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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.

BALTIMORE--(BUSINESS WIRE)--People with kidney failure in Baltimore and the surrounding area can now access dialysis treatments and a full spectrum of enhanced kidney care services at eight new care centers, all through a collaboration between Fresenius Kidney Care and The Johns Hopkins Hospital. With convenient locations in Baltimore, Dundalk and Lutherville-Timonium, the collaboration also includes Maryland’s only center dedicated to treating children with chronic kidney disease. “These new facilities have features that will enhance our patients’ dialysis experience,” said Bill Valle, executive vice president of Fresenius Medical Care North America and president of Fresenius Kidney Care. “Our vision behind these centers aligns the values we share with The Johns Hopkins Hospital to improve the quality of life of every patient, every day. We are excited to join forces with one of the leading and preeminent institutions in the United States in our effort to empower patients throughout their individual journeys so they can continue living life, doing what is important to them and thriving.” Fresenius Kidney Care is the nation’s premier network of dialysis facilities and is a business unit of Fresenius Medical Care North America, the nation’s leading provider of integrated renal care services. The new centers feature state-of-the-art offerings including overnight dialysis, individual media systems and heated, reclining massage chairs to enhance the patient experience. The new facilities are part of the network that achieved the country’s largest number of top-rated Five-Star dialysis centers, based on the Dialysis Facility Compare Five-Star Quality Rating System issued by the federal government’s Centers for Medicare and Medicaid Services (CMS). Fresenius Kidney Care’s latest Five-Star rating builds on a track record of success. Each year since 2006, the company has helped patients live longer and spend less time in the hospital, improving mortality rates of its dialysis patients and lowering the average time spent in a hospital setting by two-and-a-half days. The Johns Hopkins Hospital physicians will oversee the management of the centers’ medical operations. Dr. Paul Scheel, division chief of the nephrology department at The Johns Hopkins Hospital and vice president of the Johns Hopkins Physicians, will work alongside the medical directors of the new hemodialysis facilities. “Chronic kidney disease is a considerable, but unrecognized health issue in this country,” said Dr. Scheel. “We are pleased to be a part of this initiative, dedicated to providing optimal dialysis services to our patients.” An outpatient pediatric hemodialysis unit will be located at The Johns Hopkins Hospital, the only dialysis center in the state of Maryland dedicated to treating children with chronic kidney disease. The center, located at 1800 Orleans Street, will also have an area dedicated to serving patients receiving in-center dialysis and another for people who are on home dialysis. The other seven dialysis centers are: Dialysis is a medical treatment for individuals with kidney failure and end stage renal disease that uses sophisticated medical machines to replace many of the kidney’s essential functions required for survival. The dialysis process filters harmful wastes, salt and excess fluid from an individual’s blood, restoring a normal, healthy balance. The majority of patients receive treatment at a dialysis center three times a week, with each session lasting approximately four hours. Today, more than 450,000 people in the United States are on dialysis. Fresenius Kidney Care, a division of Fresenius Medical Care North America (FMCNA), provides dialysis treatment and services to nearly 200,000 people with kidney disease at more than 2,200 facilities nationwide. Fresenius Kidney Care supports people by helping to address both the physical and emotional aspects of kidney disease through personalized care, education and lifestyle support services so they can lead meaningful and fulfilling lives. Fresenius Kidney Care patients have access to FMCNA’s integrated network of kidney care services ranging from cardiology and vascular care to pharmacy and lab services as well as urgent care centers and the country’s largest practice of hospitalist and post-acute providers. As a leader in renal care technology, innovation and clinical research, FMCNA’s more than 67,000 employees are dedicated to the mission of delivering superior care that improves the quality of life for people with kidney disease. For more information about Fresenius Kidney Care, visit www.freseniuskidneycare.com, like us on Facebook at facebook.com/FreseniusKidneyCare and follow us on Twitter at twitter.com/FreseniusKC. Fresenius Medical Care North America is the premier health care company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis centers, outpatient cardiac and vascular labs and urgent care centers, as well as the continent’s largest practice of hospitalist and post-acute providers, Fresenius Medical Care North America provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers. As the world’s largest fully vertically integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit www.FMCNA.com.

