Novartis begins shipment of seasonal influenza vaccines to US market

CAMBRIDGE, Mass., Aug. 21, 2013 /PRNewswire/ -- Novartis announced today that it has begun shipment of its seasonal influenza vaccines to customers in the US market for the 2013-2014 season. Novartis plans to ship a minimum of 30 million doses of its influenza vaccines to the US market, including Fluvirin (Influenza Virus Vaccine), approved for use in people 4 years of age and older, and Flucelvax (Influenza Virus Vaccine), approved for use in adults 18 years of age and older. In clinical studies, both vaccines demonstrated safety and were shown to help protect against WHO-identified strains of the influenza virus.

The Centers for Disease Control and Prevention (CDC) recommends routine seasonal influenza vaccination for all individuals 6 months of age and older. In addition, the CDC advises that it is especially important for certain high-risk groups to receive an influenza vaccine each season, including: people over the age of 50; children under the age of 5; people with chronic illnesses; people with immunosuppression; and residents of nursing homes and other long-term care facilities^1,2.

"Last year's flu season, which peaked early and was intense, is a significant reminder of the importance of annual seasonal flu vaccination," said Dr. William Schaffner, professor of medicine and preventive medicine at Vanderbilt University, Nashville, Tennessee. "The CDC recommends annual influenza vaccination for all adults, and getting a flu vaccine is an important step in protecting one's health."

Novartis plans to complete the majority of shipments of Fluvirin and Flucelvax by October, in advance of the peak of influenza season. The Novartis portfolio of influenza vaccines helps to ensure diversity of supply to help meet demand and offers providers and consumers options for flu vaccination.

"Each year, Novartis is proud to help meet a significant public health need by providing its seasonal flu vaccines to enable healthcare providers and pharmacists to help protect individuals and families from the flu," said Brent MacGregor, President of US Vaccines and Head of Region North America. "We are pleased to offer a portfolio of flu vaccines that includes Flucelvax, which reflects how we are rethinking flu vaccination with a new approach to vaccine production and which offers a choice to consumers."

Flucelvax is manufactured using innovative cell-culture technology, a process that differs from the traditional influenza vaccine manufacturing process, which occurs in chicken eggs. Cell-culture technology offers several potential benefits, including flexibility in the manufacturing process, creating potential for rapid scalability in the event of a pandemic, and an alternative flu vaccine supply. Flucelvax does not contain any preservatives or antibiotics.

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 sometimes lead to complications and death³.

The number of people in the US who die every year from influenza and its complications could be comparable to the more than 40,000 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^4,5.

About Fluvirin & Flucelvax
For the 2013-2014 season, Fluvirin and Flucelvax contain antigens that target three influenza virus strains identified by World Health Organization (WHO) experts as likely to dominate circulation this winter.

For Fluvirin, these include⁶:

• A/Christchurch/16/2010, NIB-74 (H1N1) (an A/California/7/2009-like virus)
• A/Texas/50/2012, NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus)
• B/Massachusetts/2/2012

For Flucelvax, these include⁷:

• A/Brisbane/10/2010 (H1N1) (an A/California/7/2009-like virus)
• A/Texas/50/2012, NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus)
• B/Massachusetts/2/2012

Fluvirin
Fluvirin (Influenza Virus 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 vaccine⁶.

Fluvirin is contraindicated for individuals with a history of severe allergic reactions (e.g., anaphylaxis) to egg proteins, or any component of Fluvirin, or life-threatening reactions to previous influenza vaccinations⁶.

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 transient⁸.

Flucelvax
Flucelvax (Influenza Virus Vaccine) 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 older⁷.

Flucelvax is contraindicated for individuals with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine⁷.

The safety and efficacy profile of Flucelvax is comparable to other seasonal influenza vaccines.

Solicited adverse reactions are similar to those observed with administration of other seasonal influenza vaccines. Overall, in clinical studies, the most common (>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 (>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 malaise⁷. 

For more information about Flucelvax, please visit Flucelvax.com.

Important Safety Information: Fluvirin⁸
Serious allergic reactions, including anaphylactic shock, have been observed in people receiving Fluvirin Influenza Virus Vaccine. 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.

Important Safety Information: Flucelvax⁹
Warnings & Precautions

• Guillain-Barre Syndrome (GBS): 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.
• Latex: The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
• Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
• Altered Immunocompetence: After vaccination with FLUCELVAX, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
• Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX may not protect all vaccine recipients against influenza disease.

Most Common Adverse Reactions

• The most common (>10 %) solicited adverse reactions occurring in adults 18-64 years of age within 7 days of vaccination with FLUCELVAX were pain at the injection site, erythema at the injection site, headache, fatigue, myalgia  and malaise.  The most common (>10%) solicited adverse reactions occurring in adults >65 years of age within 7 days of vaccination were erythema at the injection site, fatigue, headache and malaise.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "begins," "plans," "offers," "has begun," "potential," "could," or similar expressions, or by express or implied discussions regarding potential future revenues from Fluvirin and 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 Fluvirin and Flucelvax to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Fluvirin or Flucelvax will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Fluvirin and Flucelvax could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; 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; 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 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 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. Key Facts About Influenza (Flu) & Flu Vaccine. February 13, 2013. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed on June 26, 2013.
2. Centers for Disease Control and Prevention. Summary* Recommendations: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—(ACIP)—United States, 2013-14. August 20, 2013. Available at: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm. Accessed on August 20, 2013.
3. Centers for Disease Control and Prevention. Key Facts about Influenza (Flu) & Flu Vaccine. February 13, 2013. Available at: http://www.cdc.gov/flu/keyfacts.htm.  Accessed on June 26, 2013. 
4. Centers for Disease Control and Prevention. Breast Cancer Statistics. December 20, 2012. Available at: www.cdc.gov/cancer/breast/statistics.  Accessed on June 26, 2013. 
5. 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 June 26, 2013.
6. Fluvirin Package Insert. 2013.
7. Flucelvax Package Insert. 2013.
8. Fluvirin Important Safety Information. 2013.
9. Flucelvax Professional Important Safety Information. 2013.

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