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Novartis receives regulatory approval in Germany for Celtura®, a cell culture-based Influenza A(H1N1) pandemic vaccine


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Copyright © Hugin AS 2009. All rights reserved.
2009-11-05 07:17:03 -


London, November , 05, 2009
Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this 
announcement. 
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  * Approval marks an important milestone in the process of replacing
    50 year-old egg-based flu vaccine production with modern
    biotechnology

  * Clinical trials in more than 1,850 individuals across all age
    groups show strong efficacy, that can induce immune responses
    associated with protection against influenza in individuals from
    3 to 50 years of age

  * Novartis continues to pursue registration of Celtura in other
    major countries


Basel, November 5, 2009 - Novartis announced today that it received
approval from the German regulatory authorities for its adjuvanted
cell culture-based Influenza A(H1N1) 2009 monovalent vaccine,
Celtura®. Novartis continues to pursue registration in other major
countries, including Japan and Switzerland.

Celtura  is  manufactured  in  Marburg,  Germany  and  is  an   MF59®
adjuvanted inactivated influenza virus  vaccine indicated for  active
immunization of persons six months of age and older against influenza
disease caused by  the novel  pandemic A(H1N1)  influenza virus.  The
vaccine contains  3.75 micrograms  (ug) of  antigen and  0.125 ml  of
MF59®. It  will be  offered in  multi-dose vials  and in  single-dose
pre-filled syringes.

Clinical studies conducted  with more than  1,850 subjects  evaluated
Celtura's tolerability and  immunogenicity. The  studies showed  that
even with the lowest antigen content (3.75 ug) a single Celtura  dose
can  induce  immune  responses  associated  with  protection  against
influenza in  individuals from  3  to 50  years  of age.  Safety  and
tolerability  profiles  were  as   expected.  Local  injection   site
(redness, swelling and pain) and  systemic complaints of mild  fever,
headache and fatigue were the most frequent side effects reported.

Celtura uses a validated  cell culture line  for production of  viral
antigen  components  rather  than   traditional  chicken  eggs.   The
technology has previously been licensed in Europe for the  production
of the seasonal flu vaccine, Optaflu®.

"Our modern cell culture technology  can enable a faster start-up  of
vaccine manufacturing, offering the  ability to respond more  quickly
to future  pandemic threats",  said Andrin  Oswald, CEO  of  Novartis
Vaccines and  Diagnostics.  "We quickly  ramped  up capacity  at  our
licensed cell culture facility in Marburg, Germany to respond to  the
need for a  pandemic vaccine. Also  we are close  to completion of  a
second cell culture-based influenza vaccine manufacturing site in the
US[1], which is being built in partnership with the US Department  of
Health and Human Services (HHS)."

MF59 is an adjuvant with  an established safety profile supported  by
more than 12 years of clinical safety data in Europe and more than 45
million doses  of  commercial use  in  the influenza  vaccine  Fluad®
(licensed in Europe but not the US).

Novartis has  already  begun  delivery  of  the  company's  egg-based
pandemic vaccines, Fluvirin®  A(H1N1) monovalent vaccine  to the  US,
and Focetria®  A(H1N1) monovalent  vaccine  to countries  around  the
world. The  US Food  and Drug  Administration approved  the  Fluvirin
A(H1N1) vaccine  on September  15, 2009,  and the  EMEA approved  the
Focetria A(H1N1) vaccine on September 29, 2009.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "continues to pursue," "can,"
"potentially," "offering the ability," or similar expressions, or by
express or implied discussions regarding potential additional
marketing approvals for Novartis' A(H1N1) vaccines, potential future
deliveries of influenza vaccines, or regarding potential future
revenues from influenza vaccines. 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 Novartis' A(H1N1) vaccines
will be approved for sale in any additional countries. Nor can there
be any guarantee that Novartis will successfully meet its delivery
obligations for its influenza vaccines.  Neither can there be any
guarantee that Novartis' influenza vaccines will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Novartis' influenza vaccines
could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected
manufacturing difficulties or delays, including continued unexpected
difficulties with seed virus yields, and unexpected difficulties with
our flu cell culture manufacturing facility and processes; unexpected
clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; the
company's ability to obtain or maintain patent or other proprietary
intellectual property protection; 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 Novartis
Novartis Vaccines and Diagnostics is  a division of Novartis  focused
on the development  of preventive  treatments. The  division has  two
businesses: Novartis  Vaccines  and  Novartis  Diagnostics.  Novartis
Vaccines is  the  world's  fifth-largest  vaccines  manufacturer  and
second-largest supplier of  flu vaccines  in the  US. The  division's
products also include meningococcal,  pediatric and travel  vaccines.
Novartis Diagnostics prevents  the spread of  infections through  the
development and  marketing  of innovative  technologies  that  enable
early detection of pathogens to protect the world's blood supply  and
prevent the spread of infectious diseases.

Novartis provides  healthcare  solutions that  address  the  evolving
needs of  patients  and  societies.  Focused  solely  on  healthcare,
Novartis offers a  diversified portfolio  to best  meet these  needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis  is
the only company with  leading positions in each  of these areas.  In
2008, the Group's  continuing operations  achieved net  sales of  USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion  was  invested  in  R&D  activities  throughout  the   Group.
Headquartered in Basel, Switzerland, Novartis Group companies  employ
approximately 99,000 full-time-equivalent  associates and operate  in
more than  140  countries around  the  world. For  more  information,
please visit www.novartis.com.

References
[1] This project has been funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority,
under Contract No. HHSO100200900101C.

                                # # #

Novartis Media Relations


Central media line : +41 61 324
2200
Eric Althoff                        Paul Newman
Novartis        Global        Media Novartis Vaccines and Diagnostics
Relations                           +1 (617) 871 7931 (direct)
+41 61 324 7999 (direct)            +1 (617) 710 8953 (mobile)
+41 79 593 4202 (mobile)            paulc.newman@novartis.com
eric.althoff@novartis.com
                                    nvd.communications@novartis.com

e-mail: media.relations@novartis.com

Novartis Investor Relations


Central phone:        +41 61 324
                      7944
Ruth Metzler-Arnold   +41 61 324    North America:
                      9980
Pierre-Michel Bringer +41 61 324    Richard Jarvis     +1 212 830
                      1065                             2433
John Gilardi          +41 61 324    Jill Pozarek       +1 212 830
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Thomas Hungerbuehler  +41 61 324    Edwin Valeriano    +1 212 830
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Isabella Zinck        +41 61 324
                      7188

e-mail:                             e-mail:
investor.relations@novartis.com     investor.relations@novartis.com

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Novartis International AG
Posfach Basel 

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


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