Novartis begins shipment of seasonal influenza vaccines to US market for the 2014-2015 season

CAMBRIDGE, Mass., July 2, 2014 /PRNewswire/ -- Novartis announced today that it has begun shipment of its seasonal influenza vaccines to customers in the US market for the 2014-2015 season. Novartis plans to ship a minimum of 30 million doses of vaccines (Flucelvax^® [Influenza Virus Vaccine] and Fluvirin^® [Influenza Virus Vaccine]) to the US market in advance of the peak of influenza season. Vaccines can be obtained at pharmacy retailers, wholesalers and distributors across the US. Novartis is the only influenza vaccine manufacturer to use production technologies based on cell-culture (Flucelvax) as well as eggs (Fluvirin).

"At Novartis, we are pleased to contribute with solutions to help address this significant health need by providing vaccines that help protect against seasonal influenza," said Brent MacGregor, President of US Vaccines and Head of Region North America. "Our vaccines are scheduled to be available in time to begin use prior to the start of the influenza season."

Flucelvax, which is approved for use in adults 18 years of age and older, is manufactured with cell-culture technology, a modern, alternative production method for influenza vaccines to the traditional egg-based production method^2,3. This manufacturing technology was the first major breakthrough in influenza vaccine production in 40 years, with the potential for rapid response to urgent public health needs, such as a pandemic, within weeks⁴. Pandemic vaccine production can be started on demand and can be escalated to large volumes to help address influenza virus outbreak challenges⁵. Flucelvax does not contain preservatives or antibiotics².

"Seasonal influenza is a major public health concern that can lead to hospitalization and even death," said Dr. William Schaffner, professor of medicine and preventive medicine at Vanderbilt University, Nashville, Tenn. "The CDC recommends annual seasonal influenza vaccination as the best way to help protect against this potentially serious disease."

The CDC recommends routine seasonal influenza vaccination for all individuals 6 months of age and older⁶. Flucelvax is indicated for persons 18 years and older. Fluvirin is indicated for persons 4 years and older. According to the CDC, high-risk groups should especially ensure that they are vaccinated, including people younger than 5 years (and especially those younger than 2 years of age); people 65 years and older; pregnant women; and people who live with or care for others who are at high risk of developing serious complications⁶.

About Seasonal Influenza
Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract and sometimes the lungs⁶. It can cause mild to severe illness and can sometimes lead to complications and death⁶.

The CDC estimates that from the 1976-1977 season to the 2006-2007 flu season, flu-associated deaths in the US ranged from a low of about 3,000 to a high of about 49,000 people⁷. The CDC recommends that people get vaccinated against flu as long as flu viruses are circulating⁸. Influenza seasons are unpredictable; they can begin as early as October and substantial activity can occur as late as May⁹.

About Fluvirin & Flucelvax
For the 2014-2015 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 include:

• 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 include:

• 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 vaccine. Fluvirin is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.

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 vaccinations.

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.

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 older.

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

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 (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.

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

Important Safety Information: Fluvirin
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-Barré 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.

Please see accompanying US Full Prescribing Information for Fluvirin.

FLUCELVAX Important Safety Information
What is FLUCELVAX Influenza Virus Vaccine?

FLUCELVAX is a vaccine that helps protect against influenza (flu). FLUCELVAX is for people aged 18 and older. Vaccination with FLUCELVAX may not protect all people who receive the vaccine.

Who should not get FLUCELVAX?
You should not get FLUCELVAX if you have had a severe allergic reaction to any of the ingredients in the vaccine.

Who may not be able to get FLUCELVAX?
Tell your healthcare provider if you:

• have ever had Guillain-Barré Syndrome (severe muscle weakness) after getting a flu shot
• have an allergy to rubber latex

What if I have a weakened immune system?
Tell your healthcare provider if you have problems with your immune system, as your immune response to the vaccine may be less.

What are the most common side effects of FLUCELVAX?

• pain or redness where you got the shot
• headache
• tiredness
• muscle aches
• feeling unwell (malaise)

These are not all of the possible side effects of FLUCELVAX. You can ask your healthcare provider for a complete list of possible side effects. Ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Events Reporting System (VAERS) by calling 1-800-822-7967 or by going to http://vaers.hhs.gov.

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Vaccines at 1-877-683-4732 or VAERS at 1 800 822 7967 and http://vaers.hhs.gov.

Please see accompanying US Full Prescribing Information for FLUCELVAX.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "begins," "plans," "scheduled," "potential," "potentially," "can," or similar terms, or by express or implied discussions regarding potential future revenues from Flucelvax or Fluvirin. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Flucelvax or Fluvirin will be commercially successful in the future. In particular, management's expectations regarding Flucelvax and Fluvirin could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing issues; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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 Vaccines
Novartis Vaccines is a division of Novartis, focused on the development of preventive treatments. 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. Located in Cambridge, Massachusetts, Novartis Vaccines is an affiliate of Novartis AG, which 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. For more information, please visit http://www.novartis.com.

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References

1. Center for Disease Control and Prevention (CDC). "Seasonal Influenza: Flu Basics." Seasonal Influenza (Flu) 2014. Available at: http://www.cdc.gov/flu/about/disease/index.htm. Accessed on May 19, 2014.
2. Flucelvax package insert.
3. 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. Accessed October 2012.
4. 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. Accessed on May 19, 2014.
5. Patriarca, Peter A. "Use of flu cell lines for the production of influenza virus vaccines: An appraisal of technical, manufacturing and regulatory considerations." Initiative for Vaccine Research, World Health Organization. April 10, 2007. Accessed May 2014.           
6. CDC. "Key Facts about Influenza (Flu) & Flu Vaccine." Seasonal Influenza (Flu) 2014. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed on May 19, 2014.
7. CDC. "Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu." Seasonal Influenza (Flu) 2014. Available at: http://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm. Accessed on May 19, 2014.
8. CDC. "Seasonal Influenza (Flu) 2014." Available at: http://www.cdc.gov/flu/index.htm. Accessed on May 19, 2014.
9. CDC. "What You Should Know for the 2013-2014 Influenza Season." Seasonal Influenza (Flu) 2014. Available at: http://www.cdc.gov/flu/about/season/flu-season-2013-2014.htm. Accessed on May 19, 2014.

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