CSL Opens World-Class, Advanced Manufacturing Facility for Late-Stage Production of Hemophilia Therapies Now in Development

-- Leading-edge science at the core of $250 million expansion to drive long-term growth in promising bleeding disorders portfolio

-- CSL Behring to commercialize therapies produced in part at the facility, pending required approvals

-- Opening taking place in advance of World Federation of Hemophilia 2014 Congress in Melbourne, Australia

News provided by

CSL Behring

May 09, 2014, 09:30 ET

KING OF PRUSSIA, Pa., May 9, 2014 /PRNewswire/ -- CSL Limited (ASX:CSL), parent company of CSL Behring which is based in King of Prussia, PA, today opened the CSL Behring Biotechnology Manufacturing Facility in Melbourne, Australia. The new facility, located adjacent to the site's manufacturing plant for plasma products, is the centerpiece of CSL's $250 million expansion at its Broadmeadows site and will play an increasingly important role in the company's global operations, particularly in the late-stage development of new types of hemophilia products. It is one of the largest and most advanced facilities of its kind in the world and will produce novel recombinant therapies on a large scale for international clinical trials.

CSL Behring's new biotechnology manufacturing facility in Melbourne, Australia. It is one of the largest and most advanced facilities of its kind in the world and will produce novel recombinant therapies on a large scale for international clinical trials. (PRNewsFoto/CSL Behring)

"This world-class facility is key to the ongoing success of our global R&D strategy and reflects our commitment to providing better treatment options for people who are managing certain bleeding disorders and other life-threatening conditions," said CSL Chief Executive Officer, Paul Perreault.

The company's recombinant factor development programs, which comprise the AFFINITY trial and the PROLONG trial for the study of therapies to treat hemophilia A and B, respectively, are central to its long-term growth plans. Several candidates in these trials are showing promise, including rVIII-SingleChain, rIX-FP, and rVIIa-FP.

Recombinant therapies are modified versions of naturally occurring human proteins that have been optimized to provide additional treatment options for patients. CSL has more recently developed specialist capabilities in recombinant-based research, adding to its long-standing expertise in plasma protein therapeutics. CSL's research and development pipeline currently includes recombinant therapies for a range of rare and serious disease, including bleeding disorders, inflammatory conditions and cancer.

The first therapy to be manufactured in the new Broadmeadows facility will be a novel blood clotting factor (rVIIa-FP) for the treatment of hemophilia. This is one of several longer-acting clotting factors under development by CSL that aims to reduce the number of injections required to maintain normal blood clotting in people with bleeding disorders. Clinical trials of rVIIa-FP in patients are expected to commence later this year in the United States, Europe and Australia. International recruitment is ongoing for the rVIII-SingleChain and rIX-FP studies.

About CSL

The CSL Group, headquartered in Melbourne, Australia, has a combined heritage of outstanding contribution to medicine and human health with more than 90 years of experience in the development and manufacture of vaccines and plasma protein biotherapies. With major facilities in Australia, Germany, Switzerland and the U.S., CSL has about 12,000 employees in nearly 30 countries.

About CSL Behring

CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.

CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease in the newborn. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL). For more information, visit www.cslbehring.com.

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SOURCE CSL Behring