Fresenius Medical Care North America

Waltham, Massachusetts, United States

Fresenius Medical Care North America

Waltham, Massachusetts, United States
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News Article | May 1, 2017
Site: cen.acs.org

Fresenius, a diversified life sciences company based in Bad Homburg, Germany, plans to diversify further via two acquisitions. The company says it will acquire Akorn, a Lake Forest, Ill.-based developer and manufacturer of generic drugs, and the biosimilars business of Merck KGaA. The company will pay $4.3 billion for Akorn, which manufactures animal health and over-the-counter consumer health products in addition to generic prescription drugs. Akorn, which logged sales of about $1 billion last year, employs 2,000 people. It operates three research facilities and five manufacturing plants in the U.S., Switzerland, and India. Fresenius will pay $185 million up-front for the Merck business, which includes a development pipeline focused on generic versions of biopharmaceuticals to treat cancer and autoimmune disease, therapeutic areas with a $30 billion annual market for branded drugs, Fresenius notes. The deal could include milestone payments of $544 million plus royalties. Fresenius CEO Mats Henriksson says the Akorn acquisition will serve to diversify the company’s activities in the U.S., which includes Fresenius Medical Care North America, a dialysis services business. The purchase also expands the company’s generic drugs lineup. “Akorn brings to Fresenius specialized expertise in development, manufacturing, and marketing of dosage forms currently not available in our portfolio,” he says. The deal for Merck’s biosimilars creates a “new platform for growth” in the company’s injectable pharmaceuticals business. For its part, Merck elected to sell the business to focus on branded biopharmaceutical development. “We have increasing confidence in our biopharma pipeline, and this transaction will help prioritize innovative drug development,” board member Belén Garijo says.


    --   Vifor Pharma Commits to Exclusive Distribution of Vadadustat to Fresenius Medical Care North America for Use in its Dialysis Facilities and Invests $50 Million in Akebia at a Premium --                               --    Additional Funds Support Vadadustat Global Development Program to Data -- ZURICH, SWITZERLAND & CAMBRIDGE, MA, USA - 16 May 2017  Vifor Pharma Group (SIX: VIFN) and Akebia Therapeutics, Inc. (NASDAQ: AKBA) today announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the United States upon approval by the U.S. Food and Drug Administration (FDA). Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia associated with chronic kidney disease (CKD). "Vadadustat could represent a significant advancement in the treatment of renal anemia with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease. We believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents," stated Stefan Schulze, President of the Executive Committee and Chief Operating Officer of Vifor Pharma. "This transaction strengthens the nephrology product portfolio of Vifor Pharma and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease." Under the terms of the agreement, Vifor Pharma will exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its dialysis facilities in the U.S. to meet their need for an HIF-based treatment for anemia associated with CKD. Fresenius Medical Care is the largest kidney dialysis provider in the U.S. and, in 2016, treated over 185,000 dialysis patients, or nearly 40% of the U.S. dialysis patients. This agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma. It is subject to the approval of vadadustat by the FDA and to the inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Akebia's revenue from the profit share and the milestone payment will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia's U.S. collaborator. Akebia, in collaboration with Otsuka, plans to commercialize vadadustat in other dialysis organizations and centers and in the non-dialysis market in the U.S. "This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch," said John P. Butler, President and Chief Executive Officer of Akebia. "We are pleased that Vifor Pharma has selected vadadustat as its exclusive HIF product for distribution to Fresenius Medical Care, one of the largest dialysis providers. We believe that this commitment provides significant further validation of vadadustat's potential." About Vadadustat Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat has not been approved by the FDA or any other regulatory authority. About Anemia Associated with CKD Anemia results from the body's inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production. Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.  The prevalence of anemia increases with the severity of CKD and is higher in people with CKD who are over age 60. About Vifor Pharma Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa and OM Pharma. Vifor Pharma Group is headquartered in Zurich, Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN). For more information, visit www.viforpharma.com. About Akebia Therapeutics Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia's lead product candidate, vadadustat, is an oral, investigational therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia's global Phase 3 program for vadadustat, which includes the PRO TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO VATE studies for dialysis-dependent patients, is currently ongoing. For more information, please visit our website at www.akebia.com. Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the potential commercialization of vadadustat and the anticipated financial contributions and other benefits of the license agreement with Vifor Pharma.  The words "anticipate," "appear," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia's product candidates and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the FDA and other regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; early termination of the exclusive license agreement by Akebia or Vifor Pharma; and Akebia's ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-Q for the quarter ended March 31, 2017, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.


