WASHINGTON, June 22, 2012 /PRNewswire via COMTEX/ -- Rep. John Lewis' introduction of "Kidney Disease Equitable Access, Prevention, and Research Act" seeks to assist nation's 400,000 kidney failure patients

Kidney Care Partners (KCP), a broad-based coalition of patient advocates, dialysis professionals, care providers and manufacturers working together to improve quality of care for individuals with chronic kidney disease and end stage renal disease, praised Rep. John Lewis (D-GA) for his introduction this week of a bill supporting research to improve access to care, expanding education and preventive care and ensuring patient choice for the more than 400,000 Americans with kidney failure.

The introduction of the Kidney Disease Equitable Access, Prevention, and Research Act of 2012 (H.R. 6011) underscores efforts to ensure access to quality care for all individuals diagnosed with kidney failure - also known as end stage renal disease (ESRD) by researching and addressing barriers to receiving this life-sustaining treatment, including transportation issues and any other factors that lead to disparities especially among minority populations. Senator Kent Conrad (D-ND) introduced similar legislation (S. 2163) in March of this year which reflects a majority of the key provisions.

Each year, more than 100,000 Americans are diagnosed with ESRD and require a kidney transplant or dialysis -- usually three times a week for several hours at a time for the rest of their lives -- in order to survive. Today, more than 400,000 people in the United States are living with kidney failure and are often very sick due to related conditions like diabetes and high blood pressure, the leading causes of kidney failure. Thirty one million other Americans have some form of kidney disease and are at risk of developing kidney failure absent some form of disease management education or preventive care.

Rep. Lewis' legislation seeks not only to improve access to care for those living with kidney failure but also to expand preventive and educational services offered to kidney patients. It also supports ongoing quality improvement efforts by the kidney community in the Medicare ESRD program by calling on the Secretary of the Department of Health and Human Services (HHS) to report on ways to improve care management metrics.

In addition, the legislation would help improve health disparities among minorities, especially African Americans, by directing the HHS Secretary to evaluate and report on the biological, social, and behavioral factors that affect care. Chronic Kidney Disease hits minorities disproportionately, with African Americans affected at a rate nearly three times that of Caucasians, and while African Americans make up just 12 percent of the U.S. population, they comprise 30 percent of the kidney failure patients receiving dialysis.

"I applaud Rep. Lewis for his long-time leadership and ongoing efforts to protect this vulnerable patient population," said KCP Chairman Ron Kuerbitz. "The Kidney Disease Equitable Access, Prevention and Research Act would ensure that all kidney patients have the tools, resources and care they need to live life to the fullest today and tomorrow."

About Kidney Care Partners

KCP is an alliance of patient advocates, dialysis professionals, care providers and manufacturers dedicated to working together to improve quality of care for individuals with Chronic Kidney Disease (CKD).

To learn more about Kidney Care Partners, visit http://www.kidneycarepartners.org .

SOURCE Kidney Care Partners

Copyright (C) 2012 PR Newswire. All rights reserved

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DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/635ts8/global_renal_dener) has announced the addition of the "Global Renal Denervation Device Market 2011-2015" report to their offering.

TechNavio's analysts forecast the Global Renal Denervation Device market to grow at a CAGR of 139.7 percent over the period 2011-2015. One of the key factors contributing to this market growth is the increase in the number of people suffering from hypertension. The Global Renal Denervation Device market has also been witnessing the trend of increasing usage of minimally invasive procedures. However, preference for drug-based therapy to cure hypertension could pose a challenge to the growth of this market.

Key vendors dominating this market space include Boston Scientific Corp., Medtronic Inc., ReCor Medical Technology, and St. Jude Medical Inc.

Commenting on the report, an analyst from TechNavio's Healthcare team said; The trend of developing medical devices using radiation is being widely adopted by vendors these days. High-frequency radiation is being used in the diagnosis and treatment of several medical conditions such as cancer and hypertension. Further, though the usage of radiation for medical therapy carries high risks, it has been proven to be efficient and safe if used carefully.

According to the report, the increasing number of patients suffering from hypertension increases the demand for Renal Denervation Device procedures, and this is expected to help the Global Renal Denervation Device market to grow significantly by 2015.

Further, the report also discusses that one of the most important challenges in the market is the presence of alternative treatments for curing hypertension.

