Industry Spotlight

After a rejection last year by the U.S. Food and Drug Administration (FDA) and the need for a complete response letter explaining data, Amgen (Thousand Oaks, CA) now has gained FDA approval for its drug Parsabiv. Approved in early February, the drug treats secondary hyperparathyroidism (secondary HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Drug combinations against advanced kidney cancer are the new focus in research and treatment, say many oncology experts. One combination in the news is nivolumab and ipilimumab, each an immunotherapy drug. The first approved (2016) combination for advanced kidney cancer is everolimus plus lenvatinib.

Other combinations, which include some of the aforementioned drugs, are also being tested, in a new era that medical oncologist James Hsieh is calling the Golden Era for advances against kidney cancer.

More control over vascular access in dialysis can be an important part of dialysis self-care.

In addition to dialysis centers training patients to handle their own vascular access when motivated to learn, a new maker of venous access, Advent Access (Singapore), is positioning itself as a “disruptive” new technology that will further help patients on dialysis.

Eisai (Tokyo), a maker of cancer and neurological therapies, is closer to gaining a proven new benefit for its renal cancer treatment, lenvatinib (Kisplyx), in Germany, where 15,000 people develop renal cell carcinoma (RCC) every year.

Recent news of a new kidney cancer treatment in early studies and insight into when to use alpha blockers to treat kidney stones top recent industry developments.

Amgen’s drug etelcalcetide (Parsabiv™) has been approved for marketing in Europe, through a decision by the European Commission announced in November 2016. Applications are also pending in the United States and Japan for etelcalcetide, which treats secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) who are on hemodialysis. In Europe, the prevalence of SHPT within dialysis populations ranges from 30% to 49%, Medscape reports.

The US Food and Drug Administration (FDA) approved Rayaldee (calcifediol) (OPKO Health, Miami, FL) extended-release capsules for treatment of secondary hyperparathyroidism (SHPT). The approval applies only to treating adults with SHPT who have CKD stage 3 or 4 and serum total 25-hydroxyvitamin D <30 ng/mL.

Rayaldee has a patented design intended to increase serum total 25-hydroxyvitamin D (prohormone) levels to targeted levels and also to decrease elevated intact parathyroid hormone (iPTH). It is the first drug approved for this specific purpose.

The world’s largest provider of dialysis services now has a new business: a regenerative medicine company. Frensenius Medical Care (Bad Homburg, Germany) has opened the doors of Unicyte AG, a subsidiary that will undertake research into kidney and liver diseases, diabetes, and cancer.

Acombination therapy called Byvalson has been approved by the FDA to treat high blood pressure.

Taken together once a day in a fixed dose pill from Allergan (Parsippany, NJ; Dublin, Ireland), the two drugs—Nebivolol and Valsartan—work by using different mechanisms to lower blood pressure.

A research team at the University of Michigan (U-M), Ann Arbor, has devised a technique to use cultured kidney cells to simulate the way kidneys clear drug compounds.

Nephros (River Edge, NJ), a medical device company that develops and sells high-performance liquid purification ultrafilters and a hemodiafiltration (HDF) system for use with a hemodialysis machine, reported in its first quarter 2016 results that it had gained “510(k) clearance on two additional products and successfully completed the software upgrade and additional training development for our H2H (company brand) modules needed to expand our hemodiafiltration footprint.” Nephros said the company will aim for positive cash flow from its products in the coming months.

One year after the biosimilar version of Zarxio, manufactured by Novartis and a competitor of Amgen’s drug Neupogen, landed on the market, the US Food and Drug Administration (FDA) has approved a second biosimilar drug. (Neupogen is used to treat neutropenia, lack of certain white blood cells caused by cancer, bone marrow transplant, or chemotherapy).

Fresenius Kidney Care is the new name of the dialysis division of Fresenius North America.

“We created this name to better communicate our approach to helping people with kidney disease thrive and continue doing the things that matter most to them,” said Ron Kuerbitz, CEO of Fresenius Medical Care North America. “The Fresenius Kidney Care name underscores the focus and attention that our caregivers provide to our patients’ unique health needs at more than 2200 dialysis centers across the nation.”

Baxter International Inc. announced in mid-March 2016 it had enrolled the first patient in a US clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter (Deerfield, IL), and DEKA Research & Development (Manchester, NH).

The trial is designed to study more frequent, extended-duration nighttime home HD therapy (high dose HD), which will be performed in dialysis facilities as well as in homes. The study will assess product safety and adequacy of dialysis.

