Publication

Transcription

Publication

In the News
2014-15
TABLE OF CONTENTS
8
Protein Sciences press release
November 18, 2015
Flublok® Influenza Vaccine Approved in Mexico
10
November 12, 2015
Protein Sciences Awarded a Small
Business Innovation Research
Grant for the Development of a
Novel Adenovirus Vaccine
11
October 29, 2015
Protein Sciences President and CEO
Manon Cox Elected 2015 Fellow of the
International Society for Vaccines
12
October 15, 2015
Protein Sciences Launches New Website for
Flublok® Influenza Vaccine
14
September 22, 2015
Flublok® Influenza Vaccine is Now Nationwide
16
June 25, 2015
New Clinical Study of Flublok® Influenza Vaccine Shows
That Groundbreaking Flublok Is More Effective Than the
Traditional Flu Shot
18
June 3, 2015
FDA Grants 12 Year Exclusivity to Flublok® Influenza
Vaccine
19
May 13, 2015
Protein Sciences New York Facility Receives FDA Licensure
to Manufacture Flublok®
20
April 30, 2015
Protein Sciences and the CT Association for Healthcare at
Home Will Provide Flublok® to Connecticut
21
February 24, 2015
Pre-Booking for Flublok® Influenza Vaccine Now Available
from Cardinal Health and McKesson
22
January 29, 2015
Clinical Efficacy Study of Flublok® Quadrivalent
Compares Flublok to a Traditional Egg-based Flu Vaccine
24
January 13, 2015
Protein Sciences and Hunter’s Ambulance Launch “Healthy
Choices” Mobile Flu Vaccine
26
December 29, 2014
Frost & Sullivan New Product Innovation Award Conferred
on Protein Sciences Corporation for Flublok® Influenza
Vaccine
29
December 22, 2014
DeLauro, Esty Urge CDC to Purchase Flu Vaccine from
Protein Sciences
30
December 22, 2014
Protein Sciences, UMN Pharma and IHI Corporation Enter
into Agreement to Evaluate Sourcing Flublok® from Japan
32
December 15, 2014
Flublok® Technology Could Solve the Problem of Ineffective
Flu Vaccines
34
October 30, 2014
Flublok® Influenza Vaccine Now Approved for Adults Ages
18 and Older
36
October 23, 2014
Xiaomi Tong, Ph.D. Joins Protein Sciences as Senior Vice
President & Chief Technology Officer
37
WFSB News Story
October 3, 2014
Connecticut Company Helping to Develop Ebola Vaccine
38
September 29, 2014
Flublok® Influenza Vaccine Now Available for the
2014/2015 Influenza Season
39
September 29, 2014
Rep. Elizabeth Esty Announces $669,000 Federal Grant for
Protein Sciences in Meriden
40
September 16, 2014
Protein Sciences and Diamyd Medical Deepen Commitment
to Develop New Treatment for Diabetes
42
September 5, 2014
Nadine Francis West Joins PSC as Senior Vice President,
Chief Administrative Officer and Corporate Secretary
44
August 19, 2014
Flublok® Influenza Vaccine Will Be Available at More
than 230 Passport Health Locations Nationwide
46
August 12, 2014
Protein Sciences and Liomont Announce Licensing of
Proprietary Influenza Vaccines for the Mexico Market
48
July 17, 2014
Protein Sciences and Partners Launch
Health-At-Work to Bring Flublok and Other
Vaccines to the Workplace
50
July 8, 2014
Protein Sciences Receives Approval
from FDA for 2014/15 Formulation of
Flublok® Vaccine
51
June 17, 2014
U.S. Biomedical Advanced
Research and Development
Authority (BARDA) Extends
Contract with Protein
Sciences
52
June 10, 2014
Protein Sciences Adds Distributor for Flublok® Recombinant
Influenza Vaccine to Increase Access
53
May 30, 2014
Protein Sciences Partners File for Marketing Approval of
Flublok® Influenza Vaccine in Japan
54
May 21, 2014
Protein Sciences CEO Awarded Honorary Degree for
Achievements in Science and Business
55
April 17, 2014
U.S. Congresswoman Elizabeth Esty Pays Tribute to PSC
56
Nature International Weekly Journal of Science
March 27, 2014
Mutations Explain Poor Showing of 2012 Flu Vaccine
58
March 25, 2014
CT Technology Council Names Protein Sciences President
& CEO One of Eight Recipients of Women of Innovation®
Awards
60
News from State Senator Danté Bartolomeo
March 14, 2014
Bartolomeo and Malloy Visit Groundbreaking Bioscience
Company Fighting the Flu in Meriden
61
Astellas / UMN press release
January 15, 2014
Astellas and UMN Announce Summary Results in Phase III
Clinical Trials of Seasonal Flu Vaccine ASP7374
Flublok® Influenza Vaccine Approved in Mexico
For Immediate Release:
November 18, 2015
Contact:
Courtney Goodwin, Communications Associate
(203) 606-0800, ext. 301
Meriden, CT — Protein Sciences Corporation, manufacturer of Flublok®, is pleased to announce that
Laboratorios Liomont, S.A. de C.V. (Liomont), a leading Mexican pharmaceutical company and licensee
of Flublok for the Mexican market, has obtained approval from the Mexican regulatory agency COFEPRIS
for Flublok for the prevention of influenza in adults 18
and older.
This is a landmark moment as Flublok is the first recombinant influenza vaccine to be available in Mexico, offering pure and effective protection against the
flu. Other influenza vaccines are made using 70 year
old egg-based technology that is subject to mutations. The Mexican authorities also approved a 1 year
shelf life and the use of the Flublok trade name.
“We are very pleased with the rapid approval of Flublok in Mexico and the approval of the longer shelf
life,” said Manon Cox, President and CEO of Protein
Sciences. “Recombinant technology is the only technology that can produce an influenza vaccine with
the precision to exactly match circulating flu strains.
We saw the benefit of this last year with a field study
in 9,000 older adults that showed that Flublok protected people against the flu better than a traditional,
egg-based flu vaccine – Flublok recipients were over
50% less likely to become infected with the mismatched H3N2 influenza strain that was the predominant circulating strain last season. In addition, Mexico
will now also be a nation better prepared in the event
of a pandemic as Flublok is expected to be available
within 8-12 weeks post declaration of a pandemic.
The rapid approval was the result of a strong team
effort among many members of the Protein Sciences
team, the National Autonomous University of Mexico
and Liomont. Representatives from all three institutions will be present at a press conference today in
Mexico City celebrating the approval.
Alfredo Rimoch, General Manager of Liomont, said,
“For over 75 years we have been committed to the
innovation and development of therapies to help relieve human suffering.
Flublok’s new technology for influenza vaccination
is our gateway to the field of biotech drugs and marks
the start-up of our new Life Sciences division.”
Click here to read more about the licensing agreement between Protein Sciences and Liomont.
8
About Liomont
Liomont is a 100% Mexican pharmaceutical company established in 1938, ranked number 8 in the national pharmaceutical market in units and 16 in value
in 2014, with high quality prescription and OTC products. It has one of the most dynamic growth rates in
the market. Liomont has a capacity of more than 120
million units per year in a high tech facility considered
to be one of the most modern in Latin America. It has
approximately 1500 employees of which more than
half are medical sales reps with the aim of creating a
solid and collaborative team. In addition to marketing activities, Liomont has the social mission to be a
source of employment, training and development of
its people to ensure a better quality of life.
PROTEIN SCIENCES
The Company has received the Socially Responsible Company Award for 10 continuous years due to
its outstanding commitment to society. Other public
and private institutions have also recognized several
initiatives in business and ecology among others.
About Protein Sciences
Protein Sciences specializes in vaccine development
and protein production. Our mission is our
inspiration: to save lives and improve health through
the creation of innovative vaccines and biopharmaceuticals.
Flublok, the world’s first recombinant proteinbased vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013.
Flublok is the only flu vaccine made in a 100% eggfree system using modern cell culture technology,
making it unnecessary to use an infectious influenza
virus or antibiotics in manufacturing. Flublok is highly purified and does not contain any preservatives
(e.g., thimerosal, a mercury derivative), egg proteins,
gelatin or latex. In addition, Flublok contains three
times more antigen than traditional flu vaccines
(3x45mcg hemagglutinin protein versus 3x15mcg
hemagglutinin protein)*.
Flublok is a perfect copy of the virus coat and
is not subject to the egg-adapted mutations
associated with low vaccine effectiveness (see
Skowronski et al. (2014) PLOS ONE 9(3), e92153).
Healthcare professionals wishing to pre-order Flublok should contact one of the following distributors:
IN THE NEWS
FFF Enterprises: 800-843-7477 www.myfluvaccine.com
Cardinal Health: 866-677-4844 www.cardinal.com/us/
en/SPD/Ordering
McKesson: 877-MCK-4FLU mms.mckesson.com
Henry Schein: 1-800-772-4346 www.henryschein.com
Learn more at www.proteinsciences.com and
www.flublok.com.
Flublok Safety Information
Flublok is approved for people 18 and older to
prevent influenza disease. The most common side
effect from Flublok is pain at the site of injection.
Headache, fatigue or muscle ache may occur.
Tell the doctor if you have ever experienced
Guillain-Barré syndrome (severe muscle weakness) or
have had a severe allergic reaction to any component
of Flublok vaccine.
Vaccination with Flublok may not protect all
individuals. Clinical effectiveness in adults 50 and
older is based on the immune response elicited by
Flublok and not on demonstration of decreased
influenza disease. Please see the complete
Package Insert available at www.flublok.com or call
203-686-0800 for more information.
*Flublok demonstrated a higher antibody response
to the A strains during 2 clinical trials in adults ≥50
years old.
The B strain antibody response was comparable to
traditional trivalent vaccines.
www.flublok.com.
9
Protein Sciences Awarded a Small Business
Innovation Research Grant for the Development
of a Novel Adenovirus Vaccine
November 12, 2015
Contact:
(203) 606-0800, ext. 301
Meriden, CT — Protein Sciences Corporation,
makers of Flublok® Influenza Vaccine, announced
today that it has been awarded a Phase I Small
Business Innovation Research (SBIR) Grant by the U.S.
Department of Defense (DoD) for the development
of a next generation adenovirus vaccine.
Adenovirus infection is a major cause of acute
respiratory disease in U.S. military recruits. The
existing vaccine is effective but contains live wild
type adenovirus that is capable of being transmitted
to others.
Under this award, Protein Sciences will apply its
proprietary BEVS platform technology to develop a
protein-based vaccine designed to protect against
the two major types of adenovirus, Types 4 and 7,
without using live adenovirus.
“We are very pleased to be working with the DoD to
develop a modern adenovirus vaccine,” said Indresh
Srivastava, Vice President of Process and Analytical
Development at Protein Sciences and Principal Investigator of the grant.
“Adenovirus affects a large population every year,
and our BEVS platform is well suited to address the
challenges associated with the existing vaccine. This
program is yet another way that we are continuously
working to save lives and improve health.”
Adenoviruses are common causes of respiratory
illness. The incubation period is typically 4-5 days
after which people who become infected experience
high fever, cough, nasal congestion, headache and
chest pain typically lasting 3-10 days.
“This biologics regulatory exclusivity is only the
third of such exclusivities granted by the U.S. FDA
under the Affordable Care Act, and the only one for
an influenza vaccine.”
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PROTEIN SCIENCES
Protein Sciences President and CEO
Manon Cox Elected as 2015 Fellow
of the International Society for Vaccines
October 29, 2015
Contact:
(203) 606-0800, ext. 301
Meriden, CT — Protein Sciences Corporation, the
makers of Flublok® Influenza Vaccine, announced
today that Dr. Manon Cox, President and CEO, was
elected as a 2015 Fellow of the International Society
for Vaccines (ISV). The ISV is an esteemed organization dedicated to the development, advancement
and use of vaccines to prevent and control disease.
ISV Fellows represent a distinguished pool of scientists, doctors and professionals that have contributed
significantly to this field. Past ISV Fellows include Sabin Gold Medal and Fleming Award winner Dr. Stanley Plotkin, internationally renowned microbiologist
Dr. Peter Palese, and industry leaders like Drs. Emilio
A. Emini and Rino Rappuoli.
“I am deeply honored to be elected into this prestigious circle,” said Dr. Cox. “Flublok is being recognized
as a major advance and this appointment demonstrates that the vaccine industry recognizes that innovation in vaccines is much needed.”
Dr. Indresh Srivastava, Vice President of Process and
Analytical Development at Protein Sciences, has also
been nominated to serve on the Executive Board for
the ISV. Dr. Srivastava is a leading biochemist and vaccinologist and has been involved in the development
of vaccines against malaria, HIV, SARS, HepC, Men B,
West Nile and influenza in both academic and industrial settings for the last 25 years.
For more information about Protein Sciences, Flublok, and the ISV, please visit www.proteinsciences.
com, www.flublok.com and www.isv-online.org.
