On July 31, 2015 the CSL Group and its Affiliates acquired the influenza vaccines business of Novartis AG in the US. The influenza vaccines business, previously owned by Novartis, has been integrated into CSL’s influenza vaccine business and now operates as Seqirus

Seqirus announces shipment of FLUAD™ (Influenza Vaccine, Adjuvanted) in the US for 2016-2017 flu season

• FLUAD is the first and only adjuvanted seasonal influenza vaccine approved in the United States, specifically developed to help protect adults aged 65 and older from the flu¹
• In addition to data from 15 clinical trials establishing the safety of FLUAD, a pivotal study of more than 7,000 adults aged 65 and older demonstrated the strong immune response of FLUAD²
• According to the US Centers for Disease Control and Prevention (CDC), annual vaccination is especially important for those at high risk of developing serious complications, including people 65 years and older³

PR Newswire, Holly Springs, NC, August 16, 2016
Seqirus has begun shipping FLUAD™ (Influenza Vaccine, Adjuvanted) for the 2016-2017 flu season since gaining approval from the Food and Drug Administration (FDA) late November last year. FLUAD is the first and only adjuvanted seasonal influenza vaccine approved in the United States, and was specifically developed to help protect adults aged 65 and older from the flu.¹

“As the first vaccine of its kind approved in the US for the adult population aged 65 and older, FLUAD represents an important new option for those at the highest risk for serious complications from the flu,” said Brent MacGregor, Senior Vice President, Commercial Operations. “At Seqirus, we are proud to further fulfill our mission of securing health for everyone, including those who need the greatest protection, by delivering the first shipment of FLUAD to our valued customers in the US this year.”

The CDC recognizes that annual flu vaccination is the best way to prevent influenza, and is especially important for people 65 years and older because human immune defenses weaken with age. Adults 65 years and older account for more than half of all influenza related hospitalizations and up to 90 percent of all seasonal flu deaths in the US.³

The FDA approval of FLUAD was based on the results of a pivotal Phase III study of more than 7,000 adults aged 65 and older.² In addition to demonstrating safety, tolerability and a strong immune response in patients, FLUAD was shown to be non-inferior in relation to the comparator vaccine for all three vaccine strains based on pre-defined thresholds for seroconversion rate differences and geometric mean titer (GMT) ratios.²

“Adults aged 65 years and older are at the greatest risk of serious complications from influenza because the immune system weakens with age,” said William Schaffner, M.D., Professor of Medicine and Preventive Medicine at Vanderbilt University, Nashville, Tennessee. “The flu can also trigger a worsening of chronic health problems, such as heart, kidney or liver disorders. The availability of an adjuvanted trivalent influenza vaccine provides a new vaccine option to help protect older adults against the flu.”

FLUAD was first licensed for use in Italy in 1997. Now approved in more than 30 countries, including the US, 81 million doses of FLUAD have been distributed worldwide.⁴ This 2016-2017 flu season is the first year that FLUAD will be available in the US.

For more information, please visit www.FLUAD.com

About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. Because transmission to others may occur one day before symptoms develop and up to five to seven days after becoming sick, the disease can be easily transmitted to others. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death. On average, more than 200,000 people are hospitalized due to influenza-related complications in the US each year.

About FLUAD
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.²

Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available.²

CONTRAINDICATIONS

Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.²

WARNINGS AND PRECAUTIONS

• If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.²
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.²

ADVERSE REACTIONS

• The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).²
• The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).²

Please see accompanying US Full Prescribing Information for FLUAD.

About Seqirus
Seqirus is the new global company created in July 2015 from the combined strength and expertise of bioCSL Inc. and the influenza vaccines business formerly owned by Novartis AG. As the second largest influenza vaccine provider in the world, Seqirus is driven by the promise it shares with parent company, CSL Limited, to provide medicines that help to protect and save lives.

Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally, with extensive research and production expertise and manufacturing plants in the US, Europe and Australia and a commercial presence in 20 countries.

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 16,000 people with operations in more than 30 countries.

For more information visit www.seqirus.com and www.csl.com.

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References:

1. US Food and Drug Administration. “FDA Approves First Seasonal Influenza Vaccine Containing an Adjuvant.” Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474295.htm. Accessed June 2016.
2. FLUAD [package insert] Cambridge, MA: Seqirus Inc.; 2016.
3. US Centers for Disease Control and Prevention (CDC). “What You Should Know and Do this Flu Season If You Are 65 Years and Older.” Available at: http://www.cdc.gov/flu/about/disease/65over.htm. Accessed June 2016.
4. Seqirus Inc. “About Fluad.” Available at: http://flu.seqirus.com/fluad/about-fluad.html. Accessed June 2016.

Media Contact

Monica Galimberti
Corporate Affairs, Seqirus
[email protected]
[email protected]
Phone: +39 335 7440521 (mobile)