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Decreased Hospitalizations and Health Care Costs Associated With Renagel Use

Posted on: Thursday, 16 November 2006, 09:00 CST

CAMBRIDGE, Mass., Nov. 16 /PRNewswire-FirstCall/ -- Genzyme Corp. announced today that patients using Renagel(R) (sevelamer hydrochloride) experienced lower rates of hospitalization, fewer days in the hospital, and reduced overall health care expenditures compared to patients treated with calcium-based phosphate binders according to the largest prospective dialysis outcomes study ever conducted.

The findings -- drawn from the Dialysis Clinical Outcomes Revisited (DCOR) trial -- were highlighted in two presentations today at the American Society of Nephrology annual meeting in San Diego by a team of study investigators led by Wendy St. Peter, Pharm D, of the Chronic Disease Research Group and the University of Minnesota College of Pharmacy.

According to the study investigators, patients treated with Renagel achieved an 11.0 percent reduction in the rate of all-cause hospitalization and a 13.3 percent reduction in the number of days spent in the hospital compared with patients using calcium-based phosphate binders -- results that were statistically significant. Cause-specific hospitalization rates, hospitalization days and morbidity were not statistically different between the two groups.

The difference seen in hospitalizations drove a reduction in overall Medicare costs for patients on Renagel relative to those taking calcium-based binders, as measured in the study. Patients treated with Renagel had costs that were, on average, $2,388 (3.7 percent) less per year than those treated with calcium-based binders. Outpatient, skilled nursing and other costs were not statistically different between the two treatment groups, according to the investigators. Oral medication costs, including phosphate binders, were not included in the analysis because at the time of the study most oral medications were not covered by Medicare.

Hospitalization, morbidity and cost outcomes were pre-specified secondary outcomes of the DCOR trial. The results presented today derive from analysis of combined data from DCOR and from the Centers for Medicare and Medicaid Services (CMS) end-stage renal disease database. Because Medicare funds dialysis treatment, the vast majority (1,895 or 93 percent) of patients enrolled in the DCOR study had Medicare as their primary payer. Hospitalization, outpatient utilization and cost data were drawn from Medicare inpatient and outpatient claims. The patients in this study were followed from the first day patients took either study medication.

About the DCOR Study

The DCOR study enrolled 2,103 adult hemodialysis patients at 75 sites in the United States. Patients were randomly assigned to either Renagel or calcium-based binders (PhosLo(R) (calcium acetate) or TUMS(R) (calcium carbonate)). Approximately 27 percent of patients in the calcium group opted to use calcium carbonate rather than PhosLo. Patients were treated according to the usual treatment guidelines in their dialysis center in order to capture the real world experience of those on dialysis. Patients were followed for up to 45 months. The study population for both treatment groups was similar for demographics and baseline clinical characteristics, and similar to the overall U.S. dialysis population.

A portion of the data reported here has been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.

About Renagel

Renagel controls serum phosphorus in patients with Chronic Kidney Disease on hemodialysis. Controlling serum phosphorus is an important element in the care of hemodialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular mortality. Renagel provides the added benefit of significant LDL cholesterol reduction (32 percent).

The National Kidney Foundation's 2003 K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease recommend sevelamer hydrochloride as a first-line treatment option to control phosphorus. Renagel is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. Renagel is used by more than 350,000 people worldwide.

Product Information

Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. In a 52-week study, the most common side effects included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel.

For more information about Renagel, including complete prescribing information, please visit http://www.renagel.com/.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. This year marks the 25th anniversary of Genzyme's founding. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 8,500 employees in locations spanning the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.

Genzyme(R) and Renagel(R) are registered trademarks of Genzyme Corporation.

Genzyme's press releases and other company information are available at http://www.genzyme.com/ and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.

Media Contact: Investor Contact: Dan Quinn Sally Curley (617) 768-6849 (617) 768-6140

Genzyme Corp.

CONTACT: Media: Dan Quinn, +1-617-768-6849, or Investors: Sally Curley,+1-617-768-6140, both of Genzyme

Web site: http://www.genzyme.com/http://www.renagel.com/

Company News On-Call: http://www.prnewswire.com/comp/104284.html

Source: PRNewswire-FirstCall

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