    --   Vifor Pharma Commits to Exclusive Distribution of Vadadustat to Fresenius Medical Care North America for Use in its Dialysis Facilities and Invests $50 Million in Akebia at a Premium --                               --    Additional Funds Support Vadadustat Global Development Program to Data -- ZURICH, SWITZERLAND & CAMBRIDGE, MA, USA - 16 May 2017  Vifor Pharma Group (SIX: VIFN) and Akebia Therapeutics, Inc. (NASDAQ: AKBA) today announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the United States upon approval by the U.S. Food and Drug Administration (FDA). Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia associated with chronic kidney disease (CKD). "Vadadustat could represent a significant advancement in the treatment of renal anemia with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease. We believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents," stated Stefan Schulze, President of the Executive Committee and Chief Operating Officer of Vifor Pharma. "This transaction strengthens the nephrology product portfolio of Vifor Pharma and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease." Under the terms of the agreement, Vifor Pharma will exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its dialysis facilities in the U.S. to meet their need for an HIF-based treatment for anemia associated with CKD. Fresenius Medical Care is the largest kidney dialysis provider in the U.S. and, in 2016, treated over 185,000 dialysis patients, or nearly 40% of the U.S. dialysis patients. This agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma. It is subject to the approval of vadadustat by the FDA and to the inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Akebia's revenue from the profit share and the milestone payment will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia's U.S. collaborator. Akebia, in collaboration with Otsuka, plans to commercialize vadadustat in other dialysis organizations and centers and in the non-dialysis market in the U.S. "This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch," said John P. Butler, President and Chief Executive Officer of Akebia. "We are pleased that Vifor Pharma has selected vadadustat as its exclusive HIF product for distribution to Fresenius Medical Care, one of the largest dialysis providers. We believe that this commitment provides significant further validation of vadadustat's potential." About Vadadustat Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat has not been approved by the FDA or any other regulatory authority. About Anemia Associated with CKD Anemia results from the body's inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production. Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.  The prevalence of anemia increases with the severity of CKD and is higher in people with CKD who are over age 60. About Vifor Pharma Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa and OM Pharma. Vifor Pharma Group is headquartered in Zurich, Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN). For more information, visit www.viforpharma.com. About Akebia Therapeutics Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia's lead product candidate, vadadustat, is an oral, investigational therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia's global Phase 3 program for vadadustat, which includes the PRO TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO VATE studies for dialysis-dependent patients, is currently ongoing. For more information, please visit our website at www.akebia.com. Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the potential commercialization of vadadustat and the anticipated financial contributions and other benefits of the license agreement with Vifor Pharma.  The words "anticipate," "appear," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia's product candidates and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the FDA and other regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; early termination of the exclusive license agreement by Akebia or Vifor Pharma; and Akebia's ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-Q for the quarter ended March 31, 2017, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.


