Novartis Receives FDA Approval for Flucelvax®, the First Cell-Culture Vaccine in US to Help Protect Against Seasonal Influenza

Novartis Receives FDA Approval for Flucelvax®, the First Cell-Culture Vaccine
               in US to Help Protect Against Seasonal Influenza

-Cell-culture technology, an alternative to traditional egg-based production,
is the most significant advancement in influenza vaccine manufacturing in more
than 40 years1

-Flucelvax is the only influenza vaccine of its kind in the US and does not
contain any preservatives, such as thimerosal, or antibiotics2

-Approval demonstrates Novartis leadership in advancing novel influenza
vaccine research and manufacturing technologies

PR Newswire

CAMBRIDGE, Mass., Nov. 20, 2012

CAMBRIDGE, Mass., Nov. 20, 2012 /PRNewswire/ -- Novartis announced today that
the US Food and Drug Administration (FDA) approved the use of Flucelvax^®
(Influenza Virus Vaccine), the first cell-culture-derived vaccine, for
individuals 18 years of age and older^3.

Flucelvax utilizes full-scale cell-culture manufacturing technology, an
alternative production method to traditional egg-based production^1.
Cell-culture technology utilizes a well-characterized mammalian cell line
rather than chicken eggs to grow virus strains^2. The production occurs in a
closed, sterile, controlled environment, which significantly reduces the risk
of potential impurities. Flucelvax does not contain any preservatives, such as
thimerosal, or antibiotics^2.

Cell-culture technology enables rapid response to urgent public health needs
such as a pandemic within weeks^1. Traditional influenza vaccine production
depends on a large number of fertilized chicken eggs to grow virus strains and
requires many months for organization of egg supplies, virus incubation and
actual production before the vaccine is delivered to physicians or
pharmacies^4. Cell-culture technology is successfully used to manufacture
other vaccines, including those distributed during the H1N1 pandemic, as well
as vaccines for polio, rubella and hepatitis A^5,6.

"The approval of Flucelvax is an important milestone for our influenza
franchise and brings an innovative vaccine to the US," said Andrin Oswald,
Division Head, Novartis Vaccines and Diagnostics. "Modern cell-culture
technology will likely become the new standard for influenza vaccine
production and we are proud to lead the way."

Novartis has partnered with the US Department of Health and Human Services,
Biomedical Advanced Research and Development Authority (HHS, BARDA) for the
development of the cell-culture manufacturing technology, as well as for
construction of the state-of-the-art facility in Holly Springs, N.C. Total
public/private investment in the technology development and facility is more
than $1 billion^1. Flucelvax will be produced in Holly Springs once the
facility is ready for full-scale commercial production. The facility is the
first of its kind in the US and also allows for enhanced domestic pandemic

"The availability of a cell-culture vaccine is an important step to ensuring
our readiness for seasonal influenza, as well as a potential pandemic," said
Dr. William Schaffner, professor of medicine and chairman of preventive
medicine at Vanderbilt University, Nashville, Tennessee. "Annual influenza
vaccination is an important public health measure that helps protect thousands
of people from illness and death each year."

About influenza
Influenza is a highly infectious and potentially deadly disease of the
respiratory tract, which spreads easily through transfer of respiratory
droplets typically by coughing or sneezing^7. In any given season, influenza
may cause between 3,000 and 49,000 deaths and can hospitalize more than
200,000 people in the US alone^7,8. The Centers for Disease Control and
Prevention (CDC) recommends that everyone 6 months of age and older get
vaccinated for seasonal influenza every year^7.

About Flucelvax
The basis for approval included data from clinical trials that found Flucelvax
to be well tolerated, with an efficacy of 83.8 percent against
antigenically-matched strains compared to placebo^3. A multinational,
randomized, observer-blinded, placebo-controlled trial was performed to assess
clinical efficacy and safety of Flucelvax during the 2007-2008 influenza
season in adults aged 18 to 49 years in the US, Finland and Poland^3. A total
of 11,404 subjects received Flucelvax (N=3828), seasonal influenza vaccine
Agriflu^® (N=3676) or placebo (N=3900) in a 1:1:1 ratio^3. In a separate study
in adults aged 65 years and older Flucelvax demonstrated comparable
immunogenicity to Agriflu for all three strains post-vaccination^3.

