MADISON, N.J., March 14, 2013 /PRNewswire/ -- On World Kidney Day, Quest Diagnostics, the world's leading provider of diagnostic information services, today announced its support of the updated global version of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) Chronic Kidney Disease (CKD) guideline recently released by Kidney Disease: Improving Global Outcomes (KDIGO). World Kidney Day aims to raise awareness of the important role kidneys play in overall health and to reduce the frequency and impact of kidney disease and its associated health problems worldwide. Visit the National Kidney Foundation website to learn more about the new guideline and about your kidneys and how to protect them.

The updated guideline expands the CKD classification system to include albuminuria, protein in the urine, as well as "cause of disease" and glomerular filtration rate (GFR) stage. These changes provide a more accurate view of each patient's condition to help physicians stratify risk which can help lead to improved management and treatment.

"We applaud the National Kidney Foundation for its leadership in educating patients and physicians on kidney disease risk and prevention," said Harvey W. Kaufman , M.D., Senior Corporate Medical Director, Quest Diagnostics, and co-author of a 2011 study published in the peer-reviewed online journal PLoS ONE, which found that 89 percent of those found to be at high risk for CKD through their employer's lab-based wellness program were unaware of the health concern. "The updated guideline incorporates a better understanding of the factors that contribute to the progression of kidney functional impairment and are easier for primary care physicians to understand and follow so they can better identify patients with early stages of CKD and take steps to treat common underlying conditions, preserve remaining kidney function, and adjust medication that is dependent upon kidney function for elimination."

Approximately 26 million Americans suffer from CKD, a condition characterized by the gradual loss of kidney function. Though often thought of as an older person's disease, CKD's prevalence has grown among younger adults, largely because the most important risk factors, diabetes and hypertension (high blood pressure), have both grown rapidly among younger adults due to the increases in obesity and other factors related to these conditions. Chronic kidney disease is important to identify at an early stage when the progression can be slowed or stopped before the kidneys have failed and people affected are placed on dialysis and need a kidney transplant. At its earliest stages, CKD is generally silent and only detected through laboratory tests.  Watch Quest Diagnostics short "Intro to Chronic Kidney Disease" video to learn more about how CKD impacts health.

"The new staging predicts meaningful outcomes for patients more accurately based on both blood and urine tests instead of one or the other test alone," said Joseph Vassalotti , M.D., Chief Medical Officer, National Kidney Foundation. "When you put together a patient's level of kidney function as assessed by the blood test to estimate glomerular filtration rate (eGFR) and the extent of kidney damage based on urine albumin level, you improve prediction of risk for future chronic kidney failure and subsequent cardiovascular events."

In Quest Diagnostics data of nearly 2.5 million patient encounters in which patients were tested simultaneously for serum creatinine for eGFR and urinary albumin, many patients had CKD and many were classified differently using the combination of eGFR and urinary albumin than if only eGFR was considered. Among patients who were initially considered to have mild CKD based on eGFR of 45-59, ml/min/1.73m², 69.0% were classified as moderately increased risk, 23.2% were classified as high risk, and 7.8% were classified as very high risk.

"Our data support the new guideline and suggest that many patients who may have been considered to have mild CKD based on eGFR alone really have moderate to severe progressive CKD when urinary albumin status is simultaneously evaluated," said Dr. Kaufman. "We expect the new guideline to be a useful tool to help physicians identify, manage, and treat patients with CKD."

Quest Diagnostics, a strong supporter of the recommended testing for CKD as described in the original NKF-KDOQI guidelines, was among the first laboratories to provide estimated glomerular filtration rate (eGFR) calculation along with all requests for serum creatinine. The company was also one of the first laboratories to update the basis of the equation to the CKD-EPI equation that is now recommended in the new guideline. Quest Diagnostics provides a wide spectrum of testing to support the needs of nephrologists and other physicians who are involved in classifying and managing patients with kidney disease.

About the National Kidney Foundation and KDIGO

The National Kidney Foundation is the leading organization in the U.S. dedicated to the awareness, prevention and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families and tens of millions of Americans at risk. NKF was Founding Sponsor of Kidney Disease: Improving Global Outcomes (KDIGO), an international organization focused on developing global clinical practice guidelines. For more information visit, www.kidney.org.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic information services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us atFacebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Media Contact: Barb Short / Caitlin McHugh – 973-520-2800
Investor Contact: Daniel Haemmerle– 973-520-2900

SOURCE Quest Diagnostics

Keryx Biopharmaceuticals Inc recently announced that its investigational treatment for hyperphosphatemia in end-stage renal disease patients on dialysis met its primary and all key secondary endpoints in its Phase III long-term study.