11
PROTEIN SCIENCES
Protein Sciences Launches New Website for
October 15, 2015
Contact:
(203) 606-0800, ext. 301
Meriden, CT — Protein Sciences Corporation
launched its new website for Flublok influenza
vaccine, your pure choice in flu vaccines. The website, which can be accessed at www.flublok.com, has
several new user-friendly features, including:
• The Flublok Finder, which allows you to input
a zip code to find the nearest locations offering
Flublok;
• A fun 3D animated video explains how Flublok
differs from traditional flu vaccines;
• Downloadable
resources
for
healthcare
professionals detailing the clinical benefits of
Flublok and clinical study results;
• Integrated social media
• Also, soon to come: photographs of Flublok
and video footage available for download.
Health clinics, and locally at many independent pharmacies. Flublok is fully covered by most insurance
plans – it has a unique reimbursement code because
of its advantages compared to traditional flu vaccines
and because it is an important preventative medicine.
For more information about Flublok, where to get
it, and to see the newly designed website, visit www.
flublok.com.
“We are very excited to announce the launch of our
new website,” said Manon Cox, President and CEO.
“The new site reflects an important message - that
people have a choice in flu vaccines. Flublok is the
PURE choice, both because of its purity (completely
free of egg protein, preservatives, antibiotics, gelatin,
latex, gluten, formaldehyde and influenza virus) and
its efficacy. We expect that our new interactive website will stimulate conversation and prompt people to
ask for Flublok.”
Flublok is approved for all adults 18 years and older and is available nationwide at Target pharmacies,
many pharmacies in large grocery stores, Passport
12
Protein Sciences specializes in vaccine development and protein production. Our mission is our inspiration: to save lives and improve health through
Flublok, the world’s first recombinant proteinbased vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013. Flublok is the only flu vaccine made in a 100% egg-free
system using modern cell culture technology, making
it unnecessary to use an infectious influenza virus or
antibiotics in manufacturing.
Flublok is highly purified and does not contain any
preservatives (e.g., thimerosal, a mercury derivative),
egg proteins, gelatin or latex. In addition, Flublok
contains three times more antigen than traditional
flu vaccines (3x45mcg hemagglutinin protein versus
3x15mcg hemagglutinin protein)*.
Flublok is a perfect copy of the virus coat and is not
subject to the egg-adapted mutations associated
PROTEIN SCIENCES
with low vaccine effectiveness (see Skowronski et al.
(2014) PLOS ONE 9(3), e92153).
Healthcare professionals wishing to order Flublok
should contact one of the following distributors:
• FFF Enterprises: 800-843-7477
www.myfluvaccine.com
• Cardinal Health: 866-677-4844
http://www.cardinal.com/us/en/SPD/Ordering
• McKesson: 877-MCK-4FLU
mms.mckesson.com
• Henry Schein: 1-800-772-4346
www.henryschein.com
fatigue or muscle ache may occur. Tell the doctor if
you have ever experienced Guillain-Barré syndrome
(severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine.
Vaccination with Flublok may not protect all individuals. Clinical effectiveness in adults 50 and older
is based on the immune response elicited by Flublok
and not on demonstration of decreased influenza
disease. Please see the complete Package Insert available at www.flublok.com or call 203-686-0800 for
more information.
years old. The B strain antibody response was compaFlublok is approved for people 18 and older to pre- rable to traditional trivalent vaccines.
Learn more at www.proteinsciences.com and www.
vent influenza disease. The most common side effect
from Flublok is pain at the site of injection. Headache, flublok.com.
IN THE NEWS
13
14
PROTEIN SCIENCES
Flublok® Influenza Vaccine is now Nationwide
The Pure Choice for Adults 18 and Older
September 22, 2015
Contact:
(203) 606-0800, ext. 301
Meriden, CT — Protein Sciences Corporation announced today that Flublok Influenza Vaccine, which
was shown in a recent clinical study to provide better
protection against the flu than a traditional flu vaccine, is now available nationwide.
Not only does Flublok work well, it is the only flu
vaccine that is free of all of the following undesirable
ingredients: formaldehyde, antibiotics, gluten, gelatin, egg protein, latex, thimerosal and other preservatives. This makes it the pure choice for flu protection
for adults 18 and older.
Getting Flublok has never been easier.
National retailers Target and Walmart are offering
Flublok. Flublok is also available in many regional supermarkets and independent pharmacies, including
Mariano’s and Roundy’s in the Chicago area, Brookshire’s in Texas, and Price Chopper in the Northeast.
Passport Health Clinics will once again offer Flublok at
its sites nationwide. Passport patients can even book
their vaccines online.
“We are pleased to partner with leading pharmacies
to greatly expand access to our vaccine,” said Manon
Cox, President and CEO of Protein Sciences Corporation. “Anyone over 18 years of age will be able to walk
into Target, Mariano’s, Roundy’s or Brookshire’s nationwide and receive Flublok. At other stores, people
are encouraged to call the pharmacy in advance to
make sure Flublok is in stock when they come in for
vaccination. Nearly all insurance providers cover Flublok so most people can get Flublok free of charge.”
Flublok has found special appeal among health
conscious individuals that prefer its purity and its
popularity is growing among people focused on better protection. In a recent clinical study of the quadrivalent version of Flublok in approximately 9,000
adults 50 years and older, Flublok recipients were
43% less likely to develop culture confirmed influenza than people who received a licensed quadrivalent
egg-based influenza vaccine.
IN THE NEWS
of Flublok vaccine.
years old. The B strain antibody response was comparable to traditional trivalent vaccines.
flublok.com.
15
New Clinical Study of Flublok® Influenza Vaccine
Shows That Groundbreaking Flublok Is More
Effective Than the Traditional Flu Shot
June 25, 2015
Contact:
(203) 606-0800, ext. 301
announced today topline data showing that Flublok®
Quadrivalent – the quadrivalent version of FDAapproved trivalent Flublok® influenza vaccine –
outperformed a traditional influenza vaccine last
season and was better at preventing the flu. The
company presented the results of a clinical trial
comparing Flublok Quadrivalent to a traditional eggbased quadrivalent inactivated vaccine.
The data demonstrate superior performance of Flublok based on a significantly lower number of people contracting the flu after vaccination with Flublok
Quadrivalent.
In this study of approximately 9,000 subjects aged
50 and older, half received Flublok Quadrivalent
influenza vaccine and half received quadrivalent
inactivated influenza vaccine produced in eggs. The
results show that 31% more people were protected
by Flublok than by the egg-derived vaccine.
“This study points out the advantages of using
modern technology to overcome problems with
traditional influenza vaccine manufacturing,” said
Manon Cox, President and CEO of Protein Sciences.
“Ten years ago, we had the first evidence in clinical trial PSC01 that more antigen was beneficial even
for healthy adults. Today, with support from the
Biomedical Advanced Research and Development
Authority (BARDA), we were able to show statistically
significant better performance than traditional eggproduced vaccines.”
Flublok is the only flu vaccine made without
the use of eggs and therefore is not subject to the
mutations that are sometimes introduced into the
vaccine during the process of egg adaptation that
can cause the traditional vaccines to be ineffective
(see Skowronski et al. (2014) PLOS ONE 9(3), e92153).
Flublok contains three times more active ingredients
than traditional vaccines (3 or 4x45mcg
hemagglutinin protein versus 3 or 4x15mcg
hemagglutinin protein for trivalent or quadrivalent vaccine, respectively) and produced significantly higher immune responses to the A strains of
influenza (especially H3N2) in the Flublok Quadrivalent study.*
Flublok is highly purified and does not contain
influenza
virus,
antibiotics,
formaldehyde,
preservatives, latex, gluten or gelatin unlike other flu
vaccines.
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,
Department of Health and Human Services, under
Contract No. HHSO100200900106C.
For more information about Flublok, please visit
www.flublok.com.
16
PROTEIN SCIENCES
gelatin or latex.
In addition, Flublok contains three times more
antigen than traditional flu vaccines (3x45mcg
hemagglutinin protein versus 3x15mcg hemagglutinin protein)*.
IN THE NEWS
en/SPD/Ordering
Guillain-Barré syndrome (severe muscle weakness)
or have had a severe allergic reaction to any component of Flublok vaccine.
*Flublok demonstrated a higher antibody response to the A strains during 2 clinical trials in
adults ≥50 years old.
The B strain antibody response was comparable
to traditional trivalent vaccines.
www.flublok.com.
17
FDA Grants 12 Year Exclusivity to
June 3, 2015
announced that in a rare move, the FDA is granting exclusivity to Flublok for a period of 12 years.
Flublok is the first vaccine awarded this very
important status, demonstrating Flublok as a unique
and game changing influenza vaccine.
The U.S. FDA determination of regulatory
exclusivity means that no product similar to Flublok
can be approved by the U.S. FDA before January 16,
2025.
“The FDA’s designation prevents a generic
product maker from capitalizing on the hard work
of our team,” said Manon Cox, President and CEO of
Protein Sciences Corporation.
“We are delighted that the FDA recognizes
Flublok as a singular innovation in the prevention of an
important and often deadly disease caused by the
influenza virus.”
“I am honored to be representing Protein Sciences
Corporation for nearly 20 years on matters of legal
exclusivity,” said Tom Kowalski, Esq., shareholder with
Vedder Price, P.C.
“This biologics regulatory exclusivity is only the
third of such exclusivities granted by the U.S. FDA
under the Affordable Care Act, and the only one for
an influenza vaccine.”
Contact:
Clifton MacPherson, VP Corporate Communications
(203) 599-6064, ext. 116
of Flublok vaccine.
years old.
effect from Flublok is pain at the site of injection. flublok.com.
18
PROTEIN SCIENCES
Protein Sciences New York Facility Receives FDA
Licensure to Manufacture Flublok®
Contact:
(203) 686-0800, ext. 301
announced that on May 12, 2015 the U.S. Food and
Drug Administration (FDA) licensed its Pearl River,
NY manufacturing facility for the commercial
manufacturing of Flublok® influenza vaccine. Flublok
is the world’s first licensed influenza vaccine made
using modern recombinant technology.
“The approval of our Pearl River facility accelerates the growth of Protein Sciences and Flublok,” said
Manon Cox, President and CEO.
“We will be able to manufacture Flublok at four
times the scale compared to our Connecticut facility.
This milestone enables us to substantially increase
the availability of Flublok this year and in the future.”
“Approval of the Pearl River facility has been our
passion since we acquired the facility from Pfizer at
the end of 2012,” said Mireli Fino, Vice President of
Manufacturing Operations. “It has been very rewarding to work with our dedicated Pearl River team that
was able to manufacture the first batch of Flublok
within 100 days and to now achieve FDA licensure.
We look forward to the new opportunities licensure
presents.”
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, Department of Health and Human
Services, under Contract No. HHSO100200900106C.
www.flublok.com.
ww
May 13, 2015
IN THE NEWS
en/SPD/Ordering
www.flublok.com.
19
Protein Sciences and the CT Association for Healthcare
at Home Will Provide Flublok® to Connecticut
April 30, 2015
Contact:
(203) 686-0800, ext. 301
Meriden, CT — Protein Sciences Corporation along
with The Connecticut Association for Healthcare at
Home (CTH@H) announced a new partnership today
that will bring Flublok® influenza vaccine to home
health and hospice agencies across the state. As a
new affinity partner of CTH@H, Protein Sciences will
make Flublok available to CTH@H member agencies
for the 2015/16 flu season.
“The Connecticut Association for Home Healthcare
is the united voice for home and community-based
care delivery in the state. This partnership brings new
opportunities to create awareness for Flublok from a
ground-up perspective,” said Manon Cox, President
and CEO of Protein Sciences Corporation.
“Entering into an affinity partnership with CTH@H
is an exciting opportunity to inform and engage the
community-based workforce about Flublok and its
unique features for their patients.”
“Ensuring that Connecticut’s 20,000 home health
and hospice agency employees have access to the
Flublok vaccine for both their patient population as
well as for themselves is a positive step toward the
goal of limiting exposure and spread of the flu,” said
Deborah Hoyt, President and CEO of the Connecticut
Association for Healthcare at Home.
“Home health workers are on the front line in terms
of reaching the most vulnerable patients – the frail,
homebound and disabled – making this new relationship with Protein Sciences a strategic step toward
improving population health in Connecticut.
For more information about The Connecticut
Association for Healthcare at Home, please visit:
www.cthealthcareathome.org.
For more information about Flublok, please visit:
www.flublok.com.
20
of Flublok vaccine.
Package Insert available at
www.flublok.com
or call 203-686-0800 for more information.
years old.
www.flublok.com.
PROTEIN SCIENCES
Pre-Booking for Flublok® Influenza Vaccine Now
Available from Cardinal Health and McKesson
February 24, 2015
Contact:
(203) 686-0800, ext. 301
announced today it has expanded distribution
options for its revolutionary Flublok influenza vaccine and that pre-booking for the 2015-16 influenza
season is underway.
Cardinal Health and McKesson have been added
as new Flublok distributors joining FFF Enterprises.
Together, this broad array of distributors makes
Flublok more widely available to healthcare
professionals across the United States.
“Accessibility to Flublok by healthcare professionals
and consumers has been limited in previous seasons,”
said Manon Cox, President and CEO of Protein
Sciences. “We are committed to making the vaccine
easier to access, and our first step is to create multiple
options for healthcare professionals to make Flublok
available to their patients.”
