Novartis Holly Springs facility becomes first US pandemic-ready site licensed by the FDA to produce cell-culture influenza vaccines

BASEL, Switzerland, June 16, 2014 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccines. This is the first US facility of its kind and is now approved for commercial production. The site will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic.

Novartis utilizes cell-culture technology to produce Flucelvax^® (Influenza Virus Vaccine), which was the first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs³. Flucelvax, approved for individuals 18 years of age and older, does not contain any antibiotics or preservatives². With the licensure of the Holly Springs facility, Flucelvax will be produced in the US for the first time.  

"Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years. We are proud to be at the forefront of this innovation, which will allow us to deliver on our public health and health security commitments," said Andrin Oswald, Division Head, Novartis Vaccines. "With this award-winning, state-of-the-art facility, we will be able to not only offer US consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats."

Cell-culture technology offers several potential benefits over traditional influenza vaccine production, which occurs in chicken eggs. The manufacturing process can be controlled more easily and is more flexible, enabling the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic¹. Novartis recently utilized the technology to rapidly develop a vaccine candidate for the H7N9 avian influenza virus, which was first reported in China in March 2013. This facility supplied a stockpile of H7N9 vaccine to the US Government prior to the second wave of the outbreak in January 2014.

The Holly Springs facility is a result of a joint partnership between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA). The two parties are committed to investing in innovation to better protect the public in the event of a pandemic or other health security threats. This facility was the overall winner of the ISPE Facility of the Year Award in 2013⁴.

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contracts HHSO100200600012C, HHSO100200700030C and HHSO100200900101C.

Important Safety Information: Flucelvax                      
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-Barre 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 FLUCELVAX⁵.

Disclaimer                             
The foregoing release contains forward-looking statements that can be identified by words such as "potential," "will," "commitments," "offer," "future," "can," "committed," or similar terms, or by express or implied discussions regarding potential future revenues from Flucelvax or other future products manufactured at the Holly Springs facility. 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 future products manufactured at the Holly Springs facility will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that Flucelvax or any other future products manufactured at the Holly Springs facility will be commercially successful in the future. In particular, management's expectations regarding such products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing issues; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; 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, 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                    
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, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 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. Accessed June 2014.
2. Flucelvax Package Insert. 2013. Available at: http://flucelvax.com/app_presentation/CorporateSite/images/pdf/US_in200x700_Flucelvax1314_RKXUF001.pdf. Accessed June 2014.
3. U.S. Food and Drug Administration. "FDA approves first seasonal influenza vaccine manufactured using cell culture technology." Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm328982.htm. Accessed June 2014.
4. ISPE. "2012 ISPE Facility of the Year Awards Program Names Novartis' United States Flu Cell Culture Facility as Overall Winner." November 4, 2013. Available at: http://www.ispe.org/news/2013/2013-foya-overall-winner. Accessed June 2014.
5. Flucelvax Consumer Important Safety Information. 2014.

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SOURCE Novartis