Sandoz launches Phase III clinical trial for biosimilar etanercept
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Novartis International AG /
Sandoz launches Phase III clinical trial for biosimilar etanercept
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* Trial expected to support registration in the U.S. and European Union
* Sandoz continues to advance biosimilar pipeline with seven Phase III trials
across five molecules
* Global program underscores Sandoz's leadership in biosimilars
Holzkirchen, Germany, June 24, 2013 - Sandoz, the global leader in biosimilars,
announced it has initiated a major Phase III clinical trial with its biosimilar
version of etanercept (Amgen's Enbrel(®)). The global clinical trial will seek
to confirm biosimilarity with regard to safety, efficacy and immunogenicity of
the Sandoz product versus Enbrel in patients with moderate to severe chronic
plaque-type psoriasis. The global clinical program was developed in consultation
with regulatory authorities in the U.S. and EU, and the results from this
clinical trial are expected to support regulatory submissions in both the U.S.
and EU.
"Sandoz has a strong track record in developing and commercializing biosimilars
around the world," said Ameet Mallik, Head of Biopharmaceuticals and Oncology
Injectables at Sandoz. "We will leverage this experience and our industry-
leading capabilities to bring a biosimilar version of etanercept to patients and
physicians around the world."
Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using
recombinant DNA technology, and is approved in the U.S. and EU for the treatment
of rheumatoid arthritis, psoriasis, and other conditions. Sandoz has invested
significant resources in state-of-the art analytical technologies to develop and
validate a process for producing its biosimilar etanercept. The company is also
making the necessary manufacturing investments to bring this complex biologic to
market. Extensive pre-clinical and clinical data show that the Sandoz product is
highly similar to Enbrel and justifies proceeding with late-stage clinical
studies.
"The continued increase in spending on biological agents for treatment of
immune-mediated diseases such as rheumatoid arthritis and psoriasis is a
growing concern among physicians in many developed and developing countries,"
said Alan Menter, M.D., Professor and Chairman of the Division of Dermatology at
Baylor University Medical Center, Dallas, United States and immediate past
President of International Psoriasis Council. "A high-quality and clinically-
proven biosimilar version of etanercept could play an important role in
generating much-needed savings for healthcare systems that can be used to fund
novel therapies or treat more patients."
"Sandoz remains steadfast in its commitment to significantly increase worldwide
access to essential, high-quality and life-enhancing biopharmaceuticals," said
Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical Development at
Sandoz. "The initiation of this clinical trial stands as an important testament
to our deep commitment."
Sandoz is the pioneer in biosimilars and the global market leader with over 50%
share of all biosimilars approved in the highly regulated markets of U.S.,
Canada, Europe, Japan and Australia. All three Sandoz products occupy the #1
biosimilar position in their respective categories. Sandoz biosimilars are sold
in over 50 countries and have generated over 100 million patient exposure days
in experience. Sandoz also has an unrivalled pipeline with several molecules in
various stages of development. With the start of the etanercept Phase III study,
Sandoz now has seven Phase III clinical trials across five biosimilar molecules
- more than any other company in the industry.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "launches," "expected," "pipeline," "will," "continues,"
"could," "commitment," or similar expressions or similar expressions, or by
express or implied discussions regarding potential marketing approvals for
etanercept or other biosimilar products, or regarding potential future revenues
from etanercept or such other products. You should not place undue reliance on
these statements. Such forward-looking statements reflect the current views of
management 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, performance or achievements expressed or
implied by such statements. There can be no guarantee that etanercept or any
other biosimilar products will be submitted or approved for sale in any market,
or at any particular time. Nor can there be any guarantee that etanercept or
such other products will achieve any particular levels of revenue in the future.
In particular, management's expectations regarding etanercept could be affected
by, among other things, unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally;
uncertainties regarding actual or potential legal proceedings, including, among
others, intellectual property disputes or other legal efforts to prevent or
limit Sandoz from selling etanercept or other biosimilar products, and the
uncertain outcome of any such litigation; the particular prescribing preferences
of physicians and patients; competition in general; government, industry and
general public pricing pressures; unexpected manufacturing difficulties or
delays; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Sandoz 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, the generic pharmaceuticals division of Novartis, is a global leader in
the rapidly growing generics industry. Sandoz offers a broad range of about
1,100 high-quality, affordable products that are no longer protected by patents.
With nearly 26,000 employees in approximately 140 countries, Sandoz holds the #1
position globally in biosimilars, injectables, ophthalmics and dermatology as
well as a strong global #5 position in inhalables. Key product groups include
antibiotics, treatments for central nervous system disorders, gastrointestinal
medicines, cardiovascular treatments, and hormone therapies. Sandoz develops,
produces, and markets these medicines along with pharmaceutical and
biotechnological active substances and anti -infectives. In addition to strong
organic growth in recent years, Sandoz has made a series of acquisitions
including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE
Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In
2012, Sandoz posted sales of USD 8.7 billion.
Sandoz is on Twitter. Sign up to follow (at)Sandoz_global at
http://twitter.com/sandoz.
# # #
For further information, contact:
Sreejit Mohan Neil Moorhouse
Sandoz Head Biopharma & OI Sandoz Global Head Media and External
Communications Relations
+49 (0) 162 429 7971 +49 8024 476 2597
sreejit.mohan(at)sandoz.com neil.moorhouse(at)sandoz.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778 8301
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
Footnotes:
Enbrel(®) is a registered trademark of Amgen
Media release (PDF):
http://hugin.info/134323/R/1711249/567726.pdf
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Source: Novartis International AG via Thomson Reuters ONE
[HUG#1711249]
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Datum: 24.06.2013 - 07:16 Uhr
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News-ID 272308
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