CSL CSL Limited

• Seqirus is now shipping its portfolio of over 50 million doses of influenza vaccines to the U.S. market in preparation for the upcoming 2017-2018 influenza season.
• Seqirus utilizes both egg and cell-based technologies to offer the broadest portfolio of influenza vaccines in the US, including both trivalent and quadrivalent formulations.
• The Seqirus portfolio includes FLUAD®, the only adjuvanted seasonal influenza vaccine specifically developed for people 65 years and older; and FLUCELVAX QUADRIVALENT®, the first cell-based seasonal influenza vaccine licensed in the U.S.
• According to the U.S. Centers for Diseases Control and Prevention (CDC), the best way to help prevent influenza is by getting vaccinated each year.1

Seqirus announced today it has begun shipping its portfolio of seasonal influenza vaccines to customers in the United States for the 2017-2018 influenza season. Seqirus, one of the largest influenza vaccine companies in the world, expects to distribute over 50 million doses to the U.S. market this year.

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Seqirus cell-based influenza vaccine manufacturing facility, Holly Springs, North Carolina (Photo: Seqirus).

In response to demand, Seqirus will be delivering both trivalent and quadrivalent influenza vaccines this season, manufactured using egg and cell-based technologies. The company will also provide FLUAD® (Influenza Vaccine, Adjuvanted), the only adjuvanted seasonal influenza vaccine specifically developed for people aged 65 and older; and FLUCELVAX QUADRIVALENT® (Influenza Vaccine), the first cell-based seasonal influenza vaccine licensed in the U.S.

The Seqirus 2017-2018 influenza vaccine portfolio also includes AFLURIA QUADRIVALENT® (Influenza Vaccine), an egg-based quadrivalent influenza vaccine, and AFLURIA® (Influenza Vaccine) and FLUVIRIN® (Influenza Virus Vaccine), egg-based trivalent influenza vaccines. Seqirus also distributes RAPIVAB® (Peramivir Injection), the first-and-only one-dose intravenous antiviral treatment for acute influenza.

The complete portfolio of influenza vaccines provides a range of options for children aged from four years right through to people aged 65 years and older, presented in pre-filled syringes as well as multi-dose vials. A needle-free injecting option is also available for AFLURIA and AFLURIA QUADRIVALENT.

Seqirus produces influenza vaccines across its global manufacturing network, which includes a state-of-the-art plant in Holly Springs, North Carolina. This facility utilizes the latest cell culture technology and was built in partnership with the U.S. Government to support pandemic preparedness and emergency response.2

“As the only global vaccine company solely dedicated to the prevention of influenza, Seqirus is committed to providing the broadest range of influenza vaccine options as early as possible to healthcare providers and their patients. We are pleased to build on our track record of early and reliable supply by being one of the first influenza vaccine manufacturers to ship product to the US market during this influenza season,” said Brent MacGregor, Senior Vice President, Commercial Operations at Seqirus.

“Millions of people – particularly those 65 and older, children, and anyone with an underlying medical condition, such as asthma, heart disease, or diabetes, are at increased risk from influenza and its associated complications. The CDC recommends annual influenza vaccination for anyone 6 months of age and older to help prevent transmission of this serious disease in our communities,” said Gregg Sylvester MD, Vice President of Medical Affairs at Seqirus.3

About the Seqirus Influenza Product Portfolio

FLUAD® (Influenza Vaccine, Adjuvanted)

• Fluad received approval from the US Food and Drug Administration (FDA) on November 24, 2015 and is the first and only adjuvanted seasonal influenza vaccine in the US for adults aged 65 and older.5
• Age-related decreases in immune function may cause traditional flu vaccines to be less effective in adults 65+. Adults 65 years and older may be less able to fight infection, develop sufficient protective immune responses or generate immunological memory for future protection.7
• Fluad contains an immune-enhancing adjuvant MF59® thought to boost the immune response.5
• In a large pivotal trial, Fluad elicited strong immune response in adults aged 65+ and has a demonstrated safety profile.7
• The vaccine has an extensive clinical heritage, with more than 87 million doses distributed worldwide since 1997 and licensure in 38 countries.

Please see the accompanying important safety information and the full prescribing information for FLUAD.

FLUCELVAX QUADRIVALENT® (Influenza Vaccine)

• Flucelvax Quadrivalent received approval from the FDA on 23 May, 2016, making it the first US-licensed cell-based quadrivalent influenza vaccine indicated for people aged four years and older.8
• The H3N2 component of the 2017-2018 formulation of Flucelvax Quadrivalent has been produced using a candidate virus that has been isolated in cells.
• It is available in multi-dose vials and prefilled syringes, offering healthcare providers greater flexibility to determine which vaccine presentation will best meet the needs of their immunization clinics.8
• Flucelvax Quadrivalent is manufactured at the state-of-the-art facility in Holly Springs, North Carolina, with cell culture technology, which allows for the potential to rapidly increase production of influenza vaccine in response to outbreaks or pandemic.
• Development of the technology and manufacturing facility that produces Flucelvax Quadrivalent was supported by strong public-private partnerships with the U.S. government.6

Please see the accompanying important safety information and the full prescribing information for FLUCELVAX QUADRIVALENT.