CAMBRIDGE, Mass. & ZURICH--(BUSINESS WIRE)--Akebia Therapeutics, Inc. (NASDAQ:AKBA) and Vifor Pharma Group. today announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the United States upon approval by the U.S. Food and Drug Administration (FDA). Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia associated with chronic kidney disease (CKD). “Vadadustat could represent a significant advancement in the treatment of renal anemia with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease. We believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents,” stated Stefan Schulze, President of the Executive Committee and Chief Operating Officer of Vifor Pharma. “This transaction strengthens the nephrology product portfolio of Vifor Pharma, and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease.” Under the terms of the agreement, Vifor Pharma will exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its dialysis facilities in the U.S. to meet their need for a HIF-based treatment for anemia associated with CKD. Fresenius Medical Care is the largest kidney dialysis provider in the U.S. and, in 2016, treated over 185,000 dialysis patients, or nearly 40% of the U.S. dialysis patients. This agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma. It is subject to approval of vadadustat by the FDA and inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Akebia’s revenue from the profit share and the milestone payment will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia’s U.S. collaborator. Akebia, in collaboration with Otsuka, plans to commercialize vadadustat in other dialysis organizations and centers and in the non-dialysis market in the U.S. “This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch,” said John P. Butler, President and Chief Executive Officer of Akebia. “We are pleased that Vifor Pharma has selected vadadustat as its exclusive HIF product for distribution to Fresenius Medical Care, one of the largest dialysis providers. We believe that this commitment provides significant further validation of vadadustat’s potential.” Conference Call and Webcast Akebia management will host a conference call to review the details of the transaction beginning at 4:30 p.m. Eastern Time today, Monday, May 15, 2017. A live audio webcast of the presentation will be available on the company's website at http://ir.akebia.com/events.cfm. An archived presentation will be available for 90 days. To access the conference call, follow these instructions: Dial: (877) 458-0977 (U.S.); (484) 653-6724 (international) Conference ID: 23256278 About Vadadustat Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat has not been approved by the FDA or any other regulatory authority. About Anemia Associated with CKD Anemia results from the body's inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production. Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks. The prevalence of anemia increases with the severity of CKD and is higher in people with CKD who are over age 60. About Akebia Therapeutics Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia’s lead product candidate, vadadustat, is an oral, investigational therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia’s global Phase 3 program for vadadustat, which includes the PRO TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO VATE studies for dialysis-dependent patients, is currently ongoing. For more information, please visit our website at www.akebia.com. About Vifor Pharma Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. The Vifor Pharma Group holds a leading position in all their core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa and OM Pharma. Vifor Pharma Group is headquartered in Zurich, Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN). For more information, visit www.viforpharma.com. Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the potential commercialization of vadadustat and the anticipated financial contributions and other benefits of the license agreement with Vifor Pharma. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that Akebia will not achieve the milestone; existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia's product candidates and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the FDA and other regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; early termination of the exclusive license agreement by Akebia or Vifor Pharma; and Akebia's ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia's Annual Report on Form 10-Q for the quarter ended March 31, 2017, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.


