Biovitrum strengthens its relationship with Wyeth - Starts to co-promote BeneFIX® in the Nordic countries
Stockholm, Sweden, August 8, 2007 - Biovitrum today announced it has entered into a new agreement, effective August 8, 2007, with Wyeth (NYSE: WYE) to co-promote BeneFIX®, Coagulation Factor IX (Recombinant) for hemophilia B, in the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden). With the exception of these countries, Wyeth markets BeneFIX around the world.
Under the terms of the agreement, Biovitrum will receive a commission on BeneFIX sales, including an additional incentive if certain sales targets are exceeded, for a period of up to five years, with possible one year extensions thereafter.
BeneFIX uses recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own. Hemophilia B is a rare, inherited blood clotting disorder. People with hemophilia B are deficient in factor IX which is vital in the clotting mechanism to prevent bleeding. Hemophilia B is characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with hemophilia B are dependent on protein replacement therapy with factor IX.
Biovitrum has been very successful in the Nordic market for blood diseases and will by this agreement strengthen its position with this additional product.
Comments by Martin Nicklasson, CEO of Biovitrum:
“Blood diseases and especially hemophilia is an area of great strategic importance for us. I am delighted that Wyeth has chosen Biovitrum as a partner in the Nordic region for BeneFIX®. It adds to our already strong relationship with Wyeth in the hemophilia area and it confirms our ability to deliver value in the market. It also demonstrates that we are an attractive partner for co-promoting other pharmaceutical companies products in the Nordic market. Our commercial activities within this field will thereby continue to grow and generate additional revenues.”
Biovitrum manufactures recombinant factor VIII used in Wyeth’s ReFacto® for the treatment and prophylaxis of hemophilia A. Biovitrum receives royalties on Wyeth’s global ReFacto® sales as well as co-promotion revenues from the sales of ReFacto in the Nordic countries.
BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.
BeneFIX is not indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII and X) nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver-dependent coagulation factors.
As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting or tiredness. BeneFIX® may be contraindicated in patients with a known history of hypersensitivity to hamster protein. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.
ReFacto Antihemophilic Factor (Recombinant) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto. Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur.
Please see Prescribing Information for BeneFIX and ReFacto at www.hemophiliavillage.com.
For more information, please contact:
Biovitrum AB (publ)
Martin Nicklasson, CEO
Phone: +46 8 697 20 00
Anna Karin Källén, VP, Corporate Communications
Phone: +46 8 697 20 85, Cell phone: +46 73 433 20 85
Biovitrum is one of the largest biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for unmet medical needs both for common diseases and conditions that affect small patient populations. Biovitrum has a broad and balanced R&D portfolio with several projects in clinical and preclinical phases for the treatment of obesity, diabetes, inflammation and eye and blood diseases as well as a number of well defined niche indications. Biovitrum also develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has revenues of approximately SEK 1.2 billion and 550 employees. Biovitrum´s share has been listed on the OMX Nordic Exchange since September 15, 2006. More information is available at www.biovitrum.com .