Navigation Links
Genzyme Announces Successful Completion of Study Investigating,Sevelamer Carbonate in Patients With Chronic Kidney Disease

CAMBRIDGE, Mass., April 16, 2007 /PRNewswire-FirstCall/ -- Genzyme Corp. announced today that a recently completed study of Renvela(TM) (sevelamer carbonate) achieved its primary endpoint, demonstrating a statistically significant reduction in serum phosphorus for hyperphosphatemic patients with chronic kidney disease who are not on dialysis.

Patients treated with Renvela also achieved a significant reduction in calcium-phosphorus product and in LDL cholesterol. The drug was well tolerated with a safety profile consistent with the clinical experience of patients on dialysis using Renagel(R) (sevelamer hydrochloride). The multi-center, single arm, open-label trial involved 49 patients at multiple study sites throughout Europe and Australia.

Full data will be presented at a future medical conference.

Renvela is a buffered form of Renagel, the most-prescribed phosphate binder in the United States. Like Renagel, Renvela is a calcium-free, metal- free, non-absorbed phosphate binder and will initially be available as 800mg tablets once approved.

The results announced today represent one portion of a comprehensive clinical program for sevelamer carbonate. Data showing the equivalence of sevelamer carbonate and sevelamer hydrochloride were presented last week at the spring clinical meeting of the National Kidney Foundation. In addition, enrollment is complete in two studies comparing a powder form of sevelamer carbonate to Renagel tablets dosed three times per day, including one study in which the powder form is dosed three times per day, and one in which it is dosed once per day.

A New Drug Application for Renvela is currently under review by the US Food and Drug Administration for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

About Renagel

Renagel controls serum phosphorus in patients with CKD on hemodialysis. Controlling serum ph osphorus 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 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. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 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 ne arly 90 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 diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme(R) and Renagel(R) are registered trademarks and Renvela(TM) is a trademark of Genzyme Corporation. All rights reserved.

Genzyme's press releases and other company information are available at 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:

     Bo Piela              Sally Curley

     (617) 768-6579        (617) 768-6140

CONTACT: Media, Bo Piela, +1-617-768-6579, or Investors, Sally Curley,+1-617-768-6140, both of Genzyme Corp.

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

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

Ticker Symbol: (NASDAQ-NMS:GENZ)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
2. Genzyme Announces Results of Clinical Trial of Hylastan
3. Genzyme Announces Results of Clinical Trials Investigating Powder Form of Sevelamer Carbonate
4. Genzyme Announces Results of Clinical Trials Investigating Powder Form of Sevelamer Carbonate
5. Genzyme and Bayer HealthCare Announce Detailed Interim Two-Year Alemtuzumab in Multiple Sclerosis Data Presented at AAN
6. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
7. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
9. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
10. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
11. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... , Dec. 8, 2016 Global ... report on the global interventional radiology market analyzes ... The report comprises an elaborate executive summary, including ... various segments and sub-segments. The research is ... research formed the bulk of our research efforts ...
(Date:12/8/2016)... -- Eli Lilly and Company (NYSE: LLY ) ... trial at the 9 th Clinical Trials on ... not meet the primary endpoint in the EXPEDITION3 clinical ... mild dementia due to Alzheimer,s disease (AD), and Lilly ... treatment of mild dementia due to AD. ...
(Date:12/8/2016)... Dec. 8, 2016 Bodycad announced it ... improving the accuracy, reproducibility and speed for 3D ... and small bone orthopaedic applications. These patents are ... personalized orthopaedic restorations based on each patient,s distinct ... the company harnesses the world,s first suite of ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... ... An inventor from Cana, Va., wanted to fulfill the need for a ... , The patent-pending SAFETY STRAP FOR AMPUTEES improves accessibility. It eliminates discrimination. It is ... in a matter of minutes, or even seconds. The SAFETY STRAP FOR AMPUTEES is ...
(Date:12/9/2016)... ... December 09, 2016 , ... ... Pierre Hotel in New York, NY, on December 3rd, to benefit Holy Name ... attended the annual event, which raised over $1 million - the largest event ...
(Date:12/9/2016)... ... December 09, 2016 , ... "I had a terrible time trying ... Va. "I thought that if the nebulizer had a more child-friendly design, then children ... , He developed the patent-pending NEBY to avoid the need to deliver medication via ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Quality Insights beginning January 1, 2017. The name change aligns the entire ... measuring and improving health care quality. , “We are very proud of the ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... Research Institute (WCRI) officially opened registration today for its 33rd Annual Issues ... Boston, MA . , The theme of the conference is “Persistent Challenges and ...
Breaking Medicine News(10 mins):