PharmaJet Enters into Strategic Collaboration with CSL Limited for Needle-free Delivery of Influenza Vaccines

GOLDEN, Colo. -- (BUSINESS WIRE) -- PharmaJet Inc. has entered into a collaboration with CSL Limited to enable Afluria® influenza vaccine to be delivered with the PharmaJet Stratis® needle-free jet injector, as soon as the 2013-2014 flu season. Adding PharmaJet jet injectors to the Afluria® label will expand the delivery options for flu vaccine administration, thereby helping to broaden immunization coverage.

The Centers for Disease Control and Prevention (CDC) recommends an annual flu vaccination for all US citizens over 6 months old. Flu shots have proven to reduce illness, absenteeism and flu-related medical expenses. For many people, the fear of needles is enough to deter receiving a seasonal flu shot, despite the risk of contracting and spreading the illness.

Vaccine magazine’s July 2012 issue reported that 24% of adults and 63% of children are fearful of needles and this has a direct relationship to immunization non-compliance.¹ It is estimated that 7% to 17% of the US population choose to forego vaccinations due to fear of needle injections.² Needle-free jet injectors have been used in the U.S. and other countries to deliver millions of vaccinations.³ PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick injuries, needle anxiety and the cost burden of “sharps” disposal management. The PharmaJet Stratis® device has received FDA 510(k) marketing clearance and provides easy and affordable injections, delivering vaccine in 1/5th of a second and with reduced pain sensation.

Afluria®, a CSL product, is a non-adjuvanted seasonal influenza vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials. CSL Biotherapies and PharmaJet are working to include jet injectors as a method of administration on the Afluria® label in time for the 2013-2014 flu season.

PharmaJet’s collaboration with CSL involves conducting a Phase IV clinical study to demonstrate the immunogenicity and safety of Afluria®, presented in multi-dose vials, when administered with PharmaJet Stratis® needle-free device. Pending favorable clinical results, CSL will submit a Supplement to Afluria®’s BLA to include the option of needle-free jet injection on the Afluria® labeling.

About PharmaJet Inc. and Needle-free Injection Technology:

PharmaJet’s innovative needle-free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating risks of needle-stick injuries and the cost burden of “sharps” waste management. Further benefits of PharmaJet injectors include the potential for dose-sparing of vaccines, reducing the overall cost of vaccine delivery. PharmaJet’s needle-free injectors have received FDA 510(k) marketing clearances for use to deliver various liquid medicines and vaccines. The PharmaJet system has been well received in the developed world, and is also advantageous in the developing world due to its usability, affordability and inherent safety features. For more information on PharmaJet’s needle-free injection technology, please visit http://www.pharmajet.com/.

PharmaJet® and Stratis® are trademarks of PharmaJet Inc.

About Afluria®

Afluria® is an inactivated split influenza virus vaccine indicated for active immunization of persons aged 5 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Afluria® is contraindicated in individuals with hypersensitivity to eggs, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous influenza vaccination. Immunocompromised persons may have a diminished immune response. If Guillain- Barré syndrome (GBS) has occurred within 6 weeks of prior influenza vaccination, the decision to give Afluria® should be based on careful consideration of the potential benefits and risks. Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of high fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years. Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving Afluria®. In adults, the most common local (injection-site) adverse reactions observed in clinical studies with Afluria® were tenderness, pain, redness (erythema), and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches (myalgia). In children, the most common local (injection-site) adverse reactions observed in a clinical study with Afluria® were pain, redness, and swelling. The most common systemic adverse reactions observed were irritability, rhinitis, fever, and cough, loss of appetite, vomiting /diarrhea, headache, muscle aches and sore throat. Afluria® should be given to a pregnant woman only if clearly needed. Safety and effectiveness of Afluria® in children below 5 years of age have not been established. Antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult subjects. Vaccination with Afluria® may not protect all individuals.

Afluria® is a trademark of CSL Limited.

Afluria® is distributed by Merck in the United States.

About CSL Limited and CSL Biotherapies

CSL Biotherapies has been manufacturing flu vaccine for over 45 years and its seasonal influenza vaccine is licensed in 28 countries. The United States headquarters of CSL Biotherapies are located in King of Prussia, PA. Its parent company, CSL Limited,in Melbourne, Australia (ASX:CSL) has invested USD $80 million to double the company’s influenza manufacturing capacity to 40 million trivalent influenza vaccine doses per season, making it one of the largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its United States headquarters with its sister company, is commercializing influenza vaccine products globally. The CSL Group employs more than 11,000 people and operates in 27 countries worldwide.

For more information on CSL Limited, visit us at www.csl.com.au.

For more information on CSL Biotherapies, visit us at www.cslbiotherapies-us.com.

References

1. Vaccine, Volume 30, Issue 32, 6 July 2012, pp 4807-4812, “Survey of the Prevalence of Immunization Non-compliance Due to Needle Fears in Children and Adults“.
2. The American Journal of Medicine, Vol. 121, No. 7B, July 2008, Johnson et al, “Barriers to Adult Immunization”, pp S28-S35.
3. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1