Sandoz announces phase II clinical trial for biosimilar version of leading monoclonal antibody rituximab

1/10/2011, 7:15 AM (Source: GlobeNewswire)


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Novartis International AG /
Sandoz announces phase II clinical trial for biosimilar version of leading
monoclonal antibody rituximab
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* Start of phase II clinical study in patients for Sandoz biosimilar rituximab
(Roche's Rituxan® / Mabthera®)[1]
* Sandoz already has robust, high-yield in-house production process
* Milestone reinforces Sandoz's commitment to maintain global biosimilar
market leadership, with a total of 8-10 molecules at various stages of

Holzkirchen, January 10, 2011 - Sandoz announced today that it has begun a phase
II clinical trial in patients for biosimilar rituximab (Roche's Rituxan® /
Mabthera®), a leading monoclonal antibody indicated in conditions including non-
Hodgkin's lymphoma and rheumatoid arthritis.

The phase II study in patients suffering from rheumatoid arthritis aims to
demonstrate bioequivalence to the reference product, and will collect data on
pharmacokinetics and pharmacodynamics as well as efficacy and safety data.

Over the past few years Sandoz has developed a robust, high-yield and large-
scale process for the production of biosimilar rituximab in its own facilities
in Schaftenau, Austria. To ensure biosimilarity with the reference product, a
comprehensive physico-chemical and functional analysis of the product was
conducted using modern bioanalytic techniques, followed by further studies. The
data suggest that Sandoz's biosimilar rituximab is highly similar to the
reference product, justifying initiation of clinical studies in patients.

"This key development milestone demonstrates that Sandoz, the pioneer in
biosimilars, is on track to maintain its global leadership position in the
medium to long term," said Sandoz global head Jeff George.

"With nearly 50% market share within the global regulated biosimilar market, and
with three marketed products, Sandoz plans to continue to broaden patient access
to essential high-quality biologics by consistently advancing our industry-
leading development pipeline."

Ameet Mallik, global head of Sandoz Biopharmaceuticals, added: "Our pipeline is
particularly focused on monoclonal antibodies, the largest and fastest-growing
segment of the biologics market. We are confident that we can leverage our
unrivalled development and manufacturing capabilities as well as our Novartis-
wide synergies in areas including clinical trial design and execution, to
succeed in this exciting new field."

Monoclonal antibodies are protein-based therapeutics that are produced using
genetically engineered cell lines. They function as targeted treatments that
offer genuine therapeutic hope for many areas of unmet need, particularly
complex therapeutic areas such as oncology and autoimmune diseases.

Mabthera® / Rituxan®, an antibody directed against the CD20 protein found on the
surface of B-cells, is one of the leading monoclonal antibodies on the market.
It ranks among the top three biologic (biopharmaceutical) drugs worldwide, with
2009 sales of USD 5.6 billion (IMS).

The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "will," "on track," "plans," "pipeline,"
"confident," or similar expressions, or by express or implied discussions
regarding potential future marketing approvals of a biosimilar version of
rituximab or of other biosimilar products, or regarding potential future
revenues from rituximab or from any of Sandoz's other biosimilar products. You
should not place undue reliance on these statements. Such forward-looking
statements reflect the current views of the Company 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 rituximab will be submitted or approved for sale in any market,
or at any particular time.  Neither can there be any guarantee that Sandoz will
succeed in developing and bringing to market any additional biosimilar
productions.  Nor can there be any guarantee that rituximab or any other
biosimilar products will achieve any particular levels of revenue in the future.
In particular, management's expectations regarding such products could be
affected by, among other things, unexpected development difficulties; unexpected
manufacturing difficulties; 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; competition in general; government, industry and general public
pricing pressures; 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 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 contained in this press release as a result of new information,
future events or otherwise.

# # #

About Sandoz
Sandoz, a Division of the Novartis group, is a global leader in the field of
generic pharmaceuticals, offering a wide array of high-quality, affordable
products that are no longer protected by patents.  Sandoz has a portfolio of
approximately 1000 compounds and sells its products in more than 130 countries.
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), and EBEWE Pharma (Austria).  In 2009, Sandoz employed approximately
23,000 people worldwide and posted sales of USD 7.5 billion.

For further information

|  Eric Althoff |  Chris Lewis |
|  Novartis Global Media Relations |  Sandoz  Communications |
|  +41 61 324 7999 |  +49 8024 476 2550  |
| | |
| e-mail: |

Novartis Investor Relations

| International: | North America: |
| Susanne Schaffert | Richard Jarvis +1 212 830 2433 |
| Pierre-Michel Bringer | Jill Pozarek +1 212 830 2445 |
| Thomas Hungerbuehler | Edwin Valeriano +1 212 830 2456 |
| Isabella Zinck | e- |
| Central phone no: +41 61 324 7944 | |
|| |


[1] All registered trademarks named in this release are the property of the
respective companies

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