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New Approvals and Tenders Support Increased Access to ADVATE, The Worlds Market Leading Recombinant FVIII Treatment

DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX) continues to build upon its global leadership position in hemophilia with ADVATE [Antihemophilic Factor (Recombinant)], the first recombinant treatment with no human or animal protein additives for patients with hemophilia A. ADVATE continues to be the most prescribed full-length recombinant FVIII worldwide, with more than 10 years of real-world experience and over 17 billion units distributed.

''Baxter has executed an array of strategic global initiatives designed to improve treatment options and expand access to quality care for hemophilia patients worldwide,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience. ''These important achievements will allow us to build upon our global leadership and drive continued growth across our hemophilia franchise, reaching patients in both large and established markets, as well as emerging markets.''

Recent highlights include:

  • European Union (UNP) regulatory approval of a new manufacturing facility in Singapore for the production of a variety of recombinant proteins, including ADVATE and potentially BAX 855 following regulatory approval.
  • The recent announcement by the National Blood Authority (NBA) in Australia of a four-year award for ADVATE, designated as the national preferred recombinant FVIII product. The award in Australia, which becomes effective July 1, 2014, will provide the 2,300 people diagnosed with hemophilia A access to the therapy.1 This follows a multi-year award for ADVATE in the UK, which broadens its commercial presence and provides increased access to the treatment for the 5,600 people with hemophilia A in the UK.1
  • Regulatory approvals of ADVATE in Turkey and Russia, supporting Baxters efforts to increase access to recombinant FVIII therapy in emerging markets. This follows the launch of ADVATE in China, and the building momentum in Brazil resulting from Baxters exclusive, long-term partnership with Hemobras. To date, more than 3,000 patients (roughly 30% of the diagnosed hemophilia A population in Brazil 1) are now being treated with Baxters recombinant FVIII treatment. With these approvals, ADVATE is now available to hemophilia A patients in 62 countries worldwide.
  • U.S. FDA approval of a new reconstitution system for ADVATE. The BAXJECT III reconstitution system reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers, as compared to the BAXJECT II Needle-less Transfer device.

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 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

CONTRAINDICATIONS

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

Hypersensitivity Reactions

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

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.

ADVERSE REACTIONS

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 e10% 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 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 companys work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.

About Baxter International Inc.

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.

This release includes forward-looking statements concerning ADVATE and other hemophilia treatments in Baxters R&D pipeline, including expectations with regard to regulatory approvals and business prospects. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical results; changes in laws and regulations; product quality or supply or patient safety issues; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC (SCUR) filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

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1 Report on the Annual Global Survey 2012. World Federation of Hemophilia. 2013.

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Baxter International Inc.
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Source: Baxter International Inc.

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