CSL Behring's capacity to produce Hizentra® a key product in its global immunoglobulin portfolio, has more than doubled following U.S. Food and Drug Administration (FDA) approval of the company's high tech production facility in Bern, Switzerland, where Hizentra is produced. While demand for Hizentra is growing rapidly in the United States, CSL Behring anticipates regulatory approvals of Hizentra in European countries, with subsequent product launches in individual European countries. Further, the product is in clinical development in Japan. Uptake of Hizentra in those regions is forecast to be sizeable over time.
Next month, the company plans to submit an application to the European Medicines Agency for approval of the production facility.
"The Bern facility expansion is yet another example of CSL Behring's commitment to ensuring patients have access to immunoglobulin therapy over the long term," said Paul Perreault, CSL Behring Executive Vice President, Worldwide Commercial Operations. "CSL Behring understands that Ig therapy is critically important for those who rely on it every day in order to live and to enjoy a certain quality of life. We are gratified to be able to serve patients further in this way."
Hizentra, the first and only ready-to-use 20 percent subcutaneous immunoglobulin (SCIg) can be stored at room temperature, allowing patients to self-administer it at home or in any proper setting; patients are no longer required to schedule their lives around their Ig treatment.
The CSL Behring Bern, Switzerland, facility combines state-of-the-art industrial-scale filtration technology, highly efficient separation processes and advanced formulation to generate increased volumes of immunoglobulin therapy. On March 31, 2011, CSL Behring also recently received FDA approval for further expansion of its Privigen® manufacturing capacity. CSL Behring was recently recognized by the Swiss government with a Tell Award for being the North America-based company making the most significant investment in innovative technology in Switzerland.
Primary Immunodeficiency affects 10 million people worldwide
Primary Immunodeficiency (PI) is a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system. In people with PI, the immune system is either absent or functioning inadequately, leaving them more susceptible to infection. These infections often do not improve with treatment and may keep returning. Patients may therefore face repeated rounds of antibiotics or be hospitalized. Repeated infections can lead to organ damage which can become life-threatening. PIs affect an estimated 10 million people worldwide or 1 in 10,000.
For more information on PI, please visit www.cslbehring.com or contact the leading PI patient advocate groups in the U.S., the Immune Deficiency Foundation and the Jeffrey Modell Foundation.
Hizentra® (Immune Globulin Subcutaneous [Human]), the first and only 20 percent SCIg developed for subcutaneous use, is already approved in the United States and in registration in Europe and Switzerland. It is stable at 25° C for at least 30 months due to formulation with L-proline. In the United States, Hizentra is indicated for the treatment of patients with primary immunodeficiency (PI), and contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra , and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. The most common drug-related adverse reactions, observed in 5 percent or more of subjects in the United States clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue. For more information, including full United States prescribing information, visit http://www.hizentra.com/.
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 indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
41 31 344 53 23(o)