07.21.14
Headquarters: Deerfield, IL
twitter.com/baxter
www.baxter.com
TOP SELLING DRUGS
Baxter’s BioScience business enjoys a relatively comfortable position for its products and therapies, and in 2013 revenues were up 5% to $6.6 billion, driven by its hemophilia and immunoglobulin therapy assets. Meanwhile, at the close of 1Q14, Baxter International, Inc. announced plans to separate its biopharma and medical products businesses, looking to benefit from the stand-alone companies in the areas of management, more effective commercialization, innovation, and pursuing investment strategies. As such, the BioScience business will now be run independently under Ludwig N. Hantson, Ph.D., who will take on the role of chief executive officer of the new, yet-to-be-named, biopharma company.
The BioScience business processes recombinant and plasma-based proteins to treat hemophilia and other bleeding disorders; plasma-based therapies to treat immune deficiencies, alpha-1 antitrypsin deficiency, burns and shock, and other chronic and acute blood-related conditions, as well as biosurgery products and vaccines.
Among its leading therapies, Advate continues to be the most prescribed recombinant FVIII worldwide. Hemophilia franchise sales were up 6% to $3.4 billion, driven by the recombinant therapy, Advate, and the company’s plasma-based inhibitor bypass therapy, Feiba. Contributing to sales growth in 2013 were shipments to Brazil as part of Baxter’s partnership with Hemobrás.
Regulatory approvals of Advate in the emerging markets of Turkey and Russia, and the launch of Advate in China, further support YOY growth, along with FDA’s approval of BAXJECT III, a new reconstitution system for Advate.
The BioTherapeutics franchise had modest growth of 2% to $2.1 billion, attributed to immunoglobulin therapies and accelerated demand for Gammagard Liquid [Immune Globulin Intravenous (Human)], albumin, and Alpha-1 treatments. However, this growth was partially offset by lower international sales as a result of an exit from certain markets due to previous supply constraints.
BioSurgery sales were $717 million, up 7%, favorably impacted by Synovis, which Baxter acquired during 1Q12, and growth of surgical sealants Tisseel and Floseal, while the Vaccines franchise saw a jump of 15% to $292 million, with higher sales of FSME-IMMUN (a tick-borne encephalitis vaccine) and milestone payments from ongoing flu vaccine collaborations.
On the business front, Baxter acquired Chatham Therapeutics for $70 million upfront, gaining its gene therapy programs for the development of hemophilia treatments. The two companies have been collaborating since May 2012, evaluating Chatham’s Biological Nano Particle (BNP) platform for potential hemophilia B treatments, which resulted in BAX 335, currently in Phase I/II development. Baxter will also have access to the previously partnered hemophilia B (FIX) program, a preclinical hemophilia A (FVIII) program.
In the way of pipeline progress, the FDA required additional time (until July 2014) to review supplemental data that Baxter provided as part of the ongoing BLA for HyQvia. The therapy was approved in EU member states in 2013 and is currently available in Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy. Also, the Phase III study of BAX 111, the first recombinant treatment in clinical development for von Willebrand disease, met its primary efficacy endpoint, achieving pre-specified success in the on-demand treatment of bleeding events.
On the other hand, Phase III data from the Gammaglobulin Alzheimer’s Partnership (GAP) study, did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in mild to moderate Alzheimer’s disease. While the study was not powered to demonstrate statistical significance among sub-groups within the study population, additional post-hoc and exploratory analyses of the data are ongoing.
Also, through an exclusive licensing agreement, Baxter and Cell Therapeutics, Inc. (CTI) will develop and commercialize pacritinib, an investigational JAK2/FLT3 inhibitor in Phase III development, with activity against genetic mutations linked to myelofibrosis, leukemia and certain solid tumors. Baxter paid $60 million upfront, which included a $30 million equity investment in CTI, and will pay as much as $112 million in milestones and royalties, if approved.
Further, making its foray into biosimilars, Baxter and Coherus Biosciences are collaborating to develop and commercialize a biosimilar to etanercept (Enbrel) for Europe, Canada, Brazil and other markets. For this candidate, Baxter paid $30 million upfront and will pay as much as $216 million based on development and regulatory milestones. The agreement also allows for development and commercialization of an alternative biosimilar to etanercept.
