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

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 older³.

Flucelvax utilizes full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production¹. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains². 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 antibiotics².

Cell-culture technology enables rapid response to urgent public health needs such as a pandemic within weeks¹. 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 pharmacies⁴. 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 billion¹. 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 preparedness¹.

"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 sneezing⁷. 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 year⁷.

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 placebo³. 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 Poland³. 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 ratio³. In a separate study in adults aged 65 years and older Flucelvax demonstrated comparable immunogenicity to Agriflu for all three strains post-vaccination³.

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 malaise³.

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.

Disclaimer
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 supply.

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 http://www.novartis.com.

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References

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: http://archive.hhs.gov/news/press/2006pres/20060504.html.
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: http://www.sciencedirect.com/science/article/pii/S0264410X09011177. 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: http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/production_availability/en/index.html. 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: http://www.fda.gov/downloads/biologicsbloodvaccines/ guidancecomplianceregulatoryinformation/guidances/vaccines/ucm202439.pdf. Accessed October 2, 2012.
7. Centers for Disease Control and Prevention. "Key Facts About Influenza and Flu Vaccine." 2012. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed July 2012.
8. Centers for Disease Control and Prevention. "Seasonal Influenza-Associated Hospitalizations in the United States." 2011. Available at: http://www.cdc.gov/flu/about/qa/hospital.htm.

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