New High Purity Immunoglobulin Enters Phase III in Europe and the US

General Press Releases Tuesday February 16, 2010 16:13
LACHEN--16 Feb--PRNewswire-AsiaNet / InfoQuest
  • Octapharma to Set New Standards in IVIG Development, Focused on Improving Outcomes For Patients and Physicians
Octapharma AG today announced the start of the first of a series of Phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG).

The study will investigate the efficacy and safety of this novel immunoglobulin in the treatment of primary immune deficiency and, together with results from additional upcoming studies, will support its regulatory filing in Europe and the US.

Commenting on the start of the study, Kim Bjornstrup, Deputy Chairman of Octapharma Group said, "The development of our novel 10% IVIG is part of our ongoing commitment to invest in the development of protein based immunotherapies and in particular in IgG preparations. For 25 years, our cutting-edge research programme has sought to develop new biological entities tailored specifically around the needs of clinicians and patients - delivering improved quality of life for patients and ease of delivery and management for hospitals."

"Octapharma's stated aim is not to develop just another IVIG brand but to invest extensive time and preclinical resources to ensure that the new IVIG will offer outstanding features, representing tangible added value for the patient and care giver, such as exceptional tolerability," added Kim Bjornstrup.

The development of this pioneering high purity IVIG builds upon Octapharma's experience in the area of immunoglobulin products. octagam(R), Octapharma's current leading IVIG (an immune globulin human solution for intravenous administration) is registered in about 60 countries, including the EU and the US.

"Octapharma's new 10% IVIG will be a step forward in the evolution of IVIG products. In the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at high infusion rates. Pre-clinical studies and initial clinical experiences have confirmed that a favourable tolerability profile may be expected," commented the coordinating investigator of the study, Professor Michael Borte of Leipzig, Germany.

The Phase III study in primary immune deficiency represents the start of a series of planned studies to investigate Octapharma's new 10% IVIG for a range of neurologic and haematological conditions including idiopathic thrombocytopenic purpura (ITP), Guillain-Barré syndrome (GBS) and Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

About Primary Immune Deficiency

Primary immunodeficiencies are disorders in which part of the body's immune system is missing or do not function properly(1). As one of the most important functions of the normal immune system is to protect us against infection, patients with primary immunodeficiency diseases commonly have an increased susceptibility to infection(2) including severe ones such as pneumonia or sepsis. Most primary immunodeficiencies are genetic disorders; the majority are diagnosed in children under the age of one, although milder forms may not be recognised until adulthood. About 1 in 500 people are born with a primary immunodeficiency(1).

About Octapharma AG

Octapharma, a biopharmaceutical company, was founded in 1983. Its mission is to work for the safe and optimal usage of human proteins. Octapharma products are state-of-the-art within treatment of aemophilia, immune diseases, volume expansion and plasma transfusions. Octapharma's turnover in 2008 was EUR 886 million. Octapharma is a privately held company with headquarters in Lachen, Switzerland, and employs 2,500 people worldwide.

About octagam(R)
octagam(R) is a 5% (50 mg/mL) immune globulin (human) solution for intravenous administration (IVIG), currently registered in about 60 countries worldwide.
References
(1) Lim MS, Elenitoba-Johnson KS (2004). "The molecular pathology of
primary immunodeficiencies". The Journal of molecular diagnostics: JMD 6 (2):
59-83. PMID 15096561.
(2) Immune Deficiency Foundation.
http://www.primaryimmune.org/about_pi/about_pi.htm. Accessed January 2010.
SOURCE: Octapharma AG
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