SINGAPORE, August 7, 2014 - Baxter International Inc. (BAX:NYSE) today announced the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite.
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 Singapore.
"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 Ludwig Hantson, Ph.D., president of Baxter BioScience. "The opening of the Singapore facility reinforces our continued commitment to expanding access to advanced, high quality treatments for patients around the world."
"Baxter's expansion of its biologics footprint in Singapore reinforces our position as a leading biologics hub. This facility will support Baxter's growth in the global market and Singapore celebrates its opening. Singapore Economic Development Board (EDB) will continue to invest in talent development, supporting infrastructure and new technologies to support the biologics sector," said Mr. Yeoh Keat Chuan, managing director at the Singapore Economic Development Board, who officiated the opening ceremony.
The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE2. This allows the facility to process and supply ADVATE to the European Union, Iceland and Norway. The biologics facility in Singapore currently employs more than 400 production staff and expects to reach 450 by 2015 to support the second processing suite. The facility is the third location in the world supporting ADVATE processing, making this the only recombinant factor VIII treatment processed at three separate sites and providing unprecedented security of a triple-source capability.
Speaking at the opening of the facility, Jean-Luc Butel, corporate vice president and president of Baxter's International operations said, "Singapore's biotech industry has seen tremendous growth in recent years and Baxter is proud to have been a part of this journey. Baxter is grateful to the Singapore Economic Development Board for their support in establishing this facility and for its commitment to collaborations that advance access to quality healthcare. As we have invested in training our employees to support this state-of-the-art technology, we remain committed to partnering with the Singapore Economic Development Board and other government agency partners to elevate the quality of the healthcare workforce in Singapore."
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 Health Sciences Authority (HSA) in Singapore in July 2008 and is approved in 62 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Russia, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay and Venezuela.
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
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.
About Baxter BioScience
Baxter BioScience is a leading provider of therapeutic treatments that save, sustain and improve the lives of people with rare conditions, chronic diseases or limited treatment options. Supported by advanced technical and manufacturing expertise, the business unit has a broad pipeline built on a legacy of innovation in bleeding disorders and immunology, and is expanding to address emerging opportunities in niche areas of oncology as well as technology platforms such as biosimilars.
About Baxter International
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
1Antihemophilic Factor (Recombinant)
2Coagulation Factor IX (Recombinant)