    --   Vifor Pharma Commits to Exclusive Distribution of Vadadustat to Fresenius Medical Care North America for Use in its Dialysis Facilities and Invests $50 Million in Akebia at a Premium --                               --    Additional Funds Support Vadadustat Global Development Program to Data -- ZURICH, SWITZERLAND & CAMBRIDGE, MA, USA - 16 May 2017  Vifor Pharma Group (SIX: VIFN) and Akebia Therapeutics, Inc. (NASDAQ: AKBA) today announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the United States upon approval by the U.S. Food and Drug Administration (FDA). Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia associated with chronic kidney disease (CKD). "Vadadustat could represent a significant advancement in the treatment of renal anemia with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease. We believe that vadadustat may also be a potential solution for hyporesponder patients who do not respond well to erythropoiesis stimulating agents," stated Stefan Schulze, President of the Executive Committee and Chief Operating Officer of Vifor Pharma. "This transaction strengthens the nephrology product portfolio of Vifor Pharma and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease." Under the terms of the agreement, Vifor Pharma will exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its dialysis facilities in the U.S. to meet their need for an HIF-based treatment for anemia associated with CKD. Fresenius Medical Care is the largest kidney dialysis provider in the U.S. and, in 2016, treated over 185,000 dialysis patients, or nearly 40% of the U.S. dialysis patients. This agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma. It is subject to the approval of vadadustat by the FDA and to the inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Akebia's revenue from the profit share and the milestone payment will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia's U.S. collaborator. Akebia, in collaboration with Otsuka, plans to commercialize vadadustat in other dialysis organizations and centers and in the non-dialysis market in the U.S. "This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch," said John P. Butler, President and Chief Executive Officer of Akebia. "We are pleased that Vifor Pharma has selected vadadustat as its exclusive HIF product for distribution to Fresenius Medical Care, one of the largest dialysis providers. We believe that this commitment provides significant further validation of vadadustat's potential." About Vadadustat Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat has not been approved by the FDA or any other regulatory authority. About Anemia Associated with CKD Anemia results from the body's inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production. Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.  The prevalence of anemia increases with the severity of CKD and is higher in people with CKD who are over age 60. About Vifor Pharma Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa and OM Pharma. Vifor Pharma Group is headquartered in Zurich, Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN). For more information, visit www.viforpharma.com. About Akebia Therapeutics Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia's lead product candidate, vadadustat, is an oral, investigational therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia's global Phase 3 program for vadadustat, which includes the PRO TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO VATE studies for dialysis-dependent patients, is currently ongoing. For more information, please visit our website at www.akebia.com. Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the potential commercialization of vadadustat and the anticipated financial contributions and other benefits of the license agreement with Vifor Pharma.  The words "anticipate," "appear," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia's product candidates and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the FDA and other regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; early termination of the exclusive license agreement by Akebia or Vifor Pharma; and Akebia's ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-Q for the quarter ended March 31, 2017, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.


News Article | May 17, 2017
Site: www.prnewswire.co.uk

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new 164-page report you will receive 84 tables and 93 figures - all unavailable elsewhere. The 164-page report provides clear detailed insight into the global erythropoietin market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Revenue forecasts of global erythropoietin market, segmented by product type: - Epoetin Alfa - Epoetin Beta - Darbepoetin Alfa - Biosimilars - Others This section also discusses the leading drugs as well as SWOT analysis of each submarket. • Revenue forecasts of global erythropoietin market, segmented by application: - Anemia (Cancer and HIV Treatment) - Kidney Disorders (ESRD and Dialysis) - Others Forecast for each regional market is further segmented by product type, application and country: - US - Canada - UK - Germany - France - Spain - Italy - Rest of Europe - China - Japan - India - Rest of Asia-Pacific - Brazil - Mexico - Rest of Latin America - Saudi Arabia - South Africa - Rest of Middle East and Africa • Assessment of selected leading companies that hold major market shares in the erythropoietin market: - Amgen - Johnson & Johnson - Roche - Biocon - 3SBio - Pfizer - Kyowa Hakko Kirin Co Ltd - LG Life Sciences Limited - Intas Pharmaceuticals Ltd - Novartis AG Visiongain's study is intended for anyone requiring commercial analyses for the erythropoietin market. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 3SBio Inc. Accord Healthcare Limited Actavis Akebia Therapeutics Amgen Astellas Pharma Inc AstraZeneca Bio Sidus SA Biocon Ltd Casa Marzam Casa Saba Chugai Pharmaceutical Claes-Göran Östenson Corvidia Therapeutics DaVita Inc Dr. Reddy's Laboratories FibroGen First Shanghai Investments Limited Fresenius Medical Care North America (FMCNA) Galenica Germans Trias i Pujol Hospital GlaxoSmithKline H. Lundbeck A/S Hoffmann-La Roche Hospira Janssen Biotech Japan Chemical Research Pharmaceuticals Co., Ltd. Johnson & Johnson Kissei pharmaceuticals Kosin University Gospel Hospital Kyowa Hakko Kirin Co Ltd LG Life Sciences Limited NADRO NovaQuest Co-Investment Fund I, L.P. Novartis Institutes for BioMedical Research (NIBR) Novartis Pharmaceuticals NOXXON Pharma AG Pfizer Proveedora de Medicamentos RPG Life Sciences Sandoz Sirton Pharma Stada Stem Cell Therapeutics Corp. Teva Pharmaceutical Industries Ltd. UBI Pharma Inc. Vifor Pharma List of Organizations Mentioned in the Report Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) Centers of Disease Control and Preventions China's Ministry of Health (MOH) Committee for Medicinal Products for Human Use (CHMP) Department of Health & Family Welfare of Karnataka Deutsches Ärzteblatt EMA European Commission (EC) FDA Indian Council of Medical Research (ICMR) International Agency for Research on Cancer (IARC) Ministry of Health, Malaysia National Cancer Institute National Center for Biotechnology Information National Kidney Foundation UK Nephrology - Renal Association World Cancer Research Fund International World Health Organizations To see a report overview please email Sara Peerun on sara.peerun@visiongain.com


