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CSL Behring

CSL Behring develops therapies to treat rare and serious conditions as though patients’ lives depend on them – because they do.

Around the world, CSL Behring brings life-saving and life-enhancing therapies to people with primary immune deficiencies, bleeding disorders (including haemophilia, congenital fibrinogen deficiency and von Willebrand disease), hereditary angioedema, certain neurological disorders, inherited respiratory disease and other serious conditions. Our products are also used to prevent haemolytic disease in newborns, speed recovery after heart surgery, prevent infection in people undergoing solid organ transplants, and to help victims of shock and burns to recover faster.

We listen carefully to the concerns of the patients and caregivers we serve and then work to address their needs. Not only do we provide safe and effective products aimed at delivering a better quality of life, CSL Behring also offers programs and educational tools that help patients and families manage the daily challenges of living with a chronic condition. We also collaborate with patient groups and policy makers around the world to advocate for patient access to care.

CSL Behring has a long history of manufacturing innovative products in state-of-the-art facilities. We use the most sophisticated methods available and meet or exceed stringent international safety and quality standards. Each step of our manufacturing process from plasma donor to patient reflects the Company’s unyielding commitment to ensuring its products are safe.

We are a global leader in biotherapies, with substantial markets in North America, Europe, Australia, Latin America, the Middle East and Asia. CSL Behring is committed to maintaining a reliable and consistent product supply, while continuing to expand its pipeline of new and improved plasma and recombinant therapies, by using cost-effective, high-yield manufacturing processes, efficient operations and highly skilled personnel.

Headquartered in King of Prussia, Pennsylvania (US), CSL Behring operates manufacturing plants in Kankakee, Illinois (US), Bern (Switzerland), Marburg (Germany), and in Melbourne, Australia. Regional sales and distribution centres are located throughout the world.

CSL Behring is committed to saving lives and improving the quality of life for people with rare and serious diseases worldwide.

Annual Report
In September 2013 at our Kankakee site, CSL’s Board participated in a ceremonial ribbon cutting dedication for new facilities and systems which will significantly increase capacity, including a new base fractionation facility, an Alburex® bulk purification facility, a new filling area and several final container finishing departments.

Privigen® – A Flagship IVIg

Since launching in 2007 as the world’s first 10%, proline-stabilized intravenous immunoglobulin (IVIg), Privigen® has performed well in numerous major geographies as one of CSL Behring’s flagship products in a large and growing portfolio of therapies used in treating a range of conditions, most notably primary immunodeficiency (PID), secondary immunodeficiency (SID), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

During fiscal year 2013/14, Privigen® continued to deliver strong results in multiple regions. The Company’s Intercontinental region was particularly successful with this brand, driving rapid and unprecedented expansion into new markets including Russia, Turkey, Iran and Algeria via product approvals and launches.

Globally, Privigen® is expected to gain a sizeable presence in the neurology space with its labeled indication for CIDP in Europe and with the CIDP indication approved in Canada in May 2014.

100 million grams of Privigen®

Meeting this commercial potential requires significant strategic planning and capital investment. In May 2014, only six years into production, our Bern manufacturing site reached the 100 million gram (100 tons) mark in the manufacture of Privigen®. This has been achieved through improvements in technology and productivity, strong teamwork, and a project that brought about a significant increase in manufacturing capacity. Privigen® is currently registered in more than 55 countries.

For thousands of patients with rare and serious diseases, the 100 million grams of Privigen® produced in Bern has provided a reliable supply of safe and efficacious therapy. In 2016, a new 15 million gram capacity Privigen® manufacturing facility is due to become operational at our Broadmeadows site in Melbourne, Australia.

Annual Report - Hizentra® and Privigen® Facility

Inside the IgLAB bulk manufacturing facility in Bern where chromatography and virus filtration operations are carried out for Privigen® and Hizentra®.

CEO joins Australian Trade Mission to Japan, China and Korea

Annual Report - Australian Trade Mission

CSL’s CEO Paul Perreault is introduced to President of South Korea, Park Geun-hye by Australian Prime Minister, Tony Abbott.

As CEO of Australia’s largest biopharmaceutical company with a leading global position in healthcare and innovation, Paul Perreault was invited to join Australian Prime Minister Tony Abbott’s trade delegation to Japan, China and Korea in April 2014. These countries are important strategic markets for CSL, given their combined gross domestic product of US$15 trillion and collective population of 1.5 billion.

“My role was to talk to Japanese, Chinese and Korean business leaders to share some of our experiences with them,” said Paul. “We had valuable discussions with key officials about how business operates in their regions and how we can bring innovation by opening trade channels.”

