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Stories from the dialysis comunity across the globe.



NPS Pharma to Receive $25 Million from Amgen - Renal Business Today PDF Print

NEW YORK—NPS Pharmaceuticals Inc. will receive a one-time $25 million payment this month in exchange for its rights to receive royalties earned after 2018 for sales of its Sensipar drug under an amended license agreement with Amgen Inc reported NASDAQ.

Sensipar, marketed as Mimpara in Europe, treats secondary hyperparathyroidism in chronic kidney disease patients on dialysis. In 1996 NPS licensed world-wide rights to Amgen to develop and commercialize the drug, and the drug received FDA approval in March 2004.

NPS said funds from the agreement are expected to support the launches of both Gattex, a treatment for short bowel syndrome, and Natpara, which is intended to be used for adult hypoparathyroidism, in addition to aiding its transition into a self-sustaining commercial-stage business.

The deal is expected to accelerate cash flow with at least $75 million of incremental cash expected through 2013.

The amendment also extends the royalty-advance-repayment period, limiting the offset of the royalty advance that the biopharmaceutical company received from Amgen in August 2011 to $8 million a quarter.

After repayment of the advance and a 9 percent anum discount factor on the balance of $92 million, Amgen will resume paying NPS all royalties earned through 2018.

"This innovative transaction underscores our commitment to accessing capital at the lowest possible cost and in a manner that is in the best interests of our shareholders," said Luke M. Beshar, NPS's chief financial officer.

Shares of NPS were inactive in premarket trade at $8.61, while shares of Amgen slipped 0.2 percent to $72.75. NPS is up 31 percent so far this year, while Amgen is up 14 percent.

 

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Predictions Public Policy - Cardiovascular Business PDF Print

EDITORIAL

Predictions & Public Policy

Several years ago, a nephrologist shared with me a brief history of hemodialysis in the U.S. Early technology iterations were flawed and morbidity for patients with end-stage renal disease (ESRD) was high.

In the early 1970s, lawmakers passed legislation that mandated Medicare to assume most of the financial burden for caring for eligible patients with late-stage kidney disease who required dialysis, regardless of their age. Then dialysis equipment improved, positively impacting the mortality and morbidity outlook for these patients. The U.S. Renal Data System, which collects, analyzes and reports on ESRD incidence for the Centers for Medicare & Medicaid Services (CMS) and others, estimates in its 2011 Atlas that the ESRD patient population totaled 571,414 in 2009 at a cost of $29 billion for Medicare.  

ESRD is a debilitating condition and Medicare should be commended for shouldering the financial burden for this vulnerable patient population. But the nephrologist’s tale about the unintended consequences of public policy decisions came to mind as I gathered background information for our cover story on physician compensation. To equitably determine compensation for physicians serving Medicare patients, the federal government sought an objective methodology for determining the value of a service and appropriate fees for calculating compensation.

Thus, the relative value unit and the Relative Value Update Committee (RUC) were born. It was public policy decisions that created the fee-for-service model, which—as our article details—rewards volume and partly has contributed to overutilization. The RUC, an expert advisory body of physicians that is not funded by CMS, works within the restrictions of its defined service to CMS. Although members must remain mute in discussions about their respective specialties, some critics argue that physicians have a vested interest in decisions that affect physician pay. But many critics also say physicians must be involved, otherwise decisions that affect patient care are made in a vacuum.

There are no easy answers, especially when resources are limited and needs are immense. I doubt policymakers anticipated that the fee-for-service model would strain federal coffers. Do you foresee drawbacks in the alternatives? I would love to hear.

Last updated on July 2, 2012 at 10:24 am EST

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UVA Amherst Dialysis on generator power - WSLS PDF Print

UVA Amherst Dialysis on generator power
WSLS
UVA Dialysis Amherst is currently running on generator power. Dialysis services are being provided, but we are working to reschedule patients at alternate sites.

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Unilab's summit are plain junkets - Malaya PDF Print

Unilab’s summit are plain junkets

By A Web design Company

‘The Philippine Medical Association should be a little more strict in allowing its members to join free trips abroad.’

UNITED Laboratories (Unilab), the largest and most profit­able pharmaceutical company in the Philippines has a unique but expensive way of selling its products. Apart from a large group of medical representatives all over the country, Unilab regu­larly sends physicians abroad, presumably to learn new ways of treat­ing diseases. 

Based on documents furnished this space from a source in Unilab the trips are actually junkets. His proofs are the itineraries of the physicians themselves. 

For example, Unilab sponsored what it calls a nephrology summit attended by seventy physicians who traveled in two batches. The names in the list do not tell me that at least one or two or several of them are nephrologists or experts on diseases of the kidneys. 

There is nothing in the records obtained by Malaya Business In­sight that the physicians attended a meeting of foreign high-powered nephrologists in Whistler, Canada. In fact, the itinerary does not in­dicate that there was any conference on nephrology at all. 

The trips are of course fully paid by Unilab. In fact, there were a few summits where people – not necessarily physicians -- may join. It is understood they pay a modest fee. 

The physicians are taken to shopping trips and tourist destinations. The cost of shopping is limited to a certain reasonably hefty amount but Unilab pays for whatever the physicians buy. 

The word “summit” as far as Unilab is concerned has been given a new meaning, a new twist. In the case of Unilab, physicians, not nec­essarily nephrologists attended the summit. Strangely, the itinerary does not even indicate there was a medical conference of any sort. 

So why do physicians attend these “summits”? My guess is a chance to travel for free. 

Other pharmaceutical companies hardly offer any trips at all. 

