Industry Spotlight

Two companies with products that reduce the amount of contrast dye in a patient’s system are raising money to increase sales and to support critical research. Contrast dye used in vascular and other imaging may cause such complications as acute kidney injury (AKI) in kidney-impaired patients.

B. Braun (Melsungen, Germany; US base, Bethlehem, PA), a manufacturer of dialysis equipment and disposables and other medical products, has launched a new dialyzer called the Diacap Pro. The filter device, which received FDA approval in late August 2017, uses a new type of fiber designed to improve dialysis dose.

The Diacap Pro fibers clear blood toxins like urea and creatinine, while retaining molecules like albumin, and comes in three sizes (1.3 m2, 1.6 m2, and 1.9 m2) to address differing patient needs.

Bristol-Myers Squibb (New York, NY) announced in early September 2017 a successful phase 3 study of a combination therapy to improve overall survival in kidney cancer.

The company tested a combination of its drugs Opdivo (nivolumab) and Yervoy (ipilimumab), which demonstrated better overall survival rates than a standard-of-care drug (Pfizer’s SUTENT (sunitinib malate) in previously untreated patients with advanced or metatstatic renal cell carcinoma.

Fresenius Medical Care (FMC), the world’s largest provider of dialysis products and services, will buy NxStage, a home dialysis device maker, for $2 billion. Fresenius Medical Care North America and NxStage both have corporate headquarters in the Boston area, while FMC parent company is based in Bad Homburg, Germany.

The NxStage System One is cleared by the FDA for home hemodialysis and home nocturnal hemodialysis. NxStage has also established a small number of dialysis clinics.

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American Renal Associates Holdings (ARA) (Beverly, MA) launched an initial public offering in April 2016, and has now grown to 217 clinics serving more than 15,000 patients with 385 nephrologists.

For the second time in 2017, Pfizer has received a disappointing letter about its progress toward FDA approval for a biosimilar product similar to the drug Epogen. The root of the problem lies with manufacturing facilities that may produce the biosimilar, not with the safety or biosimilarity to Epogen, Pfizer notes.

A new program sponsored by a company that develops technology-based solutions for chronic kidney disease (CKD) will give 100 patients access to new formats for care and education.

New research shows that an existing type 2 diabetes drug also significantly decreases the risk of other serious conditions. A study published in the New England Journal of Medicine demonstrated that the drug canagliflozin, in addition to helping to treat 2 diabetes, also seems to significantly lower the risk of cardiovascular disease (CVD) and kidney disease in patients with diabetes, Reuters reported.

Now that positive results from Phase 3 clinical trials have been reported, the European Medicines Agency (EMA) has recommended approval for tivozanib through the EMA’s Committee for Medicinal Products for Human Use (CHMP), as treatment for advanced renal cell carcinoma (RCC). The drug, brand named Fotivda (AVEO Pharmaceuticals, Cambridge, MA) could receive a final decision for approval by late August or early September 2017. The US Food and Drug Administration approved the drug in 2013.

A new rapid, noninvasive test that can detect infections among peritoneal dialysis (PD) patients has earned the “Conformité Européene” (CE) mark. This mark means that a product may be marketed within the European Economic Area.

The regulatory submissions are supported by positive results from a Phase 3 S-TRAC, (Sunitinib Trial in Adjuvant Renal Cancer) study.

Mologic (Thurleigh, Bedfordshire, UK) has launched the point-of-care test PERiPLEX. The test was created for use in the home by PD patients or their caregivers, and takes 10 minutes for a result.

Pfizer Inc. announced that the FDA and the European Medicines Agency (EMA) accepted the company’s regulatory submission for label expansion of its renal cell carcinoma (RCC) drug, Sutent (sunitinib). The FDA’s response is expected in January 2018.

One year after US Food and Drug Administration (FDA) approval of Rayaldee (calcifediol), Miami-based OPKO Health in June 2017 announced new agreements for the drug with several large Medicare Part D (prescription drug coverage) plan sponsors. The drug helps treat secondary hyperparathyroidism (SHPT) in patients with stages 3–4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D less than 30 ng/mL.

Baxter International (Deerfield, IL) is developing a system to produce sterile solutions for peritoneal dialysis (PD) in patients’ homes. The company said it received FDA guidance about the regulatory pathway for the system, which would be integrated into Baxter’s Amia PD System with a small water-filtration device.

