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Octanate – Factor VIII with the Safety Factor VWF

Octanate – Factor VIII with the Safety Factor VWF. High Purity Plasma-Derived Factor VIII Double Virus Inactivated Haemophilia A Treatment and Prophylaxis. Octanate at a Glance. Physiological factor VIII Naturally stabilised with VWF Highly purified Non denatured

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Octanate – Factor VIII with the Safety Factor VWF

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  1. Octanate – Factor VIII with the Safety Factor VWF High Purity Plasma-Derived Factor VIII Double Virus Inactivated Haemophilia A Treatment and Prophylaxis

  2. Octanate at a Glance • Physiological factor VIII Naturally stabilised with VWF Highly purified Non denatured • Extensive clinical use Safe Effective Well-tolerated • State-of-the-art virus safety High quality starting plasma Double virus inactivation: Solvent / Detergent (S/D) treatment Short duration dry heating, 100 °C, 30 min • Convenient handling Small injection volume Easy documentation

  3. Octanate Manufacturing Process Cryoprecipitate Ultrafiltration, diafiltration Resuspension in ethanol-heparin Sterile filtration, filling Aluminium hydroxide addition Lyophilisation, vial closure Adsorption and precipitation Terminal dry heating, 100 °C, 30 min S/D virus inactivation OCTANATE Ion exchange chromatography

  4. Octanate – Viral Safety: Conclusion • Octanate fulfils all current requirements for virus safety set out by regulatory bodies, such as the Committee for Proprietary Medicinal Products* • Two effective steps against lipid enveloped viruses • One effective step against non enveloped viruses • A combination of methods based on different principles of action • Inactivation procedures with a high safety margin • Rapid virus inactivation • Robustness in the event of process variations • Validation of each step with a wide variety of viruses • An individual step efficacy equivalent to 4 log10 • Other process steps provide additional safety *CPMP/BWP/268/95, 1996. CPMP/BWP/269/95 rev 3., 2001

  5. Octanate – Physiologically Stabilised with VWF • Importance of von Willebrand Factor • Biosynthesis of factor VIII VWF imparts correct factor VIII structure and secretion • Stabilisation of factor VIII Protects against unwanted activation and degradation • Transport of factor VIII Directs factor VIII to the site of injury

  6. Octanate – Pharmacokinetics

  7. Octanate – Clinical Efficacy 95.3 % of All Bleeding Episodes Resolved Within 3 Days No. Bleeds 1096 (Total) 167 (Study 1) 374 (Study 2) 213 (Study 3) 342 (Study 4)

  8. Octanate at a Glance – In Daily Clinical Use • Clinical safety and efficacy No inhibitors No virus transmissions Very well tolerated Very good efficacy Successful use in surgery, and in continuous infusion • Convenient handling Small injection volume Easy documentation Pull-off labels Dissolves rapidly Complete application set • Presentation • Storage and shelf-life 24 months shelf-life at + 4 °C to + 8 °C. Do not freeze. Protect from light

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