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Novartis International AG: Sandoz receives EC approval for subcutaneous route of administration in biosimilar Binocrit's® nephrology indication

Novartis International AG / Sandoz receives EC approval for subcutaneous route
of administration inbiosimilar Binocrit's® nephrology indication . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* Sandoz' epoetin alfa product offering has already generated more than
400,000[1] patient years of experience worldwide
* EC approval expands Sandoz biosimilar offering to the healthcare community

Holzkirchen, 8 April, 2016
- Sandoz, a Novartis division and the global leader in biosimilars, announced
today that the European Commission (EC) has approved a type II variation for
the addition of a subcutaneous (s.c.) route of administration in
Binocrit's®(epoetin alfa) nephrology indication*.

"By expanding our biosimilar offering to the healthcare community, the EC
approval of a subcutaneous route of administration for use in our Binocrit's
nephrology indication will mean more choice for healthcare professionals as
well as increased convenience for patients" said Carol Lynch, Global Head
Biopharmaceuticals, Sandoz.

The EU approval was based on data from the SENSE clinical study - an open
label, single arm, multicenter study to evaluate the safety and
immunogenicity of HX575 epoetin alfa in the treatment of anemia associated
with chronic kidney disease in pre-dialysis and dialysis patients.

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 make 10 regulatory filings over a three year
period (2015-2017) having already submitted five. 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

About Binocrit

*Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone
marrow to produce red blood cells (anemia in either the nephrology or
oncology setting).

For Binocrit's approved indications and the EU summary of product
characteristics including the labelled safety information please visit here.


The foregoing release contains forward-looking statements that can be
identified by words such as "will," "committed," "pipeline," "plans,"
"well-positioned," or similar terms, or by express or implied discussions
regarding potential new indications or labeling for biosimilar epoetin alfa,
or potential marketing approvals for other products in the Sandoz biosimilar
pipeline, or regarding potential future revenues from biosimilar epoetin alfa
or any other product in the Sandoz biosimilar pipeline. Such forward-looking
statements reflect the current views of the Group regarding future events,
and involve known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from any future results
expressed or implied by such statements. There can be no guarantee that any
product 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 biosimilar epoetin alfa, or any other product in the Sandoz
biosimilar pipeline, will be commercially successful in the future. In
particular, management's expectations regarding biosimilar epoetin alfa and
such other 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; global trends toward health care cost
containment, including government, industry and general public pricing
pressures; unexpected litigation outcomes; 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

About Sandoz

Sandoz, a Novartis division, 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] Periodic Safety Update Report, PSUR P7: Period until 31 Aug 2015, Date of
Report: 22 Oct 2015

# # #

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 |
| |
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 |
| |
| |

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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