Novartis begins shipment of Fluvirin® seasonal influenza vaccine in US for 2012-2013 influenza season

CAMBRIDGE, Mass., July 26, 2012 /PRNewswire/ -- Novartis announced today that the Company has commenced shipment of its seasonal influenza vaccine to customers in the US for the 2012-2013 influenza season. The early arrival of seasonal influenza vaccines will ensure healthcare professionals are equipped to provide the earliest possible protection against influenza. This year, Novartis plans to ship more than 30 million doses of the vaccine, which has been reformulated to include two new influenza strains to meet the updated World Health Organization and US Food and Drug Administration (FDA) recommendations. Fluvirin^® has been approved by FDA for persons 4 years of age and older².

During each season, influenza may cause thousands of influenza-associated deaths and hospitalizations^3,4. Federal health officials advise that the single best way to protect against influenza is to get vaccinated every year. Immunity to influenza viruses declines over time and may be too low to provide protection after one year⁵.

"We are continuing our dedication to meet customer demand by ensuring adequate supply of Fluvirin," said Brent MacGregor, President of US Vaccines and Head of Region North America. "The influenza vaccine will arrive in time to help meet a significant public health need and allow healthcare professionals to start administering vaccines in the lead up to the influenza season."

The Centers for Disease Control and Prevention (CDC) recommends routine seasonal influenza vaccination for all individuals 6 months of age and older. In addition, CDC advises that it is especially important for certain high-risk groups - seniors, children under the age of five, people with chronic illnesses such as asthma, diabetes or chronic lung disease and healthcare workers, as well as people who live with or care for high-risk individuals, to receive an influenza vaccine each influenza season¹.

About Seasonal Influenza

Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract and sometimes the lungs. It can cause mild to severe illness and can also lead to death³.

The number of people in the US who die every year from influenza and its complications could be comparable to the more than 41,500 people in the US who die each year from breast cancer, and to about half of the estimated 73,000 people who die annually of diabetes and its complications each year in the US^6,7.

Influenza vaccination is one of the most effective public health interventions ever implemented, sparing millions of people from complications, including death, from this infectious disease. Use of currently available seasonal influenza vaccines has been calculated to save more than 8 million lives annually worldwide, translating to one person saved every five seconds⁸.

About Fluvirin

Fluvirin vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine².

For the 2012-2013 season, Fluvirin contains antigens that target three influenza virus strains identified by World Health Organization (WHO) experts as likely to dominate circulation. These include:

• A/California/7/2009 (H1N1)-like virus

• A/Victoria/361/2011 (H3N2)-like virus

• B/Wisconsin/1/2010-like virus (from the B/Yamagata lineage of viruses)

Important Safety Information

Serious allergic reactions, including anaphylactic shock, have been observed in people receiving Fluvirin Influenza Virus Vaccine. Fluvirin vaccine should not be administered to individuals with a history of systemic hypersensitivity reaction to eggs or egg proteins or other components of Fluvirin vaccine, including thimerosal, or to anyone who has had a life-threatening reaction to previous influenza vaccination. In clinical trials, the most common adverse events in adults were headache, fatigue, injection site reactions (pain, mass, redness, and induration), and malaise. These adverse events were generally mild/moderate and transient. Vaccination with Fluvirin vaccine may not protect all individuals who are susceptible to influenza. Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a reduced immune response to Fluvirin vaccine. If Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to use Fluvirin vaccine should be based on careful consideration of the potential benefits and risks. All people, including those who are pregnant, nursing, and/or taking other medications, should consult their healthcare providers before receiving Fluvirin vaccine.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "plans," "will," "may," "continuing our dedication," or similar expressions, or by express or implied discussions regarding the quantities of Fluvirin which will ultimately be shipped to US customers, regarding the timing of such shipments, or regarding potential future revenues from Fluvirin. 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 regarding the quantities of Fluvirin which ultimately will be shipped to US customers, or of the timing of such shipments.  Nor can there be any guarantee that Fluvirin 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; unexpected manufacturing issues; 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, and unexpected reimbursement decisions; 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 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 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 126,000 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. Centers for Disease Control and Prevention. Seasonal Flu Vaccine. December 7, 2011. Available at: http://www.cdc.gov/flu/about/qa/fluvaccine.htm. Accessed on July 3, 2012.
2. United States Food and Drug Administration. Influenza Virus Vaccine Fluvirin® 2012-2013 Formula.
3. Centers for Disease Control and Prevention. Key facts about influenza (flu) & flu vaccine. March 28, 2012. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed on July 3, 2012.
4. Centers for Disease Control and Prevention. Seasonal influenza-associated hospitalizations in the United States: Questions & Answers. June 24, 2011. Available  at: http://www.cdc.gov/flu/about/qa/hospital.htm. Accessed on July 3, 2012. 
5. Centers for Disease Control and Prevention. Vaccine Selection for the 2012-2013 Influenza Season. July 2, 2012. Available at: http://www.cdc.gov/flu/about/qa/vaccine-selection.htm. Accessed on July 3, 2012.
6. The Centers for Disease Control and Prevention. Breast Cancer Statistics. Available at: www.cdc.gov/cancer/breast/statistics. Accessed on July 3, 2012.
7. The Centers for Disease Control and Prevention. National Diabetes Fact Sheet, United States 2005. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. Accessed on July 3, 2012.
8. Lattanzi M, Rappuoli R. The grand challenge for the future. Vaccines for poverty-related diseases from bench to field. In: Kaufmann SHE, Lambert P, eds. Basel: Birkhauser; 2005:77.

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