Fresenius is now working to settle a lawsuit brought against it by plaintiffs regarding its dialysate products GranuFlo and NaturaLyte. Although the company notified its own dialysis centers about cardiac arrest events in some patients using the products, it allegedly did not inform other dialysis centers at the same time it sent an internal memo, the New York Times reported.

The two Fresenius dialysates neutralize the normal buildup of acid in the blood.

A newly approved merger seals one of the largest recent dialysis business deals. U.S. Renal Care (USRC, Plano, TX) announced in early January that it had finalized its deal to merge with DSI Renal. U.S. Renal Care, already the nation’s third largest provider of dialysis, will now operate 300 outpatient clinics, 147 home dialysis programs, and 26 acute care hospital contracts throughout the United States.

The anemia drug Feraheme (ferumoxytol (AMAG Pharmaceuticals, Waltham, MA) will now carry the FDA’s strongest warning. The FDA has stipulated that the drug must carry a boxed warning that states “serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol).”

The US Food and Drug Administration has approved Sanofi’s new diabetes drug formulation Toujeo (insulin glargine injection, 300 U/mL). The drug, which may be used by patients with either type 1 or type 2 diabetes, is a once-daily long-acting basal insulin.

Rockwell Medical has won drug approval by the US Food and Drug Administration (FDA) for a new anemia drug, Triferic (soluble ferric pyrophosphate or SFP).

The results from two phase 3 clinical studies demonstrated that Triferic was effective in maintaining “hemoglobin during the treatment period in iron-replete patients with hemodialysis-dependent chronic kidney disease in the studies as conducted,” according to FDA documents.

Around press time, news appeared that a drug once used to lower cholesterol was showing promise for patients with chronic kidney disease (CKD).

For the fourth consecutive year since a federal data registry program was launched in 2007, Fresenius’ chronic kidney disease data registry has been the largest registry for nephrology. Fresenius and dozens of other registries have gained admittance as official registries in the federal program that requires physician quality-indicator reporting. That program, the Physicians Quality Reporting System (PQRS) is administered by the Centers for Medicare and Medicaid Services (CMS).

Pfizer Inc. says that its oral drug Inlyta (axitinib) has been granted European approval for use as a second-line therapy for kidney cancer patients, according to Reuters News. The drug, already approved in the United States, has been approved in Europe as a second-line treatment for patients who have not responded to initial chemotherapy.

New approaches to long-term vascular access problems are arriving. One group is working in trials to get approval for its system for creating vascular access. The other team is working to prevent needle sticks that penetrate into and through the vascular graft walls, causing profuse bleeding.

Two international bodies approved the drug Soliris (eculizumab) for orphan drug status, giving manufacturer Alexion Pharmaceuticals, Inc., of Cheshire, Conn., special consideration on its way through the drug approval process. Orphan drugs are those that most likely wouldn’t be developed because of the rarity of the disease they treat, in this case atypical hemolytic uremic syndrome (aHUS).

Patients with kidney disease who are treated at for-profit dialysis centers are 20 percent less likely to be informed about the transplantation option than are those at nonprofit centers, according to a study at Johns Hopkins University School of Medicine. Controversy about this finding played out recently during a forum in Oregon, when angry state insurers and others confronted representatives from for-profit dialysis centers about the transplantation option.

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In late spring, a federal judge in Tennessee awarded the United States government $82.6 million from three companies in a Medicare fraud case brought by whistleblowers.

The companies, Renal Care Group, Renal Care Group Supply Company, and Fresenius Medical Holdings, were found liable for recklessly disregarding federal law when they billed Medicare for home dialysis supplies and equipment.

DaVita’s acquisition in late May of HealthCare Partners, which has 700 staff physicians and a network of 8300 independent doctors, signaled a major dedication to a new strategy, a move that gives DaVita a major foundation with an accountable care organization (ACO), a critical component solidified by the federal Patient Protection and Affordable Care Act.

DiaSource opened virtual doors in May as a dialysis business that promises low-cost dialysis to employers who participate with DiaSource providers in its network.

The other side of the equation is that DiaSource must attract dialysis providers in an area and sign them on to participate as providers so they can serve these smaller businesses.

The employer clients are generally self-insured employers who cannot easily afford to offer dialysis treatments economically within a small employee base.

The renal denervation device market has several systems approved for use in Europe, but none so far has been approved by the U.S. Food and Drug Administration (FDA). Renal denervation is a catheter-based ablation procedure used to treat patients with high blood pressure resistant to drugs.

Rockwell Medical completed a second late-stage study in September (the earlier, identical late-stage trial ended in July) and announced that its experimental drug has met the main goal of improving hemoglobin levels in adult patients with chronic kidney disease, Reuters reported.