News Article | November 30, 2016
Site: globenewswire.com

WESTMINSTER, Colo., Nov. 30, 2016 (GLOBE NEWSWIRE) -- Surefire Medical, Inc. today announced that Mats Wahlström is joining the company’s Board of Directors and will serve as chairman. Wahlström has more than 30 years of experience in the healthcare industry, having served as CEO and CFO of large international companies in the medical field. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cc59d0f8-0ea1-499b-abab-01f58ef1aa3f “Surefire Medical is honored to have Mats join our board and serve as our Chairman,” said James E. Chomas, CEO and President of Surefire Medical. “His business acumen and experience in the medical device industry will be an essential asset to Surefire reaching our strategic objectives and helping propel our company forward as we strive to invent the future for cancer care.” Wahlström currently serves as Executive Chairman of KMG Capital Partners, LLC, Chairman of PCI | HealthDev, and Chairman of Caduceus Medical Holdings, Inc. He also serves as the Lead Director and Chairman of the Audit/Finance Committee of Coherus Biosciences, a public biotech company. In addition, he currently serves on the boards of Getinge AB and Alteco Medical AB, both public companies, as well as Triomed AB and Circuit Clinical, Inc. From March 2009 through its sale to a private equity firm in October 2010, Wahlström served as a director of Health Grades, Inc., a NASDAQ-listed healthcare ratings company. Also from January 2004 through December 2009, Wahlström served as Co-CEO of Fresenius Medical Care North America, and from November 2002 through December 2009 as President and CEO of Fresenius Medical Services, which operates more than 1,700 dialysis clinics in the U.S. Prior to joining Fresenius Medical Care in 2002, he held various positions at Gambro AB in Sweden, including President and CEO of Gambro North America as well as CFO of the Gambro Group. Surefire’s current Board Chair, Norman Weldon, will continue to serve on the Surefire Board of Directors. Surefire Medical, Inc. develops, manufactures and markets innovative infusion systems for the Interventional Radiology and Interventional Oncology markets. Surefire’s technology is designed to precisely deliver therapeutic agents through a unique microcatheter with an expandable tip that creates a pressure gradient, driving therapeutic agents deeply into the tumor while minimizing backflow that might otherwise damage healthy tissue. The Surefire Infusion System enables physicians to target tumors with superior accuracy, control and protection. The Surefire Infusion Systems and Surefire Precision have received regulatory approval in the U.S., Europe, Canada, Mexico and Brazil. For more information, please visit www.surefiremedical.com.

Sawin D.A.,Fresenius Medical Care North America
Advances in peritoneal dialysis. Conference on Peritoneal Dialysis | Year: 2012

Although dialytic removal of phosphate significantly contributes to the management of phosphate levels in end-stage renal disease, many patients on peritoneal dialysis (PD) still do not reach optimal phosphate control. The present review discusses the impact of PD modality--continuous ambulatory (CAPD) or automated (APD)--on phosphate removal. Relevant factors are the diffusive properties of the phosphate anion and the kinetics of phosphate distribution in various body compartments. Confounders that potentially affect comparisons of phosphate clearances in CAPD and APD are differences in residual renal function, membrane transport status, and prescribed dialysis dose. The evidence reviewed here is not strong enough to clearly determine if one modality has a clear advantage with respect to phosphate removal. In the absence of final proof the data suggest that, given the same residual renal function and dialysis dose, CAPD might be slightly more effective than APD at peritoneal phosphate clearance, especially in low transporters.

Wingard R.L.,Fresenius Medical Care North America
Nephrology news & issues | Year: 2012

The rate of rehospitalization is at a critical level. Twenty percent of all Medicare patients are rehospitalized within 30 days of discharge, and this rate is even higher (36%) for end-stage renal disease patients. Dialysis-dependent patients are commonly discharged from the hospital with a decline in various health measures (such as hemoglobin, albumin, and estimated dry weight) when compared to pre-hospital values, making the common response to resume previous orders" in the outpatient setting inadequate. Both quality of care and financial penalties by the Centers for Medicare & Medicaid Services have set the stage for partnerships between dialysis providers and hospitals to develop strategies to reduce readmissions for ESRD patients, and provide for the "RightReturn" to the outpatient setting with resumption of their daily lives at home in optimal health.

Maddux F.W.,Fresenius Medical Care North America
Blood Purification | Year: 2012

This article provides a perspective on the impact of the bundled end-stage renal disease prospective payment system on patient care. As the first year of the bundle comes to a close, we are beginning to see information about practice pattern changes that have resulted and the impact of those changes on the care of patients with renal disease. This review recognizes the background of the prospective payment system for renal replacement therapy and its evolution to include multiple components, as well as a description of the features of this payment system that are expected to have an impact on the clinical care by nephrologists and dialysis providers. Some of the expected impact on the dosing of erythropoiesis-stimulating agents, consolidation of dialysis providers, and a move toward more measurement are beginning to be seen. This brief summary not only reviews the components of the bundled payment system, but also the anticipated impact and some early information on the response to these predicted findings in the industry. © 2012 S. Karger AG, Basel.

McCool M.,Fresenius Medical Care North America
Nephrology news & issues | Year: 2011

Research with tens of thousands of dialysis patients has established a link between depression, health-related quality of life scores, survival, and hospitalizations. In fact, physical and mental functioning scores are as predictive of death and hospitalization as Kt/V and albumin. Some models for managing depression in the dialysis clinic have been developed. These models address barriers to accessing community mental health services. They also promote collaboration between the nephrology social worker and nephrologist to assurethat patients receive counseling and/or antidepressant medications when they need them. Part 1 of this article will introduce a promising new method designed for nephrology social workers to help patients manage depression. This method, known as symptom-targeted intervention (STI), can be used in brief intervals with patients while they are receiving dialysis treatments to help reduce depressive symptoms and improve quality of life. The second part of this article, which will appear in the June issue of Nephrology News & Issues, will report the outcomes of a 17-state pilot study in which more than 45 nephrology social workers used brief, focused STI methods with more than 75 patients in the dialysis clinic setting. The impact of STI on depression and quality of life in this sample will be explored as well as how those outcomes may impact hospitalizations, improve patient survival, and contain costs in a bundled reimbursement environment.

