandoz
biosimilar treatment option for patients needing granulocyte
colony-stimulating factors" McCamish continued.

* Neulasta is a registered trademark of Amgen Inc.

Sandoz believes that the totality of evidence in its submission, including
three pivotal clinical trials - one pharmacokinetic and pharmacodynamic study
in healthy volunteers and two comparative efficacy and safety studies in
breast cancer patients - is expected to satisfy the regulatory requirements
for demonstrating high similarity to the reference product and therefore
justifies use of biosimilar pegfilgrastim in the reference product's

Sandoz is committed to increasing patient access to high-quality,
life-enhancing biosimilars. It is the pioneer and global market leader in
biosimilars and currently markets three biosimilars. Sandoz has a leading
pipeline with several biosimilars in late stage development, including assets
in oncology. Pegfilgrastim was recently accepted by the FDA for regulatory
filing, making today's announcement the fifth of 10 that the company plans to
make over a three-year period (2015-2017). 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


The foregoing release contains forward-looking statements that can be
identified by words such as "pipeline," "momentum," "sustained," "planned,"
"believes," "proposed," "seeking," "long-term," "strategy," "priority,"
"we'll continue," "commitment," "will," "expected," "committed," "plans,"
"well-positioned," or similar terms, or by express or implied discussions
regarding potential marketing approvals for biosimilar pegfilgrastim, or
regarding potential future revenues from biosimilar pegfilgrastim. 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 pegfilgrastim will be approved for
sale in Europe, or at any particular time. Neither can there be any
guarantee that biosimilar pegfilgrastim will be submitted or approved for
sale in any additional markets, or at any particular time. Nor can there be
any guarantee that biosimilar pegfilgrastim will be commercially successful
in the future. In particular, management's expectations regarding biosimilar
pegfilgrastim 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
pegfilgrastim; 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 pegfilgrastim; the
particular prescribing preferences of physicians and patients; unexpected
safety issues; unexpected manufacturing or quality 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, 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.


[1] Dale DC (2002) Colony-stimulating factors for the management of
neutropenia in cancer patients.Drugs. 2002;62 Suppl 1:1-15.

# # #

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 |

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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