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Keryx Biopharmaceuticals Announces Upcoming Poster Presentation of Zerenex ... - DigitalJournal.com (press release)

NEW YORK, May 21, 2012 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that an abstract highlighting the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex™ (ferric citrate), has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association – European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France.

The following poster will be presented on Saturday, May 26, 2012, from 9:30am to 10:45am local time:

  • A Meta-Analysis of Ferric Citrate for Hyperphosphatemia: The Effects of an Oral Iron-Containing Phosphate Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients (Abstract # SAP534)

Zerenex, the Company's oral, ferric iron-based drug candidate for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis, is currently in Phase 3 clinical development pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.  The Zerenex Phase 3 registration program is comprised of an already completed Phase 3 short-term study, and an ongoing Phase 3 long-term study.

The above referenced abstract is available for viewing on-line at http://www.m-events.com/customer/2012/era-edta/data/12575.pdf.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex (ferric citrate) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability, and our Japanese partner's ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); the risk that the data (both safety and efficacy) from the ongoing Phase 3 trials for Zerenex (ferric citrate) will not coincide with the data analyses from previous clinical trials reported by us and our Japanese partner; our ability to meet anticipated development timelines for Zerenex due to clinical trial results, manufacturing capabilities or other factors; our ability to replicate in our ongoing long-term Phase 3 clinical study the effects on iron storage parameters, intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) use observed in previous clinical trials; the ability for Zerenex to generate cost savings for dialysis centers and payers; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website, and the M Events website, is not incorporated by reference into this press release and are included for reference purposes only.

KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

 

SOURCE Keryx Biopharmaceuticals, Inc.

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Keryx Biopharmaceuticals Announces Upcoming Poster Presentation of Zerenex(TM ... - MarketWatch (press release)

NEW YORK, May 21, 2012 /PRNewswire via COMTEX/ -- Keryx Biopharmaceuticals, Inc. /quotes/zigman/83561/quotes/nls/kerx KERX +16.24% today announced that an abstract highlighting the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex(TM) (ferric citrate), has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association - European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France.

The following poster will be presented on Saturday, May 26, 2012, from 9:30am to 10:45am local time:

A Meta-Analysis of Ferric Citrate for Hyperphosphatemia: The Effects of an Oral Iron-Containing Phosphate Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients (Abstract # SAP534)

Zerenex, the Company's oral, ferric iron-based drug candidate for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis, is currently in Phase 3 clinical development pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. The Zerenex Phase 3 registration program is comprised of an already completed Phase 3 short-term study, and an ongoing Phase 3 long-term study.

The above referenced abstract is available for viewing on-line at http://www.m-events.com/customer/2012/era-edta/data/12575.pdf .

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex (ferric citrate) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability, and our Japanese partner's ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); the risk that the data (both safety and efficacy) from the ongoing Phase 3 trials for Zerenex (ferric citrate) will not coincide with the data analyses from previous clinical trials reported by us and our Japanese partner; our ability to meet anticipated development timelines for Zerenex due to clinical trial results, manufacturing capabilities or other factors; our ability to replicate in our ongoing long-term Phase 3 clinical study the effects on iron storage parameters, intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) use observed in previous clinical trials; the ability for Zerenex to generate cost savings for dialysis centers and payers; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com . The information found on our website, and the M Events website, is not incorporated by reference into this press release and are included for reference purposes only.

KERYX CONTACT:Lauren FischerDirector - Investor RelationsKeryx Biopharmaceuticals, Inc.Tel: 212.531.5965E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

SOURCE Keryx Biopharmaceuticals, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

/quotes/zigman/83561/quotes/nls/kerx US : U.S.: Nasdaq $ 1.79 +0.25 +16.24% loading...

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Jim Hillibish: Dialysis saves your life when kidneys fail - Canton Repository

The words cause great worry: “Your kidneys are failing, you must go on dialysis.” At first, it seems a cruel sentence. Dialysis means a machine takes over, and you will be tied to it three to five times a week or more for the rest of your life.

That’s how I felt when I learned the news. Thirteen years later, I’m still alive, thanks to that machine, the people behind it and my family and friends.

My best advice came from my doctor, P. Suresh Nuchikat, director of dialysis at Aultman Hospital. His mother died of kidney disease.

“It’s a lot like a second job, an important one,” he said.

Dialysis will affect every aspect of your life, from eating the strict diet to planning your life around the unending treatments. Your relationships will change. Your reward is life beyond the machine, which eventually becomes your best friend.