News Article | May 17, 2017
Site: www.prnewswire.com

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new 164-page report you will receive 84 tables and 93 figures - all unavailable elsewhere. The 164-page report provides clear detailed insight into the global erythropoietin market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Revenue forecasts of global erythropoietin market, segmented by product type: - Epoetin Alfa - Epoetin Beta - Darbepoetin Alfa - Biosimilars - Others This section also discusses the leading drugs as well as SWOT analysis of each submarket. • Revenue forecasts of global erythropoietin market, segmented by application: - Anemia (Cancer and HIV Treatment) - Kidney Disorders (ESRD and Dialysis) - Others Forecast for each regional market is further segmented by product type, application and country: - US - Canada - UK - Germany - France - Spain - Italy - Rest of Europe - China - Japan - India - Rest of Asia-Pacific - Brazil - Mexico - Rest of Latin America - Saudi Arabia - South Africa - Rest of Middle East and Africa • Assessment of selected leading companies that hold major market shares in the erythropoietin market: - Amgen - Johnson & Johnson - Roche - Biocon - 3SBio - Pfizer - Kyowa Hakko Kirin Co Ltd - LG Life Sciences Limited - Intas Pharmaceuticals Ltd - Novartis AG Visiongain's study is intended for anyone requiring commercial analyses for the erythropoietin market. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 3SBio Inc. Accord Healthcare Limited Actavis Akebia Therapeutics Amgen Astellas Pharma Inc AstraZeneca Bio Sidus SA Biocon Ltd Casa Marzam Casa Saba Chugai Pharmaceutical Claes-Göran Östenson Corvidia Therapeutics DaVita Inc Dr. Reddy's Laboratories FibroGen First Shanghai Investments Limited Fresenius Medical Care North America (FMCNA) Galenica Germans Trias i Pujol Hospital GlaxoSmithKline H. Lundbeck A/S Hoffmann-La Roche Hospira Janssen Biotech Japan Chemical Research Pharmaceuticals Co., Ltd. Johnson & Johnson Kissei pharmaceuticals Kosin University Gospel Hospital Kyowa Hakko Kirin Co Ltd LG Life Sciences Limited NADRO NovaQuest Co-Investment Fund I, L.P. Novartis Institutes for BioMedical Research (NIBR) Novartis Pharmaceuticals NOXXON Pharma AG Pfizer Proveedora de Medicamentos RPG Life Sciences Sandoz Sirton Pharma Stada Stem Cell Therapeutics Corp. Teva Pharmaceutical Industries Ltd. UBI Pharma Inc. Vifor Pharma List of Organizations Mentioned in the Report Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) Centers of Disease Control and Preventions China's Ministry of Health (MOH) Committee for Medicinal Products for Human Use (CHMP) Department of Health & Family Welfare of Karnataka Deutsches Ärzteblatt EMA European Commission (EC) FDA Indian Council of Medical Research (ICMR) International Agency for Research on Cancer (IARC) Ministry of Health, Malaysia National Cancer Institute National Center for Biotechnology Information National Kidney Foundation UK Nephrology - Renal Association World Cancer Research Fund International World Health Organizations To see a report overview please email Sara Peerun on sara.peerun@visiongain.com

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