Sandoz launches first generic version of Prograf® capsules

8/11/2009, 7:15 AM (Source: GlobeNewswire)


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* Sandoz is first company to receive US approval to market generic
* US sales of Prograf® were USD 929 million annually through April
* Tacrolimus launch demonstrates Sandoz commitment to increasing
access for transplant patients to cost-saving treatment options

Holzkirchen, August 11, 2009 - Sandoz today announced the
introduction of tacrolimus capsules, a generic equivalent of
Prograf®, in the US. Tacrolimus is an immunosuppressive treatment
used to help prevent rejection of a kidney or liver transplant.

Sandoz is the first and only company to launch generic tacrolimus in
the US, delivering on its strategy of being first-to-market with key
products. With the introduction of tacrolimus, Sandoz is expanding
patient access to cost-saving transplant treatment options in the

"Tacrolimus is an important new product for Sandoz, further
strengthening our diverse portfolio of affordable medicines in the
key US market," said Jeff George, CEO of Sandoz.

"Sandoz is excited to be the first company to offer this new
high-quality, affordable treatment option to transplant patients.
Sandoz and our parent company Novartis have deep experience in the
transplant field and we are deeply committed to providing more
cost-saving treatment options for this community in the future."

Novartis pioneered medicines to facilitate transplantation with the
discovery over 25 years ago of cyclosporine (Sandimmune® /
cyclosporine USP) and Neoral® (cyclosporine USP MODIFIED), for the
prevention of organ rejection following kidney, liver or heart

Today, Novartis has the broadest portfolio of immunosuppressants on
the market, including Myfortic® (mycophenolic acid) delayed-release
tablets, indicated for kidney transplants, and Simulect®
(basiliximab), for the prevention of acute organ rejection. The
addition of Sandoz tacrolimus will further increase the breadth of
this portfolio.

According to IMS Health, Prograf had US sales of USD 929 million for
the 12 months through April 2009. Sandoz will market tacrolimus in
capsules of 0.5, 1 and 5 mg strengths.

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 about 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.

* * *

The foregoing release contains forward-looking statements that can be
identified by terminology such as "commitment", "strategy",
"committed", or similar expressions, or by express or implied
discussions regarding potential additional marketing approvals or
potential sales of tacrolimus capsules. 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 tacrolimus capsules will
be approved for sale in any additional markets. Nor can there be any
guarantee that tacrolimus capsules 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; the particular
prescribing preferences of transplantation physicians and patients;
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
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. Sandoz 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

* * *
For further information

Central media line : +41 61 324 2200
Eric Althoff Anna Manno
Novartis Global Media Relations Sandoz US Communications
+41 61 324 7999 +1 609 6275240


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

Prograf® is a registered trademark of Astellas.

--- End of Message ---

Novartis International AG
Posfach Basel

WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
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