Singapore-Based Facility Enhances Baxter’s Global Capabilities to
Support the Treatment Needs of Hemophilia Patients Worldwide
The current suite supports the processing of ADVATE [Antihemophilic Factor (Recombinant)]1, the market leading full-length recombinant factor VIII (rFVIII) worldwide for the treatment of patients with hemophilia A. The second suite will initially process RIXUBIS [Coagulation Factor IX (Recombinant)]2, a recombinant factor IX (rFIX) protein for the treatment of adults with hemophilia B and, when operational, will be the primary global commercial processing facility. It will also support production of the company’s investigational extended half-life recombinant FVIII treatment BAX 855 upon regulatory approval.
Today’s announcement strengthens Baxter’s leadership in hemophilia and underscores its commitment to increasing access to therapy and improving standards of care for hemophilia patients globally. In total, the establishment of the facility and new investment will have created 450 biopharmaceutical jobs by 2015 in
''As a long-standing, established leader in the global hemophilia community, Baxter has focused efforts on improving standards of care for people with hemophilia,'' said
''Baxter’s expansion of its biologics footprint in
Speaking at the opening of the facility,
About ADVATE [Antihemophilic Factor (Recombinant)]
ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for:
• Control and prevention of bleeding episodes.
• Perioperative management.
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy and safety profile. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE was approved by the
Detailed Important Risk Information for ADVATE
ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.
WARNINGS & PRECAUTIONS
Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, and pruritus.
Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (frequency =10% of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.
Please see full prescribing information for ADVATE at: http://www.baxter.com/downloads/healthcare_professionals/products/ADVATE_PI.pdf
About RIXUBIS [Coagulation Factor IX (Recombinant)]
RIXUBIS is an antihemophilic factor indicated for:
• Control and prevention of bleeding episodes in adults with hemophilia B.
• Perioperative management in adults with hemophilia B.
• Routine prophylaxis to prevent or prevent or reduce the frequency of bleeding episodes in adults with hemophilia B.
RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B.
Detailed Important Risk Information for RIXUBIS
RIXUBIS is contraindicated in patients who have:
• Known hypersensitivity to RIXUBIS or its excipients including hamster protein
• Disseminated intravascular coagulation (DIC)
• Signs of fibrinolysis
Hypersensitivity reactions (including symptoms such as dyspnea and pruritis) have been reported with RIXUBIS. Anaphylaxis and other hypersensitivity reactions are possible. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest tightness, hypotension, lethargy, nausea, vomiting, paresthesia, restlessness, wheezing, and dyspnea. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur.
Development of neutralizing antibodies (inhibitors) to factor IX may occur. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX plasma activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration. Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis if re-exposed to RIXUBIS.
Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors. The safety and efficacy of using RIXUBIS for immune tolerance induction have not been established.
The use of factor IX containing products has been associated with the development of thromboembolic complications.
The most common adverse reactions observed in >1% of subjects in clinical studies were: dysgeusia, pain in extremity, and positive test for furin antibody.
The following class adverse reactions have been seen with another recombinant factor IX: inadequate factor IX recovery, inhibitor development, anaphylaxis, angioedema, hypotension, and thrombosis.
Please see the RIXUBIS full Prescribing Information at: www.baxter.com/downloads/healthcare_professionals/products/RIXUBIS_PI.pdf.
About Baxter in Hemophilia
Baxter has more than 60 years’ experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company’s work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.
1 Antihemophilic Factor (Recombinant)
2 Coagulation Factor IX (Recombinant)