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Baxter Receives Marketing Approval from Australia's Therapeutic Goods Administration for ADVATE to Treat Haemophilia A

 

SYDNEY, AUSTRALIA, April 14, 2005 – Baxter Healthcare Pty Ltd announced today that the Therapeutic Goods Administration (TGA), Australia's pharmaceutical regulatory agency, has issued approval for Baxter to market ADVATE ® Antihaemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of haemophilia A.

ADVATE is indicated for the prevention and control of bleeding episodes in people with haemophilia A. It is the only haemophilia A therapy made without any plasma protein in the cell culture process, purification and final formulation, thereby eliminating the risk of infection from viruses and infectious prions that may be carried in these plasma protein additives.

“The regulatory agency's approval of ADVATE marks another significant achievement for Baxter and furthers our commitment to improving the lives of patients with haemophilia,” said Maree Coy, area managing director for Baxter Australia and New Zealand. “We are pleased to be able to bring this innovative product to Australia and expand access for patients to the latest haemophilia A treatment available.”

 

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 properly function.

Baxter processes ADVATE in its state-of-the-art, multi-purpose, biotechnology facility in Neuchâtel, Switzerland. This facility has the capacity to manufacture sufficient supplies of this therapy based on current and anticipated patient needs. ADVATE is approved in the United States and 14 countries in Europe.

 

About Haemophilia A

People with haemophilia A do not produce adequate amounts of factor VIII, which is necessary for blood to effectively clot. 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 Organisation, more than 400,000 people in the world have haemophilia, corresponding to a prevalence of 15-20 in every 100,000 males born worldwide.

 

About Baxter

Baxter Healthcare Pty Ltd is a subsidiary of Baxter International Inc. (NYSE:BAX). Baxter International Inc., through its subsidiaries, assists healthcare 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 including but not limited to the Neuchâtel, Switzerland facility's capacity to manufacture sufficient supplies of ADVATE based on current and anticipated patient needs, 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 effect of economic conditions; actions of regulatory bodies and other government authorities including the Food and Drug Administration and foreign counterparts that could delay, limit or suspend product sales and distribution; technological advances in the medical field; reimbursement policies of government agencies and private payers; product demand and market acceptance risks for new and existing products, such as ADVATE and other technologies; the impact of competitive products and pricing, including generic competition, drug reimportation and disruptive technologies; and other factors described 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. 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.

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