Solicited adverse reactions are similar to those observed with administration
of other seasonal influenza vaccines. Overall, in clinical studies, the most
common (greater than or equal to 10 %) solicited adverse reactions occurring
in adults 18 to 64 years within seven days of vaccination with Flucelvax were
pain at the injection site, erythema (redness) at the injection site,
headache, fatigue, myalgia and malaise. The most common (greater than or equal
to 10 %) solicited adverse reactions occurring in adults 65 years of age or
older within 7 days of vaccination were erythema at the injection site,
fatigue, headache and malaise^3.

Novartis Vaccines partnership with US Department of Health and Human Services
Development of cell-culture technology has been funded in part with Federal
funds from the Department of Health and Human Services Office of the Assistant
Secretary for Preparedness and Response, Biomedical Advanced Research and
Development Authority, under Contract No. HHSO100200600012C.

Construction of the Holly Springs facility was funded 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.

Indication and Important Safety Information
FLUCELVAX^® is an inactivated vaccine indicated for active immunization for
the prevention of influenza disease caused by influenza virus subtypes A and
type B contained in the vaccine. FLUCELVAX is approved for use in persons 18
years of age and older.

Do not administer FLUCELVAX to anyone with a history of severe allergic
reaction (e.g. anaphylaxis) to any component of the vaccine.

If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine,
the decision to give FLUCELVAX should be based on careful consideration of the
potential benefits and risks.

The tip caps of the pre-filled syringes may contain natural rubber latex which
may cause allergic reactions in latex-sensitive individuals.

Appropriate medical treatment and supervision must be available to manage
possible anaphylactic reactions following administration of the vaccine.

After vaccination with FLUCELVAX, ^ immunocompromised individuals, including
those receiving immunosuppressive therapy, may have a reduced immune response.

Vaccination with FLUCELVAX may not protect all vaccine recipients against
influenza disease.

Please see full Prescribing Information for Flucelvax.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "potential," "potentially," or
similar expressions, or by express or implied discussions regarding potential
future revenues from Flucelvax. 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 with Flucelvax
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Flucelvax will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding Flucelvax could be
affected by, among other things, unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; competition in general; government, industry and general public
pricing pressures; unexpected manufacturing issues; unexpected regulatory
actions or delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; 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, the blood testing
business, is dedicated to preventing the spread of infectious diseases through
the development of novel blood-screening tools that protect the world's blood

Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the
Group's continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 127,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit

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1.U.S. Department of Health and Human Services. "HHS Awards Contracts
    Totaling More Than $1 Billion to Develop Cell-Based Influenza Vaccine."
    2006. Available at:
2.Ambrozaitis, Arvydas et al. A novel mammalian cell-culture technique for
    consistent production of a well-tolerated and immunogenic trivalent
    subunit influenza vaccine. Vaccine. Vol 27. Issue 43. October 9, 2009:
    6022–6029. Available at:
    Accessed on October 3, 2012.
3.Flucelvax Package Insert. 2012.
4.Gerdil, Catherine. "The Annual Production Cycle for Influenza Vaccine."
    Vaccine 21 (2003): 1776-1779.
5.World Health Organization. "Production and Availability of Pandemic (H1N1)
    2009 Vaccines." 2009. Available at:
    Accessed October 2012.
6.U.S. Food and Drug Administration. "Guidance for Industry:
    Characterization and Qualification of Cell Substrates and Other Biological
    Materials Used in the Production of Viral Vaccines for Infectious Disease
    Indications." 2010. Available at:
    Accessed October 2, 2012.
7.Centers for Disease Control and Prevention. "Key Facts About Influenza and
    Flu Vaccine." 2012. Available at:
    Accessed July 2012.
8.Centers for Disease Control and Prevention. "Seasonal Influenza-Associated
    Hospitalizations in the United States." 2011. Available at:

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Novartis Corporation                   Novartis Vaccines and Diagnostics
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