For years, medical researchers have sought an early test to determine how well a transplant patient’s body is accepting an organ. Half of kidney recipients have organ failure within 10 years of a transplant.

Now, two companies have produced a test that may help to solve the problem of detecting early rejection.

The Centers for Medicare and Medicaid Services decided against coding edits that would have changed the way vascular access procedures are billed.

Coding guardians at the American Society of Diagnostic and Interventional Nephrology (ASDIN) and other industry groups formed a coalition that succeeded in keeping certain codes and definitions unchanged.

Fresenius, DaVita, and American Renal Holdings (parent company of American Renal Associates)—all providers of outpatient dialysis services—announced better than expected financial results for the year ending December 31, 2011.

Abbott Laboratories (Chicago) currently has about 20 drugs in midstage or late-stage clinical trials, versus about eight in 2009, and these include potential treatments for change to chronic kidney disease (CKD) as well as for multiple sclerosis and liver cancer.

Abbott has more drugs in its pipeline because of acquisitions and licensing deals, according to a report on the Wall Street Journal MarketWatch site. CKD has become an area of focus.

The season finale of NBC’s “30 Rock” highlighted a familiar scenario – the problem of a relative (Alec Baldwin) who was striving to find a matched kidney donor, in this case for his TV father. A chorus of popular musicians gathered at a benefit written into the show to sing “We Need a Kidney.” Reality enters and takes over because the TV shows’ producers actually teamed with Apple’s iTunes Store to distribute a music video of the star-studded song.

In Corona, Calif., Watson Pharmaceuticals announced it would continue to sell its iron deficiency treatment, Ferrlecit, in the United States until the end of the year. A Swiss arbiter ruled in favor of Watson. In March 2008, Ferrlecit’s maker, Sanofi-Aventis, let Watson know that their joint agreement for supply and distribution of Ferrlecit would expire on Feb. 18, 2009, according to a filing with the U.S. Securities and Exchange Commission. Sanofi-Aventis noted it would expect damages if any sales occur after that date.

Asahi (Japan-based Asahi Kasei Kuraray Medical) has agreed to partner with NxStage Medical to take advantage of their joint expertise and resources as makers of dialyzers. Asahi will deliver a better loan rate to NxStage, while NxStage will deliver manufacturing and business expertise to the Asian manufacturer of dialyzers. Dialyzers are part of dialysis machines that act as the filters, with patient’s blood in one compartment and dialysate in the neighboring compartment.

The United States could save more than $1 billion in five years if just 15 percent of all dialysis patients used peritoneal dialysis (PD), according to a study published in Clinical Therapeutics (2009; 31:880–888). PD is an alternative to hemodialysis that uses the peritoneal membrane around the stomach to filter the patient’s blood with the help of dialysate that is infused and drained by catheter.

Triferic, a drug approved for iron delivery through dialysate, has met its primary endpoints in two phase 3 CRUISE studies (CRUISE 1 and 2), according to published data in Nephrology Dialysis Transplantation (1). Manufactured by Rockwell Medical (Wixom, MI), Triferic is the only drug so far in the US to win approval from the US Food and Drug Administration (FDA) for delivery via dialysate to replace iron and maintain hemoglobin in patients undergoing hemodialysis.

French drugmaker Sanofi recently reported on two developments in diabetes drug development: results of a successful clinical trial of a Sanofi drug combined with another drug to lower hemoglobin A1c levels and a new partnership that intends to create a stem cell–based drug to treat diabetes.

DaVita announced in May 2013 that it had set aside $300 million in case the company would be required to pay a federal fine, revealed CEO Kent Thiry, during what he termed a “sober” conference call to announce quarterly results. Eventually, the company had set aside a total of $414 million, so it would be prepared to pay for a potential violation of the False Claims Act when the time came.

The settlement money has finally come due, and amounted to $387 million plus interest accrued between February and October of this year.

Medicare has miscalculated the costs of dialysis drugs in bundled costs, according to a report released by the US Health and Human Services Office of the Inspector General in late March.

Two companies involved in water filtration and purification inked a non-exclusive agreement in March to distribute dialysis filters to U.S. and Canadian dialysis clinics.

The companies, Nephros and Mar Cor Purification, will distribute Nephros’ ultrafilters.

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A toxic leak into water sources in West Virginia and extreme winter weather over Canada and the United States had people working hard to keep dialysis facilities safe and operational in recent weeks.

Acceleron Pharma (Cambridge, MA), focuses on designing protein therapeutics for cancer and rare diseases. Two of its new products under development involve patients with renal conditions.