For more information visit http://www.researchandmarkets.com/research/635ts8/global_renal_dener

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MANILA, Philippines—The National Commission on Culture and the Arts (NCCA) is now processing the nomination of the seriously ill comedian Dolphy as national artist.

The “King of Comedy” is suffering from chronic obstructive pulmonary disease (COPD) and is under intensive care at Makati Medical Center.

His condition improved on Friday, although doctors discontinued his dialysis treatment because he had high blood pressure.

Dolphy’s son, Eric Quizon, told reporters Friday night that his father’s doctors discontinued his dialysis because his heart rate and blood pressure had shot up.

Doctors were regulating his father’s heart rate and blood pressure, Eric said.

His condition on Friday was much improved, and doctors may resume dialysis on Saturday, Eric said.

The city government of Manila conferred on Dolphy the Gawad Diwa ng Lahi award at the annual Patnubay ng Sining at Kalinangan artists’ awards Friday on the occasion of the Araw ng Maynila festivities.

The awards have been given since the 1960s, honoring Manila artists who have contributed to the city’s cultivation of culture and the arts.

Dolphy, whose real name is Rodolfo Vera Quizon, was born in Manila’s Tondo district on July 25, 1928.

His colleagues in the entertainment industry and politicians have called on the government to confer on Dolphy the national artist award while he lives, but the Palace insists on following the proper process rather than bestowing the honor on him by fiat.

Long process

The selection of national artists goes through a long process overseen by the NCCA and the Cultural Center of the Philippines. President Aquino wants the two agencies to decide the question of Dolphy’s nomination.

But the Palace said a temporary restraining order (TRO) issued by the Supreme Court in 2009 in connection with a controversy involving questionable choices by former President Gloria Macapagal-Arroyo for national artists had stopped the selection process.

Maybe not. Trixie Angeles, a lawyer for the NCCA, said in a statement posted on Facebook on Friday that the stoppage was a “misappreciation” by the NCCA board members of the effects of the TRO on the selection process.

Only for Gloria Arroyo board

The TRO applied only to the NCCA board in the administration of former President Gloria Arroyo. With the assumption of a new board in 2010, Angeles said, the process goes on again.

“For the moment we understand that Mang Dolphy has been nominated and is now undergoing the process of evaluation—along with other noteworthy artists,” Angeles said. “In the meantime, we continue to pray for his recovery and return to full health.”

Angeles said the selection of national artists is a long process, sometimes taking up to two years.

She said Mr. Aquino should not be blamed for Dolphy’s not being given the recognition despite the growing clamor for his being named national artist.

“That Mang Dolphy has not been awarded the recognition yet does not reflect on the government’s or the arts sector’s wanting or not wanting to do so,” Angeles said. “In short, it’s not the President’s fault.”

According to NCCA records, Dolphy was nominated as national artist for film in 2009. He made it to the second phase of the deliberation process, but failed to get enough votes from the NCCA board.

Several NCCA members have earlier assured Dolphy’s fans that the actor would be on this year’s list of nominees for national artists.

Great artist

Dolphy’s son, Vandolph, accepted for him the Gawad Diwa ng Lahi award at ceremonies held at Manila City Hall Friday.

“He has brought great honor to the city of Manila by being a great artist and comedian in performances on radio, television and in Filipino films that have brought much entertainment and joy to the public … and have been praised by critics,” Manila Mayor Alfredo Lim said in Filipino.

“His excellence has paved the way for him to receive in 2011 the prestigious Grand Collar of the Order of the Golden Heart award, the highest honor bestowed by the President of the Philippines on citizens,” Lim said.

Arts and culture city

“The Gawad Diwa ng Lahi award is conferred on Dolphy as a celebration, recognition and in appreciation of his inimitable contribution in making Manila renowned as a city for culture and the arts,” Lim said.

Among the other awardees in the local arts awards were Abdul Mari de Leon Imao Jr. for sculpture, Angel Cacnio for painting, and Saul Hofileña for historical writing.

Lim said he and Dolphy were born in Tondo and they had been friends since the start of their careers. He said he supported calls for the conferment on Dolphy of the national artist award.   With a report from Marinel R. Cruz

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Tags: Cultural Center of the Philippines , dialysis , Dolphy , Makati Medical Center , National Artist , National Commission on Culture and the Arts , NCCA , Rodolfo Vera Quizon , “King of Comedy , ” chronic obstructive pulmonary disease

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LONDON, OSAKA, Japan and LEXINGTON, Massachusetts, June 22, 2012 /PRNewswire/ --

Takeda Pharmaceutical Company Limited (Takeda) and AMAG Pharmaceuticals, Inc. today announced the granting of marketing authorisation by the European Commission (EC) for ferumoxytol, a new intravenous (IV) iron therapy to treat iron deficiency anaemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorisation follows a positive opinion issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). With receipt of the EC decision, Takeda intends to launch ferumoxytol across Europe in the near future.