Vifor Pharma, a global specialty pharmaceuticals company in Zurich, Switzerland, that develops its own products and also partners with other companies, in May 2017 agreed to invest in and sell Akebia Therapeutics’ Phase 3 anemia drug vadadustat through its network of dialysis centers. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer in development for treatment of anemia associated with chronic kidney disease (CKD).

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A quietly flourishing sector of the hemodialysis products market is dialysis chairs. According to a new draft report from Persistence Market Research, the market for hemodialysis chairs in India is growing quickly as the number of people with chronic kidney disease worldwide increases.

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee in a 14–1 vote recommended approval of a Pfizer drug that is a biosimilar compound to epoetin alfa (Amgen’s brand name anemia drug Epogen). The committee voted to support the biosimilar drug for approval of all four of Epogen’s clinical indications, making it the first biosimilar of an erythropoiesis-stimulating agent in the US recommended for approval by an FDA advisory committee.

For the first quarter of 2017, the dialysis business for Fresenius Medical Care North America (FMCNA) grew by 14% (10% at constant currency). Quarterly growth was influenced by the positive effect of an agreement with the US Departments of Veterans Affairs (VA) and Justice for a settlement for underpayment, a favorable impact from commercial payers, and an increased number of treatments. Dialysis care revenue for the quarter rose to $2.65 billion from $2.32 billion from the first quarter of 2017 to the first quarter of 2016.

Cara Therapeutics (Stamford, CT) released positive data about its uremic pruritus product, intravenous CR845, which targets peripheral kappa opioid receptors.

Keryx Pharmaceuticals (Boston) announced that the US Food and Drug Administration (FDA) will review its drug Auryxia (ferric citrate) for use in patients who have iron deficiency anemia and non-dialysis–dependent chronic kidney disease (CKD). Ferric citrate is a phosphate binder indicated for controlling serum phosphorus levels, typically in patients with CKD who are on dialysis.

A review for the new use of the drug should be complete by Nov. 6, 2017, according to Drugs.com.

The search for effective treatments for non-dialysis–dependent chronic kidney disease (NDD-CKD) is gaining renewed interest. In the United States, more than one and a half million people suffering from stages 3 to 5 non-dialysis dependent NDD-CKD have iron deficiency anemia, but no oral iron supplements have yet been approved by the FDA for use for the condition. Likewise, no FDA-approved phosphate binders exist for use in NDD-CKD.

Fresenius Medical Care North America (FMCNA), a division of Fresenius Medical Care, has been busy forming partnerships with national insurers. FMCNA announced a partnership in March 2017 with Humana Inc. with plans for a new program to improve care and health outcomes for Humana’s members with end stage renal disease (ESRD). In February 2017, FMCNA announced a partnership with Cigna in a national program to lower the cost and improve quality of care for people with ESRD who are undergoing dialysis.

The US Food and Drug Administration (FDA) has approved a new filter from Nephros (River Edge, NJ).

In early March 2017, Nephros received 510(k) clearance to market its EndoPur™ Endotoxin 10-Inch Filter.

The filter is designed to provide hemodialysis-quality water to dialysis machines. It fits into existing filter cartridge housings of the reverse osmosis (RO) water systems that provide dialysis clinics with high volumes of ultrapure water. The EndoPur™ has an endotoxin barrier with the smallest pore size on the market, the company announced.

The National Institute for Health and Care Excellence (NICE), has approved everolimus (brand name Afinitor, manufactured by Novartis) for routine use as a regular National Health Service (NHS) treatment option for patients with advanced renal cell carcinoma (RCC). NICE provides evidence-based guidelines on health care for the NHS and other medical organizations in England.

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.

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.

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.

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.

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.

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.

DaVita, the second largest provider of dialysis services in North America, is acquiring its first operations in Europe—in Germany.

What makes the deal particularly interesting is that Germany is the headquarters of the largest provider of dialysis services and products worldwide. Fresenius Medical Care is based in Bad Homburg, Germany. Fresenius North America is well established, but DaVita is just starting to get its feet wet across the oceans.

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

DaVita dialysis services is now reaping the benefits of its acquisition of a rival firm, DSI Renal.

In the third quarter of 2011, DaVita reported a higher profit because of new revenue streams from its acquisition. According to Associated Press (AP), for the quarter that ended September 30, DaVita earned $135.3 million, an improvement over the $119.4 million for the same time period last year. The company’s revenue increased 9.5 percent to $1.8 billion for the period.