Acceleron and Celgene Corp., based in Summit, NJ, are jointly developing a drug candidate called sotatercept, a fusion protein that acts by increasing the production of mature red blood cells into circulation, which may benefit patients with advanced chronic kidney disease.

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DaVita, the second largest provider of dialysis services in the United States, has agreed to a framework for “a global resolution with government officials for both the 2010 and the 2011 U.S. Attorney Physician Relationship Investigations,” the company shared in its most recent financial report.

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La Jolla Pharmaceutical Company announced on March 10 that its lead experimental drug, which treats chronic kidney disease, met its primary goal of improving kidney function as measured by blood filtering through the kidneys.

Biopharmaceutical company Rockwell Medical in Wixom, MI, reported its third quarter results for calendar year 2013. With a modest increase in sales of 3.2 percent over the same quarter in 2012, the company also had a gross profit of $1.6 million, the same amount as in the company’s 2012 third quarter.

U.S. Renal Care (USRC), based in Plano, TX, has nearly doubled its business reach by acquiring Ambulatory Services of America (ASA), an evidence-based practice of dialysis and radiation oncology services in Brentwood, TN.

The merger will nearly double USRC’s current patient volume to about 14,000 with operations in more than 200 outpatient, home, and specialty hospital dialysis programs and facilities, business website Modern Healthcare reported. ASA had 79 dialysis centers at the time of the merger.

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A new type of erythropoietin product may be coming soon for patients with chronic and advanced kidney disease in whom anemia may develop.

NxStage, which is a maker of home-based dialyzers as well as models for health care setting use, set a revenue record in its last financial quarter and had noteworthy sales of its home-use dialysis systems.

Revenue for the second quarter of 2013 increased 11 percent to $65.5 million. The same quarter in 2012 showed revenue of $59 million.

On April 30, the U.S. Food and Drug Administration (FDA) granted NxStage Medical clearance for its new high-flow capabilities with the NxStage System One, a portable hemodialysis system cleared for home use. With this clearance, NxStage Medical, based in Lawrence, Mass., expects to begin offering its System One with new higher flow capabilities in the United States later in 2013.

The higher flow capabilities will allow practitioners to adjust the duration and frequency of patient prescriptions for dialysis at home.

Medgenics has announced early data from its phase II clinical trial with the EPODURE biopump device. This trial used the company’s proprietary biopump to deliver the drug erythropoietin, or EPO, to anemic patients with chronic kidney disease who had not yet begun dialysis.

The company, based in Karmiel, Israel, has produced biopump applications for treating several chronic diseases, including hepatitis C, and is in the early stages of developing a biopump application that would treat hemophilia.

In July 2015, Fresenius issued a voluntary recall of more than 1.8 million 6.4-L bottles of NaturaLyte Liquid Bicarbonate Concentrate (see FDA website for details about the recalled units). The concentrate is formulated for use with a three-stream hemodialysis machine that is calibrated for acid and bicarbonate concentrates, the FDA noted.

During the first three quarters of 2008, Fresenius Medical Care, a renal services company, had a strong showing in its international markets and in the United States. Chief Executive Officer Ben Lipps gave an optimistic assessment for the company in the near future: “Despite cost pressures, an uncertain economic environment, and volatile currency developments, we are confident of achieving our midterm financial targets for 2010.”

For the first time, the U.S. Centers for Disease Control and Prevention (CDC) has issued in effect a map of the regional incidence of diabetes. Although national survey data have shown that the overall incidence of diabetes has grown in the United States dramatically in the past decade or so, data now show a geographic distribution of the disease. The CDC looked at data from 1995 to1997, and from 2005 to 2007. Thirty-three states and territories had the data needed to conduct statistical analysis for the two different three-year periods.

Renal Advantage of Brentwood, Tenn., has several new dialysis centers in its national circle, thanks to the completion of an acquisition by its parent company. RA Group Holdings acquired National Renal Alliance, based in Franklin, Tenn.

The combined company, number three in the field after Fresenius and DaVita, will now operate 136 dialysis centers in 18 states, and serve about 11,000 patients.

A well-known computer printer technology is in line to help dialysis patients at home. Inkjet injection technology from Hewlett Packard (HP) will merge with dialysis devices from Home Dialysis Plus (HD+) in a new dialysis system to be used at night. HP’s inkjet technology will be used within HD+’s dialysis machine proportioning system to mix the correct amount of water and concentrated dialysate, as well as the needed salt and electrolyte solution in real time, and to pump the dialysis solution into the dialyzer.

