Sandoz initiates two more Phase III biosimilar trials, reinforcing long-term global leadership commitment

1/19/2012, 7:15 AM (Source: GlobeNewswire)

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Sandoz initiates two more Phase III biosimilar trials, reinforcing long-term
global leadership commitment
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* Phase III clinical study for filgrastim biosimilar (Neupogen(®))[1]( )is
expected to support expansion to the US market
* Phase III study for Sandoz pegfilgrastim (Neulasta(®)) represents next major
step in Sandoz's global biosimilar development program
* Latest milestones further reinforce Sandoz's commitment to continued global
biosimilar leadership, with a total of 8-10 molecules at various stages of
development

Holzkirchen, January 19, 2012 - Sandoz announced today that it has initiated two
milestone Phase III clinical trials - one for biosimilar filgrastim (Amgen's
Neupogen(®)) in the US market, the other for its global pegfilgrastim
development program (Amgen's Neulasta(®)).

The filgrastim study is to evaluate the efficacy and safety of Sandoz's
biosimilar filgrastim versus Neupogen(®) in breast cancer patients eligible for
myelosuppressive chemotherapy treatment. It is expected to support extension of
commercialization to the US, the largest global market for biologics. Sandoz's
filgrastim biosimilar is already marketed under the brand name Zarzio(® )in more
than 30 countries outside the United States.

The pegfilgrastim study, which is being conducted in breast cancer patients
undergoing myelosuppressive chemotherapy treatment, represents the next major
step in the Sandoz global biosimilar development program.

"Sandoz is already the clear global leader in biosimilars overall and in each of
our three marketed products, with approximately 50% total segment share in the
highly regulated markets of North America, Europe, Japan and Australia", said
Sandoz's global head, Jeff George.  "These two development milestones
demonstrate that we also continue our efforts to make good on the longer-term
promise of our leading pipeline."

In addition to Zarzio, Sandoz markets biosimilar somatropin (Omnitrope(®)) and
epoetin alfa (Binocrit(®)) in countries across Europe and elsewhere.  Omnitrope
is also marketed in the US, under a different approval pathway.

Ameet Mallik, global head of Sandoz Biopharmaceuticals, added: "The start of
these two studies represents significant progress for our broad ongoing
development program, which includes previously announced late-stage trials for
biosimilar rituximab (Roche's Rituxan(®)). We will work to leverage our strong
capabilities and our unique position within Novartis to drive the continued
success of our biosimilar pipeline, with eight to 10 molecules at various stages
of development."

As with all its biosimilar development programs, Sandoz has focused on using
state-of-the-art analytical techniques and process development to produce
molecules that are highly similar to their reference product, prior to launching
tailored clinical programs to generate appropriate supportive data.

Zarzio is already the #1 filgrastim biosimilar worldwide, accepted in multiple
markets as the first choice for primary prevention of febrile neutropenia (low
white blood cell counts) and rapidly expanding global patient access to this
essential biologic. Pegfilgrastim is a pegylated [2] form of recombinant human
granulocyte-colony stimulating factor (G-CSF), or filgrastim, and Amgen's
Neulasta(® )remains the best-selling G-CSF worldwide. It is the goal of Sandoz
to create the #1 overall G-CSF franchise worldwide, with both its daily
filgrastim and its once-per-cycle pegfilgrastim as the most-prescribed medicines
in their respective areas.

Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "expected," "longer-term promise,"
"pipeline," "plan," "goal," or similar expressions, or by express or implied
discussions regarding potential future marketing approvals of follow-on versions
of filgrastim or pegfilgrastim or of other biosimilar products, or regarding
potential future revenues from filgrastim or pegfilgrastim or other Sandoz
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 filgrastim or pegfilgrastim 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 products.  Nor can there be any
guarantee that filgrastim or pegfilgrastim 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 clinical trial results including new clinical data and
additional analysis of existing clinical data; unexpected regulatory actions or
delays or government regulation generally; unexpected development difficulties;
unexpected manufacturing difficulties; 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.  It 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.  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

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References:

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

[2] Pegylation is the process of covalent attachment of polyethylene
glycol polymer chains to another molecule, normally a drug or therapeutic
protein.


--- End of Message ---

Novartis International AG
Postfach Basel

WKN: 904278;ISIN: CH0012005267;

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