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

Tuesday, February 16, 2010 Press Release J E 4
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LACHEN, Switzerland, February 16

- Octapharma to Set New Standards in IVIG Development, Focused onImproving Outcomes For Patients and Physicians

Octapharma AG today announced the start of the first of a series of PhaseIII studies for its new 10% high purity intravenous immunoglobulin (IVIG).The study will investigate the efficacy and safety of this novelimmunoglobulin in the treatment of primary immune deficiency and, togetherwith results from additional upcoming studies, will support its regulatoryfiling in Europe and the US.

Commenting on the start of the study, Kim Björnstrup, Deputy Chairman ofOctapharma Group said, "The development of our novel 10% IVIG is part of ourongoing commitment to invest in the development of protein basedimmunotherapies and in particular in IgG preparations. For 25 years, ourcutting-edge research programme has sought to develop new biological entitiestailored specifically around the needs of clinicians and patients -delivering improved quality of life for patients and ease of delivery andmanagement for hospitals."

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

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

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

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

About Primary Immune Deficiency

Primary immunodeficiencies are disorders in which part of the body'simmune system is missing or do not function properly(1). As one of the mostimportant functions of the normal immune system is to protect us againstinfection, patients with primary immunodeficiency diseases commonly have anincreased susceptibility to infection(2) including severe ones such aspneumonia or sepsis. Most primary immunodeficiencies are genetic disorders;the majority are diagnosed in children under the age of one, although milderforms may not be recognised until adulthood. About 1 in 500 people are bornwith a primary immunodeficiency(1).

About Octapharma AG

Octapharma, a biopharmaceutical company, was founded in 1983. Its missionis to work for the safe and optimal usage of human proteins. Octapharmaproducts are state-of-the-art within treatment of haemophilia, immunediseases, volume expansion and plasma transfusions. Octapharma's turnover in2008 was EUR 886 million. Octapharma is a privately held company withheadquarters in Lachen, Switzerland, and employs 2,500 people worldwide.

About octagam(R)

octagam(R) is a 5% (50 mg/mL) immune globulin (human) solution forintravenous administration (IVIG), currently registered in about 60 countriesworldwide.

References

(1) Lim MS, Elenitoba-Johnson KS (2004). "The molecular pathology ofprimary 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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