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

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

             CSL will seek FDA approval for 2013-2014 flu season

Business Wire

GOLDEN, Colo. -- November 29, 2012

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

Contact:

PharmaJet, Inc.
James Bowman, +1-303-526-4278
President, Chief Operations Officer
jim.bowman@pharmajet.com
or
Heather Callender-Potters, +1-303-526-4278
Chairman of the Board
potters@pharmajet.com
 
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