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Noteworthy mergers continue in the dialysis field. In late 2010, Liberty Dialysis of Mercer Island, Washington, merged with Renal Advantage in Brentwood, Tennessee, to create the number three firm in dialysis. Then in August, Fresenius Medical Care, a global provider of dialysis services and products, agreed to purchase the newly fashioned Liberty Dialysis Holdings for $1.7 billion.

Affymax, a company based in Palo Alto, CA, and its partner, Takeda Pharmaceuticals of Osaka, Japan, are making a bid for U.S. Food and Drug Administration (FDA) approval of the drug peginesatide, used to treat anemia in patients with advanced chronic kidney disease.

The companies have submitted a new drug application to the FDA. The drug is a synthetic PEGylated peptidic compound that binds to and activates the erythropoietin receptor. It acts like an erythropoiesis-stimulating agent.

Pfizer Inc. announced in June that it had asked European Union regulators to approve axitinib as a treatment for advanced kidney cancer.

According to Bloomberg Businessweek, Pfizer is seeking to market the drug to patients who have not had good results with other therapies for advanced kidney cancer. Many pharmaceutical business analysts are calling axitinib one of Pfizer’s top drug candidates.

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.

DaVita recently settled a whistle-blower lawsuit from 2002 regarding its anemia management practices with a $55 million payment but no admission of wrongdoing by the company.

In March 2012, Affymax and Takeda Pharmaceuticals obtained U.S. Food and Drug Administration approval for Omontys (peginesatide) injection, a once-a-month treatment for anemia in patients with chronic kidney disease (CKD) who are on dialysis.

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.

In 2011, Fresenius successfully concluded a 5-year pilot project that showed costs could be lowered with an integrated provider program focusing on patients with chronic kidney disease (CKD). By capturing patients earlier in the course of CKD, the provider of dialysis services and products was able to show noteworthy savings in the project sponsored by the Centers for Medicare & Medicaid Services (CMS).

Several kidney cancer drugs made the news lately.

The U.S. Food and Drug Administration (FDA) recently approved Inlyta (axitinib) for treating advanced renal cell carcinoma (RCC) after treatment with a systemic therapy has failed. An oral drug made by Pfizer, Inlyta blocks certain receptors that can influence tumor growth and also the progression of kidney cancer. Forty percent to 65 percent of patients whose cancer progresses after first-line therapy go on to receive a second-line treatment, the company said.

Abbott Laboratories is expanding its pipeline into renal care drugs with a new addition, a potential kidney treatment from the privately held Danish company Action Pharma, Abbott announced May 3.

The company will pay $110 million to buy the compound, which is in midstage clinical testing, according to an Associated Press report. The drug is designed to prevent acute kidney injury in patients undergoing major cardiac surgery.

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 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.

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.

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.

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.

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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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.

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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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The U.S. Food and Drug Administration (FDA) is revising, for the first time since 2009, its draft guidance on how to present and publish information about off-label use of a drug or device.

Fresenius’ North America unit this year will launch a drug approved in late November by the U.S. Food and Drug Administration.

Velphoro (sucroferric oxyhydroxide) received approval for controlling serum phosphorus levels in dialysis patients with chronic kidney disease.

One of the latest innovations in home dialysis is a machine that weighs less and uses less water.

Switzerland-based Debiotech SA and Singapore-based AWAK Technologies have joined forces to develop and manufacture a miniaturized home hemodialysis machine they call DialEase.

DialEase uses Debiotech’s mini peritoneal dialysis equipment and a novel sorbent technology for fluid purification developed by AWAK.

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.

The U.K.’s National Institute for Health and Clinical Excellence (NICE) has issued a final appraisal decision and rejected the drug axitinib (marketed by Pfizer as Inlyta) for the treatment of advanced kidney cancer. NICE also recently provided management guidance for patients with hyperphosphatemia, which often accompanies chronic kidney disease (CKD).

Cytori Therapeutics, Inc., has received a patent for a new method of treating renal diseases using adipose-derived regenerative cells (ADRCs), cells derived from fat tissue. The company announced that the patent covers treatment of a broad range of renal disorders, including acute kidney disease as well as chronic kidney disease (CKD).

The patent also covers several ways of delivering the cells, including directly to the kidney or to the renal blood vessels.

Aeo Pharmaceuticals of Cambridge, MA, said that its partner Astellas Pharma, whose world headquarters is in Japan, would not seek marketing approval for an experimental kidney cancer drug in Europe, Reuters reported.

This news comes just after a U.S. Food and Drug Administration (FDA) panel decision in early May, with a 13-to-1 vote in favor of not approving the drug immediately and of recommending an additional clinical trial before the drug tivozanib could be approved for renal cell cancer. A final decision will come after July 26.

