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Influenza Prevention from CSL BiotherapiesVaccines with Reliable Quality...Dependable Delivery
Company Roots
CSL Biotherapies is a company of CSL Limited, a publicly traded, global,specialty biopharmaceutical business.CSL Limited develops, manufactures andmarkets products to treat and preventserious human medical conditions.
The company was founded by theAustralian government in 1916 to produce vaccines and other biologicalsduring World War I. Over the years CSLLimited grew to produce a broad rangeof biotherapies. Today the company
Vaccines are our business, our passion—and our history
at CSL Biotherapies. A new name in the U.S. flu vaccine
market, CSL Biotherapies is no newcomer to the global
vaccine business. We’ve been making flu vaccines for
40 years. CSL Biotherapies’ flu vaccines are licensed
and sold in 16 countries and we supply the antigen
for vaccine in 24 countries.
CSL Biotherapies is one of the fewproviders of flu vaccines in the worldtoday. That gives CSL Biotherapies acentral role in helping to protect publichealth. It is a role we take seriously. Inthe face of rising global demand for fluvaccines, potentially straining internationalsupplies, our commitment to our businessand the patient is stronger than ever.
CSL is distinctive in the global vaccinemarket because we are extraordinarilypassionate about our work—and mind-ful of how important our products areto the health of the patients we serve.
has 8,500 employees in 21 countries(more than 4,000 in the U.S.), and is a world leader in plasma therapeutics.CSL Limited’s life-saving and life-prolonging therapies are used to treathemophilia, bleeding disorders and primary immune deficiency disorders—as well as to prevent Rh factor incom-patibilities in newborns, assist recoveryfrom heart surgery and treat shock andsevere burns.
About CSL Biotherapies
Our roots in CSL Limited’s long history—and CSL Biotherapies’ 40-year trackrecord in vaccines—are good reasonsto have complete confidence in ourability to produce quality vaccines anddeliver them reliably.
Our four decades in this work—drivenby productive and innovative research—have allowed us to bring to marketproducts that can mean the differencebetween sickness and health, betweenlife and death. CSL Biotherapies has
Vaccines Are Our Business, Our Passion
CSL EstablishedThe Commonwealth SerumLaboratories are established inMelbourne, Australia, to servicethe health needs of a nationisolated by war.
Poliomyelitis VaccineProduction Beginsat CSLBetween 1956 and 1960, nearly18 million doses of the Salkpolio vaccine are administered.
1916 ●1919 ●
1956 ●1994 ●
Spanish Flu Pandemic
CSL produces three milliondoses of mixed bacterial vaccine.
CSL Produces SplitVirion Influenza Vaccine
1968 ●
CSL Becomes PublicCompany
CSL is listed on Australian Stock Exchange.
developed vaccines for flu; pneumonia;meningitis; diphtheria and tetanus;hepatitis; measles, mumps and rubella;rotavirus-induced gastroenteritis—andmost recently, cervical cancer. Thosecontributions to human health come as a result of our primary dedication to the lives of our patients.
Why CSL Biotherapies Should
Supply Your Flu Vaccine
At CSL Biotherapies, we focus on
vaccines. CSL Biotherapies produced flu vaccine in 1968 for that year’sinfluenza pandemic. With 40 years’experience, CSL Biotherapies is committed to this area of medicine—and to future growth. Our facilities provide state-of-the-art manufacturingof Afluria™, Enzira™, Fluvax™,Nilgrip™, and X-Flu™ to meet international demand. Our antigenmanufacturing plant is equipped tomeet demand for flu vaccines from customers in both Northern andSouthern Hemisphere markets.
CSL Biotherapies means quality. Toassure consistent quality of our vaccine,we tightly control every step of themanufacturing process and supplychain. This includes close monitoring of egg production, skillful seed development, stringent control of
individual batch quality in compliancewith applicable regulatory guidelines,and distribution of product that is temperature and environment controlled. This assures that every dose of vaccine reaching our patients is of consistently high quality.
At CSL's center for the manufacture of influenza vaccine, a technician monitors the buffer
preparation area.
GARDASIL®—A VaccineAgainst Cervical CancerCSL’s collaboration with Merck& Co., Inc. to develop a cervicalcancer vaccine succeeds. Theproduct enters Phase III clinicaltrials and in 2006 receives FDA approval.
2002 ●2002 ●
2004 ●2007 ●
Expansion of ParkvilleInfluenza PlantCSL expands operations, effec-tively doubling the productionof influenza vaccine to supplythe demands in the Northernand Southern Hemispheres.
Thimerosal-freeInfluenza VaccineIntroduced
Development of aPandemic Flu Vaccine
CSL continues to worktoward the development,production and planned distribution of a vaccineagainst pandemic influenza.
CSL Acquires Aventis Behring
CSL creates ZLB Behring, nowknown as CSL Behring, a globalleader in biotherapies.
2005 ●
CSL Biotherapies is a leading-edge
innovator. In 2002, innovations inmanufacture led to the approval of a thimerosal-free influenza vaccine.Our strong commitment to researchand development continues to deliverimportant advances in health care.