AFLURIA QUADRIVALENT® (Influenza Vaccine)

• Afluria Quadrivalent received approval from the FDA on August 29, 2016 and is indicated for persons 18 years of age or older.9
• The vaccine is available in single-dose, preservative-free pre-filled syringes and multi-dose vials to provide choice and convenience to patients and caregivers who administer it.
• It is the only quadrivalent flu vaccine with a needle-free injection delivery option (PharmaJet® Stratis® 0.5mL Needle-Free Jet Injector) for persons 18 through 64 years of age.9

Please see the accompanying important safety information and the full prescribing information for AFLURIA QUADRIVALENT.

AFLURIA® (Influenza Vaccine)

• Afluria is a trivalent influenza vaccine developed with egg-based technologies and is indicated for persons aged five or older.10
• Afluria is available in both prefilled syringes and multi-dose vials to provide choice and convenience to patients and caregivers who administer it.10
• It is the only trivalent flu vaccine with a needle-free delivery option (PharmaJet® Stratis® 0.5mL Needle-Free Jet Injector) for persons 18 through 64 years of age.10

Please see the accompanying important safety information and the full prescribing information AFLURIA.

FLUVIRIN® (Influenza Virus Vaccine)

• Fluvirin is a trivalent influenza vaccine developed with egg-based technologies and is indicated for persons four years and older.11

Please see the accompanying important safety information and the full prescribing information for FLUVIRIN.

RAPIVAB® (Peramivir Injection)

• Rapivab® is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.12

Please see the accompanying important safety information and the full prescribing information for RAPIVAB.

About Seasonal Influenza

Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, the CDC encourages annual vaccination for all individuals aged six months and older.1 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.1

Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death.1 The CDC estimates that 310,000 people in the United States were hospitalized due to influenza-related complications during the 2015-2016 influenza season.4 Since it takes about two weeks after vaccination for antibodies to develop in the body that protect against influenza virus infection, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.1

About Seqirus

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.

Seqirus was established on 31 July 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As the second largest influenza vaccine provider in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

Seqirus operates state-of-the-art production facilities in the US, the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.

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

About PharmaJet

Based in Golden, Colorado, PharmaJet’s mission is worldwide acceptance of PharmaJet® needle-free devices as a standard of care in the vaccine delivery market. PharmaJet’s devices are also integral in the development of multiple novel pharmaceuticals. The innovative Stratis® device has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. In August 2014, the PharmaJet Stratis® device was cleared for delivery of an influenza vaccine to deliver needle-free flu shots. The Tropis® device for intradermal injections received authorization to apply the CE Mark in May 2016. The PharmaJet Needle-free devices are safe, fast and easy-to-use. They eliminate needlestick injuries, needle reuse and cross contamination, and help reduce sharps waste disposal. For more information, visit www.pharmajet.com.

References

1. Centers for Disease Control and Prevention (CDC). “Key Facts About Seasonal Flu Vaccine.” Available at: http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed April 2017.

2. 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. HHSO100200900101C.

3. CDC. “People at High Risk of Developing Flu–Related Complications.” Seasonal Influenza (Flu) 2016. Available at: http://www.cdc.gov/flu/about/disease/high_risk.htm. Accessed on April 2017.

4. CDC. “Seasonal Influenza-Associated Hospitalizations in the United States.” Available at: https://www.cdc.gov/flu/about/qa/hospital.htm. Accessed April 2017.

5. U.S. 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.

6. US Department of Health & Human Services. A milestone in protection from influenza. US Department of Health and Human Services website. Available at: https://wayback.archive-it.org/3926/20150618190057/http://www.hhs.gov/news/press/2014pres/06/20140617a.html. Accessed April 2017.

7. FLUAD (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus; 2016.

8. FLUCELVAX QUADRIVALENT (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus, Inc. 2016.

9. AFLURIA QUADRIVALENT [prescribing information]. King of Prussia, PA: Seqirus, Inc. 2016.

10. AFLURIA (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus; 2016.

11. FLUVIRIN (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus; 2016.

12. RAPIVAB (Peramivir Injection) [prescribing information]. Durham, NC: BioCryst Pharmaceuticals, Inc. 2014.

FLUAD® (Influenza Vaccines, Adjuvanted) Indication

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.7 FLUAD is approved for use in persons 65 years of age and older.7

Important Safety Information

CONTRAINDICATIONS

• Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.7

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.7
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.7

ADVERSE REACTIONS

• The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).7
• The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).7

Please see full prescribing information for FLUAD here.

