TOKYO, JAPAN – October 23, 2006 – Baxter Limited (Japan) announced today that the Ministry of Health, Labour and Welfare has approved ADVATE® (rurioctocog alfa , recombinant, Plasma/Albumin Free Method)* as a replacement therapy indicated for blood coagulation and to reduce the tendency to bleed for people with factor VIII deficiency (hemophilia A). ADVATE is the only recombinant factor VIII therapy processed without any added blood components.

 

All currently available factor VIII therapies use human or animal blood-derived components at various stages of processing.  Baxter developed ADVATE in response to the needs of the hemophilia community, which called for a therapy that would reduce the potential risk of infections that may be caused by pathogens carried in human or animal blood-derived additives. Since the effectiveness of inactivation techniques cannot be guaranteed, one way to eliminate this potential risk for people with hemophilia is to remove these blood-based components from the factor VIII processing.

 

ADVATE will be available in three different potencies: 250 IU/vial; 500 IU/vial; and 1,000 IU/vial. The volume of all the formulations, when fully reconstituted, is 5mL, making the therapy convenient to administer.

 

ADVATE is already approved in the United States, Canada, Australia and 28 countries in Europe. Accumulated sales of ADVATE surpassed 1.7 billion activity units in October 2006, due in large part to rapid adoption in the United States and Europe.

 

ADVATE CLINICAL DATA

 

ADVATE has been clinically tested in previously treated pediatric, adolescent and adult patients in various treatment regimens and settings designed to evaluate its safety and efficacy.

 

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

 

In Japan, a clinical study conducted in patients aged 10 years and older found that ADVATE’s efficacy was rated by the investigators as excellent or good in 97% of 170 bleeding episodes in 13 patients. Furthermore, pharmacokinetics of ADVATE and RECOMBINATE  [Antihemophilic Factor (Recombinant)] were assessed in a comparative pharmacokinetic study reporting demonstrated results for AUC0-48 hours (area under the curve).

 

A total of four adverse events were judged to be possibly, or probably related to ADVATE, including feeling of hot flushes in one patient, fuzzy and headache in one patient and increased monocytes in one patient. These events were mild in severity.

 

ABOUT HEMOPHILLIA A

 

Hemophilia A is a genetic bleeding disorder primarily affecting males.  People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary to effectively clot blood. Without enough factor VIII, patients can experience spontaneous internal bleeding involving acute pain, debilitation or damage to joints. If such bleeds are left untreated, they can become life threatening.

 

ABOUT BAXTER LIMITED (JAPAN)

 

Baxter Limited is a Japanese subsidiary of Baxter International Inc. a global healthcare company specialized in treatment of kidney disease and hemophilia, intravenous solutions, anesthesia and pain control systems. Baxter provides healthcare services including pharmaceutical products, medical devices and bioscience technology, to patients and healthcare professionals. Baxter Limited is a leading company in hemophilia care in Japan. For more information about the company, please visit Baxter Limited (Japan) at www.baxter.co.jp.

 

ABOUT ADVATE

 

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes.  ADVATE is also indicated in the preoperative management of patients with hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. ADVATE is also indicated in the preoperative management of patients with hemophilia A.  ADVATE is not indicated for the treatment of von Hillenbrand’s disease.

 

Important Safety Information

 

There is a possibility that you can have an allergic reaction to ADVATE.  Symptoms of an allergic reaction may include rash, hives, itching, tightness in throat or chest, difficulty breathing or feeling dizzy, and light-headed or weak pulse.  If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.  Let your doctor know if you have had any previous allergic reactions to other factor VIII products or mouse or hamster proteins.

 

The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness and flushing.

 

The formation of inhibitors has been observed with all factor VIII products, including ADVATE.  Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of prescribed factor VIII therapy.

 

Please see ADVATE Prescribing Information for full prescribing details.  http://www.advate.com/pdf/prescribing_info_english.pdf

 

ABOUT RECOMBINATE

 

RECOMBINATE [Antihemophilic Factor (Recombinant)] is a genetically engineered factor VIII protein indicated for prevention and control of bleeding episodes in people with hemophilia A (classical hemophilia).  RECOMBINATE, an infusion therapy that works as a substitute for the missing or non-functioning factor VIII protein.  RECOMBINATE rAHF is not indicated in von Willebrand’s disease.

 

Important Safety Information

 

RECOMBINATE may be contraindicated in patients with known hypersensitivity to mouse, hamster, or bovine protein.  Adverse events related to the administration of RECOMBINATE observed during the clinical studies included flushing, nausea, fatigue and nose bleeds.  RECOMBINATE is stabilized with Albumin (human).

 

Reactions associated with albumin are rare, although nausea, fever, chills or urticaria have been reported.  Certain components used in the packaging of RECOMBINATE contain natural rubber latex.  Please review the RECOMBINATE Prescribing Information for full prescribing details.

 

The formation of inhibitors has been observed with all factor VIII products, including RECOMBINATE.  Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of prescribed factor VIII therapy.

 

Please see RECOMBINATE Prescribing Information for full prescribing details. 

http://www.hemophiliagalaxy.com/pdfs/therapies/Recombinate.pdf