Healthcare professionals wishing to pre-order
Flublok should contact one of the following
distributors:
Cardinal Health: 866-677-4844 http://www.cardinal.
com/us/en/SPD/Ordering
Flublok is fully reimbursed by most insurance
companies, including Medicare. Healthcare professionals should use the Flublok-specific CPT code
90673 to ensure compensation occurs at an appropriate rate.
www.flublok.com.
is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see
Healthcare professionals can order Flublok by
contacting FFF Enterprises at 800-843-7477.
IN THE NEWS
www.flublok.com.
21
Clinical Efficacy Study of Flublok® Quadrivalent Compares
Flublok to a Traditional Egg-based Flu Vaccine
January 29, 2015
Contact:
(203) 686-0800, ext. 301
announced today that results from a double-blind
comparative efficacy study of Flublok Quadrivalent in
adults over 50 are anticipated in June.
The study is expected to demonstrate that Flublok’s
higher antigen content and its modern production
process that avoids the introduction of egg-based
mutations into the vaccine’s active ingredients will
result in better efficacy than the recently announced
flu vaccine efficacy of 14% in adults older than 50.
PSC12 is a large trial in adults 50 years of age and
older intended to demonstrate the protective efficacy of Flublok Quadrivalent in prevention of influenza
disease. The trial enrolled 9,000 participants at sites
across the U.S. The efficacy of Flublok Quadrivalent
is being compared to that of a licensed conventional
egg-based inactivated quadrivalent vaccine.
Flublok Quadrivalent is a quadrivalent version of
Flublok influenza vaccine that is designed to protect against two A subtypes and two B lineages of
influenza.
Trivalent Flublok that protects against two A subtypes and one B lineage of influenza is licensed by
the FDA for all adults 18 and older and is available
for general use. Flublok has gained popularity due to
its purity, egg- free nature and high antigen content
and is considered especially important in a flu season
such as this that is severe due to the predominance
and drift in the H3N2 virus. The recombinant technology used to make Flublok is able to perfectly match
circulating flu strains and, therefore, may prove more
effective than traditional vaccines. Clinical trials have
suggested that the higher antigen content of Flublok
provides significant protection against drifted influenza viruses.
A separate Phase 3 clinical trial of Flublok Quadrivalent is being conducted in adults 18-49 years of age.
PSC16 is intended to demonstrate that satisfactory
immune responses are elicited for all four influenza
proteins by Flublok Quadrivalent. The trial enrolled
1,350 adults across the U.S. and will compare Flublok
Quadrivalent to a licensed conventional egg-based
inactivated quadrivalent vaccine. Results are also expected in June.
“There has been a shift in influenza vaccines to
quadrivalent formulations,” commented Manon Cox,
President and CEO of Protein Sciences.
“Our recombinant platform technology that we use
to make Flublok and all other vaccines allows us to
rapidly and predictably manufacture antigens that
are perfectly matched to circulating influenza strains,
whether it be the addition FB14052 of a fourth antigen as in the case of Flublok Quadrivalent, or to
update the annual formulation of Trivalent Flublok.
PSC12 and PSC16 put us on track for receiving regulatory approval of Flublok Quadrivalent in the next year
or two.”
Trivalent Flublok is available now. Healthcare
professionals seeking the vaccine should contact FFF Enterprises at 800-843-7477 or online at
www.myfluvaccine.com. Consumers seeking Flublok
should visit www.flublok.com.
22
PROTEIN SCIENCES
is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see
IN THE NEWS
of Flublok vaccine.
influenza disease.
Please see the complete Package Insert available
at www.flublok.com or call 203-686-0800 for more
information.
years old.
www.flublok.com.
23
Protein Sciences and Hunter’s Ambulance Launch “Healthy
Choices” Mobile Flu Vaccine Clinic:
Flublok® Influenza Vaccine at Your Door
January 13, 2015
Contact:
Manon Cox, President & CEO
(203) 686-0800, ext. 308
Meriden, CT — Protein Sciences Corporation and
Hunter’s Ambulance announced today the launch
of their new wellness initiative “Healthy Choices”
Mobile Flu Vaccine Clinic that provides affordable,
easy access to Flublok® influenza vaccine to people in
Connecticut. Influenza is widespread across the
United States and the Centers for Disease Control and
Prevention has warned that this flu season may be
especially bad because of the H3N2 flu virus that is
circulating. The “Healthy Choices” clinic is designed to
make flu vaccination simple and convenient, thereby
promoting healthy communities.
The clinic is offering Flublok vaccine to all adults
18 years and older. Flublok is a highly pure flu vaccine- made without eggs, preservatives, antibiotics,
latex, gelatin or flu virus- and contains 3 times more
antigen than traditional flu vaccines. The vaccine is
made in Meriden, CT.
There are two easy ways people can access the
mobile clinic:
1. Call the reservation line 203-514-5191 to make
an appointment for a licensed registered nurse to
administer vaccine in the privacy of your own
home. Bilingual registration specialists are available.
Serving Meriden, Wallingford, Middletown, Cheshire,
New Britain and Berlin.
2. Attend one of the pre-scheduled mobile clinics
offered at key locations at designated times each
week. Visit http://goo.gl/ihnw04 for an up-to-date
list of locations and times. Serving locations throughout the state. “Healthy Choices” is partnered with the
Meriden Housing Authority (MHA) to provide
vaccination clinics for their residents at their
complexes. Other communities wishing to schedule a clinic should contact Susan Manganello at
860-916-0172 or [email protected].
Flublok is fully covered by insurance. Clinic
participants should have their insurance card and ID
available. As part of our initial launch, “Healthy Choices” will provide the vaccine for free to individuals with
no insurance.
Eddie Siebert, Community Relations, MHA, said,
“The MHA residents and entire Meriden Community are pleased to have this opportunity available to
us. We have a state of the art vaccine available with
Flublok that was conceived by Meriden’s own Protein
Sciences.” He added, “I will be getting the shot. It is a
gift to our community to have access to it.”
24
and protein production.
Our mission is our
making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing. Flublok is
PROTEIN SCIENCES
Zach Bowden, www.firenews.org
highly purified and does not contain any preservatives
(2014) PLOS ONE 9(3), e92153).
www.flublok.com.
Hunter’s Ambulance Service
Hunter’s Ambulance Service is a leading Mobile
Integrated Healthcare Provider. Hunter’s provides
Emergency and Non-Emergency - Basic, Paramedic
and Critical Care Ambulance and Transportation
throughout the state of Connecticut.
Established in 1963, Hunter’s employees pride
themselves on professional and compassionate care
utilizing state of the art vehicles, communications
and medical equipment. Hunter’s main base of
operations and administrative offices are located in
Meriden and our services are provided throughout
IN THE NEWS
the state from four additional strategically placed
satellite facilities.
Hunter’s is a proud community partner in the
“Healthy Choices” Mobile Flu Vaccine Clinic.
of Flublok vaccine.
influenza disease.
information.
years old.
25
Frost & Sullivan New Product Innovation
Award Conferred on Protein Sciences
Corporation for Flublok® Influenza Vaccine
Flublok is the world’s first FDA approved recombinant form, which eliminates the use of chicken eggs and influprotein vaccine for the prevention of seasonal influenza enza virus, Flublok enables a faster start-up of the vaccine
manufacturing process, as it does not depend on either egg
LONDON, Dec. 29, 2014 /PRNewswire/ -- Based on its supply or the availability of influenza virus,” noted Frost &
recent analysis of the influenza vaccines market, Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram.
Sullivan recognises Protein Sciences with the 2013 Global “This speed is critical in the face of a pandemic outbreak of
New Product Innovation Award. Flublok is the world’s first influenza when quick production of vaccine is essential to
recombinant protein vaccine for the prevention of seasonal deal with the pandemic effectively.”
influenza disease to gain U.S. FDA approval. Flublok is
approved for individuals 18 and older.
Additionally, the Centers for Disease Control and Prevention (CDC) recently warned that flu vaccines may be inefClick here for the full multimedia experience of this fective this season because a new strain of H3N2 influenza
release.
virus is circulating that is not included in this year’s vaccines. The technology used to make Flublok offers a soluFlublok is the first influenza vaccine in the world to be made tion.
in a 100 per cent egg-free medium without live influenza
viruses. As a result, it can be produced quickly and without “A drift in influenza virus strain can effectively be addressed
the risk of infections associated with the manufacture of tra- by a strong antibody response,” said Protein Sciences’
ditional influenza vaccines grown in chicken eggs.
President and CEO Dr. Manon Cox. “Flublok contains 3x
more antigen than traditional trivalent flu vaccines and in“Made from a novel insect cell line-based technology plat- duces a stronger antibody response against the influenza
26
PROTEIN SCIENCES
A viruses and a comparable response against influenza B
viruses. The H3N2 virus is an influenza A virus and therefore we expect similar results to those observed in our
2007/08 clinical study where Flublok was effective against
drifted H3N2 viruses.”
during pandemic attacks. Furthermore, the majority of the
high-risk population are those aged above 65 years, as well
as immune-compromised individuals.
“Traditional flu vaccines are shown to be only 16 to 63 per
cent effective against influenza,” remarked Chidambaram.
Unlike the other influenza vaccines that contain a part of “Flublok is formulated to contain three times the active inthe whole flu virus, Flublok comprises purified recombinant gredients in the regular shot, thereby making it a potentially
hemagglutinin antigens (HA), which correspond to the HAs superior immunogenic vaccine.”
expressed on the surface of influenza viruses, but are made
without growing live flu viruses. The vaccine is tailored an- In line with its recent product launch and commercializanually to provide protection against the latest strains of in- tion efforts, Protein Sciences has made Flublok available
fluenza by containing the corresponding recombinant HAs at over 230 Passport Health locations across the U.S. as
for those strains.
of August 2014, in order to improve product availability
and accessibility. Furthermore, Protein Sciences entered
It is estimated that nearly 30 per cent of people do not take into a strategic alliance with Laboratorios Liomont, S.A. de
influenza vaccines owing to the misperception that they C.V, a leading Mexican pharmaceutical company, during
contract the disease from the vaccine. Since Flublok con- the same time of the year. Under the terms of the alliance,
tains recombinant HA proteins, rather than HAs from the Protein Sciences has provided Liomont with an exclusive
inactivated or live-attenuated influenza virus, it eliminates license to sell Flublok® (seasonal) and Panblok® (panthe perceived risk of contracting the flu from the vaccine.
demic) influenza vaccines in Mexico and other potential
Latin American Markets, in return for milestone payments
Flublok is made using Protein Sciences’ proprietary Bacu- and royalties on sales.
lovirus Expression Vector System (BEVS) platform technology, wherein baculovirus vectors are re-engineered using With a strong commitment to expand its horizon and techthe genetic information that encodes HA protein and the nical know-how across therapeutic areas, Protein Sciences
expresSF+® cells that express the HA protein grown inside has further solidified its partnership with Diamyd Medical in
large stainless steel tanks.
September 2014, in order to develop a novel treatment for
diabetes. Protein Sciences plans to manufacture products
“The BEVS technology platform is characterised by several for upcoming late-stage clinical trials for type 1 diabetes
advantages that include low cost, rapid protein production, involving Diamyd Medical’s recombinant glutamic acid deproper folding of proteins, high cell densities, large volume carboxylase (GAD) protein based on Protein Sciences’ proscalability, and compliance with current good manufactur- prietary BEVS technology. Additionally, in the wake of the
ing practices (cGMP),” stated Chidambaram. “Additionally, Ebola outbreak in West Africa and beyond, Protein Sciencthe expresSF+ cells have a rapid doubling time of 18–24 es initiated development of an Ebola vaccine. A vaccine for
hours, easy scalability for cGMP manufacturing, and have Ebola is more readily made using recombinant technology,
been qualified for identity, stability and the lack of retrovi- as traditional vaccine manufacturing would require growth
rus-like particles.”
of Ebola virus, which would be very dangerous.
As a result, this time-tested proprietary technology platform
and cell line has been widely adopted by several leading
companies, such as Boehringer Ingelheim Vetmedica, Merck, Diamyd Medical and BioArctic Neurosciences among
others, for the development of a broad range of vaccines
and therapeutics.
This award is presented to the company that has excelled
in developing an innovative product that leverages leading edge technologies and offers significant value added
features/benefits. The product is also acknowledged for its
potential for increased customer ROI and customer acquisition/penetration.
Frost & Sullivan Best Practices awards recognise comInfluenza affects nearly 20 per cent of the global population panies in a variety of regional and global markets for
every year, a number that can rise as high as 50 per cent demonstrating outstanding achievement and superior
IN THE NEWS
27
performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and
measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.
Clinical effectiveness in adults 50 and older is based on
the immune response elicited by Flublok and not on demonstration of decreased influenza disease. Please see the
complete Package Insert available at www.flublok.com or
call 203-686-0800 for more information.
