CAMBRIDGE, Mass., June 18 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) today announced the results of two new studies comparing a
powder form of Renvela(TM) (sevelamer carbonate) to Renagel(R) tablets
(sevelamer hydrochloride), including one trial in which patients received
the powder form three times per day, and one in which it was administered
once per day.
Genzyme is developing Renvela in powder form to provide an additional
option for patients with chronic kidney disease in managing their phosphate
levels. A New Drug Application for Renvela tablets is already on file with
the FDA, and previous studies have shown that the tablet formulation
provides equivalent phosphate control to Renagel in patients on dialysis
and significant phosphorus control in patients with chronic kidney disease
who are not on dialysis. Today's results are the first from trials
comparing the efficacy of the powder form of Renvela to Renagel tablets.
In the first powder trial, patients treated with the powder form of
Renvela three times per day experienced equivalent phosphorus control to
patients treated with Renagel tablets three times per day. As a result,
this trial successfully met its primary endpoint.
In the second trial, patients dosed with the powder form of Renvela
once per day and those treated with Renagel tablets three times per day
achieved statistically significant reductions in serum phosphorus, with
both groups reaching target levels for phosphorus control outlined in the
K/DOQI treatment guidelines. Phosphorus levels in the Renagel arm (4.6
mg/dL) were lower than those in the Renvela arm (5.3 mg/dL), and this trial
did not achieve its primary endpoint of demonstrating non-inferiority of
Renvela powder dosed once per day to Renagel tablets dosed three times per
day.
In both trials, the safety profile of Renvela was consistent with the
previous clinical experience of patients on dialysis using Renagel.
With today's results, Genzyme has concluded that the powder formulation
of Renvela dosed three times per day may represent a promising alternative
for patients with chronic kidney disease. The company will continue to move
ahead aggressively with clinical and regulatory plans for the powder
formulation dosed three times per day, and these data will form part of an
NDA submission in the first half of 2008.
"We are very pleased with the progress we have made to date in our
multi- faceted development program for Renvela, including filing an NDA for
patients on dialysis, completing a successful trial in the pre-dialysis
population, and demonstrating the effectiveness of the powder formulation
dosed three times per day," said John P. Butler, president, Genzyme Renal.
"Results of the once- per-day trial were greatly influenced by the strong
phosphorus reduction seen in the Renagel arm, which was superior to that
seen in all but one previously conducted clinical trials. While today's
results will not currently support a regulatory filing for once-per-day
dosing, they are clinically meaningful and give us confidence that this
approach can be effective. We will continue to work with regulatory
authorities to design an appropriate clinical plan to gain approval for
this dosing regimen."
About Renvela
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 be available as 800mg
tablets once approved. 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.
In April, Genzyme announced that a new clinical trial showed that
Renvela significantly reduced serum phosphorus, calcium-phosphorus product
and LDL cholesterol in hyperphosphatemic patients with chronic kidney
disease who are not on dialysis. Additionally, data showing the equivalence
of sevelamer carbonate and sevelamer hydrochloride were presented at the
2007 spring clinical meeting of the National Kidney Foundation.
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.
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. 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 nearly
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.
This press release contains forward-looking statements including,
without limitation, statements about the development of Renvela(TM) for
chronic kidney disease and alternative dosing regimens for the powder
formulation of Renvela(TM). 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: additional analysis of the data
comparing the powder form of Renvela(TM) to Renagel(R); the results of
other studies and whether such results are consistent with this data; the
actual efficacy and safety of Renvela(TM) for chronic kidney disease; the
outcome of discussions with regulatory authorities regarding clinical
studies and the approval of Renvela(TM) for chronic kidney disease and the
timing of such discussions; the timing and content of submissions to and
decisions made by regulatory authorities; the availability and extent of
third-party reimbursement for Renvela(TM); 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 "Risk Factors" 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 March 31, 2007. 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'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 Catie Forte
(617) 768-6849 (617) 768-6881
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com/
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CONTACT:
media, Dan Quinn, 617-768-6849, or investors,
Catie Forte, 617-768-6881
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