Maddux F.W.,Fresenius Medical Care North America | Nissenson A.R.,HealthCare Partners
Clinical Journal of the American Society of Nephrology | Year: 2015

The medical director has been a part of the fabric of Medicare’s ESRD program since entitlement was extended under Section 299I of Public Law 92-603, passed on October 30, 1972, and implemented with the Conditions for Coverage that set out rules for administration and oversight of the care provided in the dialysis facility. The role of the medical director has progressively increased over time to effectively extend to the physicians serving in this role both the responsibility and accountability for the performance and reliability related to the care provided in the dialysis facility. This commentary provides context to the nature and expected competencies and behaviors of these medical director roles that remain central to the delivery of high-quality, safe, and efficient delivery of RRT, which has become much more intensive as the dialysis industry has matured. © 2015 by the American Society of Nephrology

Ketchersid T.,Fresenius Medical Care North America
Blood Purification | Year: 2014

The phrase 'big data' has arrived in today's lexicon with great fanfare and some degree of hyperbole. Generally speaking, big data refer to data sets that are too complex to be successfully interrogated using standard statistical software. A wide variety of business sectors has utilized big data to garner competitive advantage within their respective markets. Medicine and nephrology, in particular, have been late to this table. This is beginning to change, however, as data scientists begin to work with these large data sets, developing predictive models that permit us to peer into the future. Coupled with an expanding understanding of genomics, predictive models constructed with the assistance of big data may soon provide us with a powerful tool to use as we provide care to patients with renal disease. © 2013 S. Karger AG, Basel.

News Article | February 22, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), today announced that it has entered into a collaboration with Frenova Renal Research, a leading drug and medical device contract clinical development services provider dedicated exclusively to renal research. “The opportunity to collaborate with Frenova enhances our ability to connect our clients with researchers recognized as world leaders in the field of nephrology and further strengthens our industry-leading global site and patient capabilities by helping to deliver seamless access to patients, sites and data sources,” said Ulrich Zoeller, vice president, project management, general medicine for PPD. “Frenova’s access to more than two-thirds of all U.S. nephrology patients, coupled with the breadth of its resources and experience in renal research, will enable PPD to continue to build on its already strong presence in nephrology trials.” As part of Fresenius Medical Care North America (FMCNA) - a leading provider of kidney care products and services, and a network of more than 2,200 dialysis centers nationwide - Frenova maintains a world-class network of resources encompassing 260 research sites with 450 principal investigators and access to more than 183,000 active ESRD patients and 390,000 active CKD patients. The breadth and depth of Frenova’s data access is rooted in FMCNA’s unmatched ability to gather and analyze immense amounts of patient data from within the company’s own care ecosystem. The company has collected data on more than 1 million patients, including data on more than 250 million dialysis treatments, more than 1 billion medication administrations and more than 1 billion laboratory results. “Our collaboration with PPD expands the reach of our nephrology experts and broadens the impact of our invaluable treatment data in clinical trials,” said Kurt Mussina, general manager, Frenova. “We are pleased to join forces with PPD through our shared commitment of improving the lives of patients living with kidney disease, around the world, through the advancement of renal research.” Through this relationship, PPD will offer its clients the therapeutic expertise of Frenova’s global nephrology experts, as well as access to F1RST Up™ (Frenova Rapid STart Up), Frenova’s exclusive alliance of research sites designed to streamline, initiate and enroll clinical studies dramatically faster than industry norms with just-in-time patient recruitment. Frenova is active in more than 260 sites across the United States, 15 of which are the proprietary F1RST Up sites with a strong track record of patient recruitment and retention. The F1RST Up sites use coordinated research processes that enable faster site startup and streamlined study execution. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Frenova is the world’s only drug and medical device contract clinical development services provider dedicated exclusively to renal research. As a Fresenius Medical Care North America company, Frenova manages a networked system of clinical research assets and resources including 450 principal investigators and 260 research sites with clinical trials in kidney disease and its adjacent medical conditions. For more information, visit www.FrenovaRenalResearch.com. Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the collaboration with Frenova, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: risks associated with and dependence on strategic relationships; rapid technological advances that make our services or capabilities less competitive; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; compliance with drug development regulations; changes in the regulation of the drug development process; PPD’s ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; actual operating performance; risks associated with acquisitions and investments; and the ability to control SG&A spending. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD’s estimates or views as of any date subsequent to the date hereof.

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