THOUSAND OAKS, Calif., July 5, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the completion of the acquisition of KAI Pharmaceuticals, a privately held company based in South San Francisco. The acquisition was initially announced April 10, 2012 and includes KAI's lead product candidate KAI-4169, which is a novel agent being studied initially for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis.  KAI has previously reported compelling Phase 2a clinical results for KAI-4169 in this indication. KAI-4169 is administered intravenously at the same time the patient is undergoing dialysis.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2011, and in our periodic reports on Form 10-Q and Form 8-K.  Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. 

No forward-looking statement can be guaranteed and actual results may differ materially from those we project.  The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products.  In addition, sales of our products are affected by reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement.  Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products.  Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.  We, or others, could identify safety, side effects or manufacturing problems with our products after they are on the market.  Our business may be impacted by government investigations, litigation and product liability claims.  Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.  We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.  In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products.  Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.  Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers.  Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

Contact: Amgen, Thousand Oaks
Mary Klem, 805-341-0687 (media)
Arvind Sood, 805-447-1060 (investors)

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen

...

THOUSAND OAKS, Calif., July 5, 2012 /PRNewswire via COMTEX/ -- Amgen /quotes/zigman/19815/quotes/nls/amgn AMGN -1.10% today announced the completion of the acquisition of KAI Pharmaceuticals, a privately held company based in South San Francisco. The acquisition was initially announced April 10, 2012 and includes KAI's lead product candidate KAI-4169, which is a novel agent being studied initially for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. KAI has previously reported compelling Phase 2a clinical results for KAI-4169 in this indication. KAI-4169 is administered intravenously at the same time the patient is undergoing dialysis.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com . Follow us on www.twitter.com/amgen .

Forward-Looking Statements

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2011, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others, could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

Contact: Amgen, Thousand OaksMary Klem, 805-341-0687 (media)Arvind Sood, 805-447-1060 (investors)

SOURCE Amgen

Copyright (C) 2012 PR Newswire. All rights reserved

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Action Points

Using cystatin C levels along with serum creatinine to estimate the glomerular filtration rate (GFR) did a better job of assessing kidney impairment than the standard GFR formula, researchers said.

Substantially more patients were correctly classified as having GFR values above or below the critical threshold of 60 ml/min/1.73 m² when it was estimated with the combined method versus the conventional GFR calculation that relies only on serum creatinine, according to Lesley Inker, MD, of Tufts Medical Center in Boston, and colleagues.

About 17% of those with a conventional GFR value of 45 to 59 ml/min/1.73 m² were reclassified with the combined equation as having GFR above the critical threshold. Also, 19% of those were reclassified with the combined method in the other direction, the researchers reported in the July 5 issue of the New England Journal of Medicine.

"The new equations represent an advance over currently available equations across the range of GFR and in relevant subgroups," Inker and colleagues wrote.

They also suggested that a GFR estimate based on cystatin C alone may be useful for confirming a diagnosis of chronic kidney disease in subgroups of patients such as those with decreased muscle mass or chronic illnesses.

But in an accompanying editorial, a nephrologist at the University of Maryland in Baltimore expressed skepticism. "My guess is that the incremental cost of improving GFR estimation with a cystatin C measurement may be less valuable when compared with consideration of the urine albumin:creatinine ratio in addition to a creatinine-based estimating equation," wrote Matthew R. Weir, MD.

He also noted that, although the combined equation is clearly an improvement over the conventional GFR calculation, whether it would "result in improved clinical care and a reduction in healthcare costs" should be examined in future studies.

That conventional GFR estimates based on serum creatinine alone are less than perfect is not in dispute. Such estimates may vary, not only with the severity of kidney impairment, but also with age, diet, muscle mass, gender, and race.

Cystatin C has already been suggested as a useful analyte for assessing kidney impairment, either by itself or in addition to other markers.

For this study, Inker and colleagues developed two new equations for GFR, one based solely on cystatin C and one that combined it with serum creatinine.

These equations were based on patient data collected in the course of 13 previous studies involving 5,352 people of divergent backgrounds. They were then tested in a validation dataset drawn from 1,119 participants in five studies, comparing both new GFR estimating methods with the standard equation.

Data in the validation set included measured GFR values, which served as the gold standard for evaluating the estimates' accuracy.

The equation combining both markers had a narrower interquartile range than either of the single-marker estimates, Inker and colleagues reported (13.4 versus 15.4 and 16.4 ml/min/1.73 m² for the creatinine and cystatin C equations, respectively, both P<0.001).

Also, only 8.5% of combined-marker GFR estimates were more than 30% above the measured values, compared with 12.8% and 141.1% of the single-marker estimates (both P<0.001).

Inker and colleagues added that the results were essentially duplicated in subgroups defined by age, diabetes status, body mass index, and gender.

However, adding race as another variable in the equation did not improve the combined equation's performance in the black race subgroup. Other racial groups were not well-represented in either the development or validation datasets.

Limitations to the new equations cited by Inker and colleagues included their reliance on previously published data for development and validation of the methods. Few participants were malnourished, and only 3% of the validation set was from African Americans.

Also, the data generally lacked information on participants' medications and muscle mass, which may have affected the biomarkers and measured GFR values.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Disease.

Two study authors reported relationships with Gentian, Gilead, and Pharmalink.

Weir reported relationships with Amgen, Novartis, Merck, Daiichi Sankyo, Sanofi, and Pfizer.

Primary source:New England Journal of Medicine
Source reference:
Inker L, et al "Estimating glomerular filtration rate from serum creatinine and cystatin C" N Engl J Med 2012; 367: 20-29.

Additional source: New England Journal of Medicine
Source reference:
Weir M "Improving the estimating equation for GFR -- a clinical perspective" N Engl J Med 2012; 367: 75-76.

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John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/2kcrxd/spain_nephrology_a) has announced the addition of GlobalData's new report "Spain Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters" to their offering.

“Spain Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters”

GlobalData's new report, Spain Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters provides key market data on the Spain Nephrology and Urology Devices market. The report provides value (USD million), volume (units) and average price (USD) data for each segment and sub-segment within three market categories - Incontinence Devices, Lithotripters and Renal Dialysis Equipment. The report also provides company shares and distribution shares data for each of the aforementioned market categories. The report is supplemented with global corporate-level profiles of the key market participants with information on company financials and pipeline products, wherever available.

Scope

- Market size and company share data for Nephrology and Urology Devices market categories - Incontinence Devices, Lithotripters and Renal Dialysis Equipment.

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Companies Mentioned

- Svenska Cellulosa Aktiebolaget SCA

- Coloplast A/S

- Fresenius Medical Care AG & Co. KGaA

- Baxter International Inc.

- HARTMANN GROUP

- ONTEX International N.V.

- First Quality Enterprises, Inc.

- B. Braun Melsungen AG

- Astra Tech Inc.

- Kimberly-Clark Corporation

- Covidien plc

- Bellco Srl

- NIPRO CORPORATION

- Medline Industries, Inc.

- Teleflex Incorporated

- Asahi Kasei Corporation

- Dornier MedTech GmbH

- Siemens Healthcare

- Gambro AB

- NxStage Medical, Inc.

For more information visit http://www.researchandmarkets.com/research/2kcrxd/spain_nephrology_a

Source: GlobalData

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