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Novartis in Holly Springs

Novartis

Novartis is a world leader in offering medicines to help protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance their quality of life. Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. Novartis Vaccines in Holly Springs Novartis is proud of its leadership in flu vaccine technology. We will be the first to bring large scale cell culture-based flu vaccine manufacturing to the United States. At the Holly Springs facility, Novartis is pioneering this next-generation vaccine manufacturing technology, which may offer many advantages over traditional egg-based production, providing enhanced manufacturing control and a reduction in production lead time. These advantages could be pivotal in the event of another influenza pandemic. Facts about the Site ­ The Holly Springs site is the first flu cell culture and adjuvant manufacturing facility in the US ­ The site will use novel cell-based vaccine manufacturing technology, a vital alternative to traditional egg-based vaccine production ­ The site will have the capacity to produce up to 150 million adjuvanted doses within six months of declaration of an influenza pandemic ­ The site lies on 167 acres and consists of 430,000 gross square feet of space ­ The buildings range from 30 to >90 feet in height ­ Five buildings connected by a central corridor, including production, warehousing, maintenance and office buildings ­ The site has been designed to reduce operational environmental impact in line with Novartis corporate citizenship and sustainability guidelines that will make us a model facility for vaccine manufacturing ­ There are approximately 8,000 total process automation input/output points ­ The site underwent >160 validation/commissioning plans ­ Novartis is a partner with the North Carolina State University's BTEC program and BioNetwork's community college program to build a pipeline of talent for future positions

Flu Cell Culture

What is it? Flu cell culture-derived vaccines represent the first major innovation in inactivated influenza vaccine manufacturing technology in more than 50 years. This new technology uses mammalian cell cultures rather than chicken eggs for antigen production. It also promises to bring greater speed, reliability and flexibility to the manufacturing process, which will be especially important in the event of an influenza pandemic. Why is it so important? This next-generation technology offers a number of advantages over traditional, egg-based vaccine manufacturing. The most important potential advantages of flu cell culture include: ­ It is faster. Lead times of traditional egg-based flu vaccine production are significantly reduced. ­ It simplifies manufacturing logistics due to elimination of the need for eggs. ­ It enhances "grow-ability" of virulent strains that may be toxic to eggs without genetic engineering, which is likely to be particularly important when lead time is critical (e.g., pandemic). ­ It enhances manufacturing consistency and reliability. In November 2009, Novartis opened its first flu cell culture and adjuvant manufacturing facility, the first of its kind in the United States, in Holly Springs, North Carolina. Novartis has made a significant investment in partnership with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA), and the Office of the Assistant Secretary for Preparedness and Response, to support and reinforce vaccine innovation and commitment to ensure pandemic vaccine supply.

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At the Holly Springs facility, Novartis is pioneering this next-generation vaccine manufacturing technology.

In May 2006, Novartis received a contract from the HHS to develop an influenza cell culture vaccine and to develop and design a manufacturing facility for such a vaccine in the US. Separately, in October 2005 and November 2006 Novartis was awarded contracts for a pre-pandemic vaccine by the HHS to contribute to the US National Strategic Stockpile, which was built in accordance with the US Pandemic Preparedness Plan, and as well as to support production of pre-pandemic vaccines for three years. In 2009 Novartis was awarded funding to support the development of H1N1 antigens and adjuvants.1 Additionally, the project has been funded, in whole or in part, to support the development efforts to evaluate the safety and effectiveness of the MF59 adjuvant in a cell culture-based pandemic influenza vaccine. MF59 adjuvant technology could extend vaccine supplies by allowing smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive. The campus lies on 167 acres within the Holly Springs Business Park and consists of 430,000 gross square feet of space with production, warehousing and maintenance capabilities as well as office buildings. The facility will provide more than 350 new job opportunities in Holly Springs, including entry level staff, technicians, supervisors and management.

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 Contract No's. HHSO100200600012C, HHSO100200700030C, HHSO100200900101C.

Novartis will manufacture flu cell culture-derived seasonal influenza vaccines, and in the event of a pandemic, the plant can also be used to manufacture a pandemic influenza vaccine. When fully operational, seasonal capacity would be at least 50 million doses of trivalent influenza vaccine. In a pandemic, the facility could produce up to 150 million adjuvanted doses within six months of a pandemic declaration.

Products Globally Novartis Vaccines has important influenza-, pediatric-, meningococcal- and travel-vaccine franchises. The company's portfolio of products includes vaccines for: ­ ­ ­ ­ ­ ­ Influenza* Meningitis Rabies* Tick-borne encephalitis Japanese Encephalitis* Haemophilus influenzae B (Hib) ­ Polio ­ Mumps, Measles and Rubella ­ Diphtheria ­ Tetanus ­ Pertussis (Whooping Cough)

Globally Novartis Vaccines and Diagnostics provides more than 20 products to fight vaccine-preventable viral and bacterial diseases. The Novartis Vaccines product and research pipeline includes: ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ Aflunov® Agriflu®** Agrippal® Begrivac® Celtura® Dif-Tet-AllTM Encepur® Fluad® Fluvirin®* Fluvirin® based A(H1N1)* Focetria® HAVpur® IPV-Virelon® ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ Ixiario®* MenB® Menjugate® MenveoTM** MenZBTM Optaflu® Polioral® Quinvaxem® Rabavert®* Rabipur® Td-pur® and Td-Virelon® Tetanol®/Tetanol pur® Vaxem Hib®

About Novartis Vaccines & Diagnostics

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 worldwide also include meningococcal, pediatric and travel vaccines. Novartis Diagnostics helps prevent the spread of infections through the development and marketing of innovative technologies that enable early detection of pathogens to protect the world's blood supply and prevent the spread of infectious diseases.

To learn more about how Novartis is furthering its global leadership in vaccine development and manufacturing, please visit novartisvaccines.com

* Licensed in the US ** Pending US regulatory approval

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Novartis in Holly Springs

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