CAMBRIDGE, Mass., Dec. 21 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that it has filed a New Drug Application
(NDA) with the U.S. Food and Drug Administration seeking approval of
sevelamer carbonate for the control of serum phosphorus in patients with
chronic kidney disease on dialysis. Sevelamer carbonate will be marketed
under the trade name Renvela(TM) (ren-VEL-uh).
Renvela is being developed as a next generation phosphate binder to
replace Renagel(R) (sevelamer hydrochloride), the most-prescribed phosphate
binder in the United States. Genzyme is seeking approval for use of Renvela
in patients with chronic kidney disease (CKD) on dialysis. Like Renagel,
Renvela is a non-calcium, non-metal, non-absorbed phosphate binder and will
be available in 800mg tablets.
"Submission of this NDA marks an important milestone as we prepare to
introduce our next generation of sevelamer," said John P. Butler,
president, Genzyme Renal. "Development of this therapy demonstrates our
commitment to meeting the needs of all patients who can benefit from using
sevelamer."
In addition to today's filing, Genzyme is advancing a clinical program
investigating the use of Renvela for hyperphosphatemic patients with
chronic kidney disease who have not progressed to dialysis. Enrollment has
been completed in the study evaluating Renvela for this indication.
Enrollment is also complete in a study comparing a powder form of
sevelamer carbonate dosed once a day to Renagel tablets dosed three times a
day. Development of a powder form of the product would offer a more
convenient option for patients, thereby improving compliance.
About Renagel
Renagel controls serum phosphorus in patients with CKD 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.
This press release contains forward-looking statements including,
without limitation, statements about: potential uses and benefits of, and
indications for, Renvela; the potential approval of Renvela; plans for new
indications, formulations and dosing regimens; and plans to continue the
clinical development program. These statements are subject to risks and
uncertainties that could cause actual results to differ materially from
those projected in these forward-looking statements. These risks and
uncertainties include, among others: the timing of discussions with the FDA
regarding the approval of Renvela; the timing and content of decisions by
the FDA relating to the approval of Renvela; the actual efficacy and safety
of Renvela; the actual timing and results of clinical trials; further
analysis of clinical trial data; and the risks and uncertainties described
in reports filed by Genzyme with the Securities and Exchange Commission
under the Securities Exchange Act of 1934, as amended, including without
limitation the information under the heading "Factors Affecting Future
Operating Results" in the Management's Discussion and Analysis of Financial
Condition and Results of Operations section in Genzyme's Quarterly Report
on Form 10-Q for the period ended September 30, 2006. Genzyme cautions
investors not to place substantial reliance on the forward-looking
statements contained in this press release. These statements speak only as
of the date of this press release, and Genzyme undertakes no obligation to
update or revise these statements.
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
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:
Bo Piela Sally Curley
(617) 768-6579 (617) 768-6140
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
http://www.renagel.com
CONTACT:
Media, Bo Piela, +1-617-768-6579, or
Investors, Sally Curley, +1-617-768-6140, both of Genzyme Corp.
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