Sandoz receives positive EU opinion for biosimilar filgrastim

11/21/2008, 12:48 PM (Source: GlobeNewswire)


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* Approval would expand patient choice, in particular for those
undergoing chemotherapy
* Sandoz further reinforces pioneer position, with third biosimilar
* Leading Sandoz biosimilar pipeline includes two dozen further

Holzkirchen, November 21, 2008 - Sandoz has received a positive
opinion from European regulators for its third biosimilar medicine,
filgrastim, marking another important milestone in its efforts to
bring affordable high-quality biopharmaceuticals to patients

Filgrastim is indicated for use in treating neutropenia, a condition
characterized by lack of neutrophils - one of the most common types
of white blood cells - that is often associated with chemotherapy or
bone marrow transplants. Filgrastim is a natural man-made protein
produced commercially by recombinant DNA technology, which stimulates
production of white blood cells.

Sandoz CEO Andreas Rummelt says: "The positive opinion from the CHMP
(Committee on Medicinal Products for Human Use) is an important first
step towards receiving EU regulatory approval. Such approval would
provide an important new option, in particular for patients
undergoing chemotherapy.

"Filgrastim enables them to stay on their required course of therapy
at the optimal dose level by raising neutrophil counts to within the
normal range. In addition to significant potential cost savings, our
product offers patients and healthcare providers a very pure form of

This is the third time that the CHMP, which reviews medicines
scientifically in the EU, has issued a positive opinion for a Sandoz
biosimilar. In a precedent-setting decision in April 2006, Sandoz was
the first company to obtain EU approval for such a 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, the biosimilars pioneer, also has a comprehensive
pipeline, with two dozen projects at various stages of development.

# # #


The foregoing release contains forward-looking statements that can be
identified by terminology such as "would," "pipeline," "potential,"
or similar expressions, or by express or implied discussions
regarding potential marketing approvals for filgrastim or other
biosimilar products, or regarding potential future revenues from
filgrastim or other such 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 filgrastim will be
approved for sale in any market, or 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 such other
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
regulatory actions or delays or government regulation generally;
unexpected developmental delays, including unexpected clinical or
other laboratory data; 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 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.

# # #

For further information

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

Novartis Investor Relations

International: North America:
Ruth Metzler-Arnold Richard Jarvis +1 212 830 2433
Pierre-Michel Bringer Jill Pozarek +1 212 830 2445
John Gilardi Edwin Valeriano +1 212 830 2456
Thomas Hungerbuehler E-mail:
Isabella Zinck
Central phone no: +41 61 324 7944

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