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BRIEF-Galenica: Vifor Fresenius Medical Care Renal Pharma enters into ... - Reuters PDF Print

BRIEF-Galenica: Vifor Fresenius Medical Care Renal Pharma enters into ...
Reuters
BRIEF-Galenica: Vifor Fresenius Medical Care Renal Pharma enters into partnership with Relypsa. Aug 11 Galenica AG : * Vifor Fresenius Medical Care Renal Pharma enters into partnership with Relypsa to commercialise patiromer FOS Source text ...

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Govt sat on temple donation of dialysis machines - Times of India PDF Print
MUMBAI: A day after CM Devendra Fadnavis declared his ambitious plan to rope in leading temple trusts to strengthen health care at the grassroots level, it has emerged that the Shri Siddhivinayak Ganpati temple trust's Rs 7.5 crore proposal for setting up 102 dialysis units and water purification plants in 24 districts across the state had been gathering dust in the corridors of power for four months from April 9, 2015.

If a senior bureaucrat is to be believed, the proposal was lying in the office of minister of state for home and law and judiciary Ranjeet Patil, an orthopaedic surgeon by profession, for all these months though the gesture from the trust was a benevolent one, with no strings attached. "Our information is that the proposal was not approved as a senior cabinet member was keen on procuring MRI machines for his constituency. As per rules, it is beyond the powers of the trust to donate funds for procuring equipment for a private organization," he said.

When TOI contacted Ranjeet Patil, he claimed to have cleared the proposal a week ago. "I had cleared the proposal recently," said Patil. However, Patil did not comment on the delay in clearing the proposal.

Fadnavis had told a meeting in Pune on Sunday that his government was keen on securing financial assistance from temple trusts for improving health care and for setting up medical colleges on a public-private partnership basis across the state. Pune's Shrikant Dagadu Seth Ganpati temple trust has donated state-of-the-art medical equipment to a state-run medical college.

The bureaucrat said that on April 1, 2015, the state directorate of health services had submitted a comprehensive proposal for providing financial assistance for setting up 102 dialysis units, along with RO (water purification) plants in 24 districts across the state. Subsequently, a high-level meeting was convened in Mantralaya to discuss the proposal. "The scheme of providing financial assistance is exclusively for the government and semi-government hospitals. While it is the responsibility of the public health department to procure equipment, the trust provides financial assistance for the purpose," the bureaucrat said.

A senior BJP cabinet member said it was unfortunate that though the entire proposal was cleared long ago, dialysis units had failed to take off owing to red tape and procedural wrangles. "I feel the CM should initiate a high-level probe into the prolonged delay and fix the responsibility. Prima facie, it appears that the entire project was delayed owing to a casual approach," he said.

The BJP cabinet member said at a juncture when an estimated 35,000 persons are waiting for kidney transplant, the only hope for them is dialysis. "In private hospitals, the cost of dialysis ranges between Rs 1,150 to Rs 1,600. If dialysis facilities are available in all district and sub-district hospitals, it will reduce the financial burden on kidney patients," he said.

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Relypsa and Vifor Fresenius Medical Care Renal Pharma Enter Into Partnership ... - MarketWatch PDF Print

REDWOOD CITY, Calif., and ST. GALLEN, Switzerland, Aug 10, 2015 (GLOBE NEWSWIRE via COMTEX) --

Relypsa, Inc. RLYP, -5.02% a biopharmaceutical company, and Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), a common company of Galenica and Fresenius Medical Care, today announced they have entered into an exclusive partnership to commercialize Patiromer for Oral Suspension (Patiromer FOS), Relypsa's investigational medicine for the treatment of hyperkalemia.

Under the terms of the agreement, Relypsa will receive an upfront cash payment of $40 million and will be eligible to receive payments of up to $125 million upon achieving certain regulatory and sales based milestones. In addition, Relypsa will receive tiered double-digit royalties on net sales of Patiromer FOS in the licensed territories. VFMCRP will obtain an exclusive marketing right from Relypsa in worldwide territories except the United States and Japan, where Relypsa retains all commercial rights. Relypsa and VFMCRP will collaborate on ongoing development of Patiromer FOS, including submission of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).

Patiromer FOS is an oral potassium binder being developed for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood. Hyperkalemia occurs most frequently in patients with chronic kidney disease (CKD) and heart failure. A New Drug Application (NDA) for Patiromer FOS for the treatment of hyperkalemia is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of October 21, 2015. A MAA for Patiromer FOS is expected to be submitted with the EMA in the first half of 2016.

"We are excited to partner with Vifor Fresenius Medical Care Renal Pharma, which has a well-established commercial organization with a proven track record in cardiorenal diseases. If approved, Patiromer FOS will be promoted by the largest dedicated renal and heart failure sales forces in Europe," said John A. Orwin, president and chief executive officer of Relypsa. "We are confident they will be an excellent partner to commercialize and develop Patiromer FOS outside the United States and look forward to working with them to bring this medicine to patients around the world."