FLUCELVAX QUADRIVALENT® (Influenza Vaccine) Indication

FLUCELVAX QUADRIVALENT 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.8 FLUCELVAX QUADRIVALENT is approved for use in persons four years of age and older.8

Important Safety Information

CONTRAINDICATIONS

• History of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

WARNINGS AND PRECAUTIONS

• Guillain-Barré Syndrome: If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.8
• Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.8
• Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.8
• Altered Immunocompetence: After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response. 8
• Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.8

ADVERSE REACTIONS

• The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%) headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).8
• The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%), and injection site erythema (11.9%).8
• The most common (≥10%) local and systemic reactions in children 4 to <6 years of age after first dose of vaccine were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%) and change in eating habits (10%).8
• The most common (≥10%) local and systemic reactions in children 6 through 8 years of age after first dose of vaccine were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%) and myalgia (12%).8
• The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%) myalgia (16%), and injection site induration (15%).8

Please see full prescribing information for FLUCELVAX QUADRIVALENT here.

AFLURIA QUADRIVALENT® (Influenza Vaccine) Indication

AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 18 years of age and older.9

Important Safety Information

CONTRAINDICATIONS

• Known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.9

WARNINGS AND PRECAUTIONS

• Guillain-Barré Syndrome: If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.9
• The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.9
• Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.9
• Altered Immunocompetence: If AFLURIA QUADRIVALENT is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.9
• Limitations of Vaccine Effectiveness: Vaccination with AFLURIA QUADRIVALENT may not protect all individuals.9

ADVERSE REACTIONS

• In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%).9
• In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).9
• In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions when AFLURIA® (trivalent formulation) was administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%).9

Please see full prescribing information for AFLURIA QUADRIVALENT here.

AFLURIA® (Influenza Vaccine) Indication

AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.10 AFLURIA is approved for use in persons 5 years of age and older.

Important Safety Information

CONTRAINDICATIONS

• Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.10

WARNINGS AND PRECAUTIONS

• Administration of CSL’s 2010 Southern Hemisphere influenza vaccine has been associated with increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years.10
• If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.10
• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.10
• Immunocompromised persons may have a diminished immune response to AFLURIA.10

ADVERSE REACTIONS

• In children 5 through 17 years of age, the most common injection-site adverse reactions when administered by needle and syringe were pain (≥60%), redness (≥20%) and swelling (≥10%). The most common systemic adverse events were headache, myalgia (≥20%), irritability, malaise and fever (≥10%).10
• In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), and redness, itching (≥10%). The most common systemic adverse events were muscle aches (≥30%) and headache, malaise (≥20%).10
• In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events within this period were myalgia, malaise (≥30%), and headache (≥20%).10
• In adults 65 years of age and older, when administered by needle and syringe the most common injection-site adverse reactions were tenderness (≥30%) and pain (≥10%). No systemic adverse events occurred in ≥10% of subjects in this age group.10

Please see full prescribing information for AFLURIA here.

FLUVIRIN® (Influenza Virus Vaccine) Indication

FLUVIRIN® 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.9 FLUVIRIN® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.11

Important Safety Information

CONTRAINDICATIONS

• History of severe allergic reactions (e.g., anaphylaxis) to egg proteins, or any component of FLUVIRIN, or life-threatening reactions to previous influenza vaccinations.11

WARNINGS AND PRECAUTIONS

• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN should be based on careful consideration of the potential benefits and risks.11
• Immunocompromised persons may have a reduced immune response to FLUVIRIN.11
• The tip caps of the FLUVIRIN prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.11

ADVERSE REACTIONS

• The most frequently reported adverse reactions are mild hypersensitivity reactions (such as rash), local reactions at the injection site, and influenza-like symptoms.11

Please see full prescribing information for FLUVIRIN here.

RAPIVAB® (Peramivir Injection) Indication

RAPIVAB® (peramivir injection) is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.12

• Efficacy of Rapivab was based on clinical trials in which the predominant influenza virus type was influenza A; a limited number of subjects infected with influenza B virus were enrolled.12
• Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Rapivab.12
• Efficacy could not be established in patients with serious influenza requiring hospitalization.12

Important Safety Information

CONTRAINDICATIONS

• RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome.12

WARNINGS AND PRECAUTIONS

• Rare cases of serious skin reactions, including erythema multiforme, have been reported with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in postmarketing experience with RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to RAPIVAB.12
• Patients with influenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. There have been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatric patients. The contribution of Rapivab to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior.12
• Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Rapivab has not been shown to prevent such complications.12

ADVERSE REACTIONS

• The most common adverse reaction was diarrhea (8% Rapivab vs 7% placebo).12
• Lab abnormalities (incidence ≥ 2%) occurring more commonly with Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose greater than 160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%) and neutrophils less than 1.0 x 109/L (8% vs 6%).12

CONCURRENT USE WITH LIVE ATTENUATED INFLUENZA VACCINE

• Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV). The concurrent use of Rapivab with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.12

Please see full prescribing information for RAPIVAB here.

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For SeqirusDani Jurisz, 612-455-1726Dani.Jurisz@PadillaCo.com