Two Nephrology TreatmentTrends™ publications released late last year analyze the market trends of products that help nephrologists and renal dietitians manage their patients’ renal anemia, hyperphosphatemia, and secondary hyperparathyroidism. The reports, issued by BioTrends Research Group, are based on survey results from 204 nephrologists and 201 renal dietitians in the United States.

Patients with high blood pressure may have a new way to improve their health beyond bypassing the salt shaker and taking blood pressure medications. A national clinical trial is finding that the Minneapolis-based CVRx® Rheos ® System is effective in treating early-stage heart failure.

Several kidney-related drug trials have recently yielded results. ProMetic Life Sciences (Laval, Quebec), announced that it had successfully completed its phase 1b clinical trial of PBI-4050 in patients with chronic kidney disease (CKD).

Hydra Biosciences, Inc., a leader in the field of transient receptor potential channel modulation, and Boehringer Ingelheim announced that they have entered into a worldwide research collaboration and license agreement to identify small-molecule transient receptor potential inhibitors, to focus on renal disease treatments.

Hydra Biosciences, a biopharmaceutical company based in Cambridge, MA, develops drugs to treat several conditions involving ion channels.

NephroGenex, a drug development firm based in Raleigh, NC, plans to raise $34.5 million in a secondary public offering, according to the Triangle Business Journal. The goal is to increase the number of clinical trial sites to test the company’s drug Pyridorin, a treatment for diabetic nephropathy, commonly stemming from acute kidney injury (AKI) and diabetes.

The two largest dialysis firms in the US reported higher revenues recently. Fresenius had a first quarter revenue of $3.96 billion, which was an increase of 11 percent, but its dialysis product revenue of $778 million remained unchanged compared with the first quarter of 2014, the company reported. Zack’s online investment research experts had predicted total revenue of $3.92 billion, or about $40 million less for the enterprise.

Welcome to the expanding market for factory-produced low-potassium lettuce aimed at people with chronic kidney disease (CKD).

Outset Medical (San Jose, CA) has eclipsed an initial funding level of $9.5 million thanks to Warburg Pincus, a private equity investment firm. Warburg Pincus reported recently that it had invested $60 million in the company.

The US Food and Drug Administration has issued a safety announcement about potential side effects of a class of diabetes drugs. The SGLT2 inhibitors, which aid excretion of blood sugar through urine, may cause dangerous levels of blood acidity.

For the first time, the U.S. Food and Drug Administration (FDA) has approved a fixed-dose antihypertensive pill combining angiotensin-converting enzyme inhibitor and beta blocker compounds. The drug, brand name Prestalia (Symplmed, Cincinnati, Ohio), contains perindopril arginine, an angiotensin-converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker.

The NephroCheck test system is now being marketed by Ortho Clinical Diagnostics to help identify risk of acute kidney injury (AKI). The urine test is designed to detect both insulin-like growth factor binding protein 7 and tissue inhibitor of metalloproteinases, factors associated with AKI.

DaVita started using the Nephros hemodiafiltration system in a pilot program based in its Colorado Springs facility to learn how the system compares with traditional hemodialysis in patient care. Nephros gained approval from the FDA in 2012 for the hemodiafiltration system, which may enhance traditional hemodialysis by filtering out a range of different-sized contaminants.

A Fresenius product used in dialysis was recalled after one death by bacterial infection and other cases of sickness after certain lots of the drug were administered.

The U.S. Food and Drug Administration (FDA) issued the class 1 recall related to the use of Fresenius NaturaLyte Liquid Bicarbonate Concentrate. The FDA reported that laboratory tests identified Halmonas species, a bacterial strain typically found in water with a high salt concentration, in the product during its shelf life.

DaVita, the second largest provider of dialysis services in the United States, is rearranging at the top. DaVita HealthCare Partners is making moves in both of its divisions: DaVita, which provides dialysis care, and HealthCare Partners (HCP), which manages and operates medical groups and affiliated physician networks in several states and provides integrated care management for about 829,000 managed care patients, according to the company website (http://www.davitahealthcarepartners.com/).

AMG 416, a drug designed to treat secondary hyperparathyroidism (SHPT), has met its endpoints in a phase 3 clinical trial, the manufacturer Amgen in Thousand Oaks, CA, reported in July.

SHPT is common and can be severe in patients with chronic kidney disease (CKD) and in those receiving dialysis. At first, the parathyroid glands produce more parathyroid hormone in an effort to maintain normal serum calcium and phosphorus levels. However, as CKD progresses, SHPT can develop as the body shifts to a combination of abnormal levels of parathyroid hormone (PTH), calcium, and phosphorus.