Company Overview of Octapharma AG
Octapharma AG, a plasma fractionation company, develops, produces, and sells human proteins that are derived from human plasma and human cell-lines in Europe and internationally. It offers haematology products, such as Nuwiq, a human coagulation factor VIII recombinant DNA for the treatment and prophylaxis of bleeding in all age groups with haemophilia A; octanate, a human factor VIII/von Willebrand factor (VWF) concentrate, which is used for the prophylaxis and treatment of bleeding in haemophilia A patients; wilate, a human VWF concentrate to treat von Willebrand disease and haemophilia A patients; and octanine F, a human factor IX concentrate for the prophylaxis and treatment of bleeding ...
Founded in 1983
Key Executives for Octapharma AG
Chairman of Management Board and Chief Executive Officer
Chief Financial Officer and Member of Management Board
Member of Management Board and President of Octapharma Plasma Inc USA
Member of Management Board and President of Octapharma USA INC
Senior Vice President of R&D Plasma - Vienna
Compensation as of Fiscal Year 2016.
Octapharma AG Key Developments
Octapharma Announces Positive Results from Haemophilia A Study
May 22 17
Octapharma AG has announced positive new clinical data in 66 previously treated patients, or PTPs, with severe haemophilia A, or HA, undergoing PK-guided personalized prophylaxis with Nuwiq according to the NuPreviq Approach. The NuPreviq study was initiated in August 2013 with the aim of developing a fully personalized service for HA patients undergoing prophylactic therapy. Octapharma's aim is to improve patient treatment experiences by recognizing that no two HA patients are the same, therefore a 'one size fits all' approach to prophylaxis is not ideal. The NuPreviq study investigated a novel approach, allowing the Nuwiq treatment regimen to be adapted to the specific needs of each individual patient. The NuPreviq Approach measures and profiles each individual patient's pharmacokinetic response to treatment, which then allows the dosing of Nuwiq to be personalized according to the specific circumstances of that patient. The results of the study showed that this personalized prophylaxis approach was very effective at preventing bleeds, while reducing the frequency of dosing and the amount of Nuwiq needed. Over 80% of patients did not experience a spontaneous bleed during the 6 months of personalized prophylaxis with Nuwiq. More than half of the patients received infusions twice a week or less, and dose requirements were reduced by 7%. The study shows that personalized prophylaxis with Nuwiq provides excellent bleeding protection, extension of the dosing interval for most patients, and a reduction in dose. These data further differentiate Nuwiq from other products on the market. The GENA-21 and GENA-21b studies, initiated in August 2013 and March 2015, respectively, are prospective, open-label, multicentre, Phase IIIb studies assessing the safety and efficacy of PK-guided personalized prophylaxis with Nuwiq in previously treated adult patients with severe HA. The studies are each conducted across 29 study locations worldwide. Nuwiq is a naturally long-acting, 4th generation rFVIII protein, produced in a human cell line without chemical modification or fusion with any other protein. Nuwiq is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor. Nuwiq treatment has been assessed in seven completed clinical trials which included 201 PTPs (190 individuals) with severe HA, including 59 children. Nuwiq is approved for use in the treatment and prophylaxis of bleeding across all age groups of PTPs with haemophilia A in the EU, US, Canada, Australia, Latin America and Russia.
The Octapharma Group Announces Earnings Results for the Year 2016
Mar 1 17
The Octapharma Group announced earnings results for the year 2016. For the year, the company reported sales of €1.6 billion, which represents an increase of €87 million or 5.8% compared with 2015. Octapharma achieved an unprecedented operating income of €383 million.
Octapharma AG Announces Interim Data from Phase III Hemophilia A Study
Dec 21 16
Octapharma AG has announced interim data from the ongoing Phase III study, NuProtect, in patients with hemophilia A, at the 58th ASH Annual Meeting & Exposition in San Diego, California. The presentation was nominated for inclusion in the 2017 North American Highlights of ASH Roadshow meeting with an abstract published in Blood. The NuProtect Study examines the immunogenicity, efficacy and safety of treatment with human cell-line derived recombinant FVIII (Nuwiq) in previously untreated patients (PUPs) with severe haemophilia A. The presentation focused on immunogenicity of Nuwiq in 66 haemophilia A patients who have received at least 20 days of treatment in the ongoing NuProtect study, with no previous exposure to FVIII concentrates or other blood products. The cumulative incidence (95% confidence interval) of all inhibitors was 20.8% (10.7-31.0); 12.8% (4.5-21.2) for high-titre inhibitors and 8.4% (1.3-15.6) for low-tire inhibitors. These data were reported as part of a pre-planned interim analysis for the NuProtect study, which plans to ultimately evaluate at least 100 PUPs.
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