In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million international units (IUs) of protein therapies to the World Federation of Hemophilia (WFH). WFH is an international not-for- profit organization which has worked to improve the lives of people with hemophilia and other inherited bleeding disorders. The donation supports the WFH’s Global Alliance for Progress (GAP) Program aimed at improving the diagnosis and treatment of bleeding disorders in developing countries. CSL was the first biotherapies company in the world to make a multiyear commitment to WFH to aid the GAP Program with coagulation factor donations over an extended period of time, starting in 2009. Rare Disease Day, February 28, is coordinated by the European Organization for Rare Diseases (EURORDIS) and by several national alliances and patient organizations around the globe.

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, to include the ability to individualize therapy with flexible dosing – treatment at regular intervals from daily to once every two weeks (biweekly) – for people with primary immunodeficiency (PI). Self-administered subcutaneously, Hizentra delivers consistent levels of immunoglobulin G (IgG) regardless of dosing schedule. Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once-weekly IgG replacement therapy to help protect people with PI against infections and was approved for biweekly (once every two weeks) dosing in September 2013.

CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Once approved by the FDA, rIX-FP (Coagulation Factor IX {Recombinant}, Albumin Fusion Protein) will provide people with hemophilia B and their physicians a long-acting treatment option with dosing intervals up to 14 days.

Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious genetic form of emphysema called Alpha-1 Antitrypsin Deficiency, also known as Alpha-1.