The dialysis clinic is the last stop for many suffering End Stage Renal Disease. This and their other diseases are the reason behind the high mortality of dialysis patients. More than 90 percent of those who started dialysis with me are gone.

ATTITUDE IS EVERYTHING

I soon found that attitude is about 80 percent of the process. Some people give up, skip treatments and die within a week or so. Others accept Dr. Nuchikat’s second job, because it is.

You must learn about it. I found this and adjusting my life takes away fear. You learn to cope with it no matter what. (There are no holidays, no snow days.) That’s the personal choice for all who face it.

I tell new patients that dialysis seems abusive. In one session, your blood flows 65 times or more through a filter in the machine. Needles are inserted into your fistula, the surgical connection of two blood vessels, usually in your arm. The average treatment is about three hours.

We arrive at the center with blood filled with water and toxins which would have been filtered by our kidneys. The early devices basically were guesswork. A patient had to be weighed during treatments to see how much liquid had been removed.

The new machines are electronic and monitor everything automatically.

The experience is surprising. You’d figure there would be some pain as your blood courses from your access to the machine and back again. There isn’t, and many patients sleep or watch TV.

When I got out of the chair after my first treatment, I passed out cold. That’s common, called “crashing.” Your blood pressure is too low and you took too much weight off.

The nurses caught me and soon brought me back. They said a lot of new patients do this. Your blood volume decreases when you remove fluid from it. That lowers your blood pressure, and that lowers the amount of oxygen reaching your brain. The key to dialysis is finding the right amount of fluid to remove without crashing.

On routine days, I had about a half-hour to drive home. Then my body went into a form of mild shock with the cleansed condition of my blood. I headed for bed, slept three hours and was fine for the rest of the day.

A big change happened four years ago when Aultman started blood dialysis with a NxStage home machine. I do five treatments instead of three, and that’s a lot easier on my body. It smoothes out the peaks and valleys as my body shifts from a highly toxic condition to temporarily clean.

The only bad part was leaving the center. The crew and the patients at Aultman became my family. I missed them, and still do. Such is the price of progress.

PROGRESS

Your kidneys are one of the few organs that can fail and be replaced by a machine.  Aultman Hospital’s dialysis unit began operations in 1989. Since then, 28 other centers have opened at area hospitals and free-standing clinics.

Dr. Nuchikat is Aultman’s first and only dialysis director. Since he began, the hospital has more than doubled its dialysis capacity.

“Stark County is seeing increases just like other areas are,” he said. People living longer is part of it, but he blames the increase on lifestyles, mainly obesity.

Dr. Arup Maitra, Dr. Nuchikat’s associate, sees no slowing down in the dialysis trend, “increasing 6 to 8 percent a year. Diabetes is driving it. It must be brought under control,” he said.

He and Dr. Nuchikat are seeing younger dialysis patients. “It takes about 10 to 15 years of diabetes before needing dialysis,” Dr. Maitra said.

The treatment’s cost, about $1,500 a week, is paid 80 percent by Medicare (for all ages) and 100 percent for those on Medicaid. Private insurance and personal savings make up the rest.

“Kidney transplants are not relieving the problem,” Dr. Maitra said. “There are just not enough organs available. And then, patients must take very expensive drugs for the rest of their lives. After three years, Medicare does not pay for them.”

More than 80 percent of dialysis patients are diabetics. In my case, I had kidney cancer three times. Mary Lou Hiles, 80, suddenly lost control of her kidneys and immediately went on dialysis. She is not a diabetic.

“When I first started, I didn’t want to do it. Then I found the wonderful people here. I’m doing well now. I love the nurses,’ she said.

Mary Lou is back to her favorite hobby, cooking for others. She caters holiday food events at the center for the staff, patients and families — “payback time.”

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DaVita acquires HealthCare Partners - Financial Times
Financial Times
By Alan Rappeport in New York DaVita, a US company that runs dialysis clinics, said on Monday that it will acquire HealthCare Partners, which operates physician groups in several US states, for $4.42bn, marking the latest merger in the quickly

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Medgenics gets US FDA nod to begin Epodure trial for anaemia treatment in ... - pharmabiz.com
pharmabiz.com
Treatment of anaemia in dialysis patients with Epodure is intended to replace frequent injections of EPO or other erythropoietic stimulating agents (ESAs). “This timely acceptance of our first Investigational New Drug (IND) to the FDA marks a

...

 
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