LACHEN, Switzerland (November 15, 2011) – Octapharma today reported that global sales totaled 1.7 million grams of octagam® 5% and octagam® 10%, [Immune Globulin Intravenous (Human) Liquid Preparation] in the period January 1 through October 30, 2011, an estimated 60,000 treatments, during which there were no reports of thromboembolic events (TEEs).
In August 2010, Octapharma implemented a voluntary market withdrawal of octagam® 5% and octagam® 10% in response to an observed increase of TEEs, which occur when a clot or thrombus forms locally in a blood vessel or breaks loose in the blood stream to occlude another vessel.
“Octapharma’s 10-month product analysis confirms our commitment to provide patients with an octagam® 5% and octagam® 10% that offers an enhanced level of safety,” said Octapharma Chairman Wolfgang Marguerre. “Industry-wide, immune globulin products can lead to TEEs in approximately 1 individual or less for every 10,000 treatments. But our analysis indicates that octagam® 5% and octagam® 10% outperformed this industry benchmark with no reported TEEs in approximately 60,000 patient treatments.”
The U.S. Food and Drug Administration (FDA) last week cleared the way for the U.S. market return of octagam® 5%. The product is expected to again be available in the U.S. within two weeks.
Earlier this year, multiple international regulatory agencies authorized the return of octagam® 5% and octagam® 10% in important worldwide markets. The product is presently approved for distribution in the U.S., Austria, Belgium, Bulgaria, Bosnia, Cyprus, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, and the United Kingdom. octagam® 10% is not approved for marketing in the U.S.
The marketing approvals are based on changes Octapharma has made in the octagam® 5% and octagam® 10% manufacturing process and the company’s decision to implement a quality control test on every batch of product that is released to the marketplace for the absence of thrombogenic potential. Additionally, Octapharma will implement post-marketing studies to ensure product safety.
Octapharma’s estimate of 60,000 octagam® 5% and octagam® 10% patient treatments is based on the reported global sales of 1.7 million grams, not on actual recorded patient treatment sessions. The number of treatments is based on average patient utilization per treatment. The data has not been submitted to the FDA for evaluation.
About octagam® 5%
octagam® [Immune Globulin Intravenous (Human) 5% Liquid Preparation] is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. octagam® 5% liquid is a solution for infusion which must be administered intravenously.
octagam® 5% is an immune globulin intravenous (human liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.
About octagam® 10%
octagam® 10% is a liquid (100 mg/mL) Immune Globulin (Human) solution for intravenous administration (IVIG) which is currently registered mainly in European countries, where it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 28 years. Octapharma’s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma’s IGIV product, octagam® (Immune Globulin Intravenous [Human] 5%), is used to treat primary immune deficiencies, and Octapharma’s Albumin (Human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma’s wilate® (Von Willebrand Factor/Coagulation Factor VIII Complex [Human]) received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of certain types of Von Willebrand Disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com or www.wilateusa.com.