Our research on adjuvants is welladvanced. CSL’s ISCOMATRIX® adjuvant,which may boost the effectiveness ofvaccine applications, is in clinical trials. ISCOMATRIX is well suited for vaccinesthat require a rapid and high antibodyand cellular immune response, such as for flu prevention in the elderly. Thetechnology has moved to a larger scalemanufacturing environment at ourKankakee, Illinois, plant.
The most recent vaccine that has cometo market with CSL Biotherapies’ participation is GARDASIL®. This is theworld’s first vaccine against cervicalcancer, the second most prevalent cancer in women. GARDASIL is thepowerful result of more than 15 yearsof collaborative work among CSL scientists and investigators at theUniversity of Queensland, Australia,and since 1995, the strong support ofMerck, our licensee for this product. It has the potential to benefit millionsof women.
CSL has responded quickly and vigor-ously to the international public healththreat of bird flu. We have producedand are testing an experimental vaccine against the H5N1 strain.
1020 First Avenue, P.O. Box 60446, King of Prussia, PA 19406-0901 ■ 1-888-435-8633
www.cslbiotherapies-us.com
© 2007 CSL Biotherapies. ISCOMATRIX is a registered trademark of CSL. GARDASIL is a registered trademark of Merck & Co., Inc.
Reliable Quality...Dependable Delivery
■ Innovation We seek better ways of doing things.
■ Integrity We are ethical and honest at all times.
■ Collaboration We work togetherto achieve better results.
■ Superior Performance We striveto be the best at what we do.
We advocate for health. That’s whatCSL Biotherapies stands for. Vaccinescan be a strong ally to people theworld over in staying healthy. But theymust be of the highest quality anddelivered reliably. We are proud to be a leader in doing that—and we lookforward to continuing to provide safeand effective vaccines that improve the quality of life for years to come.
We are working closely with publichealth and regulatory authorities todevelop and license a safe and effectiveprototype vaccine as soon as possible.
Our Commitment
At CSL Biotherapies, we care aboutpatients. We never forget that people’slives depend upon our products. Thepatient is always at the center of ourefforts, and we offer support servicesand patient-focused resources as partof this primary ongoing commitment.
That commitment to the patient isembedded in the culture of the company.Our core values are:
■ Customer Focus We are passionateabout meeting the needs of our customers.
Egg harvesting machine in CSL’s new state-of-the-art flu vaccine center.
CSL Behring
1020 First Avenue
PO Box 61501
King of Prussia, PA 19406-0901
Embargoed Until 9:00 am August 1
For Release: August 1, 2007
CSL Behring is a company of CSL Limited
CSL Behring To Build High-Speed Syringe Fill Line
at its Kankakee (Il) Facility
--$15 million investment to fill single-dose syringes for seasonal influenza vaccine --
Kankakee, Il—August 1, 2007 -- CSL Behring today announced plans to
invest $15 million to expand its manufacturing facility here by adding a
high-speed, single-dose syringe filling line. Plans call for the line to be
operational in 2010, when the company intends to contract with its sister
company, CSL Biotherapies, to provide filling and packaging services for
seasonal influenza vaccine.
CSL Biotherapies anticipates introducing its influenza vaccine to the U.S.
beginning with the 2007/08 season. CSL Biotherapies has filed a
Biologics License Application (BLA) with the U.S. Food and Drug
Administration. The BLA requests that the vaccine be approved to
immunize people 18 years of age and older. The approved vaccine will be
made available in single-dose, thimerosal-free, pre-filled syringes and in
multi-dose vials, providing choice and convenience to caregivers who
administer it.
Page 2 of 3
CSL Limited, the parent company of both CSL Behring and CSL
Biotherapies, previously announced plans to invest $60 million in plant
and equipment to double flu manufacturing capacity at its Melbourne,
Australia facility.
“This additional $15 million investment underscores our continuing
commitment to the Kankakee site,” said Randy Furby, Senior Vice
President and General Manager of the facility. “CSL has made a major,
long-term commitment to the U.S. vaccine market, and this building plan
represents a key part of our overall business strategy.” The Kankakee
facility currently employs 600 people.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics
industry. Passionate about saving and improving the quality of patients'
lives, CSL Behring manufactures and markets a range of safe and effective
plasma-derived and recombinant products and related services. The
company's therapies are used in the treatment of rare diseases such as
immune deficiency disorders, hemophilia, von Willebrand disease, other
bleeding disorders and inherited emphysema. Other products are used for
the prevention of hemolytic diseases in the newborn, in cardiac surgery,
organ transplantation and in the treatment of burns. The company also
operates one of the world's largest plasma collection networks, ZLB Plasma.
CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company
Page 3 of 3
with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
About CSL Biotherapies The U.S. headquarters of CSL Biotherapies is located in King of Prussia, Pa. Its parent company, CSL Limited, operates one of the world’s largest influenza vaccine facilities for global markets in Melbourne, Australia. CSL Biotherapies is commercializing influenza vaccine products globally. At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Bioplasma and CSL Behring, has more than 8,500 employees in 21 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com.
Contacts: Roger Bentley, Senior Director, Corporate Communications CSL Behring 1020 First Avenue, King of Prussia PA 19406 610-878-4155 [email protected]
Sheila A. Burke, Director Public Relations & Communications Worldwide Commercial Operations, CSL Biotherapies 1020 First Avenue, King of Prussia, PA 19406-0901 610-290-7403 [email protected]