*Flublok demonstrated a higher antibody response to the A
strains during 2 clinical trials in adults ≥50 years old. The
B strain antibody response was comparable to traditional
Protein Sciences specializes in vaccine development and trivalent vaccines.
protein production. Our mission is our inspiration: to save
lives and improve health through the creation of innova- About Frost & Sullivan
tive vaccines and biopharmaceuticals. The Company’s
proprietary BEVS technology provides a fast, reliable and Frost & Sullivan, the Growth Partnership Company, works
inexpensive platform for the production of high quality re- in collaboration with clients to leverage visionary innovation
combinant proteins, making it a powerful tool for producing that addresses the global challenges and related growth
vaccines and therapeutics when they are needed most. opportunities that will make or break today’s market parLearn more at www.proteinsciences.com.
ticipants.
About Flublok
Our “Growth Partnership” supports clients by addressing
these opportunities and incorporating two key elements
Flublok, the world’s first recombinant protein-based vac- driving visionary innovation: The Integrated Value Proposicine for the prevention of seasonal influenza disease, was tion and The Partnership Infrastructure.
approved by FDA in January 2013. Flublok is the only flu
vaccine made in a 100% egg-free system using modern The Integrated Value Proposition provides support to our
cell culture technology, making it unnecessary to use an clients throughout all phases of their journey to visionary
infectious influenza virus or antibiotics in manufacturing. innovation including: research, analysis, strategy, vision,
Flublok is highly purified and does not contain any preser- innovation and implementation.
vatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok contains three The Partnership Infrastructure is entirely unique as it contimes more antigen than traditional flu vaccines (3x45mcg structs the foundation upon which visionary innovation behemagglutinin protein versus 3x15mcg hemagglutinin pro- comes possible. This includes our 360 degree research,
tein)*. Flublok is a perfect copy of the virus coat and is not comprehensive industry coverage, career best practices as
subject to the egg-adapted mutations associated with low well as our global footprint of more than 40 offices.
vaccine effectiveness (see Skowronski et al. (2014) PLOS
ONE 9(3), e92153).
For more than 50 years, we have been developing growth
strategies for the global 1000, emerging businesses, the
Safety Information
public sector and the investment community. Is your organisation prepared for the next profound wave of industry
Flublok is approved for people 18 and older to prevent influ- convergence, disruptive technologies, increasing competienza disease. The most common side effect from Flublok tive intensity, Mega Trends, breakthrough best practices,
is pain at the site of injection. Headache, fatigue or muscle changing customer dynamics and emerging economies?
ache may occur. Tell the doctor if you have ever experienced Guillain-Barre syndrome (severe muscle weakness) Contact:
or have had a severe allergic reaction to any component of Rachael Felberbaum, Director, Corporate Communications
Flublok vaccine.
Protein Sciences Corporation
T: +1 203-599-6064 ext.164
Vaccination with Flublok may not protect all individuals. E: [email protected]
28
PROTEIN SCIENCES
DeLauro, Esty Urge CDC to Purchase
Flu Vaccine from Protein Sciences
December 22, 2014
Contact:
Dan Adams, Executive Chairman
(203) 686-0800, ext. 162
New Haven, CT — Connecticut Representatives
Rosa DeLauro and Elizabeth Esty today urged the
Centers for Disease Control and Prevention (CDC)
to consider purchasing 250,000 of the Flublok vaccine from Meriden’s Protein Sciences Corporation.
and has also been working on an Ebola vaccine.
“In light of the CDC’s recent warning that flu vaccines might be ineffective this season given that the
newest strain, H3N2, was not included, we are asking
the CDC to consider purchasing the 250,000 doses
offered by Protein Sciences through their response
to Solicitation # 2014-N-16818,” the representatives
wrote. “Protein Sciences maintains that because Flublok ‘contains 3x more antigen than traditional trivalent flu vaccines and induces a stronger antibody response against the influenza A viruses’ it is expected
that Flublok would be more effective with the H3N2
virus as it is an influenza A virus.”
“We have worked with Protein Sciences Corporation
on a variety of issues and have always been impressed
with the dedication and resolve that the company and
its leadership have demonstrated in their innovative
approach to vaccine development,” the representatives continued. “Protein Sciences is at the forefront of
technological advancements in their field. Flublok is
the only the only flu vaccine made in America by an
American company and only flu vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) for people who have known or suspected
egg allergies, regardless of severity.”
DeLauro is the senior Democrat on the subcommittee responsible for funding the Department of
Health and Human Services, including the CDC. Esty
is the Representative for Connecticut’s 5th District,
which includes Meriden where Protein Sciences in
headquartered.
IN THE NEWS
and protein production. Our mission is our inspiration: to save lives and improve health through the creation of innovative vaccines and biopharmaceuticals.
Flublok, the world’s first recombinant protein-based
vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013. Flublok
is the only flu vaccine made in a 100% egg-free system
using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing. Flublok is highly purified and
does not contain any preservatives (e.g., thimerosal, a
mercury derivative), egg proteins, gelatin or latex. In
addition, Flublok contains three times more antigen
than traditional flu vaccines (3x45mcg hemagglutinin
protein versus 3x15mcg hemagglutinin protein)*.
subject to the egg-adapted mutations associated with
low vaccine effectiveness (see Skowronski et al. (2014)
PLOS ONE 9(3), e92153).
Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477. Learn more
at www.proteinsciences.com and www.flublok.com.
29
Protein Sciences, UMN Pharma and IHI Corporation Enter
into an Agreement to Evaluate Sourcing Flublok® from Japan
December 22, 2014
Contact:
(203) 686-0800, ext. 162
Connecticut and New York, USA and Japan —
Protein Sciences Corporation (Meriden, CT and Pearl
River, NY), UMN Pharma Inc. (Akita, Akita prefecture,
Japan) and IHI Corporation (Koto-ku, Tokyo, Japan) announced today that they have entered into an agreement to assess the feasibility of sourcing the active
ingredients of Flublok influenza vaccine from Japan.
The drug substances would be manufactured at
the Gifu (Japan) Plant of UNIGEN, a subsidiary of UMN
Pharma in which IHI holds 50% of the common shares.
UNIGEN manufactures Flublok for UMN Pharma at the
21,000L scale – ten times the scale the vaccine is manufactured in the United States. The Gifu plant has two
21,000L bioreactors and has the capacity to add six
additional bioreactors.
UMN holds a license from Protein Sciences for Flublok for the territories of Japan, China, Korea, Hong
Kong, Taiwan and Singapore. UMN is partnered with
Astellas to market Flublok in Japan.
Dan Adams, Executive Chairman and Global Head
of Business Development at Protein Sciences said,
“We have established a solid manufacturing base for
Flublok in the United States; however, we are constantly evaluating alternative sources of supply and
the Gifu plant is potentially a very attractive source.”
Flublok is the world’s first recombinant proteinbased vaccine for the prevention of seasonal influenza disease and is FDA approved for adults 18 and
older.
The vaccine is highly purified and does not contain
any preservatives, egg proteins, gelatin or latex. In
addition, Flublok contains three times more antigen
than traditional flu vaccines*. Flublok is available this
season in the U.S. and is fully reimbursed by Medicare
and other insurances.
30
Protein Sciences specializes in vaccine development and protein production. Our mission is our
virus or antibiotics in manufacturing. Flublok is highly
purified and does not contain any preservatives (e.g.,
thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok contains three times
more antigen than traditional flu vaccines (3x45mcg
hemagglutinin protein versus 3x15mcg hemagglutinin protein)*.
(2014) PLOS ONE 9(3), e92153).
Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477. Learn more
at www.proteinsciences.com and www.flublok.com.
PROTEIN SCIENCES
About IHI Corporation
IHI Corporation (Koto-ku, Tokyo) was established in
1853. It is a heavy industries manufacturer undertaking design and manufacture related to shipbuilding,
aerospace, turbines and various plants.
In January 2010, UMN and IHI concluded a ‘basic
agreement on cooperation’ for joint business, concerning the manufacture of new bio-pharmaceutical
ingredients using BEVS technology, including pharmaceutical ingredients such as UMN-0502 developed
by UMN Pharma.
With this cooperation agreement, UMN Pharma
and IHI established UNIGEN Inc., focusing on the production of pharmaceutical ingredients required for
recombinant influenza HA vaccine in May 2010.
Gifu Plant, a world-renowned bio-pharmaceutical
drug production facility, was established in May 2013
and is jointly operated by UMN Pharma and IHI.
About UMN Pharma
UMN Pharma is a bio-venture established in 2004
and is headquartered at Akita, Akita prefecture in
Japan.
The company received a license from Protein
Sciences for dealership and exclusive development
and manufacture of the recombinant influenza
HA vaccine in Japan in August 2006 and for other
regions in Asia (China, Korea, Taiwan, Hong Kong and
Singapore) in October 2010.
In Japan, the company concluded a cooperation
agreement for joint development and exclusive sales
IN THE NEWS
of the recombinant influenza HA vaccine with Astellas Pharma in September 2010.
The companies have submitted an application for
approval of manufacture and sale of the recombinant
seasonal influenza HA vaccine UMN-0502 (Astellas
Pharma development code: ASP7374) to the Ministry
of Health, Labor and Welfare, based on its results and
efficacy on May 30, 2014.
Flublok is approved for people 18 and older to prevent influenza disease. The most common side effect
from Flublok is pain at the site of injection. Headache,
fatigue or muscle ache may occur.
Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) or
of Flublok vaccine.
influenza disease.
information.
years old.
31
Flublok® Technology Could Solve the Problem
of Ineffective Flu Vaccines
December 15, 2014
Contact:
(203) 686-0800, ext. 308
Meriden, CT — The Centers for Disease Control and
Prevention (CDC) recently warned that flu vaccines
may be ineffective this season because a new strain
of H3N2 influenza virus is circulating that is not included in this year’s vaccines. The technology used
to make Protein Sciences’ Flublok influenza vaccine
could be the solution.
“A drift in influenza virus strain can effectively
be addressed by a strong antibody response,” said
Protein Sciences’ President and CEO Dr. Manon Cox.
“Flublok contains 3x more antigen than traditional
trivalent flu vaccines and induces a stronger antibody response against the influenza A viruses and
a comparable response against influenza B viruses.
The H3N2 virus is an influenza A virus and therefore
we expect similar results to those observed in our
2007/08 clinical study where Flublok was effective
against drifted H3N2 viruses.”
The manufacturing process for Flublok is
significantly faster than egg-based methods and
provides an exact match to circulating flu strains
unlike traditional manufacturing that changes a
virus as it is passaged in eggs.
Dr. Cox added, “If the government deemed it
necessary, we could begin manufacturing an H3N2
vaccine that matches the new circulating flu virus
immediately and have it ready for release within a
few months.”
Flublok is still available this season for those seek-
ing the vaccine. Influenza typically peaks in February
and the CDC advises that people protect themselves
by getting vaccinated. Flublok is FDA approved for
all adults 18 and older and is fully reimbursed by
Medicare and other insurances.
Healthcare professionals wanting to order Flublok
should contact FFF Enterprises at 800-843-7477 or
online at www.myfluvaccine.com.
32
Flublok
is
approved
for
people
18
and
older
to
prevent
influenza
disease. The most common side effect from
Flublok is pain at the site of injection. Headache,
fatigue or muscle ache may occur. Tell the doctor if
you have ever experienced Guillain-Barré syndrome
(severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine.
Vaccination with Flublok may not protect all individuals. Clinical effectiveness in adults 50 and older
is based on the immune response elicited by Flublok and not on demonstration of decreased influenza disease.Please see the complete Package Insert
available at www.flublok.com or call 203-686-0800
for more information.
*Flublok demonstrated a higher antibody response to the A strains during 2 clinical trials in
adults ≥50 years old. The B strain antibody response
was comparable to traditional trivalent vaccines.
PROTEIN SCIENCES
IN THE NEWS
33
Flublok® Influenza Vaccine Now Approved for Adults
Ages 18 and Older
October 30, 2014
announced today that the U.S. FDA has approved
Flublok influenza vaccine for all adults aged 18 years
and older, granting approval for use in people 50 and
older under the accelerated approval of biological
products regulations, 21 CFR 601.40-46.
Flublok is the only licensed flu vaccine that is made
using modern recombinant technology and the only
flu vaccine that is 100% egg-free and highly purified.
It also contains three times more active ingredients
than traditional flu vaccines.
The expanded age indication means Flublok is now
available for everyone over 50 who have been waiting
patiently to receive his or her vaccine.
Lisa Dunkle, MD, Chief Medical Officer of Protein
Sciences said, “Older adults are known to be at high
risk for contracting and developing complications
from influenza.”
She continued, “Flublok has been shown to induce
high antibody levels in seniors.”
“We are excited with this approval,” said Dr. Manon
Cox, MBA, President and CEO of Protein Sciences.
“We set out to develop a better vaccine for the
older population by increasing the amount of active
ingredients in the vaccine. People of all ages have
been calling and asking for Flublok and now it is
terrific to be able to (finally) tell them that the
product is approved for all adults.
Flublok is a modern vaccine with particular
benefits to individuals who want (need) to avoid
34
Contact:
(203) 686-0800, ext. 308
exposure to egg proteins, gelatin, latex, formaldehyde or antibiotics as Flublok is free of all of these unnecessary and avoidable components.”
