Sandoz begins Phase III clinical trial for biosimilar adalimumab
Novartis International AG /
Sandoz begins Phase III clinical trial for biosimilar adalimumab
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* Sandoz advances leading biosimilars pipeline by strengthening Immunology
portfolio
* Global program marks Sandoz' sixth biosimilar molecule to enter Phase III
testing
* Trial will support registration in the U.S. and European Union
Holzkirchen, Germany, December 19, 2013 - Sandoz, the global leader in
biosimilars, announced it has initiated a Phase III clinical trial with its
biosimilar version of adalimumab (AbbVie's HUMIRA(®)) - the leading treatment of
several autoimmune conditions including rheumatoid arthritis, psoriasis, and
Crohn's disease. This is Sandoz's eighth Phase III trial initiation across six
compounds.
The aim of the study is to demonstrate equivalent efficacy, similarity, and
immunogenicity of the Sandoz product versus HUMIRA(®) in patients with moderate
to severe plaque-type psoriasis. Sandoz is working closely with physicians and
patients on this global trial, which spans 12 countries across Europe, the
United States and Asia including Japan.
Psoriasis affects approximately 3% of the world's population[1]. There is
significant unmet need in psoriasis with between nine and 30 percent of patients
with severe psoriasis receiving no treatment at all[2]. "Because psoriasis is a
chronic condition that often requires lifelong management, treatment can become
a significant financial strain for many patients and healthcare systems," said
Professor Dr. Peter van de Kerkhof, Chairman of the Department of Dermatology at
the Radboud University Nijmegen Medical Centre in The Netherlands and President
of the International Psoriasis Council (IPC) Board of Directors. "A high-quality
and clinically proven biosimilar version of adalimumab could play a meaningful
role in alleviating cost burdens related to this disease."
"This latest advancement in our pipeline represents our unwavering commitment to
expanding patient access to biologics - particularly in disease areas where
there is a significant need for more treatment choices," said Mark McCamish,
M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables
Development at Sandoz. "We look forward to bringing a high-quality and
affordable biosimilar version of adalimumab to individuals around the world
living with psoriasis and other debilitating autoimmune diseases such as
rheumatoid arthritis."
"Adalimumab will be a key building block in our growing Immunology portfolio,
which includes other biosimilar candidates currently in Phase III trials such as
etanercept (Amgen's Enbrel(®)) and rituximab (Roche's Rituxan(®)/MabThera(®)),"
said Ameet Mallik, Sandoz' Head of Biopharmaceuticals and Oncology Injectables.
"This key development milestone further strengthens our global leadership in
biosimilars and builds on our industry-leading pipeline."
Sandoz is the pioneer in biosimilars and the global market leader with over 50
percent market segment share of all biosimilars approved in the highly regulated
markets of U.S., Canada, Europe, Japan and Australia. All three Sandoz
biosimilars occupy the #1 biosimilar position (volume market share) in their
respective categories. Sandoz biosimilars are sold in over 50 countries and have
generated over 100 million patient exposure days in experience.
Disclaimer
This press release contains forward-looking statements that can be identified by
terminology such as "begins," "will," "aim," "can," "could," "commitment," "look
forward to," "growing," or similar expressions, or by express or implied
discussions regarding potential new biosimilar products; or regarding potential
future sales of biosimilar products. Such forward-looking statements reflect the
current views of the Novartis 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, performance or achievements
expressed or implied by such statements. There can be no guarantee that any new
biosimilar products will be submitted or approved for sale in any market. Nor
can there be any guarantee that Sandoz will achieve any particular financial
results from its biosimilar products. In particular, management's expectations
could be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally, including the potential outcome of
the FDA's biosimilars regulatory process; unexpected clinical trial results,
including additional analyses of existing clinical data or unexpected new
clinical data; unexpected product manufacturing issues; government, industry,
and general public pricing pressures; competition in general; unexpected
development difficulties; unexpected patent litigation outcomes; the impact that
the foregoing factors could have on the values attributed to the 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 US 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 described herein as anticipated,
believed, estimated or expected. 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 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 employs over 26,000 employees in
more than 140 countries, offering broad range of over 1,000 high-quality,
affordable products that are no longer protected by patents. With USD 8.7
billion in sales in 2012, Sandoz holds the #1 position globally in biosimilars
as well as generic injectables, ophthalmics, dermatology and antibiotics as well
as strong positions in the 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. In addition to strong organic growth
since consolidating its generics businesses under the Sandoz brand name in 2003
, Sandoz has benefitted from strong growth of its acquisitions including Lek
(Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma
(Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).
Sandoz is on Twitter. Sign up to follow @Sandoz_global at
http://twitter.com/sandoz.
# # #
For further information, contact:
Eric Althoff Sreejit Mohan
Novartis Global Media Relations Sandoz Head Biopharma & OI
+41-61-324-7999 Communications
+41-79-593-4202 +49 (0) 162 429 7971
eric.althoff@novartis.com sreejit.mohan@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 Susan Donofrio +1 862 778 9257
e-mail: investor.relations@novartis.com e-mail:
investor.relations@novartis.com
Footnotes:
HUMIRA® is a registered trademark of AbbVie
ENBREL® is a registered trademark of Amgen
Rituxan®/MabThera® are registered trademarks of Roche
References:
[1] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About
Psoriasis."Â http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed
August 2013.
[2] Armstrong AW et al. JAMA Dermatol 2013 Aug 14.
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