ZURICH March 3, 2004 -- Baxter Healthcare S.A. announced today that the European Commission has issued a Marketing Authorisation for ADVATE (Octocog Alfa Recombinant Coagulation Factor VIII).

 

ADVATE is indicated for the prevention and control of bleeding episodes in people with haemophilia A.  It is the first and only factor VIII made without the addition of any human or animal plasma proteins and albumin in the cell culture process, purification and final formulation, thereby eliminating the risk for transmission of infections caused by viruses that could be carried in these proteins.

 

“The approval of ADVATE by the European Commission marks another important milestone for Baxter and furthers our commitment to enhancing care for patients living with haemophilia,” said Louise Makin, president of Biopharmaceuticals in Europe for Baxter.  “Based on the success of ADVATE following its launch in the United States, we are pleased to bring this important new treatment option to patients throughout Europe.”

ADVATE received a unanimous positive opinion recommendation from the Committee for Proprietary Medicinal Products (CPMP) on 23 October 2003, which served as the basis for approval by the European Commission.  Approval from the European Commission will allow Baxter to market ADVATE in all 15 European Union (EU) Member States as well as in Norway and Iceland, as these countries, per agreement with the EU, take part in the centralised evaluation procedure for new drug applications.  In addition, Estonia, Latvia, Lithuania, Poland, the Czech Republic, Slovakia, Hungary, Slovenia, Cyprus, and Malta will join the European Union as of 1 May 2004, at which time the marketing authorisation for ADVATE will be extended to these countries.  The availability of ADVATE will vary country by country based on the timing of reimbursement approvals.

 

ADVATE received regulatory approval from the U.S. Food and Drug Administration (FDA) on 25 July 2003, and marketing authorization from Swissmedic on 18 February 2004 in Switzerland.

 

“For years, the potential risk of viral transmission has been a considerable concern among haemophilia patients and this issue has continued to grow as new diseases have emerged over time,” said Professor Claude Negrier, M.D., Ph.D., Head of the Haemophilia Comprehensive Care Centre at Edouard Herriot University Hospital, Lyon, France.  “Now, with the approval of ADVATE, patients can have reassurance that they are receiving a therapy that addresses that risk with a process that eliminates the need to add any human or animal proteins that may carry viruses.” 

 

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 is processed by Baxter in its state-of-the-art, multi-purpose, biotechnology facility in Neuchâtel, Switzerland.  This facility has the capacity to help ensure sufficient supplies of this therapy based on current and anticipated patient needs.

 
Side effects with the use of ADVATE are uncommon, with no serious adverse events related to treatment with ADVATE reported to date.  Non-serious, mild or moderate adverse events related to ADVATE include: a strange taste, itching at the infusion site, dizziness, headaches, catheter-related infections, chills, hot flushes, diarrhoea, lower limb edema, sweating, nausea, pain in the upper abdomen or lower chest, prolonged bleeding after post-operative drain removal, decreased red blood cell count, joint swelling and shortness of breath.  Non-serious but severe related adverse events include: fever, headache and decreased coagulation factor VIII levels.

People with haemophilia A do not produce adequate amounts of factor VIII, which is necessary to effectively clot blood.  Without enough factor VIII, patients can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating and damaging to joints.  If untreated, patients with severe haemophilia A have a greatly reduced life expectancy.

 

According to the World Health Organization, more than 400,000 people in the world may have haemophilia, corresponding to a prevalence of 15-20 in every 100,000 males born worldwide.  

 

People with haemophilia A infuse themselves with clotting factors three times a month, on average, unless they are on a preventive regimen, in which case their physician may prescribe infusing a therapy as often as three or four times per week. 

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.

 

 

Why do you expect ADVATE will be successful in the European marketplace?
In the United States, recombinant therapies have been very successful, with more than 75 percent of patients receiving a recombinant therapy.  In Europe, we believe there is a significant growth opportunity for recombinant therapies, including ADVATE, based on the current use of plasma-based therapies; approximately 50 percent of patients in Europe continue to use plasma-derived therapies.  ADVATE will be an important treatment option as it is the first to become available in Europe that does not add any animal or human plasma-proteins or albumin in its processing.

 

When will Baxter begin to book sales for ADVATE in Europe?

Baxter expects sales of ADVATE in Europe to begin in the second quarter.  Availability in countries outside the United States will vary based on timing for reimbursement approvals.

 

What manufacturing approvals have been received for ADVATE?
Baxter has received European regulatory approvals for all the manufacturing sites requested for ADVATE.  These include suites A and B in the Neuchâtel, Switzerland plant.  In the US, Baxter has FDA approval for Suite A in Neuchâtel and submitted its request to the FDA for approval of Suite B in December 2003.

 

 

Baxter and ADVATE are trademarks of Baxter International Inc.

 

This news release contains forward-looking statements that involve risks and uncertainties, including technological advances in the medical field, the effect of economic conditions, actions of regulatory authorities and other government authorities, reimbursement policies of government agencies and private payers, product demand and market acceptance, the impact of competitive products and pricing, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.