Earlier this year, the FDA approved a shelf life
extension for Flublok to six months.
Flublok is available at Passport Health locations
nationwide and select pharmacies, clinics and
doctor’s offices. A list of locations can be found at
www.flublok.com.
Healthcare professionals seeking Flublok should
contact FFF Enterprises at 800-843-7477 or online at
www.myfluvaccine.com.
FFF Enterprises will begin shipment immediately
or delivery dates can be specified.
PROTEIN SCIENCES
(2014) PLOS ONE 9(3), e92153).
Healthcare professionals can order Flublok
Protein Sciences specializes in vaccine develop- by contacting FFF Enterprises at 800-843-7477.
ment and protein production. Our mission is our in- Learn more at www.proteinsciences.com and
spiration: to save lives and improve health through www.flublok.com.
the creation of innovative vaccines and biopharmaFlublok Safety Information
ceuticals.
Flublok is approved for people 18 and older to prevent
vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013.
influenza disease. The most common side effect from
Flublok is the only flu vaccine made in a 100% egg-free Flublok is pain at the site of injection. Headache, fasystem using modern cell culture technology, making tigue or muscle ache may occur.
Tell the doctor if you have ever experienced Guilit unnecessary to use an infectious influenza virus or
antibiotics
in
manufacturing.
Flu- lain-Barré syndrome (severe muscle weakness) or
blok is highly purified and does not con- have had a severe allergic reaction to any component
tain any preservatives (e.g., thimerosal, a of Flublok vaccine.
Vaccination with Flublok may not protect all indimercury derivative), egg proteins, gelatin or latex.
Inaddition,Flublokcontainsthreetimesmoreantigen viduals. Clinical effectiveness in adults 50 and older
than traditional flu vaccines (3x45mcg hemagglutinin is based on the immune response elicited by Flublok
and not on demonstration of decreased influenza
protein versus 3x15mcg hemagglutinin protein).
Flublok is a perfect copy of the virus coat and is not disease.Please see the complete Package Insert availsubject to the egg-adapted mutations associated able at www.flublok.com or call 203-686-0800 for
with low vaccine effectiveness (see Skowronski et al. more information.
IN THE NEWS
35
Xiaomi Tong, Ph.D. Joins Protein Sciences as Senior
Vice President & Chief Technology Officer
October 23, 2014
announced today that Xiaomi Tong, Ph.D. has
joined the Company as Senior Vice President and
Chief Technology Officer.
Xiaomi will be responsible for Process Development,
Product Realization, Regulatory and Clinical, with
special emphasis on the Company’s Ebola vaccine
program.
Xiaomi has extensive experience in biopharmaceutical product development, manufacturing and
commercialization.
Previously, she served as Vice President of Advanced
Development and Manufacturing at Emergent
BioSolutions Corporation and Principal Investigator
for Emergent’s Centers for Innovation in Advanced
Development and Manufacturing (CIADM), a publicprivate partnership with the U.S. Department of
Health and Human Services responsible for developing and manufacturing vaccines and other medical
countermeasures against pandemic influenza, and
biological, chemical, radiological and nuclear threats.
She also served as Vice President of Regulatory
Affairs, responsible for the development and
implementation of global regulatory strategies.
Prior to joining Emergent, Xiaomi served as Senior
Regulatory Affairs Representative at DynPort Vaccine
Company and Product Team Leader and Manufacturing Manager at Aventis Pasteur (now Sanofi Pasteur)
of the commercial viral vaccines (influenza vaccine,
yellow fever vaccine and mumps skin test antigen).
36
Contact:
(203) 686-0800, ext. 308
She received her Ph.D. in Bioengineering from University of Utah and her bachelor’s degree in Biomedical Engineering from Shanghai Jiao Tong University.
Dr. Manon Cox, MBA, President and CEO of Protein
Sciences said, “It is a great pleasure to welcome Xiaomi
to our senior management team.” She added, “Xiaomi
brings us a wealth of knowledge in areas that are
critical to our continued growth into a major player in
the vaccine industry.”
PROTEIN SCIENCES
Connecticut company helping to develop Ebola vaccine
Posted: Oct 03, 2014 5:38 PM EDT Updated: Oct 31, 2014 5:45 PM EDT
MERIDEN, CT (WFSB)
The Ebola epidemic continues to cause a frightening death toll overseas.Protein Sciences in
Meriden is on the forefront of the fight to develop a
vaccine for the deadly virus. Hundreds have died
in West Africa as Ebola spread through human
contact.
Scientists on Friday showed Eyewitness News
some of their research.
“There’s no danger because there’s no Ebola virus
anywhere here,” said Dr. Rachael Felberbaum.
Protein Sciences said it is able to build a vaccine
based on the coding of the virus, which was provided by the Centers for Disease Control and Prevention.
Scientists are basically creating a protein that
mimics what the body would see if it contracted
Ebola. They then just use it in the vaccine so the
body can protect itself.
“So if you ever became infected with the real Ebola, your body would already be armed to defend
against it,” Felberbaum said.
IN THE NEWS
Dan Adams, who runs Protein Sciences, said the
vaccine would not help someone who already has
the virus. It would be a better defense for someone going into a plagued area.
“It would be used for researchers who don’t want
to research the virus because they don’t want to
work on it because it’s too dangerous,” Adams
said.
The company hopes to be able to use the vaccine
in December. It planned to first test it on monkeys.
“Typically it would be an injection,” Felberbaum
said. “So just like you would get a flu shot in your
arm.”
If the tests are successful, the federal government
could start using the vaccine on humans through
the Emergency Authorization Classification. However, it would ultimately have to be approved by
the Food and Drug Administration before it’s ready
for regular use.
Copyright 2014 WFSB (Meredith Corporation). All
rights reserved. Read more: http://www.wfsb.com/
story/26700837/connecticut-company-helping-todevelop-ebola-vaccine#ixzz3MYGaU7Nj
37
Flublok® Influenza Vaccine Now Available for the
2014/2015 Influenza Season
September 29, 2014
Contact:
(203) 686-0800, ext. 308
Meriden, CT — Protein Sciences Corporation, manufacturer of the revolutionary Flublok influenza vaccine, announced today that doses of the vaccine
have been released and are now available for shipment.
Flublok is triple the strength of traditional flu vaccines and is the only flu vaccine made without eggs,
antibiotics and influenza virus. Flublok is highly pure
and does not contain thimerosal (mercury derivative), gelatin or latex.
Manon Cox, President and CEO of Protein Sciences
said, “We are pleased to deliver Flublok on schedule
and with ample time for people to get vaccinated
this season.”
She continued, “Last year, many consumers allergic to eggs or gelatin or those seeking a pure flu
vaccine told us they were grateful to receive
Flublok. By being earlier to market and having a wider distribution network this year, we hope we can
reach even more people who want or need Flublok.”
Consumers looking for Flublok are encouraged
to ask their healthcare professionals to order it for
them. Flublok is also available at all Passport Health
locations nationwide and select doctor’s offices,
clinics and pharmacies, a list of which is updated
regularly and can be viewed at www.flublok.com/
FlublokFinder.pdf.
Flublok has a unique CPT code (90673) and is fully
reimbursed by most insurance companies.
Healthcare professionals seeking Flublok
should contact one of the following distributors:
FFF Enterprises at 800-843-7477 or online at
www.myfluvaccine.com. FFF Enterprises will begin shipment immediately or delivery dates can be
specified. Vaccine can also be obtained through ASD
Healthcare at 800-746-6273 or online at www.asdhealthcare.com.
38
Protein Sciences is a vaccine development and
protein production company that is dedicated to
saving lives and improving health through the creation of innovative vaccines and biopharmaceuticals. Flublok, the world’s first recombinant protein-based vaccine for the prevention of seasonal
influenza disease, was approved by FDA in January 2013. Flublok is the only flu vaccine made in a
100% egg-free system using modern cell culture
technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.
preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok is triple the strength of conventional influenza
vaccines. Flublok is a perfect copy of the virus coat
and is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE 9(3), e92153). We
have filed for FDA approval of Flublok for ages 50
and above and expect to receive approval in time
for the 2014/15 influenza season. Learn more at
www.proteinsciences.com and www.Flublok.com.
PROTEIN SCIENCES
Congresswoman Elizabeth H. Esty
CONNECTICUT’S 5TH DISTRICT
FOR IMMEDIATE RELEASE
September 29, 2014
Contact: Courtney Chandler, 860-223-8412
Rep. Elizabeth Esty Announces $669,000 Federal Grant
for Protein Sciences in Meriden
Department of Health and Human Services grant will support lung cancer treatment
MERIDEN – Today, Rep. Elizabeth Esty (CT-5) announced that Protein Sciences in Meriden
received a $669,156 grant from the Department of Health and Human Services (HHS). The funding is from the National Cancer Institute through the Small Business Innovation Research (SBIR)
program and will be used to support lung cancer treatment.
“Protein Sciences is on the cutting edge of developing innovative healthcare solutions for the 21st
century, and it is no surprise that the Department of Health and Human Services awarded this
funding,” said Esty. “Last year, when I toured their facility, I saw first-hand how Protein Sciences
stands as a global leader in the biotech industry, creating jobs here in Connecticut. This grant will
allow Protein Sciences to continue to deliver life-saving technologies to effectively treatlung cancer
patients and keep our families healthy.”
“We are gratified to be awarded this grant to help develop a novel approach to treating patients with
lung cancer,” said San Adams, Executive Chairman and Global Head of Business Development at
Protein Sciences. “We are collaborating with UCLA and Vault Nano Inc., developers of the vault
approach to targeted cell delivery, and using our proprietary baculovirus technology to manufacture
recombinant vaults that will deliver a potent chemokine to tumors.
“Elizabeth Esty has been a strong supporter of our company and its proprietary technology, which
can transform the vaccine business with products such as Flublok and vaults. She has been a leader
in promoting groundbreaking Connecticut technologies such as ours in Washington, and we greatly
appreciate her help,” said Adams.
The National Cancer Institute is one of 11 agencies in the U.S. Department of Health and Human
Services. The Small Business Administration coordinates the SBIR pogram with other agemcies to
incetivize commercialization and encourage small businesses to engage in research and development.
Founded in 1983, Protein Sciences develops vaccine and biopharmaceuticals for the prevention and
treatment of a variety of diseases.
IN THE NEWS
39
Protein Sciences and Diamyd Medical Deepen
Commitment to Develop New Treatment for Diabetes
September 16, 2014
Contact:
(203) 686-0800, ext. 303
Meriden, CT and Stockholm, Sweden —
Protein Sciences Corporation and Diamyd Medical AB
announced today that Protein Sciences has
broadened its commitment to diabetes and become
a strategic and significant shareholder in Diamyd
Medical, its long-time partner in this domain.
Protein Sciences will manufacture product for
upcoming late stage clinical trials for type 1
diabetes
involving
Diamyd
Medical’s
recombinant GAD (glutamic acid decarboxylase)
protein made using Protein Sciences’ proprietary
BEVS technology.
The diabetes vaccine Diamyd® (GAD formulated
with alum) has been evaluated as a monotherapy
for type 1 diabetes in a Phase 3 study and data
suggests Diamyd® may be a critical component of
combination therapies that pair the tolerance-inducing GAD antigen with anti-inflammatory agents for
the treatment and prevention of type 1 diabetes. This
is being evaluated in ongoing and upcoming Phase
2 studies. Under the Agreement, Diamyd Medical is
placing an order for cGMP production of recombinant
GAD protein, for which Protein Sciences receives a cash
payment and 400,000 new series B shares in Diamyd
Medical corresponding to a 2.0% ownership in
Diamyd Medical.
The ownership stake will make Protein Sciences
a strategic and one of the largest shareholders
in Diamyd Medical.
Onehundred thousand of the new shares will be
issued upon entering the Agreement and the remainder at completion of production. The shares
will be issued under the Annual General Meeting’s
authorization of the Board.
“Diamyd Medical has been a longstanding partner
of Protein Sciences, and we believe their approach
to treating diabetes holds great promise,” said Dan
Adams, Executive Chairman of Protein Sciences.
He continued, “The GAD product is an excellent
demonstration of the versatility of our BEVS platform
that can be used to make a wide variety of products,
including our revolutionary Flublok® influenza
vaccine.”
Anders Essen-Möller, Chairman of Diamyd Medical,
said, “It is strategically important for the development
of Diamyd that the relationship between manufacturing and commercialization is deepened and we
welcome Protein Sciences to become one of our
largest shareholders.”
He added, “We believe their technology is the best
for making recombinant proteins such as GAD. FDA
approval of Flublok only makes the platform more
valuable to partners such as us, as the significant
regulatory hurdles that typically face new
technologies have already been cleared.”
40
saving lives and improving health through the creation
PROTEIN SCIENCES
of innovative vaccines and biopharmaceuticals.
vaccine for the prevention of seasonal influenza
disease, was approved by the FDA in January 2013.
gelatin or latex.
In addition, Flublok is triple the strength of conventional influenza vaccines. Flublok is a perfect copy of
the virus coat and is not subject to the egg-adapted
mutations associated with low vaccine effectiveness
(see Skowronski et al. (2014) PLOS ONE 9(3), e92153).