Starting out on its own should prove a successful venture, as the Bioscience business has all the building blocks for continued and steady growth, with expansion of its existing therapies, and progress with new ones.
twitter.com/baxter
www.baxter.com
Headcount: | 61,000 | |
Year Established: | 1931 | |
Biopharma Revenues: | $6,564 | 5% |
Total Revenues: | $15,259 | 8% |
Net Income: | $2,012 | -13% |
R&D Budget: | $1,246 | 8% |
TOP SELLING DRUGS
Drug | 2013 Sales | (+/- %) |
Hemophilia | $3,437 | 6% |
BioTherapeutics | $2,118 | 2% |
BioSurgery | $717 | 7% |
Vaccines | $292 | 15% |
Baxter’s BioScience business enjoys a relatively comfortable position for its products and therapies, and in 2013 revenues were up 5% to $6.6 billion, driven by its hemophilia and immunoglobulin therapy assets. Meanwhile, at the close of 1Q14, Baxter International, Inc. announced plans to separate its biopharma and medical products businesses, looking to benefit from the stand-alone companies in the areas of management, more effective commercialization, innovation, and pursuing investment strategies. As such, the BioScience business will now be run independently under Ludwig N. Hantson, Ph.D., who will take on the role of chief executive officer of the new, yet-to-be-named, biopharma company.
The BioScience business processes recombinant and plasma-based proteins to treat hemophilia and other bleeding disorders; plasma-based therapies to treat immune deficiencies, alpha-1 antitrypsin deficiency, burns and shock, and other chronic and acute blood-related conditions, as well as biosurgery products and vaccines.
Among its leading therapies, Advate continues to be the most prescribed recombinant FVIII worldwide. Hemophilia franchise sales were up 6% to $3.4 billion, driven by the recombinant therapy, Advate, and the company’s plasma-based inhibitor bypass therapy, Feiba. Contributing to sales growth in 2013 were shipments to Brazil as part of Baxter’s partnership with Hemobrás.
Regulatory approvals of Advate in the emerging markets of Turkey and Russia, and the launch of Advate in China, further support YOY growth, along with FDA’s approval of BAXJECT III, a new reconstitution system for Advate.
The BioTherapeutics franchise had modest growth of 2% to $2.1 billion, attributed to immunoglobulin therapies and accelerated demand for Gammagard Liquid [Immune Globulin Intravenous (Human)], albumin, and Alpha-1 treatments. However, this growth was partially offset by lower international sales as a result of an exit from certain markets due to previous supply constraints.
BioSurgery sales were $717 million, up 7%, favorably impacted by Synovis, which Baxter acquired during 1Q12, and growth of surgical sealants Tisseel and Floseal, while the Vaccines franchise saw a jump of 15% to $292 million, with higher sales of FSME-IMMUN (a tick-borne encephalitis vaccine) and milestone payments from ongoing flu vaccine collaborations.
On the business front, Baxter acquired Chatham Therapeutics for $70 million upfront, gaining its gene therapy programs for the development of hemophilia treatments. The two companies have been collaborating since May 2012, evaluating Chatham’s Biological Nano Particle (BNP) platform for potential hemophilia B treatments, which resulted in BAX 335, currently in Phase I/II development. Baxter will also have access to the previously partnered hemophilia B (FIX) program, a preclinical hemophilia A (FVIII) program.
In the way of pipeline progress, the FDA required additional time (until July 2014) to review supplemental data that Baxter provided as part of the ongoing BLA for HyQvia. The therapy was approved in EU member states in 2013 and is currently available in Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy. Also, the Phase III study of BAX 111, the first recombinant treatment in clinical development for von Willebrand disease, met its primary efficacy endpoint, achieving pre-specified success in the on-demand treatment of bleeding events.
On the other hand, Phase III data from the Gammaglobulin Alzheimer’s Partnership (GAP) study, did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in mild to moderate Alzheimer’s disease. While the study was not powered to demonstrate statistical significance among sub-groups within the study population, additional post-hoc and exploratory analyses of the data are ongoing.
Also, through an exclusive licensing agreement, Baxter and Cell Therapeutics, Inc. (CTI) will develop and commercialize pacritinib, an investigational JAK2/FLT3 inhibitor in Phase III development, with activity against genetic mutations linked to myelofibrosis, leukemia and certain solid tumors. Baxter paid $60 million upfront, which included a $30 million equity investment in CTI, and will pay as much as $112 million in milestones and royalties, if approved.
Further, making its foray into biosimilars, Baxter and Coherus Biosciences are collaborating to develop and commercialize a biosimilar to etanercept (Enbrel) for Europe, Canada, Brazil and other markets. For this candidate, Baxter paid $30 million upfront and will pay as much as $216 million based on development and regulatory milestones. The agreement also allows for development and commercialization of an alternative biosimilar to etanercept.
Starting out on its own should prove a successful venture, as the Bioscience business has all the building blocks for continued and steady growth, with expansion of its existing therapies, and progress with new ones.