Sandoz receives approval for first-ever Japanese biosimilar

6/25/2009, 7:15 AM (Source: GlobeNewswire)


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* Sandoz receives approval for first-ever Japanese biosimilar,
recombinant human growth hormone somatropin, further reinforcing
global pioneer position in field
* Approval paves way for greater access to high-quality
biopharmaceuticals in Japan, the world's second largest
pharmaceutical market
* Sandoz somatropin already marketed as Omnitrope® in EU, US and

Holzkirchen, June 25, 2009 - Sandoz has received marketing
authorization for the first-ever Japanese biosimilar, recombinant
human growth hormone somatropin. The precedent-setting decision
further reinforces Sandoz's global leadership position in the
rapidly-emerging market for biosimilars, or follow-on versions of
existing state-of-the-art biopharmaceuticals.

Sandoz CEO Jeff George said: "We are pleased that Sandoz, the pioneer
in biosimilars and a company with a global reputation for offering
high quality medicines at affordable prices, is paving the way in
Japan as well. Together with our parent company Novartis, we are
fully committed to broadening access to innovative and affordable
biopharmaceuticals over the years and decades to come, both in Japan
and worldwide."

The Ministry of Health, Labor and Wealth (MHLW) announced the
approval on June 22, barely three months after the Japanese
authorities published guidelines that paved the way for a national
biosimilar regulatory pathway, based on similar scientific principles
to the approval pathway already in place in the European Union.

The Sandoz product will be marketed in Japan as Somatropin BS S.C.
injection 5mg / 10mg [Sandoz]. It is approved for the treatment of
growth hormone deficiency in children and growth disturbance
associated with Turner's syndrome or chronic renal insufficiency.
This is the same range of indications covered by the reference
product, Genotropin®, as approved in Japan[1]. It is approved on the
basis that it offers patients comparable quality, safety and efficacy
to the reference product.

Sandoz pioneered the field of biosimilars / follow-on biologics with
the approval and subsequent launch of Omnitrope® in the US and
Europe. Omnitrope was the first such product to be made available
to patients in both regions and the first ever medicine to be
approved in the EU as a biosimilar, the European regulatory term for
such products. Sandoz today is the only company with three
biosimilar medicines marketed in Europe.

Biosimilars are an integral part of the Sandoz strategy to focus on
difficult-to-make products that provide added patient benefits. Due
to the rising costs of health care and the growing need for more
complex treatments, they will play an increasingly important role in
ensuring and broadening global access to medicines. Sandoz is
building a strong global biosimilar pipeline, with numerous projects
at all stages of development.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "paves way for," "paving the way,"
"committed," "will," or similar expressions, or by express or implied
discussions regarding potential marketing approvals for other
biosimilar products, or regarding potential future revenues from
somatropin/Omnitrope or other biosimilar 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 other biosimilar
products will be submitted for approval or approved for sale in any
market. Nor can there be any guarantee that somatropin/Omnitrope, or
other biosimilar products, will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding these products could be affected by, among other things,
unexpected developmental delays, including unexpected clinical or
other laboratory data; unexpected regulatory actions or delays or
government regulation generally; competition in general; government,
industry and general public pricing pressures; 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 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) and Eon Labs (US). In
2008, Sandoz employed around 23,000 people worldwide and posted sales
of USD 7.6 billion.

[1] Genotropin® is a registered trademark of Pfizer

# # #

For further information

Eric Althoff Chris Lewis
Novartis Global Media Sandoz Global Communications
Relations +49 172 141 8749
+41 61 32 47999

Novartis Investor Relations

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Pierre-Michel Bringer Jill Pozarek +1 212 830 2445
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Thomas Hungerbuehler E-mail:
Isabella Zinck
Central phone no: +41 61 324 7944

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