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Relypsa and Vifor Fresenius Medical Care Renal Pharma Enter Into Partnership ... - MarketWatch |
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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
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VFMCRP Contact: Beatrix Benz Head of Global Communications & Public Affairs +41 58 851 80 16
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Copyright (C) 2015 GlobeNewswire, Inc. All rights reserved.
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Global Medical Dialysis Devices Market 2015 Industry Opportunities and ... - Medgadget.com (blog) |
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The recent report on Medical Dialysis Devices market offers insightful information about the present scenario of the market across the globe. The report, titled Medical Dialysis Devices points out the key factors affecting the growth of the market. Latest market trends as well as the future growth opportunities have been mentioned in the report. The report takes into account the various micro- and macro-economic factors governing the overall growth of the Medical Dialysis Devices market and assesses the valuation and size of the market in the coming years.
Full information about report @ http://www.9dresearchgroup.com/market-analysis/medical-dialysis-devices-market-2015-global-industry-size.html
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Information about report sample here http://www.9dresearchgroup.com/report/9921#request-sample
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.
Several analytical tools such as market attractiveness analysis, investment feasibility analysis, and investment return analysis are employed to study the global Medical Dialysis Devices market, whereas SWOT analysis and Porter’s five forces analysis are utilized to evaluate the major players in the Medical Dialysis Devices market in this report.
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Contact us
Joel John
Email :
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Phone: 1-855-465-4651
Web: 9D Research Group
Blog: http://www.9dimenreports.com/
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Massachusetts-based dialysis company seeks to place services at Gloversville ... - Albany Business Review (blog) |
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Related Content
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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Argos Therapeutics Announces Pilot Clinical Trial of AGS-003 as Neoadjuvant ... - GlobeNewswire (press release) |
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DURHAM, N.C., Aug. 10, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced the initiation of a single-center pilot clinical trial of AGS-003 as a neoadjuvant immunotherapy in patients with localized renal cell carcinoma. The study is being conducted at Roswell Park Cancer Institute (RPCI) in Buffalo, New York, and is designed to enroll a maximum of ten patients who will be treated with AGS-003 before nephrectomy in order to assess immune system response and tumor effects.
"There is tremendous potential for approaches that use the body's own defense mechanisms to treat cancer, and we are dedicated to advancing promising approaches in this rapidly expanding area of cancer research," said Thomas Schwaab, MD, PhD, chief of strategy, business development & outreach, associate professor in the departments of urology and immunology and urology clinic director at Roswell Park Cancer Institute and principal investigator for the AGS-003 pilot study. "AGS-003 has shown strong potential in trials targeting metastatic renal cell carcinoma, and we look forward to advancing research to determine whether this therapy can help the body build an effective immune response to kill tumor cells in patients with localized disease. The goal is to develop a treatment that will interrupt the cancer's progression before it has a chance to spread to additional organs."
AGS-003 is an autologous dendritic-cell-based immunotherapy designed to induce a memory T-cell response specific to each patient's unique tumor antigens. It is produced using a small sample from a patient's own tumor and dendritic cells derived from a leukapheresis procedure. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable-risk metastatic renal cell carcinoma patients. Argos is evaluating AGS-003 in the pivotal phase 3 ADAPT trial in combination with standard targeted therapy for the treatment of metastatic renal cell carcinoma. The ADAPT trial is fully enrolled; interim data analyses are expected next year, with final data expected in the first part of 2017.
The pilot study is in patients with localized renal cell carcinoma, who must be eligible to undergo a partial or radical nephrectomy. Patients will receive five weekly doses of AGS-003 prior to surgery and will remain in the study for approximately six months.
"With this pilot study, for the first time we will be able to assess the effects of AGS-003 in patients with kidney cancer that has not spread to nearby lymph nodes or other parts of the body," said Charles Nicolette, chief scientific officer and vice president of research and development at Argos Therapeutics. "It is also an important opportunity to manufacture AGS-003 using a needle biopsy procedure for tumor collection prior to surgery and to directly study immune changes within the primary tumor before and after administration of AGS-003."
To learn more about the clinical research study, call 1-877-ASK-RPCI (1-877-275-7724) or send an e-mail to
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.
Dr. Schwaab was also recently named to Argos' inaugural Scientific Advisory Board and receives compensation from Argos for this service.
About Roswell Park
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email
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. Follow Roswell Park on Facebook and Twitter.
About the Arcelis® Technology Platform
Arcelis® is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient's disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis® process uses only a small tumor or blood sample and the patient's own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform. Argos' most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). The Company is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of HIV, currently being evaluated in a phase 2 clinical trial aimed at HIV eradication in adult patients. For more information about Argos Therapeutics, visit www.argostherapeutics.com.
Forward Looking Statements
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about Argos and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund our continuing operations for the period anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Argos' Annual Report on Form 10-K for the year ended December 31, 2014 which is on file with the SEC. In addition, the forward-looking statements included in this press release represent Argos' views as of August 10, 2015. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to August 10, 2015.
Media contacts:
Adam Daley
Berry & Company Public Relations
212-253-8881
Annie Deck-Miller
Roswell Park Cancer Institute
716-845-8593
Investor contact:
John Menditto
Argos Therapeutics, Inc.
919-908-0687
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