Sandoz receives EC approval for subcutaneous route of administration in biosimilar Binocrit's® nephrology indication
(Thomson Reuters ONE) -
Novartis International AG /
Sandoz receives EC approval for subcutaneous route of administration in
biosimilar Binocrit's® nephrology indication
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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 commercialization.
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.
Disclaimer
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
otherwise.
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.
References
[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 sreejit.mohan(at)sandoz.com
eric.althoff(at)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(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/2001797/738621.pdf
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originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
[HUG#2001797]
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Datum: 08.04.2016 - 07:15 Uhr
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