The study evaluated the drug Zerenex (ferric citrate), which is a ferric iron-based phosphate binder drug candidate. Zerenex met the study’s primary endpoint demonstrating a highly statistically significant change in serum phosphorus versus the placebo during the four-week Efficacy Assessment Period. Key secondary endpoints were also met, which included increasing ferritin and transferrin saturation (TSAT) and reducing the use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) versus the active control over the 52 week Safety Assessment Period of the study.

The long-term study was conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA).

“We are very excited by the results announced today. The data from this study confirm that Zerenex is a safe and effective phosphate binder with the added benefit of improving patients’ iron levels while utilizing significantly less IV iron and ESAs. There is a clear need for viable alternatives to the marketed phosphate binders, and Zerenex can play a major role by not only providing adequate phosphate binding, but also providing additional benefits,” Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine and Executive Committee of the Collaborative Study Group and Study Chair of the Zerenex Phase III registration program stated.

According to the company, full efficacy and safety data from the study is expected to be presented at a future medical conference, and Keryx anticipates US and European New Drug Application Submissions by the second quarter of 2013.

“We are thrilled by the robust outcome of this pivotal study for Zerenex, particularly with the magnitude of the drugs’ effect on iron and anemia parameters, which should prominently differentiate Zerenex versus all the currently marketed phosphate binders. We believe that the ability to treat hyperphosphatemia, while also increasing iron storage parameters and reducing the need for IV iron and ESAs, sets a new paradigm for how a phosphate binder can be used to treat patients with end-stage renal disease on dialysis. We believe that these data position Zerenex to potentially become market leader in phosphate binder market,” Rob Bentsur, Chief Executive Officer at Keryx stated.

Keryx shares rose the most in almost four years after the company’s announcement.

Source: Keryx Biopharmaceuticals, Inc.

Last Updated: 1/29/13; 3:20PM EST

DEERFIELD, Ill. - Dec. 4, 2012 - Baxter International Inc. (NYSE:BAX) has entered into a definitive agreement to acquire Gambro AB, a privately held dialysis product company based in Lund, Sweden, for total consideration of 26.5 billion SEK (approximately $4.0 billion USD at current exchange rates). Gambro is a global medical technology company focused on developing, manufacturing and supplying dialysis products and therapies for patients with acute or chronic kidney disease. The acquisition gives Baxter a comprehensive dialysis product portfolio, complements Baxter's global home dialysis offerings, and positions the company to better meet the evolving needs of the large and growing dialysis market.

"Baxter has a legacy of innovation in dialysis, including the development of peritoneal dialysis for the treatment of end-stage kidney disease patients in the home. This acquisition further strengthens our global dialysis offerings by extending our portfolio in the hemodialysis segment," said Robert L. Parkinson, Jr., chairman and chief executive officer of Baxter. "This transaction will provide attractive returns and enhance Baxter's sales and earnings growth over the company's current long-range financial plan."

Gambro is a global provider of dialysis products and technologies used in hemodialysis (HD) and continuous renal replacement therapy (CRRT), with annual sales of approximately $1.6 billion in 2011. Its portfolio in the traditional chronic care segment consists of HD devices including advanced monitors, dialyzers, bloodlines, cyclers and dialysis solutions. Gambro's in-center HD devices include the Artis™ system and the AK 96™ system. In the acute care segment, which includes CRRT and treatment for fluid overload, among others, Gambro offers the Prismaflex® system used for the treatment of critically ill patients with acute kidney injury.

"Both companies have a longstanding heritage in kidney care with innovative technologies and a dedication to saving, sustaining and improving the lives of patients worldwide," said Guido Oelkers, president and chief executive officer of Gambro. "This acquisition responds to the needs of the nephrology community, healthcare providers and patients seeking a comprehensive dialysis offering of proven products and therapies."

More than two million patients globally are on some form of dialysis, with dialysis treatment rates increasing more than 5 percent annually in part due to the rising rates of diabetes and hypertension.  Additionally, healthcare providers are seeking comprehensive dialysis offerings, which vary by region, to serve patients based on clinical need, existing infrastructure and reimbursement policy.

