FDA Approves First Needle-Free Flu Vaccine Delivery System From PharmaJet

FDA Approves Use of AFLURIA® Influenza Vaccine with PharmaJet’s Needle-Free Injector

KING OF PRUSSIA, Penn. / GOLDEN, Colo. – [August 19, 2014] – PharmaJet® Inc., the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL Inc., the maker of AFLURIA® (Influenza Vaccine) today announced the U.S. Food and Drug Administration (FDA) has approved the PharmaJet Stratis® 0.5mL Needle-Free Jet Injector for delivery of AFLURIA in individuals aged 18 to 64 years. This is the first needle-free delivery system approved by the FDA for the administration of an inactivated influenza vaccine.

“Healthcare providers now have the option of delivering AFLURIA without a needle,” said Ron Lowy, PharmaJet CEO and co-chairman. “The PharmaJet injection technology is an especially important innovation for the millions of individuals who suffer from fear of needles and who consequently forego their annual flu vaccination. We believe this is a significant step forward in the effort to improve public health through broader immunization coverage, as well as improved safety of caregivers.”

Needlestick injuries pose a serious risk to healthcare workers who administer vaccinations and manage sharps disposal. Among retail pharmacists alone, a National Institute for Occupational Safety and Health study reveals that the incidence of needlestick injury is up to 3.62 per 100,000 vaccinations administered. PharmaJet’s needle-free injection technology eliminates needlestick injuries, needle re-use and potential cross contamination, as well as reduces sharps waste management and disposal costs.

The PharmaJet injector delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second. “The importance of being vaccinated yearly against seasonal influenza cannot be overstated,” said Dr. Marie Mazur, president of bioCSL Inc. “We are talking about a common respiratory infection that can affect anyone and that can lead to serious complications. Encouraging influenza vaccination acceptance requires a multi-pronged approach, including educating the public about the importance of influenza vaccination, ready access to vaccine and options for vaccine administration. PharmaJet’s needle-free technology, when used to administer AFLURIA, could play a significant role in increasing adult vaccination rates by helping to personalize vaccine delivery. We are pleased to be partnering with PharmaJet on this exciting new delivery option.”

About the PharmaJet Stratis®

The PharmaJet Stratis 0.5mL Needle-Free Injection System consists of a reusable Injector that delivers a single-dose with a disposable cartridge. Each injection consists of a narrow, precise fluid stream, which penetrates the skin in about one-tenth of a second. No external power source is required. The device contains an Adapter that can be used with vaccine vials. FDA approval of the PharmaJet Stratis Needle-Free Injector is based on data from a randomized controlled clinical trial that demonstrated non-inferiority of the immune response to the three strains of influenza contained in AFLURIA when the vaccine was administered with the Stratis Injector compared with traditional needle and syringe.

About PharmaJet, Inc.

Based in Golden, Colorado, PharmaJet was founded with the goal of reducing the use of medical needles throughout the world. PharmaJet’s innovative Needle-Free Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously by means of a narrow, precise fluid stream. The PharmaJet Needle-Free Injector is easy-to-use and eliminates needlestick injuries, needle re-use and cross contamination, and reduces sharps waste disposal. For more information, please visit www.PharmaJet.com. PharmaJet® and Stratis® are trademarks of PharmaJet Inc.

About AFLURIA®

Influenza Vaccine, AFLURIA® is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Administration of AFLURIA with a needle and syringe is approved for use in persons 5 years of age and older. Administration of AFLURIA with the PharmaJet® Stratis® Needle-Free Injection System is approved for use in persons 18 through 64 years of age only.

Select Safety Information

AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age.

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.

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

AFLURIA should be given to a pregnant woman only if clearly needed.

AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.

Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects.

In children 5 through 17 years of age, most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, irritability, malaise, and fever.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness, pain, swelling, and redness, itching. The most common systemic adverse reactions observed were muscle aches, headache and malaise.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness, swelling, pain, redness, itching and bruising. The most common systemic adverse events within this period were myalgia, malaise, and headache.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness and pain.

Vaccination with AFLURIA may not protect all individuals.

Please see full prescribing information for AFLURIA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About bioCSL Inc.

bioCSL Inc. is the United States subsidiary of bioCSL and is headquartered in King of Prussia, Pennsylvania. bioCSL is part of the CSL Group (ASX:CSL), which employs more than 12,000 employees in 27 countries. It is headquartered in Melbourne, Australia.

bioCSL is a leading provider of essential vaccines, pharmaceuticals and diagnostic reagents. For over 50 years, bioCSL has manufactured seasonal and pandemic influenza vaccines. It operates one of the world’s largest influenza vaccine manufacturing facilities in Australia, and maintains fill and finish facilities in the United States and Germany for the timely, reliable supply of influenza vaccines to global markets. Today, bioCSL’s influenza vaccine is registered in 27 countries. bioCSL also specializes in the production of antivenoms and is the world’s only producer of Q Fever vaccine. Visit bioCSL Inc. at www.biocsl-us.com.

Contacts:
For PharmaJet
Jill Thompson (720-438-8289)
Amanda King (720-833-5918)

for bioCSL
Anthony Farina (610-290-7403)

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