Protein Sciences has filed for FDA approval of Flublok for ages 50 and above and expects to receive
approval in time for the 2014/15 influenza season.
Healthcare professionals in the U.S. can order Flublok by contacting FFF Enterprises at 800-843-7477
or ASD Specialty Healthcare at 866-281-4FLU.
www.flublok.com.
ingredient GAD, which has the potential to become
a key piece of the puzzle of a future solution to
prevent, treat or cure type 1 diabetes and other
forms of autoimmune diabetes. Diamyd Medical has
independently pursued the development of Diamyd®
to global Phase 3 trials, leading to one of Sweden’s
largest biotech agreements ever. Diamyd Medical’s
series B share is traded on NASDAQ OMX First North
under the ticker DMYD B. Learn more at www.diamyd.com.
Flublok is approved for people 18-49 years old to
Other side effects may occur and include fatigue,
headache and muscle aches.
Flublok should not be administered to anyone with
a severe allergic reaction (e.g., anaphylaxis) to any
vaccine component.
Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) within
6 weeks of receipt of a previous dose of influenza
vaccine.If you notice any other problems or
symptoms following vaccination, please contact your
About Diamyd Medical
healthcare professional immediately.Vaccination
Diamyd Medical is a publicly traded diabetes with Flublok may not protect all individuals.
company headquartered in Stockholm, Sweden. The
Company develops the diabetes vaccine Diamyd®, at www.flublok.com or call 203-686-0800 for more
an Antigen Based Therapy (ABT) with the active information.
IN THE NEWS
41
Nadine Francis West Joins Protein Sciences
Corporation as Senior Vice President, Chief
Administrative Officer and Corporate Secretary
September 5, 2014
Contact:
(203) 686-0800, ext. 308
Meriden, CT — Protein Sciences Corporation Street organization. She has been selected three
announced today that Nadine Francis West of times as one of the Hartford Business Journal’s 40
Hartford has been appointed Senior Vice Presi- Under Forty.
dent, Chief Administrative Officer and Corporate
Secretary. Nadine joins the Company at a time of
considerable growth stemming from the 2013 FDA
approval of the Company’s revolutionary Flublok®
influenza vaccine.
Nadine is an accomplished leader and has held
strategic roles in multiple Connecticut organizations. Prior to joining Protein Sciences, she served
as the Vice President and Chief Administrative Officer of the MetroHartford Alliance, where she oversaw the Alliance’s $4.9M budget, served as the
Corporate Secretary and led the Finance and
Administration Team.
Previously, Nadine served in the administration of
former Hartford Mayor Michael Peters and practiced
law in the corporate law department of Aetna, Inc.
She has also held key volunteer leadership roles for
the Hartford Stage Company, the Bushnell Performing Arts Center, the UConn Foundation, Hartford
Hospital, Saint Francis Hospital and Medical Center,
Upper Albany Main Street, the Aurora Women and
Girls Foundation and the YWCA.
Nadine has been named a WonderWoman by the
Malta House of Care and has received the Board
Nadine Francis West
Member of the Year award from the National Main
42
PROTEIN SCIENCES
said, “We are thrilled to have Nadine join us. She is
a local powerhouse and a welcome addition to our
growing management team.”
“This is a fantastic company and I am very excited to be a part of it,” said West. “Flublok is a game
changer, and I look forward to contributing to its
success.”
saving lives and improving health through the creation
of innovative vaccines and biopharmaceuticals.
virus or antibiotics in manufacturing.
egg proteins, gelatin or latex.
In addition, Flublok is triple the strength of
conventional influenza vaccines. Flublok is a
perfect copy of the virus coat and is not subject to the
egg-adapted mutations associated with low vaccine
IN THE NEWS
effectiveness (see Skowronski et al. (2014) PLOS
ONE 9(3), e92153). We have filed for FDA approval of
Flublok for ages 50 and above and expect to receive
contacting FFF Enterprises at 800-843-7477 or ASD
Specialty Healthcare at 866-281-4FLU.
www.Flublok.com.
prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Other
side effects may occur and include fatigue, headache
and muscle aches. Flublok should not be administered to anyone with a severe allergic reaction
(e.g., anaphylaxis) to any vaccine component.
within 6 weeks of receipt of a previous dose of
influenza vaccine. If you notice any other problems
or symptoms following vaccination, please contact
your healthcare professional immediately.
Vaccination with Flublok may not protect all individuals. Please see the complete Package Insert
available at www.Flublok.com or call 203-686-0800
for more information.
43
Flublok® Influenza Vaccine Will Be Available At More
Than 230 Passport Health Locations Nationwide
August 19, 2014
Contact:
(203) 686-0800, ext. 308
Meriden, CT and Scottsdale, AZ — Protein Sciences
Corporation and Passport Health announced today that Flublok® influenza vaccine will be available
this fall at all 230+ Passport Health locations across
the United States. In addition, all employers who
arrange their influenza vaccination clinics through
Passport Health will be able to request Flublok.
“We created Flublok to save lives and our
obligation is to make it readily available to those
who need or want it,” said Dr. Manon Cox, President
and CEO of Protein Sciences.
“It is disappointing to hear that people have been
asking for it by name only to be told that it’s not
available.”
She continued, “We are delighted that our agreement with Passport Health will help change that.”
“We are proud to bring this modern vaccine to
our patients,” said Fran Lessans, CEO and founder of Passport Health. She added, “Flublok is the
perfect choice for those seeking pure, safe and
effective influenza protection.”
Passport Health has set up an educational page
on their website to raise awareness about Flublok.
To make an individual appointment to get vaccinated in a Passport Health clinic, please visit the
company website at www.passporthealthusa.com.
Employers who would like to schedule an onsite
Flublok event at their workplace should email
[email protected], or visit this
webpage: www.passporthealthusa.com/employersolutions/on-site-flu-clinics/ so that Passport Health’s
sales and client services staff can coordinate the
event.
44
saving lives and improving health through the
creation of innovative vaccines and biopharmaceuticals.
Flublok, the world’s first recombinant proteinbased vaccine for the prevention of seasonal
influenza disease, was approved by FDA in
January 2013. Flublok is the only flu vaccine made in
a 100% egg-free system using modern cell culture
technology, making it unnecessary to use an infectious
influenza virus or antibiotics in manufacturing.
conventional influenza vaccines. Flublok is a perfect
copy of the virus coat and is not subject to the eggadapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE
9(3), e92153). We have filed for FDA approval of
PROTEIN SCIENCES
headache and muscle aches.
Flublok should not be administered to anyone
with a severe allergic reaction (e.g., anaphylaxis) to
any vaccine component. Tell the doctor if you have
ever experienced Guillain-Barré syndrome (severe
muscle weakness) within six weeks of receipt of a
previous dose of influenza vaccine.
If you notice any other problems or symptoms
following vaccination, please contact your
About Passport Health
Passport Health is the largest and leading healthcare professional immediately. Vaccination
provider of travel medicine and vaccination services with Flublok may not protect all individuals.
in the North America.
With more than 230 clinic locations, 20+ years at www.Flublok.com or call 203-686-0800 for more
of experience, a commitment to first class medical information.
care, and rigorously trained medical staff, Passport
Health sets the immunization industry standard.
Passport Health’s core services have grown
from travel medicine to include on-site flu clinics,
specialty physical exams, routine immunizations,
and vaccination records management solutions for
public and private sector clients of all sizes.
For more information, visit: www.passporthealthusa.com.
Flublok for ages 50 and above and expect to receive
contacting FFF Enterprises at 800-843-7477 or ASD
Specialty Healthcare at 866-281-4FLU.
www.Flublok.com.
IN THE NEWS
45
Protein Sciences and Liomont Announce Licensing of
Proprietary Influenza Vaccines for the Mexico Market
August 12, 2014
Contact:
(203) 599-6064, ext. 162
Meriden, CT and Mexico City, Mexico
— Protein Sciences Corporation and Laboratorios
Liomont, S.A. de C.V. (Liomont), a leading Mexican
pharmaceutical company, announced today that
they have signed a licensing agreement that grants
Liomont an exclusive license to Flublok® (seasonal)
and Panblok® (pandemic) influenza vaccines for
the Mexico market and, potentially, other Latin
American countries.
Under the terms of the agreement, Liomont will
seek regulatory approval for Flublok in Mexico
and initially sell Flublok manufactured by Protein
Sciences. Liomont has also obtained rights to
manufacture Flublok and Panblok in Mexico. Protein
Sciences is entitled to significant license and milestone payments and double-digit royalties on sales.
“The revolutionary nature and broad technology
platform behind Flublok and Panblok afford these
vaccines important advantages over other vaccines
on the market - both can be made safely, accurately
and much faster than other vaccines,” said Alfredo
Rimoch, CEO of Liomont.
“Flublok and Panblok complement our pipeline
as we look into building a solid biotech portfolio
which we can market in Latin America by 2015. Most
importantly, the modern recombinant technology
behind the products will allow us to rapidly supply the Mexican market with an effective pandemic
influenza vaccine if and when the need arises.”
of Business Development for Protein Sciences said,
“This partnership with Liomont will make Flublok
broadly available to our Southern neighbors as
Liomont is a growing company with an outstanding track record in marketing branded products in
Mexico.”
He added, “Flublok represents a breakthrough in
vaccine technology, and we will continue to work
with partners like Liomont to make the vaccine and
our technology available globally.”
46
saving lives and improving health through the
creation of innovative vaccines and biopharmaceuticals.
About Laboratorios Liomont
Liomont is one of the five largest Mexican
pharmaceutical companies, having achieved
a solid, sustained growth for the past 20 years.
Liomont is constantly looking for novel and promising products and technologies for the Mexican and
Latin American markets. For more information about
Liomont, please visit www.liomont.com.
About Flublok
Flublok, the world’s first recombinant proteinbased vaccine for the prevention of seasonal
PROTEIN SCIENCES
influenza disease, was approved by FDA in January
2013.
Flublok is the only flu vaccine made in a 100%
egg-free system using modern cell culture
technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.
conventional influenza vaccines. Flublok is a perfect
copy of the virus coat and is not subject to the eggadapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE
9(3), e92153). Protein Sciences has filed for FDA
approval of Flublok for ages 50 and above and
expects to receive approval in time for the 2014/15
influenza season.
Healthcare professionals in the U.S. can order
Flublok by contacting FFF Enterprises at 800-8437477 or ASD Specialty Healthcare at 866-281-4FLU.
IN THE NEWS
www.Flublok.com.
headache and muscle aches. Flublok should not
be administered to anyone with a severe allergic
reaction (e.g., anaphylaxis) to any vaccine
component.
within six weeks of receipt of a previous dose of
influenza vaccine.
If you notice any other problems or symptoms
following vaccination, please contact your healthcare professional immediately. Vaccination with
Flublok may not protect all individuals.
at www.Flublok.com or call 203-686-0800 for more
information.
47
Protein Sciences and Partners Launch Health-At-Work
to Bring Flublok®, Other Vaccines to the Workplace
July 17, 2014
FB14042
Contact:
(203) 686-0800, ext. 308
announced today that it has partnered with
physicians from Velocity Urgent Care and launched
a new initiative, called Health-At-Work, that offers
onsite influenza and other vaccinations to employers
in Connecticut and surrounding regions.
Unlike many vaccination providers, Health-At-Work
offers the egg-free, highly pure Flublok influenza
vaccine in the convenience of the employer’s workplace. Employers can customize their clinics and can
choose to offer single or multiple vaccinations as part
of the same clinic. Billing is handled by Health-AtWork and most insurance is accepted.
“We are a Company dedicated to saving lives and
promoting health through the creation of better,
safer vaccines,” said Manon Cox, President and CEO of
Protein Sciences.
“Health-At-Work is a way we are taking things a step
further to make vaccination easy and convenient for
improved health for the entire community.”
“Based on the median income for the state of
Connecticut, the average employer will lose $1,070
per employee due to flu-related illness this season,”
said Susan Manganello, Director of Medical Services
at Protein Sciences.
“Health-At-Work provides a seamless vaccination
program that enables employers to improve the
health and wellbeing of employees and save money
for their businesses.”
Protein Sciences will host a business network-
ing breakfast that will feature the medical staff from
Health-At-Work on Wednesday, July 23rd from 7:30 to
9:30 a.m. at 875 Research Parkway, Meriden, CT.
To schedule a clinic, find out more about HealthAt-Work, or if you plan to attend this event, contact
Susan Manganello, RN at [email protected].
48
Protein Sciences is a vaccine development and protein
production company that is dedicated to saving lives
and improving health through the creation of innovative
vaccines and biopharmaceuticals. Flublok, the world’s
first recombinant protein-based vaccine for the
prevention of seasonal influenza disease, was approved by FDA in January 2013. Flublok is the only
flu vaccine made in a 100% egg-free system using
modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in
manufacturing.
preservatives (e.g., thimerosal, a mercury derivative), egg
proteins, gelatin or latex. In addition, Flublok is triple the
strength of conventional influenza vaccines. Flublok is a
perfect copy of the virus coat and is not subject to the eggadapted mutations associated with low vaccine effectiveness [see Skowronski et al. (2014) PLOS ONE 9(3), e92153].
