Sandoz receives FDA approval for Omnitrope® Pen 10 with liquid cartridge

9/3/2008, 7:15 AM (Source: GlobeNewswire)


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* New 10mg strength offers increased treatment flexibility and more
convenient dosage form

* Comparable quality, safety and efficacy combined with
cost savings

* Approval further demonstrates Sandoz leadership in high quality

follow-on biologics

* New 10mg strength offers increased treatment flexibility and more
convenient dosage form

* Comparable quality, safety and efficacy combined with significant
cost savings

* Approval further demonstrates Sandoz leadership in high quality
follow-on biologics

Princeton, New Jersey, September 3, 2008 -- Sandoz has received US
Food and Drug Administration approval for its Omnitrope® Pen 10 with
liquid cartridge. Omnitrope, a somatropin, is approved for long-term
treatment of pediatric patients who have growth failure and long-term
replacement therapy in adults with growth hormone deficiency.

There are approximately 50,000 pediatric patients and 25,000 adult
patients who use a somatropin in the US.[1] The Omnitrope Pen 10 with
liquid cartridge provides increased treatment flexibility for
physicians and a more convenient dosage form for patients. It will
also offer significant cost savings compared to the reference
product, Genotropin®, and other leading recombinant growth hormones.

"The FDA approval of the 10 mg strength of Omnitrope will allow
physicians to treat a broader spectrum of patients with a high
quality, lower cost treatment option," said Bernhard Hampl, chief
executive officer of Sandoz Inc., the US subsidiary of Sandoz.
"Follow-on biologics are a key part of the Sandoz strategy and we are
committed to increasing patient access through follow-on biologics
once patents have expired."

The 10 mg version has been marketed by Sandoz in key European
countries since earlier this year. A 5 mg strength version, Omnitrope
Pen 5 with liquid cartridge, has been available in the US since

Omnitrope is highly similar to Genotropin in its safety and efficacy

Sandoz pioneered the field of follow-on biologics with the approvals
and subsequent launches of a lyophilized powder form of Omnitrope in
the US and Europe. Omnitrope was the first follow-on biologic to
receive approval and be made available to patients in both regions.
It was the first ever medicine to be approved in the EU as a
biosimilar, the European regulatory term for such products.

Follow-on biologics are a key part of the Sandoz strategy to focus on
difficult-to-make generics 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 access to medicines. Sandoz is building a strong global
pipeline of follow-on biologics, with 25 projects currently under
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 more than 950 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
2007, Sandoz employed around 23,000 people worldwide and posted sales
of USD 7.2 billion

The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "rising," or similar
expressions, or by express or implied discussions regarding the
launch of Omnitrope Pen 10, potential future approvals of other
follow-on biologic products, or regarding potential future revenues
from Omnitrope Pen 10, other Omnitrope products, or from any such
other follow-on biologic products. 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 the launch of Omnitrope
Pen 10 will be successful. Nor can there be any guarantee that any
other follow-on biologic products will be approved for sale. Neither
can there be any guarantee that Omnitrope Pen 10, or any such other
follow-on biologic products will achieve any particular levels of
revenue in the future. In particular, management's expectations could
be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; an inability to obtain
needed legislative changes to create new regulatory approval pathways
for follow-on biologic products; competition in general; production
delays or business interruption generally; government, industry and
general public pricing pressures; the effect 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 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.
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.

* * *

For further information

Novartis Media Relations

Central media line : +41 61 324 2200
Eric Althoff Charles A. Bruns
Novartis Global Media Sandoz US Communications
Relations +1 609 6278881
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)


Novartis Investor Relations

Central phone: +41 61 324
Ruth Metzler-Arnold +41 61 324 North America:
Pierre-Michel Bringer +41 61 324 Richard Jarvis +1 212 830
1065 2433
John Gilardi +41 61 324 Jill Pozarek +1 212 830
3018 2445
Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830
8425 2456
Isabella Zinck +41 61 324

e-mail: e-mail:

[1] According to external data compiled by Sandoz.
[2].FDA Citizen Petition Response Docket NOs 2004 P-0231/CP1 and SUP
1, 2003 P-0176/CP1 and EMC1, 2004 PO 171/CP1 and 2004 N-0355, May 30,
2006: at 12.

Omnitrope® is a trademark of Sandoz.
Genotropin® is a registered trademark of Pfizer.

--- End of Message ---

Novartis International AG
Posfach Basel

WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SWX Swiss Exchange, ZLS in BX Berne eXchange;

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