When they do, few physicians in their fields of specialization are sent – also free. But they learn a few things in the medical conferences. 

How can Unilab send 70 physicians in two batches to attend what it calls a nephro summit? I do not believe there are that many ne­phrologists in this country. The only one I personally know is Dr. Filoteo Alano who is married to my cousin Flora Macasaet. The sec­retary of health Dr. Enrique Ona is also known as a nephrologist. 

It might have been the desire of Unilab or its subsidiaries to sug­gest to physicians who join the junkets to prescribe a drug brand called Renogen made in India. The medicine or drug, according to my source is used in hemo dialysis, a procedure applied to victims of uremia or malfunctioning of the kidneys. 

A university hospital in the outskirts of Manila where my distant grandfather, the late Dr. Ramon K. Macasaet was dean of medicine for many years discovered that Renogen is a defective drug. I heard that key representatives of Unilab went to talk to the pharmacist of the university hospital and requested her not to talk about it. 

The Unilab officials assured the pharmacist that the medicine has been withdrawn from Mercury Drug, the country’s largest drug retail chain. 

Renogen is the third medicine imported from India, not only by Unilab, which has been discovered to have some defects. 

The first was Amoclav which, in two instances, turned reddish brown after it was mixed with diluents. The second was Merop which, according to the report of the US Food and Drug Adminis­tration, was reported by Pfizer to be contaminated with fungi. 

We learned from friends and physicians that St. Luke’s Medical  Center has stopped storing Amo­clav and Merop.

It is presumed that all drugs and medicines – locally manufactured or imported – are tested by the laborato­ries of the Bureau of Food and Drugs. How the defects escaped the agency is a question Unilab does not ask.

In fairness, it might have been possible that one capsule, tablet or vial in hundreds of thousands may be defective. The BFAD does not test all the drugs and medicines.

However, the discovery of de­fects should keep the ears of the BFAD on the ground. Upon dis­covery of a defect, the importer should take it upon itself to stop distributing the medicine. In fact the defects are grounds for the importer to sue the manufacturer.

Going back to Renogen, the med­icine used in dialysis, one wonders why the so-called nephro summit was not held in India where the product is manufactured. The phy­sicians – nephrologists or general practitioners – could have learned a thing or two about Renogen and the good it does to victims of kid­ney malfunction. 

Unilab chose Canada but there was no such summit, not even a medical conference if the itinerary tells what the trip was all about. 

Dialysis can be self-administered with the assistance of a nurse. Unilab had expected more than P150 million in sales from Reno­gen. The target may not have been met. So, there went the expenses of physicians in the nephrology summit that never was.

The other point here is the Philippine Medical Association should be a little more strict in allowing its members to join free trips abroad. If the trips improve the competence of the physicians, they should be encouraged and in fact funded by the PMA.

But if the trips are intended to en­courage the physicians to prescribe cer­tain drugs and medicines of the spon­sor, they should be shunned. They tend to reduce the dignity of physicians as guardians of human health.

Unilab has the wisdom of capital­izing on the Filipino trait or virtue of gratitude (utang na loob). If I were a physician who cannot even afford to go to say, Hong Kong on my own, why shouldn’t I prescribe the drugs and medicines of any company that sends me – all ex­penses paid and shopping to boot?

This space has the details of two more such summits, one in. urol­ogy and the other described as anti-infective in Amsterdam. The participants were sent in three batches or groups. Readers who may want to know the identities of the physicians can communi­cate with us at our email address: This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

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Hungary Nephrology and Urology Devices Investment Opportunities, Analysis ... - SBWire (press release) PDF Print

Naperville, IL -- (SBWIRE) -- 07/02/2012 -- Hungary Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018 a new report provides key market data on the Hungary 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 key recent developments.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Global Markets Direct’s team of industry experts.

Scope

- Nephrology and Urology Devices market size and company share data for market categories – Incontinence Devices, Lithotripters and Renal Dialysis Equipment.
- Annualized market revenues (USD million), volume (units) and average price (USD) data for each of the segments and sub-segments within three market categories. Data from 2004 to 2011, forecast forward for 7 years to 2018.
- 2011 company shares and distribution shares data for each of the three market categories.
- Global corporate-level profiles of key companies operating within the Hungary Nephrology and Urology Devices market.
- Key players covered include Fresenius Medical Care AG & Co. KGaA, Svenska Cellulosa Aktiebolaget SCA, Baxter International Inc., Gambro AB, HARTMANN GROUP, ONTEX International N.V. and others.

Reasons to buy

- Develop business strategies by identifying the key market categories and segments poised for strong growth.
- Develop market-entry and market expansion strategies.
- Design competition strategies by identifying who-stands-where in the Hungary Nephrology and Urology Devices competitive landscape.
- Develop capital investment strategies by identifying the key market segments expected to register strong growth in the near future.
- What are the key distribution channels and what’s the most preferred mode of product distribution – Identify, understand and capitalize.

Companies Mentioned

Fresenius Medical Care AG & Co. KGaA Svenska Cellulosa Aktiebolaget SCA Baxter International Inc. Gambro AB HARTMANN GROUP ONTEX International N.V. B. Braun Melsungen AG Coloplast A/S First Quality Enterprises, Inc. Kimberly-Clark Corporation Covidien plc Dornier MedTech GmbH Siemens Healthcare Teleflex Incorporated Medline Industries, Inc. STORZ MEDICAL AG

To view the detailed table of contents for this report please visit: http://www.reportstack.com/product/67564/hungary-nephrology-and-urology-devices-investment-opportunities-analysis-and-forecasts-to-2018.html

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