Date: 2014-08-07
Type of information: Validation of a production plant
Compound: Advate®, Rixubis®, BAX 855
Company: Baxter (USA - IL)
Therapeutic area: Hematological diseases - Genetic diseases - Rare diseases
Type agreement:
Action mechanism: 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 a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. 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. 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. Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors.
Disease: hemophilia A, hemophilia B
Details: * On August 7, 2014, Baxter International 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)], 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)], 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. This 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 . The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of Advate®. 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.
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