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Novartis International AG: Phase III data shows Sandoz' proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product

Novartis International AG / Phase III data shows Sandoz' proposed biosimilar
pegfilgrastim has similarsafety and efficacy as the reference product .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* PROTECT 2 study compared safety and efficacy of the proposed biosimilar
pegfilgrastim with the reference product for the prevention of neutropenia
in patients with breast cancer.
* The study met its primary endpoints demonstrating equivalence and
non-inferiority to the reference product.
* Data presented at the 57th American Society of Hematology (ASH) Annual
Meeting and Exposition.

Holzkirchen, 7 December 2015
- Sandoz, a Novartis company and global leader in biosimilars, today announced
results from the PROTECT 2 study which compared the safety and efficacy of
proposed biosimilar pegfilgrastim with the reference product, Neulasta®*. The
study met its primary endpoints - showing it to be both equivalent and
non-inferior to the reference product. Data was presented at the American
Society of Hematology (ASH), Orlando, Florida.

Additional data from the study showed that there were no clinically meaningful
differences between the proposed biosimilar pegfilgrastim and the reference
product. Adverse events were similar and consistent with the known safety
profile of pegfilgrastim, and no neutralizing anti-pegfilgrastim antibodies
were detected.

"The positive data from the PROTECT 2 study is promising in that it will add
to the body of evidence being developed on biosimilars. These findings could
lead to another high-quality supportive care treatment option for physicians
and oncology patients" said Kimberly Blackwell, MD, Professor of Medicine,
Assistant Professor of Radiation Oncology, Duke University School of Medicine
and primary investigator for the study.

Malte Peters, Head Biopharmaceutical Clinical Development, Sandoz said "The
PROTECT 2 data is yet another demonstration of the substantial progress we
are making with our biosimilar programs and the commitment we have made to
improve patient access to these important medicines."

Sandoz has an unwavering commitment 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 - the company plans to make 10 regulatory
filings over a three year period (2015-2017) having already announced two. On
November 18, 2015, Sandoz announced that the FDA accepted its regulatory
filing for the proposed biosimilar pegfilgrastim. 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


The PROTECT 2 study was a global, randomized, double-blind trial involving 308
patients carried out in the United States, Latin America, Asia and Europe.
The safety and immunogenicity of the proposed biosimilar was assessed for
four weeks after the final study drug administration. The study analyzed the
duration of severe neutropenia (DSN), which was also the primary endpoint.


PROTECT 1 was a randomized, double-blind trial comparing the efficacy and
safety of the proposed biosimilar pegfilgrastim (LA-EP2006) with reference
pegfilgrastim in patients with breast cancer. PROTECT 1 data will be
presented at San Antonio Breast Cancer Symposium, December 9, 2015 at 5 PM
CST (SABCS Abstract #P1-10-01).


The foregoing release contains forward-looking statements that can be
identified by words such as "promising," "will," "could," "commitment,"
"pipeline," "plans," or similar terms, or by express or implied discussions
regarding potential marketing submissions or approvals for pegfilgrastim, or
regarding potential future revenues from 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 pegfilgrastim will be submitted or approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that pegfilgrastim will receive additional regulatory approvals or
be commercially successful in the future. In particular, management's
expectations regarding pegfilgrastim 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; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing or quality issues; unexpected safety
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

About Sandoz

Sandoz, a Novartis company, is a global leader in generic pharmaceuticals and
biosimilars, driving sustainable access to high-quality healthcare. Sandoz
employs more than 26,000 people worldwide and 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 2014 sales of USD 9.6 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 |
| |
| |
| |
| |
| |
|Leslie Pott |
| |
|Sandoz US Communications |
|+1-609-627-5287 |
|+1-201-354-0279 |
| |
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 |
| |
| |
©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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