Dialysis provider Fresenius Medical Care has announced its second accountable care organization (ACO) arrangement. The latest deal is with ApolloMed ACO of Glendale, CA, announced in May. Fresenius will provide integrated health care management for its patients with ESRD.

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.

A phase three trial showed that an already approved drug, sorafenib (Nexavar, manufactured by Bayer Pharma), and tivozanib share a similar survival period for patients with advanced renal cell cancer.

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NxStage, a manufacturer of home-based dialysis equipment like the NxStage System One (to date the only portable home system cleared by the U.S. Food and Drug Administration for use in home hemodialysis) and other dialysis products, announced fourth-quarter and year-end results for 2012.

A novel iron supplement therapy under development at Rockwell Medical significantly reduced erythropoietin-stimulating agent (ESA) dosing by 37 percent over the course of a recent 9-month study. A randomized placebo-controlled phase II clinical trial demonstrated that the drug—soluble ferric pyrophosphate (SFP)—met the primary end point of lowering ESA use in patients with end stage renal disease (ESRD) receiving hemodialysis.

Amgen finished 2012 with lower fourth-quarter profits—reporting a net income of $788 million—despite an 11 percent increase in revenue for the quarter to $4.42 billion. Increased spending on research and development and other administrative costs led to the 16 percent decline for the quarter compared to 2011.

Abbott Laboratories announced a 35 percent decrease in profits in the fourth quarter of 2012. Despite an increase in sales of more than 4 percent, net earnings for the quarter were $1.05 billion, down from $1.62 billion in 2011.

Keryx Biopharmaceuticals recently announced that the phase III clinical trial of its drug Zerenex (ferric citrate) successfully met its predetermined end points. Conducted under a Special Protocol Agreement, the study assessed the oral ferric iron–based compound for the treatment of hyperphosphatemia in patients with ESRD who are receiving dialysis.

Two Canadian biotechnology firms—the publicly traded Isotechnika Pharma and privately held Aurinia Pharmaceuticals—will combine forces to concentrate on the nephrology therapeutic market. The companies will join together under the Aurinia banner to focus on developing the calcineurin inhibitor voclosporin, an immunosuppressant, for approval.

Questions are being raised about the effectiveness of axitinib as a life-prolonging second-line treatment for patients with advanced renal cancer.

Baxter International, one of the largest health care suppliers in the world, is in discussions with Swedish dialysis product maker Gambro in a bid to buy the company for $4 billion. The acquisition would be a long-sought addition to Baxter’s dialysis holdings, according to the Wall Street Journal (WSJ).

A health care industry analyst has made a prediction for 2013 that American companies like Denver-based DaVita, the second largest provider of dialysis services in the United States, may be best positioned to “benefit from changes in the health care market stemming from Obamacare.”

Dialysis takes numerous hours of patients’ time per week, which can greatly interfere with family, work, and recreational schedules. Now Fresenius Medical Care North America (FMCNA), the largest provider of dialysis services in the United States, has established more than 140 nighttime dialysis center sites.

Just after Baxter bid $4 billion to purchase Gambro, a maker of dialysis-related products, in the hope of being a dominant force in the dialysis marketplace, there is another news item out of Gambro’s Brentwood, Tennessee home base. Ambulatory Services of America (ASA), of Brentwood, has bought a majority interest in six dialysis centers and an acute dialysis program in the Los Angeles area.

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.

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.

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.

Amgen Inc. recently completed its acquisition of KAI Pharmaceuticals for $315 million. Initially agreed to on April 10, Amgen said the move was spurred by the “compelling” phase 2A trial results of KAI-4169, KAI’s compound to treat hyperthyroidism. The deal calls for Amgen to make a loan to KAI so it can plan late-stage trials of the drug.

Researchers at Translational Genomics Research Institute (TGen) of Phonenix, AZ, have developed a promising way to isolate exosomes—tiny cell components that contain genetic and other useful information—from urine.

Exosomes are being widely studied because they may contain biomarker clues that could serve as the basis of new early diagnostic tests for chronic kidney disease (CKD). Found in urine, these cellular components may provide information about the very earliest changes in kidney function.

The injectable iron drug Feraheme (ferumoxytol) received European approval to treat iron deficiency anemia in adult patients with chronic kidney disease on dialysis. This triggered a $15 million milestone payment from Takeda Pharmaceutical company to its partner AMAG Pharmaceuticals, the manufacturer of Feraheme.

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).

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.

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.

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.