Octapharma News August 1st, 2003

August 1st, 2003

Octaplex receives approval in Germany

Octapharma´s new-generation prothrombin complex concentrate (PCC) - OCTAPLEX has recently received approval from the German regulatory authorities.

The product has been licensed for prophylaxis, peri-operative substitution and treatment of bleeding in patients with congenital or acquired deficiencies of clotting factors II, VII, IX and/or X.

Although congenital factor deficiencies are rare, Octapharma is committed to offer all patients with inherited bleeding disorders access to products with the highest levels of viral safety and purity.

Octaplex also represents a new standard of therapy for patients with acquired life-threatening bleeding, such as those taking oral anticoagulants, who require emergency surgery.

Octaplex is a state-of-the-art PCC. It undergoes two distinct and complementary steps for virus inactivation and removal:

Solvent detergent: for the inactivation of enveloped viruses such as HIV, hepatitis B and hepatitis C,
Nanofiltration: for the removal of both enveloped and non-enveloped viruses such as hepatitis A

In addition, Octaplex contains physiological amounts of each of the 4 prothrombin complex clotting factors: FII, FVII, FIX & FX as well as the coagulation inhibitors protein C and protein S.

By contrast existing products in the market, only undergo one inactivation step and many lack FVII.

The efficacy of Octaplex has been extensively evaluated in clinical trials. Patients were treated with Octaplex for control of bleeding episodes, prophylaxis, and during surgery. Overall, the efficacy of Octaplex was rated as “excellent” in 96% and as “good” in 4% of cases during these studies.

Octaplex has been used “off label” in Norway since 1998, in the framework of the national self-sufficiency programme. During this time >1.5 million IU have been used in approximately 1000 treatment episodes. Efficacy and tolerability of the product have been good and no adverse events i.e. virus transmissions or thrombogenicity have been reported.

Based on the German registration, Octapharma plans to register Octaplex in all European countries through a Mutual Recognition Procedure that will start at the end of 2003.

Deficient Factor	Prevalence
II	< 50 cases documented worldwide
VII	2.0 cases / million
IX	1 cases / 30,000*
X	1.5 cases / million