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Baxter Receives Health Canada Approval for Advate(R) [Antihemophilic Factor (Recombinant)

Advate is the first and only factor VIII therapy for the treatment of hemophilia A made without the addition of human or animal blood-derived components

TORONTO, CANADA -- August 2, 2006 -- Baxter Corporation (Canada) announced today that Health Canada has approved Advate ® [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM)] for the prevention and control of bleeding episodes in people with hemophilia A (classical hemophilia). Advate is also indicated for perioperative management of patients with hemophilia A.

All currently available recombinant factor VIII therapies utilize human or animal blood-derived components at various stages in their manufacturing process. Advate is the first and only factor VIII therapy made without the addition of human or animal blood-derived components.

Baxter developed Advate, the most recent advance in recombinant factor VIII therapy, in response to the needs of the hemophilia community, who called for the removal of these human and animal blood-derived additives from recombinant factor VIII therapies.

Since the effectiveness of inactivation techniques cannot be guaranteed to eliminate future emerging pathogens, one way to eliminate the risk of blood borne pathogens for people with hemophilia is to remove these added human and animal blood-derived components from factor VIII processing. The technology used to prepare Advate is the newest innovation in factor VIII treatment for hemophilia A and is based on the same full-length factor VIII molecule as Recombinate TM [Antihemophilic Factor (Recombinant)].

"This represents a very important advance in the care of patients with hemophilia," said Dr. Victor Blanchette, Chief, Division of Hematology/Oncology at The Hospital for Sick Children in Toronto. "Advate relieves patients and their families of any worry with respect to the transmission of infectious diseases that may occur with other human plasma based factor concentrates."

People with hemophilia A, an inherited disorder that primarily affects males, 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 hemophilia A have a greatly reduced life expectancy.

"The Canadian Hemophilia Society is pleased to see the launch of Advate," s aid Eric Stolte, President of the Canadian Hemophilia Society. " A component of quality factor replacement therapy for the treatment of hemophilia requires that a patient and his/her physician have the option to choose products which meet a patient's individual needs. We therefore welcome the addition of Advate to the range of quality recombinant factor VIII products currently approved by Health Canada and other international regulators, and available to Canadians with factor VIII deficiency hemophilia."

Hemophilia A affects one in 10,000 people, or about 3,000 people in Canada. People with hemophilia A infuse themselves with clotting factors on average three times a month. Infused directly into the bloodstream, Advate works by temporarily raising the level of factor VIII in the blood, thus allowing the blood-clotting process to function properly.

Advate is approved for use in the United States, Australia and 14 countries in Europe. The therapy has been clinically tested in previously-treated pediatric, adolescent and adult patients in various on-demand, prophylactic and surgical settings.

Advate availability
Baxter is a major supplier to Canadian Blood Services (CBS) and Héma-Québec (HQ), the two agencies responsible for managing Canada's blood system. It is expected that product will be available for distribution by CBS and HQ in the coming months.

Advate is available in several different potencies, including a super-high potency format (1500 IU/vial), and it has a small infusion volume (5mL diluent), meaning patients can administer their therapy conveniently and quickly. In addition, while Advate should be refrigerated it also has the advantage of being stored for up to six months at room temperature, or up to the expiration date, which ever comes first. It is packaged with a 10mL syringe, butterfly needle and Baxject needleless reconstitution device.

Advate Clinical Data
To date, more than 200 patients worldwide have completed participation in clinical trials on Advate, making it one of the largest hemophilia clinical study programs. In addition, a number of other studies are ongoing or planned, including a study involving previously untreated patients, as well as post-market safety surveillance studies on Advate.

Specifically, phase II-III clinical trials evaluated the safety, immunogenicity and efficacy of Advate in the treatment and prevention of bleeding in previously treated hemophilia patients in a variety of clinical settings. In one study comparing Advate and Recombinate pharmacokinetic properties, the pharmacokinetic data observed for Advate, AUC and in vivo recovery were found to meet pre-established study criteria.

The most common related adverse reactions observed during the Advate clinical studies include strange taste in mouth, headache, dizziness and flushing. Advate should be administered cautiously in patients with previous hypersensitivity to mouse or hamster proteins.


SOURCE: Baxter Corporation (Canada)

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