"Patiromer FOS has the potential to become an important new treatment option for hyperkalemia. We are pleased about partnering with Relypsa to bring this exciting medicine to patients in Europe and other markets as soon as possible," said Stefan Schulze, CEO, Vifor Fresenius Medical Care Renal Pharma. "The agreement with Relypsa is a recognition of Vifor Fresenius Medical Care Renal Pharma's growing leadership in nephrology as we continue to expand our renal pharma product portfolio and commercial organization."

Conference Call Today at 5:00 PM ET (2:00 PM PT)

The Relypsa management team will host a teleconference and webcast to discuss the partnership. The live call may be accessed by phone by calling (866) 410-4428 (domestic) or (704) 908-0287 (international), conference code 8382449. The webcast may be accessed live on the investor relations section of the Relypsa website at investor.relypsa.com and will be archived for 30 days following the call.

About Patiromer for Oral Suspension

Patiromer FOS is an oral potassium binder in development for the treatment of hyperkalemia. This investigational medicine has been studied in both treatment and prevention studies, primarily in patients with CKD, and/or heart failure, as well as patients with diabetes and hypertension. The clinical program includes a two-part pivotal Phase 3 program conducted under Special Protocol Assessment with the FDA, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial.

About Hyperkalemia

Hyperkalemia, or abnormally elevated levels of potassium in the blood, is a serious condition that can lead to life-threatening cardiac arrhythmia and sudden death. It is frequently prevalent in patients who suffer from CKD, hypertension, diabetes and/or heart failure. Patients with CKD or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors, which can increase blood potassium levels in patients taking these medicines.

About Relypsa, Inc.

Relypsa, Inc. is a biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The company's two-part pivotal Phase 3 trial of its lead product candidate, Patiromer for Oral Suspension, has been completed and the primary and secondary endpoints were met. A New Drug Application for Patiromer for Oral Suspension for the treatment of hyperkalemia was accepted by the U.S. Food and Drug Administration and is currently under review. Relypsa has global royalty-free commercialization rights to Patiromer for Oral Suspension, which has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.

About Vifor Fresenius Medical Care Renal Pharma Ltd.

Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Galenica and Fresenius Medical Care, develops and commercializes innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease worldwide. The company was founded at the end of 2010 and is owned 55 percent by Galenica and 45 percent by Fresenius Medical Care.

Forward-Looking Statements Related to Relypsa, Inc.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Relypsa, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential approval and launch of Patiromer for Oral Suspension, or Patiromer FOS, the experience and capabilities of Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, the expected impact of Relypsa's partnership with VFMCRP, the therapeutic and commercial potential of Patiromer FOS and the potential Prescription Drug User Fee Act action date. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Relypsa's regulatory filings, Relypsa's substantial dependence on Patiromer FOS, Relypsa's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Patiromer FOS. Relypsa undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Relypsa in general, see Relypsa's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, and its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015.

 CONTACT: Relypsa Contact: Charlotte Arnold Vice President, Corporate Communications 650.421.9352 
 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
  VFMCRP Contact: Beatrix Benz Head of Global Communications & Public Affairs +41 58 851 80 16 
 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
  

Copyright (C) 2015 GlobeNewswire, Inc. All rights reserved.

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Global Medical Dialysis Devices Market 2015 Industry Opportunities and ... - Medgadget.com (blog) PDF Print
9DResearchGroup-logo27

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The report talks about the distinct traits of the Medical Dialysis Devices market and provides in-depth study of the various segments of the market. The report especially focusses on the development of the Medical Dialysis Devices market in China owing to the increased demand from the region which has attracted the attention of the key manufacturers. Various regulations directly or indirectly affecting the Medical Dialysis Devices market in the region have been discussed in the report. The report takes note of the present state of the global economy, which after witnessing double-digit growth for three decades, is slowing down. Government’s efforts to push the economy is expected to positively affect the various sectors and increase demand from the market.

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The report discusses the competitive vendor landscape of the Medical Dialysis Devices market in the globe. Some of the key players in the market have been profiled in the report and crucial information about them such as their business overview, revenue segmentation, and product segmentation have been mentioned in the report. The report takes note of the market share held by the key players and estimates their future growth through SWOT analysis. It serves as a useful guide for the new entrants in the Medical Dialysis Devices market.

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Massachusetts-based dialysis company seeks to place services at Gloversville ... - Albany Business Review (blog) PDF Print

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Home of the Day

American Renal Associates, a Massachusetts-based dialysis company, is seeking state approval to open a location at Nathan Littauer Hospital and Nursing Home in Gloversville, New York.

The company would partner with two local physicians and invest about $1.3 million to operate a 13-station facility at the 74-bed hospital, according to documents filed with the New York Department of Health.

The dialysis center would provide out-patient services and care for patients at the Nathan Littauer Hospital and Nursing Home.

“This is the right project, at the right time, with the right partners,” Laurence E. Kelly, Nathan Littauer's CEO, said in a statement. American Renal Associates "brings a wealth of understanding of dialysis facility operations coupled with an outstanding management team to the table."

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