Biovitrum strengthens its relationship with Wyeth - Starts to co-promote BeneFIX® in the Nordic countries
Biovitrum strengthens its relationship with Wyeth - Starts to co-promote BeneFIX® in the Nordic countries
Biovitrum today announced it has entered into a new agreement, effective August 8, 2007, with Wyeth (NYSE: WYE) to co-promote BeneFIX®, nonacog alfa (Recombinant Coagulation Factor IX) 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. About BeneFIX BeneFIX is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors. Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, chills (rigors), flushing, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. If allergic or anaphylactic reactions occur, administration of BeneFIX® should be stopped immediately, and appropriate medical management should be given, which may include treatment for shock. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur. Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX. The safety and efficacy of using BeneFIX® for immune tolerance induction has not been established. Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation. About ReFacto ReFacto moroctocog alfa (Recombinant Coagulation Factor VIII) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). ReFacto is indicated for prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. ReFacto does not contain von Willebrand factor and therefore is not indicated in von Willebrand's disease. 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. For more information, please contact: Biovitrum AB (publ) Martin Nicklasson, CEO Phone: +46 8 697 20 00 martin.nicklasson@biovitrum.com Anna Karin Källén, VP, Corporate Communications Phone: +46 8 697 20 85, Cell phone: +46 73 433 20 85 annakarin.kallen@biovitrum.com About Biovitrum 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 .