With a sales office and manufacturing site in Japan, CSL has had a long-standing presence in the country. Paul said his focus for this part of the trip was to gain a better understanding of how to work more effectively with regulators and the government. In China, Paul said the mission afforded him an opportunity to open discussions with health authorities and others to determine how CSL could both help expand healthcare in China and share global best practices in the plasma sector.

A Model of Strength and Endurance

Annual Report - A Model of Strength and Endurance

Robbie and Tricia with Karen Lewis, Assistant Manager at CSL Plasma’s Dayton Ohio collection centre.

Robbie Skrinak looks like any 15-year-old teenager but what most people don’t know is he has Common Variable Immune Disease (CVID), characterized by low levels of serum immunoglobulins (antibodies) causing increased susceptibility to infection.

“Robbie was sick within the first couple weeks after we brought him home from the hospital” says his mother Tricia. “From that point on, he was always sick. Robbie was our fifth child so I knew something was not right. Diagnosed with CVID when he was four, Robbie now receives subcutaneous Hizentra® every week. We have been very happy with his treatment and outlook on life”. Robbie enjoys tennis but due to chronic fatigue caused by CVID he mostly enjoys computers, chess and magic cards. “Robbie is a computer genius” says Tricia.

Adopt-a-Patient visits to the CSL Plasma centre in Dayton are important to Robbie and his parents. “Without the donors, there would be no Robbie” says Tricia. “He is our light. Robbie is our model of strength and endurance. The CSL Plasma Adopt-a-Patient program really helps because I believe when people can connect a face to a need they are more willing to help make a difference. For us, that means donors continue to donate plasma and employees work together for patients like Robbie. Thank you CSL!”

Jenn stays fit and healthy

Annual Report - Jenn stays fit and healthy With a love for the outdoors and physical fitness, last year alone Jenn Koles cycled more than 4,000 miles and peddled up hills and mountains totalling more than 330,000 feet – more than 11 times the height of Mount Everest. “When I am outdoors, I enjoy the ability to get away and be in an open space to explore and smell fresh air. I feel like there is an unlimited area for me to enjoy when I’m on my bike and cycling helps me get away from stress.”

One source of stress in Jenn’s life is von Willebrand disease or VWD, the most common hereditary bleeding disorder affecting about one percent of the population. Caused when von Willebrand factor (a blood protein necessary for clotting) is missing or not working properly, VWD is equally likely to affect men and women.

“I had multiple surgeries before I was 18 that all resulted in severe bleeding. It was not until I went for a consult to have my wisdom teeth removed at the age of 18 that tests determined I had a bleeding disorder. Jenn manages VWD with Humate-P® (plasma-derived factor VIII/von Willebrand factor complex) which restores the clotting factor missing from her blood.

When not on the bike, Jenn enjoys snowboarding, snowshoeing, hiking, rock climbing and writing about the outdoors. She also serves as a member of the VWD Consumer Advisory Board for CSL Behring, where she shares her story with women and men who are managing VWD. “It’s critical that people with VWD learn about the importance of exercise, fitness and stress management,” says Jenn. “In life, my goal is to be as happy and as healthy as I can.”

Hizentra® approved in Japan

Annual Report - Hizentra® approved in Japan

Hizentra® subcutaneous immunoglobulin therapy is now available in Japan following product approval in September 2013 by the Japanese Ministry of Health, Labour and Welfare.

Among presenters at the January 2014 Hizentra® launch event was Professor Shigeaki Nonoyama (above) from the Department of Pediatrics, National Defense Medical College, in Saitama, Japan.

Hizentra® brings Primary Immunodeficiency (PID) and Secondary Immunodeficiency (SID) patients access to the convenience of this first and only 20% subcutaneous immunoglobulin therapy for treatment of these conditions.

Ben's future is looking bright

Annual Report - Ben Growing up near his family’s dairy farm, Ben Davies developed an enthusiasm for working with animals. Now a teenager, Ben raises pigs and cattle and occasionally travels more than a thousand miles to show them in exhibitions.

“Ben has always been an outdoor kid with a great sense of adventure,” said his mother, Traci. “However, as a boy, he was frequently ill.”

When Ben was eight years old, he was finally diagnosed with Primary Immunodeficiency (PID), a group of serious diseases of the immune system affecting millions of children and adults worldwide. For people living with PID, infections may be common, severe, long-lasting, and/or hard to cure.

Hizentra® every two weeks

Nowadays, Ben self-administers Hizentra®, a subcutaneous immunoglobulin, once every two weeks. This bi-weekly treatment regimen helps Ben keep up with his life as an active teenager. “I can go on trips and go to shows.” Ben no longer sees treating his condition as infringing on his time.

Ben heads off to college in the next year and Traci is excited for his prospects. “I think his future is very bright. PID has taught him a lot about himself. He’s learned a lot about acceptance, responsibility and taking control of what he can control.”