Octapharma News February 15th, 2005

February 15th, 2005

Wilate®, Octapharma’s New Generation VWF/FVIII-concentrate, Receives Registration Approval in Germany .

Octapharma AG, a worldwide company dedicated to the production of therapeutic plasma proteins, has received the approval from the Paul-Ehrlich Institute (PEI) to market and sell Wilate® in Germany .

Raising the standard
Wilate® represents a new generation VWF/FVIII-concentrate for the treatment of von Willebrand Disease (VWD) and haemophilia A. A significant move forward for patients suffering from VWD, Wilate raises the standard in the treatment options with respect to its combination of double virus safety, purity and clinical efficacy.

Wilate® is the first high purity VWF/FVIII-concentrate with two independent virus inactivation steps licensed for the treatment of all types of VWD and haemophilia A in Germany. VWD is estimated to affect 1% of the population, making it the most common inherited bleeding disorder in humans.

Double & complementary virus inactivation
With the introduction of Wilate®, Octapharma complies with the call of many VWD treaters, patients and authorities for a VWF/FVIII-concentrate, manufactured by using two independent, complementary and robust virus inactivation steps and most advanced purification techniques.

An optimised terminal dry-heat treatment step, PermaHeat (100°C for 120 min), of the lyophilised concentrate has been added to the proven efficacious solvent / detergent (S/D)-treatment. PermaHeat is effective in inactivating both enveloped and nonenveloped viruses and thus adds an additional safety margin to the S/D-treatment.

High purity for excellent tolerability
Wilate®`s high purity minimises potential proteolytic fragmentation, therefore maintaining greater stability and optimised pharmacokinetic properties. The high purity of the product was developed to preserve the integrity and functionality of Wilate®`s VWF/FVIII complex at a natural, physiological ratio of about 1:1. Moreover, the high purity minimises the burden of protein impurities for the patient as a requirement to ensure excellent tolerability, thereby reducing the potential for adverse reactions.

Prospectively proven clinical efficacy
Multiple prospective clinical trials have proven the excellent safety, tolerability and haemostatic efficacy of Wilate® in the treatment of acute bleeding episodes, surgical procedures and prophylaxis in patients with various types of VWD and haemophilia A. Wilate demonstrated “excellent” or “good” clinical efficacy in 95% of the cases in the treatment of more than 600 bleeding episodes in VWD patients, representing the largest prospective clinical data record for this indication.

As a product of high purity, Wilate® documented favourable pharmacokinetic properties with optimised half-life of von Willebrand Factor activity also in severe VWD patients making this product especially suitable for prophylactic treatment. Furthermore, Wilate® demonstrated safety and haemostatic efficacy during surgical procedures including cases of major surgery.

New level of convenience
In addition Wilate®`s low reconstitution volumes of 5 and 10 ml for the 450 and 900 IU filling sizes, respectively, and excellent solubility introduce a new levels of convenience for the patients.

The approval of Wilate® in Germany is a major milestone and confirms Octapharma`s commitment to bring a new generation of improved VWF/FVIII-concentrate to all the VWD patients around the world.

Wilate® - Actual Improvements in the Treatment of VWD

	Double & Complementary Virus Inactivation
	High Purity for Excellent Tolerability
	Optimized Pharmacokinetics
	Prospectively Proven Clinical Efficacy
	New Level of Convenience

For more information, please contact the International Business Manager for Coagulation, Dr. Olaf Walter.

© Octapharma AG, 2004