The transaction will provide a number of long-term growth opportunities for Baxter around the world.  With a broad and complementary dialysis product portfolio, Baxter can accelerate product sales in established markets such as Europe, where Gambro has an extensive footprint.  Baxter can also expand Gambro's reach in high-growth regions of Latin America and Asia-Pacific, where Baxter has steadily grown its peritoneal dialysis (PD) business.  In addition, Baxter will also build upon its pipeline of investigational home HD and automated PD systems by adding Gambro's highly innovative and next-generation monitors, dialyzers, devices and dialysis solutions.

Excluding special items, the company expects this transaction to be dilutive to adjusted earnings per diluted share by $0.10 to $0.15 in 2013 and neutral to modestly accretive to adjusted earnings per diluted share in 2014.  Excluding the impact of special items and estimated amortization of intangible assets, the company expects this transaction to be neutral to adjusted earnings per diluted share in 2013, and accretive in 2014 by $0.20 to $0.25 per diluted share. The company expects this transaction to be increasingly accretive to adjusted earnings per diluted share beyond 2014 and, in addition to an array of commercial synergies, projects opportunities for annual cost synergies totaling approximately $300 million by 2017.  Baxter now expects over its five-year long-range financial plan to increase sales (excluding the impact of foreign currency) by 7 to 8 percent and to grow adjusted earnings per diluted share in the 8 to 10 percent range, both on a compounded annual basis.

The transaction will be financed through a combination of cash generated from overseas operations and debt.  Baxter expects to maintain its current dividend payout ratio of approximately 40 percent.  The closing of the transaction is subject to regulatory approvals and other customary closing conditions and is expected to occur in the first half of 2013.

CAMBRIDGE, Mass. and TOKYO, Japan, September 28, 2012 -- AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors.

The NDA submission is based on results of the global Phase 3 TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced RCC) trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced RCC who had no prior treatment with a systemic therapy, as well as data from 17 clinical studies involving over 1,000 subjects who received tivozanib. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) versus sorafenib, an approved targeted agent, and a favorable tolerability profile.

Results from the study were first presented in early June 2012 at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting in Chicago, IL.

About Kidney Cancer

Advanced RCC, or kidney cancer, is the ninth most commonly diagnosed cancer in men and women in the U.S.¹ Worldwide it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from the disease each year. ² RCC accounts for more than 90 percent of all kidney cancers.³

Currently available therapies provide less than one year of median PFS in treatment naive patients and are associated with significant toxicities.⁴ These toxicities not only lead to high rates of dose reductions and interruptions (potentially compromising efficacy), but also can impact a patient’s quality of daily living.⁵

About Tivozanib

Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off target toxicities. Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a Phase 3 clinical study in advanced renal cell carcinoma have been reported. Tivozanib is also under evaluation across a broad range of solid tumors, including metastatic colorectal cancer and metastatic breast cancer.

About Astellas

Astellas Pharma Inc., headquartered in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in Oncology, Urology, Immunology (including Transplantation) and Infectious Diseases, Neuroscience and DM Complications and Kidney Diseases. For more information on Astellas Pharma Inc., please visit the company’s website at www.astellas.com/en.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. AVEO’s proprietary Human Response Platform™ provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,”

“potential,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: tivozanib’s potential and role in treating patients with kidney cancer; AVEO’s plans for advancing the registration process for tivozanib; and AVEO’s plans to leverage its Human Response Platform™. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the results of TIVO-1 are sufficient to obtain marketing approval for tivozanib, which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities the safety and efficacy of tivozanib based upon the findings of TIVO-1, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine to be relevant to approvability; AVEO’s ability to demonstrate in subsequent trials any safety and efficacy it demonstrated in earlier trials of tivozanib; ongoing regulatory requirements with respect to the approval of tivozanib, including the risk that FDA or any comparable foreign regulatory agency could require additional positive clinical trials as the basis for product approval; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; unplanned operating expenses; AVEO’s ability to raise the substantial additional funds required to achieve its goals; adverse general economic and industry conditions; competitive factors; AVEO’s ability to maintain its collaboration with Astellas; AVEO’s and Astellas’ ability to successfully launch and commercialize tivozanib if and when it may be approved for commercialization; and those risks discussed in the section titled “Risk Factors” and elsewhere in AVEO’s most recent Quarterly Report on Form 10-Q and in its other filings with the Securities and Exchange Commission. The forwardlooking statements in this press release represent AVEO’s views as of the date of this press release.  AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release

Source: Aveo Oncology

Last Updated: 10/1/12; 11:30AM EST