We have filed for FDA approval of Flublok for ages 50
and above and expect to receive approval in time for the
2014/15 influenza season. Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477
or ASD Specialty Healthcare at 866-281-4FLU. Learn more
at www.proteinsciences.com and www.Flublok.com.
PROTEIN SCIENCES
Protein Sciences Receives Approval from FDA for
2014/15 Formulation of Flublok® Influenza Vaccine
July 8, 2014
FB14028
Contact:
(203) 686-0800, ext. 308
announced today that the FDA has approved
the Company’s strain change amendment for its
seasonal influenza vaccine, Flublok. Every year
influenza vaccine manufacturers must receive
approval from the Agency for changes they make
to the upcoming season’s manufacturing process
and product formulation, as the influenza vaccine
is adapted annually. Early approval for Flublok will
enable delivery on time to healthcare providers in
the fall. This is especially important for those that
rely on Flublok’s unique properties for protection
from the flu; namely, that the vaccine is egg-free,
highly pure and triple the strength compared to
conventional influenza vaccines.
President and CEO of Protein Sciences, Manon
Cox said, “We anticipate having the first doses of Flublok available in September and the FDA’s approval
supports this timeline.
She added, “We are still accepting orders for the fall
and providers are encouraged to order through our
distributors FFF Enterprises and ASD Healthcare.”
flu vaccine made in a 100% egg-free system using
modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in
manufacturing.
proteins, gelatin or latex. In addition, Flublok is triple the
strength of conventional influenza vaccines. Flublok is a
perfect copy of the virus coat and is not subject to the eggadapted mutations associated with low vaccine effectiveness [see Skowronski et al. (2014) PLOS ONE 9(3), e92153].
We have filed for FDA approval of Flublok for ages 50
and above and expect to receive approval in time for the
2014/15 influenza season. Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477
or ASD Specialty Healthcare at 866-281-4FLU. Learn more
at www.proteinsciences.com and www.Flublok.com.
vaccines and biopharmaceuticals. Flublok, the world’s
first recombinant protein-based vaccine for the
prevention of seasonal influenza disease, was approved by FDA in January 2013. Flublok is the only
50
Flublok is approved for people 18-49 years old to prevent influenza disease. The most common side effect from
Flublok is pain at the site of injection. Other side effects
may occur and include fatigue, headache and muscle
aches. Flublok should not be administered to anyone with
a severe allergic reaction (e.g., anaphylaxis) to any vaccine
component. Tell the doctor if you have ever experienced
Guillain-Barré syndrome (severe muscle weakness) within
6 weeks of receipt of a previous dose of influenza vaccine.
If you notice any other problems or symptoms following
vaccination, please contact your healthcare professional
immediately. Vaccination with Flublok may not protect all
individuals. Please see the complete Package Insert available at www.Flublok.com or call 203-686-0800 for more
information.
PROTEIN SCIENCES
U.S. Biomedical Advanced Research and Development
Authority (BARDA) Extends Contract with Protein Sciences
June 17, 2014
FB14006
Contact:
(203) 686-0800, ext. 308
announced today that BARDA, within the U.S.
Department of Health and Human Services,
exercised Option Period 2 of its contract with the
Company (contract number HHS0100200900106C)
to support development, scale-up and expanded
licensure of the Company’s influenza vaccines,
Flublok® (seasonal) and Panblok® (pandemic).
Option Period 2 has a budget of $50.6 million and
will run through December 31, 2015. The total value
of the contract, originally awarded in 2009, is $146.9
million.
BARDA funds supported the initial licensure of
Flublok, the world’s first recombinant influenza
vaccine, which was approved by FDA in January
2013.
The recombinant technology used to make
Flublok and Panblok is the pandemic solution; these
vaccines can be made safely, accurately and much
faster than they could by using other technologies.
The Option Period 2 funds will support licensure
of Protein Sciences’ newly acquired larger-scale
manufacturing facility in Pearl River, New York that
manufactures Flublok and is planned to have the
capacity to produce 50 million doses of Panblok
within 6 months of declaration of a pandemic as
required by the BARDA contract.
The funds will also be used for clinical studies to
support licensure of Panblok and a quadrivalent
formulation of Flublok.
said, “We are fortunate to have been able to build a
strong partnership with BARDA.”
She added, “An analysis of past pandemics
revealed that vaccines were available too late and
in short supply. Recombinant technology such as
that used to make Flublok and Panblok ensures
abundant vaccines with the correct sequence are
available when they are needed.”
IN THE NEWS
Flublok is approved for people 18-49 years old to prevent influenza disease. The most common side effect from
Flublok is pain at the site of injection. Other side effects
may occur and include fatigue, headache and muscle
aches. Flublok should not be administered to anyone with
a severe allergic reaction (e.g., anaphylaxis) to any vaccine
component. Tell the doctor if you have ever experienced
Guillain-Barré syndrome (severe muscle weakness) within
6 weeks of receipt of a previous dose of influenza vaccine.
If you notice any other problems or symptoms following
vaccination, please contact your healthcare professional
immediately. Vaccination with Flublok may not protect all
individuals. Please see the complete Package Insert available at www.Flublok.com or call 203-686-0800 for more
information.
51
Protein Sciences Adds Distributor for Flublok®
Recombinant Influenza Vaccine to Increase Access
June 10, 2014
FB14030
Contact:
(203) 686-0800, ext. 308
announced it will have more doses, earlier
availability and broader distribution coverage of its
modern, egg-free Flublok® Influenza Vaccine for the
2014/2015 season.
Up to 500,000 doses of the vaccine will be
manufactured, and the first doses will be available in
September. ASD Specialty Healthcare and its Besse
Medical and Oncology Supply divisions have been
added as a distributor of Flublok.
FFF Enterprises will continue to be a distributor.
Wayne Hachey, DO (Colonel, U.S. Army, ret.),
Head of Government and Clinical Affairs at Protein
Sciences, made these announcements at the
National Adult and Influenza Immunization Summit
Meeting earlier this month in Atlanta, GA.
Dr. Hachey said, “Last year, healthcare professionals wanted Flublok available sooner and from more
access points. We are pleased to give them just
that.”
Dr. Manon Cox, MBA, President and CEO of Protein
Sciences said, “We are excited to add ASD Specialty
Healthcare and its Besse Medical and Oncology
Supply divisions to our distribution network.
Both FFF and ASD offer fast, reliable
delivery of Flublok to healthcare professionals
nationwide.”
Healthcare professionals can pre-order Flublok
by contacting FFF at 800-843-7477 or ASD at
866-281-4FLU.
52
effect from Flublok is pain at the site of injection. Other
and muscle aches. Flublok should not be administered
to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component. Tell the doctor if you
have ever experienced Guillain-Barré syndrome (severe
muscle weakness) within six weeks of receipt of a previous dose of influenza vaccine.
If you notice any other problems or symptoms following vaccination, please contact your healthcare
professional immediately. Vaccination with Flublok may
not protect all individuals.
at www.Flublok.com or call 203-686-0800 for more
information.
PROTEIN SCIENCES
Protein Sciences Partners File for Marketing Approval
of Flublok® Influenza Vaccine in Japan
May 30, 2014
FB14028
Contact:
(203) 686-0800, ext. 162
announced today that Astellas Pharma has submitted an application for marketing approval of recombinant influenza HA vaccine ASP7374 (marketed as
Flublok® in the United States by Protein Sciences) to
the Ministry of Health, Labour and Welfare in Japan
for the prevention of influenza.
UMN Pharma, which is partnered with Astellas,
holds an exclusive license from Protein Sciences for
the development and marketing of Flublok in Japan.
Protein Sciences will receive a significant milestone
payment as a result of the filing.
The announcement made by Astellas Pharma and
UMN Pharma can be found at http://ir.umnpharma.
com/en/irnews/irnews-3759171731789488075/
TopLink/TopLinkDocument/News_20140530_2.pdf.
of Business Development at Protein Sciences said,
“Japan is a terrific franchise for our BEVS platform as
they value our broad technology platform for making recombinant vaccines and therapeutics that are
fast to make, precise and pure. In addition to Japan,
UMN Pharma has exclusively licensed Flublok and
Panblok®, the pandemic version of Flublok, for the
territories of China, Korea, Hong Kong, Taiwan and
Singapore.”
vaccines and biopharmaceuticals.
vaccine for the prevention of seasonal influenza disease,
was approved by FDA in January 2013. Flublok is the
only flu vaccine made in a 100% egg-free system using
modern cell culture technology, making it unnecessary
to use an infectious influenza virus or antibiotics in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, it contains
3x more active ingredient than traditional flu vaccines.
subject to the egg-adapted mutations associated with
low vaccine effectiveness (see Skowronski et al. (2014)
PLOS ONE 9(3), e92153). We have filed for FDA approval
Protein Sciences is a vaccine development and pro- of Flublok for ages 50 and above and expect to receive
tein roduction company that is dedicated to saving lives approval in time for the 2014/15 influenza season. Learn
and improving health through the creation of innovative more at www.proteinsciences.com and www.Flublok.com.
IN THE NEWS
53
Protein Sciences CEO Awarded Honorary Degree for
Achievements in Science and Business
May 21, 2014
FB14020
Contact:
(203) 686-0800, ext. 308
President and CEO, Dr. Manon Cox, MBA, received
the degree of Doctor of Humane Letters, honoris
causa from The University of Saint Joseph for her
achievements in science and business.
As CEO, Dr. Cox has led Protein Sciences through
enormous growth, including FDA approval of
the Company’s first product, Flublok® Influenza
Vaccine, which the FDA called “Revolutionary” upon
licensure, and expansion of the Company’s
workforce from less than 40 to over 130 employees
during the past five years.
The award was bestowed as part of the 79th
Commencement Ceremony held on May 11th on
the University’s West Hartford campus.
In response to receiving her degree, Dr. Cox
said, “It is a great honor to be recognized by a
university dedicated to science and its founding
mercy mission. Clearly, contributions of the entire
Protein Sciences team enable us to accomplish such
great things like Flublok.”
She added, “We go to work every day to work
on new, modern vaccines that make people’s lives
better, or even save lives.”
vaccine for the prevention of seasonal influenza disease,
was approved by FDA in January 2013. Flublok is the only
flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use
an infectious influenza virus or antibiotics in manufacturing. Flublok is highly purified and does not contain any
proteins, gelatin or latex. In addition, it contains 3x more
active ingredient than traditional flu vaccines. Flublok is
a perfect copy of the virus coat and is not subject to the
egg-adapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE 9(3),
e92153). We have filed for FDA approval of Flublok for
ages 50 and above and expect to receive approval in time
for the 2014/15 influenza season. Learn more at www.
proteinsciences.com and www.Flublok.com.
vaccines and biopharmaceuticals.
54
prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Other
and muscle aches. Flublok should not be administered
to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component. Tell the doctor if you
have ever experienced Guillain-Barré syndrome (severe
muscle weakness) within 6 weeks of receipt of a previous
dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact
your healthcare professional immediately. Vaccination
with Flublok may not protect all individuals. Please see
the complete Package Insert available at www.Flublok.
com or call 203-686-0800 for more information.
PROTEIN SCIENCES
U.S. Congresswoman Elizabeth Esty
Pays Tribute to Protein Sciences
April 17, 2014
Contact:
(203) 686-0800, ext. 308
Meriden, CT — U.S. Representative Elizabeth Esty
visited Protein Sciences this week to meet with
Company representatives and learn how she can
support the Company in our work of bringing
modern, innovative vaccines to market.
Congresswoman Esty represents Connecticut’s
5th District , in which Protein Sciences is located.
As part of her visit, the Congresswoman met with
senior executives, toured the facility and spoke with
employees.
She reinforced her commitment to help remove roadblocks in Washington that slow down
the speed at which important new vaccines like
Flublok® become available to the public.
Manon Cox, President and CEO of Protein
Sciences, commented, “The Congresswoman is an
important ally; through her voice, we have a voice
in Washington. We are thankful she took the time to
visit with us and welcome her back in the future to
see the incredible progress we are making.”
IN THE NEWS
55
NATURE | NEWS March 27, 2014
Mutations explain poor showing of 2012 flu vaccine
Study raises questions over production of flu vaccines in chicken eggs.
By Declan Butler
In November 2012, as an early and severe flu season bore down on North America, the news from
the US Centers for Disease Control and Prevention
(CDC) in Atlanta, Georgia, was reassuring. “So far, this
season, most (90%) of the influenza viruses … are
well-matched to the 2012–2013 influenza vaccine;
this should mean that the vaccine will offer good
protection,” the agency stated.
were the highest in almost a decade. What went
wrong?