"The granting of European marketing authorisation for ferumoxytol marks an important milestone for Takeda in our ongoing commitment to the field of renal medicine. We look forward to providing ferumoxytol, a valuable new therapeutic option, to clinicians in the near future" said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals.

The marketing authorisation, which will be held by Takeda Global Research & Development Centre (Europe) Ltd, is valid in the current EU Member States as well as in Iceland and Norway, and is based on data obtained from an extensive clinical development programme. Across the three pivotal Phase III safety and efficacy studies, 1,726 subjects were exposed to ferumoxytol, including 1,562 patients with all stages of CKD; in which ferumoxytol was administered as a rapid injection.^[1,2,3] From these studies, ferumoxytol significantly increased haemoglobin levels as compared to oral iron across the spectrum of CKD.^[1,2,3] Moreover, ferumoxytol was well tolerated by CKD patients with IDA and had a similar overall treatment-related adverse event rate to oral iron.^[1] These outcomes were further supported by additional retrospective observational data from three large haemodialysis clinics in the United States involving more than 8,600 patients and more than 33,300 administered doses of ferumoxytol.^[4,5]

Iron deficiency is a common cause of anaemia often seen in the later stages of CKD, as renal function deteriorates and erythropoiesis (red blood cell production) declines. IDA can have a profound impact on patients' lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular (CV) complications including congestive heart failure. ^[6,7]

"While treatments for iron deficiency anaemia have been widely available for many years, the disease continues to place a significant burden on the everyday life of CKD patients worldwide, and its management should be tailored to appropriately address the clinical consequences of this debilitating condition" says Francesco Locatelli, Scientific Director, Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy. "Ferumoxytol offers an effective and convenient alternative to current therapies in the management of anaemia, and news of its approval will be warmly received by the renal community".

Notes to Editors

About Rienso^® (ferumoxytol)  

Ferumoxytol is an IV iron therapy with an approved indication for the treatment of IDA in adult patients with CKD. The maximum total dose of ferumoxytol is 1020mg, which is administered as an initial 510mg intravenous injection, followed by a second 510mg intravenous injection 2-8 days later. The intended treatment course for most adults is two injections of 510mg intravenous iron. Ferumoxytol significantly increases Hb levels in CKD patients with IDA, both on dialysis and in patients not on dialysis compared with oral iron. Clinical trials have also highlighted that ferumoxytol is well tolerated.

Ferumoxytol was developed by AMAG Pharmaceuticals, Inc and is marketed outside the US by Takeda Pharmaceuticals following announcement of a comarketing agreement in March 2010. Ferumoxytol is currently approved for use in Canada and the US as Feraheme^®.

A Summary of Product Characteristics will be available on the EMA website shortly.

References

1. Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008; 19: 1599-1605.
2. AMAG Pharmaceuticals. Data on file.
3. Provenzano R, Schiller B, Rao M, et al. Clin J Am Soc Nephrol 2009; 4: 386-393.  
4. Schiller B, Bhat P, Sharma A, et al. Safety of Feraheme^® (Ferumoxytol) in hemodialysis patients at 3 dialysis chains over a 1-year period. J Am Soc Nephrol 2011; 22: 477A-478A. Abstr FR-PO1573.
5. Sharma A, Bhat P, Schiller B, et al. Efficacy of Feraheme^® (Ferumoxytol) administration on target hemoglobin levels and other iron parameters across 3 dialysis chains. J Am Soc Nephrol 2011; 22: 485A. Abstr FR-PO1603.
6. O'Mara NB. Anemia in patients with chronic kidney disease. Diabetes Spectrum 2008; 21: 12-19.
7. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006; 47:S11-15.

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. As the largest pharmaceutical company in Japan and a leader in the global industry, Takeda's mission is to strive toward better health for patients worldwide through leading innovation in medicine. It has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Takeda is ranked 12th by global Rx sales, 14th in the BRIC countries and 18th in Europe. Takeda's commercial presence mainly covers the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

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