ZURICH, March 3, 2005 -- Baxter Healthcare S.A. announced today that in the first year following marketing authorization by the European Commission, the acceptance of ADVATE® (Octocog Alfa Recombinant Coagulation Factor VIII), shows strong momentum.
Since European approval on March 3, 2004, ADVATE has been launched in 14 European countries. Over the past three months, ADVATE accounted for the majority of Baxter’s total rFVIII units sold in Europe. ADVATE is the first and only factor VIII concentrate available in Europe that is made without the addition of any human or animal plasma proteins, such as albumin, in the cell culture process, purification and final formulation, thereby eliminating the potential risk of known and unknown pathogen transmission from these plasma protein additives.
“Fifty percent of the patients worldwide currently being treated with ADVATE are from Europe,” said Hartwig Gajek, MD, medical director in Europe for Baxter’s BioScience business.
Baxter also announced plans for continued investments in clinical research on ADVATE and on important clinical issues related to haemophilia in general. A global Post Authorization Safety Surveillance was put in place immediately after licensing and more than 160 patients are currently enrolled. Additionally, the initiation of a global clinical study assessing the effect of different ADVATE prophylactic dose regimens is in the planning stage.
“Besides the continued generation of meaningful clinical data, Baxter is committed to investing in the improved convenience of ADVATE,” said Norbert Riedel, chief scientific officer for Baxter. “We will introduce new features to make the storage and reconstitution of ADVATE even more convenient for patients. Our plasma-albumin-free technology platform will also enable us to explore the potential for haemophilia therapies with enhanced clinical features such as a longer half-life or reduced inhibitor formation.”
ABOUT HAEMOPHILIA A
People with haemophilia A do not produce adequate amounts of factor VIII, which is necessary to effectively staunch bleeding. Without enough factor VIII, patients can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating and damaging to joints. If left untreated, patients with severe haemophilia A may have a greatly reduced life expectancy.
ABOUT ADVATE
ADVATE is a blood clotting therapy that helps people with haemophilia A prevent and control bleeding episodes. Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body’s blood clotting process to function properly.
ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of factor VIII preparations or known sensitivity to mouse or hamster proteins. The most common related adverse events observed during the ADVATE clinical studies included: strange taste in mouth, headache, dizziness and flushing.
More information, including U.S. full prescribing information for ADVATE, is available at www.ADVATE.com.
ABOUT BAXTER
Baxter Healthcare S.A. is the principal European operating subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
Statements in this press release regarding plans for continued investments in clinical research on ADVATE and on important clinical issues related to haemophilia in general, and the initiation of a global clinical study assessing the effect of different ADVATE prophylactic dose regimens, are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risk and uncertainties related to the timing and results of clinical trials and other development activities, actions of regulatory bodies and other government authorities, reimbursement policies of government agencies and private payers, technological advances in the medical field, product demand and market acceptance, the impact of competitive products and pricing, and other factors described in the Company's filings with the Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise, and all forward-looking statements speak only as of the time when made. Actual results or experience could differ materially from the forward-looking statements.