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New Generation Recombinant Factor VIII Treatment for Haemophilia ALeverkusen - Bayer announced today that the EU Commission has granted the Marketing Authorisation for Kogenate Bayer Recombinant Coagulation Factor VIII with new formulation and more convenient administration. The new generation recombinant factor VIII product for the treatment of haemophilia A is asignificant development for the nearly 19,000 Europeans who are living with this life-threatening disease.

Kogenate Bayer has the following benefits over KOGENATE, Bayer
,s first recombinant product: · Does not require human albumin as a stabiliser in the formulation of or during the purification processes. · Contains an additional viral inactivation step. · It also has a reduced diluent fluid volume, resulting in faster, easier infusion.

&The approval for Kogenate Bayer is the next step in providing the haemophilia community with a significant advancement in the treatment of haemophilia A. We are taking a giant step forward to a time when people with haemophilia will have no fears of viral transmission,
8 said Dr. Gert Seidl, head of Bayer
,s Biological Products European Business Unit.

&Bayer Corporation, Biological Products, has more than two decades of proven success in the haemophilia market. Kogenate Bayer continues our tradition of offering safe and effective therapy to individuals with haemophilia and their physicians,
8 Seidl added.

 Clinical Data Establish Kogenate Bayer
,s Safety and Efficacy A Phase III clinical study conducted in Europe and North America demonstrated that KOGENATE Bayer was effective in correcting or preventing bleeding episodes in patients with haemophilia A. In 24 months of home therapy, 71 patients, ages 12 to 59, who were previously treated with other recombinant or plasma-derived FVIII products received KOGENATE Bayer. A total of 12,546 infusions were administered in this portion of the study, or 22.4 million units of KOGENATE Bayer. Treatment of 2,585 bleeding episodes during the study period required 3,648 infusions of KOGENATE Bayer. The majority of bleeding episodes (93.5 percent) was treated successfully with one or two infusions. Regularly scheduled treatment accounted for 75 percent of infusions administered on study.

Fifteen study participants received KOGENATE Bayer on 22 occasions for prophylaxis for bleeding with surgery. These surgeries included minor and major procedures ranging from tooth extractions and circumcisions to total knee replacements and the removal of a brain tumor. Haemostasis was excellent in all cases. Side effects occurring in the clinical trial associated with the infusions were reported at a rate of 0.20 percent and were considered
&mild
8 or
&moderate.
8

&Clinical studies were performed according to international Guidelines and Standards and demonstrate that KOGENATE Bayer provides excellent and safe haemostatic control of bleeding episodes in patients with haemophilia A. This new product is the latest example of Bayer
,s commitment to improve and extend the lives of people with haemophilia,
8 stated Dr.Eduard Gorina, European clinical project director for KOGENATE Bayer.

Safety Key for People with Haemophilia The European introduction in 1994 of KOGENATE®, Bayer
,s first recombinant factor VIII product, represented a significant improvement over plasma-derived FVIII products in reducing the risk for viral transmission. More than two billion units of Kogenate® have been infused since its introduction without any confirmed reports of viral transmission. However, the theoretical risk remains a concern for people with haemophilia. To alleviate these concerns, Bayer developed and patented a new sucrose formulation, refined the purification process, and added an additional viral inactivation step. Sucrose, now used in the formulation of KOGENATE Bayer as a stabiliser of recombinant factor FVIII, replaces human plasma protein, which is used to stabilise KOGENATE®.

Treating Individuals with Haemophilia Worldwide Bayer anticipates European introduction of KOGENATE Bayer beginning in the summer of 2000. Aventis-Behring, Bayer
,s long-term partner for haemophilia products, will act as local representative and provide KOGENATE Bayer in Europe under the trade name HelixateNexGen. In the United States, Bayer will market the product under the trade name Kogenate FS, while Aventis-Behring will distribute in the United States as HelixateFS. Currently, the product is approved in US and Canada and available in Switzerland and New Zealand.

KOGENATE Bayer will be manufactured at Bayer
,s state-of-the-art biotechnology facility in Berkeley, California, USA.

The Effect of Haemophilia Haemophilia is an inherited bleeding disorder characterised by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. The disease is caused by deficient or defective blood coagulation proteins, which are either factor VIII or IX. The most common form of the disease is haemophilia A, or classic haemophilia, in which the clotting factor VIII is either deficient or defective. Haemophilia B is characterised by deficient or efective factor IX. The World Federation of Haemophilia estimates that more than 350,000 people globally has a form of the disease.

The Bayer Biological Products Business Unit, headquartered in Research Triangle Park, North Carolina. (USA) is responsible for the global development and marketing of KOGENATE Bayer.

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