Sandoz receives European Commission approval for biosimilar filgrastim

2/13/2009, 7:15 AM (Source: GlobeNewswire)

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* Sandoz receives approval for its third biosimilar medicine,
further reinforcing pioneer position in field
* Approval increases access to high-quality oncology medicines,
offering patients comparable quality, safety and efficacy to
reference product combined with greater cost-effectiveness
* Sandoz committed to bringing more high-quality biosimilars to
patients worldwide

Holzkirchen, February 13, 2009 - Sandoz has received final approval
for its third biosimilar, filgrastim, paving the way for this
important oncology medicine to be made available to patients across
the European Union.

Filgrastim is indicated for the treatment of neutropenia, a condition
characterized by a lack of neutrophils - one of the most common types
of white blood cells - whose role is to fight infection in the body.
Neutropenia is often associated with chemotherapy or bone marrow
transplants, as well as advanced HIV infections. Filgrastim is a
natural protein produced commercially by recombinant DNA technology,
which stimulates production of white blood cells.

The Sandoz product is approved for the same range of indications as
the reference product, Neupogen®[1] and offers patients comparable
quality, safety and efficacy combined with greater
cost-effectiveness. The novel Sandoz filgrastim needlestick
protection device decreases the risks of injury and exposure to
blood-born infection, thus contributing significantly to protecting
health professionals.

Sandoz CEO Jeff George says: "As the pioneer of biosimilars and a
company with a global reputation for offering high quality medicines
at affordable prices to patients and payors worldwide, Sandoz is
looking forward to providing this important new cost-effective option
for oncology patients.

"Filgrastim particularly helps patients receiving chemotherapy to
increase their neutrophil counts, meaning they can better avoid the
risk of the serious life threatening infections that so often force
clinicians to change their optimal therapeutic chemotherapy regimen,
dose or schedule."

Sandoz is the only company with marketing authorization for more than
one biosimilar medicine. In a precedent-setting decision in April
2006, Sandoz received the first-ever EU approval for a biosimilar
medicine, human growth hormone Omnitrope®. Binocrit® / Epoetin alfa
Hexal®, the first follow-on erythropoetin and the first complex
(glycoprotein) biosimilar, was approved in the EU in August 2007 and
launched the same year. Sandoz has a comprehensive biopharmaceuticals
pipeline, with numerous projects at various stages of development.

The European Commission approval followed a positive opinion issued
in November by the European Medicines Agency's Committee on Medicinal
Products for Human Use (CHMP), which provides scientific reviews of
medicines for the Commission.

# # #

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by terminology such as "committed," "looking forward,"
"pipeline," or similar expressions, or by express or implied
discussions regarding potential marketing approvals for other
biosimilar products, or regarding potential future revenues from
filgrastim 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 filgrastim, 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] Neupogen® is a registered trademark of Amgen

# # #


For further information


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