The MHRA has announced the removal of Advate's (Octocog Alfa Recombinant Coagulation Factor VIII) black triangle symbol, confirming its risk/benefit balance. The move marks the end of a period of detailed surveillance following the UK launch of Advate, the first and only haemophilia therapy without blood-based additives used for the prevention and control of bleeding episodes in people with haemophilia A.

This announcement follows data presented at the recent World Federation of Haemophilia 27th World Congress in Vancouver, that reinforced Advate's safety and efficacy. The preliminary results of Baxter's extensive post-marketing surveillance programme (Post Authorization Safety Surveillance (PASS)), further validated the low-inhibitor risk profile of Advate. The programme was specifically created to monitor the safety profile of Advate in patients with haemophilia A and is the largest of its kind in haemophilia.

This extensive monitoring programme has only documented one case of a recurrent inhibitor and one case of a de novo inhibitor in previously treated patients with an estimated or documented history of greater than or equal to 50 prior factor VIII exposure days. The rate of inhibitor development in previously treated patients infusing with Advate is estimated to be less than 0.0028 events per million international units.

Dr Mark Bechter, Medical Director of Baxter BioScience commented; "We are extremely pleased that the MHRA has come to such a timely decision with regards to the risk/benefit balance of Advate. This decision should help to reassure all those receiving Advate of the product's well established safety profile."

Since it's launch in 2004 more than 2 billion units of Advate have been used worldwide by people with haemophilia A.

About Haemophilia A:

Haemophilia and related bleeding disorders are lifelong inherited conditions in which an essential blood-clotting factor is either partly or completely missing or faulty. The most common form of haemophilia is called Haemophilia A and in this case clotting factor VIII is faulty or missing. Treatment usually involves replacing the missing clotting factor with regular infusions. If left untreated, internal bleeding causes acute pain and long-term joint damage.

Baxter Healthcare:

Baxter Healthcare Ltd. is the primary domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). 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.

Baxter, and ADVATE are trademarks of Baxter International Inc.

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 the first and only factor VIII haemophilia therapy made without the addition of any human or animal plasma proteins, thereby virtually eliminating the risk for transmission of infections caused by pathogens that could be carried with these plasma protein additives.

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.

The PASS Programme

PASS captured data during a 12-month observational period from more than 400 patients with haemophilia A in the United States and Europe who are being treated with Advate for the first time.

The Black Triangle

Black triangle products are new drugs and vaccines, which are being intensively monitored by the Commission on Human Medicines (CHM) and the MHRA in order to confirm their risk/benefit profile. A black triangle symbol will be indicated against a product:

-- in the 'British National Formulary' (BNF);
-- in the 'Nurse Prescribers' Formulary' (NPF);
-- in 'MIMS';
-- in the 'ABPI Medicines Compendium'; and
-- on advertising material.

A black triangle is assigned to a product if the drug is a new active substance. However, a product containing previously licensed active substances may also be monitored if it meets one or more of the following criteria:

-- a new combination of active substances;
-- administration via a new route of administration or drug delivery system; or
-- a significant new indication which may alter the established risk/benefit profile of that drug

There is no standard time for a product to retain black triangle status. However, an assessment is usually made following two years of post-marketing experience and the black triangle symbol is not removed until the safety of the drug is well established.

Baxter Healthcare UK
Baxter Healthcare Corporation
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