Research published on 25 March in PLoS ONE1 by
Danuta Skowronski from the BC Centre for Disease Control in Vancouver, British Columbia, and
colleagues at other Canadian public-health research
centres, shows that the H3N2 vaccine strain selected
by the World Health Organization (WHO) was indeed
Yet vaccine effectiveness against H3N2, the main well matched to the wild viruses circulating at the
flu strain circulating that season, proved to be time. But the strain sent to vaccine makers — which
only 46% in adults aged 18–49, 50% in those aged is first adapted to grow better in the hens’ eggs used
50–64, and a dismal 9% in people aged over 65, a to produce the vaccine — was mismatched and
poorly effective, they find.
vulnerable group. Flu hospitalizations and deaths
56
PROTEIN SCIENCES
The likely cause, the scientists found, is three
mutations in the egg-adapted strain that were not
present in the WHO strain, resulting in changes at
key sites of the haemagglutinin surface protein
known to affect antibody responses.
microbiologist at New York Medical College in
Valhalla, New York, whose lab creates such seed
strains. Efforts are made to monitor mutations and
select for the least changes, she says. Quality control
of the seed strains is done by the WHO Collaborating
Centres.
Moreover, the Canadian researchers found that
the same problem probably arose with a revised
H3N2 component of the 2013–14 flu vaccine (each
season’s vaccine is also designed to ward off H1N1
and influenza B type viruses) and the upcoming 2014–15 vaccine. This suggests that effectiveness against H3N2 may be poor in these seasons’
vaccines, too.
“I’m surprised that the antigenic difference did
not become obvious much earlier in the process of
testing the high growth reassortant before it was
provided to the manufacturers,” says an official at
one flu vaccine company who did not wish to be
named.
The WHO briefly alluded to the problem of
mismatch in February 2013 when it recommended
that the H3N2 strain used in the 2012–13 season
should not be used for the 2013–14 season but
should be substituted with a different strain.
Such mismatches are unlikely to be one-off
incidents, says Michael Osterholm, who heads
the University of Minnesota’s Center for Infectious
Disease Research and Policy in Minneapolis. “I’m sure
this has had to have happened before,” he says. “It’s
But the Canadian scientists found that the
another reason why we need to accelerate efforts to egg-adapted version of the new vaccine strain
come up with really game-changing flu vaccines.”
is similarly mismatched against 2012–13 wild
virus, and data in a WHO report released last month
Flu viruses are continually evolving, and so suggest a similar mismatch for 2013–14 wild virusseasonal flu vaccine strains are changed from year es. The finding, says Bucher, “is clearly of concern
to year to better match the circulating strains. Any for the 2014–15 vaccine effectiveness of the H3N2
reduction in effectiveness has previously been component.”
explained as ‘antigenic drift’ taking place in the
circulating strains, a process in which mutations
The WHO has recommended that the new strain
accumulate in the genes encoding the flu antigens be used in the 2014-15 season. The UN agency had
seen by the immune system, producing strains that not responded to Nature’s questions by this article’s
it no longer recognizes.
deadline.
But the new findings show that it is important to
Skowronski says that the findings should prompt
ensure that the egg-adapted virus is well matched, discussion of switching vaccine production from
and also to better understand how particular eggs, a 1930s technology, to modern production
mutations affect vaccine effectiveness, says systems using cultured human cells.
Skowronski.
Flu vaccination remains the best tool to protect against flu, says Osterholm, but its overall
H3N2 viruses do not grow well in eggs, so in effectiveness is poor compared to vaccines for other
preparing the vaccine, the WHO strain is ‘reassorted’ diseases. “We need much improved vaccines than
with other strains that do. These fast-growing ‘seed what we have now,” he says.
strains’ are used for manufacture (see ‘The virus
grower’).
Nature doi:10.1038/nature.2014.14940
“There is always a concern about egg-adapta- References
tion mutations resulting in alteration of antigenic- Skowronski, D.M. et al. PLoS ONE http://dx.doi.
ity of the vaccine seed strain,” says Doris Bucher, a org/10.1371/journal.pone.0092153 (2014).
IN THE NEWS
57
Connecticut Technology Council
Names Protein Sciences President & CEO
One of Eight Recipients of
Women of Innovation® Awards
Women leaders in technology, science and engineering honored March 24.
Wallingford, Conn., March 25, 2014 – Protein
Sciences is proud to announce that Manon Cox,
the company’s president and CEO, was named
one of eight Women of Innovation® honored and
celebrated by the Connecticut Technology
Council during a ceremony held at the Aqua Turf
Club in Southington on March 27.
The program recognizes women across
Connecticut – those in the workforce and students
– who are innovators, role models and leaders in the
fields of science, technology engineering and math.
Fifty-nine women were selected as finalists for the
tenth annual awards dinner.
“These Connecticut women are extraordinary and
outstanding contributors to their professions, to
their employers, and in many cases to their communities,” said Beth Alquist, planning committee chair
for the awards program.
This year’s list of 59 women includes researchers,
educators, engineers, managers, and entrepreneurs
who work in biotech, pharmaceuticals, software,
computer hardware, advanced materials, medical
devices, and Information technology.
A winner in each of eight award categories was
announced during the awards dinner. The complete
list of 2014 Women of Innovation® is posted on the
CTC website.
58
Cox and the other seven winners were
nominated by their peers and selected based on
their professional experience, history of innovation,
ability to think creatively and solve problems, and
demonstration of leadership.
Students were judged on inventiveness,
accomplishment in science and technology,
independent research, and academic achievement.
Retired Air Force Major General Suzanne Vautrinot
kicked the night off with a meaningful keynote
presentation. “You are the people who imagine,
and what you imagine is changing a nation. You
are imagination, and tonight, you are my heroes,”
she said. She discussed not only the rewards of
innovation but the importance of its diversity,
saying some of the Women of Innovation in the
room would or have already develop extraordinary
technologies, some of which would save lives, while
others would pave the way for business growth and
job creation.
“You are scientists, engineers, teachers,
mothers, sisters… all very different but with so
much in common. First and foremost, you are all innovators, and second, you are all very real.” She said
being a leader is tough but being innovative enables
people to take new steps in order to solve problems.
She stressed the importance of living with integrity
PROTEIN SCIENCES
ABOVE: Top category winners (from left): Oei, Cox, Smith, Odess, Cappello, Pagliaro, Xia
RIGHT: Manon Cox
and seeking excellence in all you do. She said that
not every decision can be your own, but when it
is, you have the opportunity to blaze a trail that is
completely unique.
Elaine Pagliaro, assistant executive director at
Henry C. Lee Institute of Forensic Science, University of New Haven, was the recipient of the
Academic Innovation and Leadership award.
She urged people to stay innovative, no matter what
profession or stage of life they are in.
“Be curious. Think about everything, not just
science,” she said. “We live in a world, not just a lab.
You need to be excited and emotional.”
Laura Smith, winner of the Large Business
Innovation and Leadership award, acknowledged
the strong competition for such a prestigious award.
“I’ve always thought I have the coolest job in the
world,” she said. “But after hearing everyone tonight,
I may have to revisit that!”
The Connecticut Technology Council said it would
like to congratulate each and every one of this year’s
Women of Innovation.
“We are very proud of the top category winnersfor their hard work, determination and continued
passion in the science, technology, engineering and
mathematics fields. Each and every one of these
59 ladies is deserving of the title ‘Woman of
IN THE NEWS
Innovation.’ Connecticut will look to them to be
game changers, job creators, passion infusers,
mentors, teachers and leaders. We are honored that
they call Connecticut home.”
2014 Women of Innovation Top Category Winners
Small Business Innovation and Leadership:
Manon Cox, President & CEO, Protein Sciences Corporation
Community Innovation and Leadership:
Nancy Cappello, Executive Director & Founder, Are You
Dense, Inc.
Research Innovation and Leadership:
Robin Chazdon, Professor, University of Connecticut
Entrepreneurial Innovation and Leadership:
Ilana Odess, CEO & Founder, Woven Orthopedic
Technologies, LLC
Youth Innovation and Leadership:
Bridget Oei, High School Student, East Catholic High School
Academic Innovation and Leadership:
Elaine Pagliaro, Assistant Executive Director, University of
New Haven
Large Business Innovation and Leadership:
Laura Smith, Director of Engineering, General Dynamics
Electric Boat
Collegian Innovation and Leadership:
Zengmin Xia, Graduate Student, University of Connecticut
59
Bartolomeo and Malloy Visit Groundbreaking
Bioscience Company Fighting the Flu in Meriden
Protein Sciences is the only U.S.-owned company making flu vaccines in this country
March 7, 2014
MERIDEN, CT—The next generation of flu prevention is being developed and sold by a bioscience company in Meriden. Senator Danté Bartolomeo joined Governor Malloy and Representative Buddy Altobello at Protein Sciences to tour the campus and talk about what Connecticut can do
to help this growing company.
“Connecticut’s bioscience industry is changing the way people think about fighting diseases,” said Senator Bartolomeo. “Here in Meriden we
have the world’s first flu vaccine developed without a live virus or ingredients like mercury and formaldehyde. I received the Flublok shot this
winter, and can attest to its effectiveness. This same, groundbreaking technology will eventually be used to fight rabies and a variety of other
dangerous viruses.”
“When I think about all the factors that go into building momentum for our Bioscience CT initiative, groundbreaking firms like Protein Sciences
are exactly what comes to mind and I am proud they call Connecticut home,” said Governor Malloy. “As a company on the cutting edge of biopharmaceutical production, Protein Sciences’ presence here reinforces our efforts to cultivate a competitive industry hub and raise our international
profile as a leader in bioscience and personalized medicine.”
“I am pleased to support a homegrown company that provides much needed high skilled jobs,” Rep. Altobello said. “I will continue to support
providing resources that will allow work on innovative solutions that will make it a stronger and continuously growing global business.”
Flublok is the only flu vaccine made by an American-owned company in the United States. During her visits with Protein Sciences, Senator Bartolomeo spoke with several young people who decided to stay in Connecticut after receiving advanced degrees because of the opportunity to work
on Flublok and other exciting bioscience projects. Protein Sciences has grown from less than 40 employees six years ago to 120 employees today.
“We have been located in Connecticut since our founding more than 30 years ago, said Daniel Adams, Protein Sciences Executive Chairman and
Global Head of Business Development. “At that time, Flublok was just a concept. We are proud to have developed the technology that enables us
to make modern vaccines such as Flublok and to showcase Connecticut as a leader in innovation.”
Flublok is the only licensed flu vaccine that does not use eggs, antibiotics, or live flu virus in the manufacturing process. As a result of this, it is
specifically recommended for individuals with egg allergies. Flublok also does not contain thimerosal, a mercury derivative, or latex. According to
Protein Sciences, Flublok has three times the protective ingredient found in many other flu vaccines.
60
PROTEIN SCIENCES
January 15, 2014
Astellas and UMN Announce Summary Results in Phase III
Clinical Trials of Seasonal Flu Vaccine ASP7374
Astellas Pharma Inc. (TSE: 4503; Headquarters: Tokyo; President & CEO: Yoshihiko Hatanaka) and
UMN Pharma Inc. (TSE: 4585; Headquarters: Akita; CEO: Tatsuyoshi Hirano) today announced that the
summary results for two Phase III clinical trials of the recombinant seasonal influenza HA vaccine ASP7374
(former code: UMN-0502), that completed administration in October 2013.
One of these clinical trials enrolled 900 healthy volunteers aged 20 to 64 years to compare the
immunogenicity and safety of subcutaneously-administered ASP7374 with approved egg-derived trivalent
inactivated vaccine and to prove non-inferiority of ASP7374 to the egg-derived vaccine.
This clinical trial showed non-inferiority of the recombinant seasonal influenza HA vaccine ASP7374
in comparison with the egg-based vaccine in terms of immunogenicity. No major safety problem was
observed in ASP7374 in this trial. Astellas Pharma is conducting this clinical trial following the
successfully-completed clinical trial among 1,060 elderly volunteers. Astellas Pharma and UMN Pharma
announced the results of the clinical trial in elderly volunteers on March 11, 2013 in the news release titled
“Non-inferiority Observed in Phase III Clinical Trials of Seasonal Flu Vaccine ASP7374.”
Another clinical trial enrolled 55 healthy volunteers aged 61 and over to evaluate the immunogenicity
and safety of intramuscularly-administered ASP7374. This clinical trial showed favorable immunogenicity. No major safety problem was also observed in ASP7374 in this trial. The recombinant seasonal influenza HA vaccine ASP7374 containing three different strains of antigens has been produced by a cell-culture
manufacturing method employing the Baculovirus Expression Vector System (BEVS), a next-generation technology platform for manufacturing biopharmaceutical products.Protein Sciences Corporation
obtained approval of this vaccine from the U.S. Food and DrugAdministration in January 2013. Astellas
Pharma and UMN Pharma believe that the results of these clinical trials showed favorable potential of the
recombinant seasonal influenza HA vaccine ASP7374 produced by a cell-culture manufacturing method
employing the BEVS.
Now, Astellas Pharma and UMN Pharma are preparing for the application for marketing approval of
ASP7374 in Japan.
For Media Inquiries
Corporate Communications, Astellas Pharma, Inc.
TEL: +81-3-3244-3201
FAX: +81-3-5201-7473
Business Development Division, UMN Pharma, Inc.
TEL: +81-45-624-8341
E-mail: [email protected]
IN THE NEWS
61

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