CAMBRIDGE, Mass., Oct. 22 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) today announced that the U.S. Food and Drug Administration
has granted marketing approval for Renvela(TM) (sevelamer carbonate) for
the control of serum phosphorus in patients with chronic kidney disease on
dialysis. Renvela is a next-generation version of Renagel(R) (sevelamer
hydrochloride), the most-prescribed phosphate binder in the United States.
"Since its approval in 1998, Renagel has made an important difference
for hundreds of thousands of patients around the world. Today's approval of
Renvela -- an improved form of Renagel -- is a key milestone in our ongoing
effort to innovate on behalf of patients," said John P. Butler, president,
Genzyme Renal. "As we prepare to launch Renvela for patients on dialysis,
we will move forward with regulatory filings to gain approval for the
product's use in earlier stages of chronic kidney disease, so that all
patients who can benefit from this treatment have access to it."
Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed
phosphate binder and will initially be available as 800mg tablets. Renvela
offers all of the advantages of Renagel with the added benefit of a
carbonate buffer. In a clinical study comparing Renvela to Renagel, both
drugs controlled serum phosphorus equally to within KDOQI recommended
ranges. Patients on Renvela, however, were more likely to maintain
bicarbonate levels within the recommended KDOQI ranges, and had a lower
incidence of gastrointestinal adverse events.
Genzyme expects to launch Renvela for dialysis patients in the United
States during the first quarter of next year, and is pursuing regulatory
approvals in Europe, South America and in other markets internationally.
The company will continue to make Renagel available, with the long-term
goal of transitioning patients to Renvela.
"Renvela's approval represents an important advance for chronic kidney
disease patients," stated Craig Langman, M.D., the Isaac A. Abt M.D.
professor of kidney diseases, Feinberg School of Medicine, Northwestern
University. "It is an improved version of a well-established product that
has been shown to provide significant advantages to patients."
During the first half of next year, Genzyme also plans to file a
supplemental New Drug Application with the FDA seeking approval of Renvela
for hyperphosphatemic patients with chronic kidney disease who are not on
dialysis. In addition, Genzyme expects to file for approval of a powder
form of Renvela that may make it easier for patients to comply with their
prescribed treatment program.
Renagel in Peritoneal Dialysis
The FDA also recently approved a label extension for Renagel for the
control of serum phosphorus for patients on peritoneal dialysis. The
treatment had previously been approved in the U.S. only for patients on
hemodialysis. The Renvela approval announced today includes patients on
both types of dialysis.
About Renagel and Renvela
Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate)
both control serum phosphorus in patients with chronic kidney disease (CKD)
on dialysis. Controlling serum phosphorus is an important element in the
care of dialysis patients. Elevated serum phosphorus levels are common in
dialysis patients and associated with increased risk of cardiovascular
morbidity and mortality. Sevelamer provides the added benefit of
significant LDL cholesterol reduction.
Sevelamer 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. The National Kidney Foundation's 2003
Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone
Metabolism and Disease in CKD recommend sevelamer as a first-line treatment
option to control phosphorus. Sevelamer hydrochloride is currently used by
more than 350,000 patients worldwide.
Product Information
Renvela is indicated for the control of serum phosphorus in patients
with CKD on dialysis. Renvela is contraindicated in patients with
hypophosphatemia or bowel obstruction. Caution should be exercised in
patients with dysphagia, swallowing disorders, severe gastrointestinal (GI)
motility disorders including severe constipation, or major GI tract
surgery. The most common adverse events 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 Renvela. Please see prescribing information at
http://www.genzyme.com/corp/investors/Renvela_PI.pdf. For additional
information, please visit http://www.renvela.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 nearly 10,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was 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.
This press release contains forward-looking statements, including the
statements regarding Genzyme's intention to move forward with regulatory
filings to gain approval for use of Renvela(TM) in earlier stages of
chronic kidney disease, the initial availability of the 800mg tablet
formulation of Renvela(TM), Genzyme's expectations with respect to timing
of commercial launch of Renvela(TM), its pursuit of regulatory approvals in
Europe, South America and other markets, the continued availability of
Renagel(R), Genzyme's plans to file a supplemental New Drug Application
with the FDA seeking approval of Renvela(TM) for hyperphosphatemic patients
with chronic kidney disease who are not on dialysis and Genzyme's
expectation that it will seek approval of a powder form 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, the inability or delay of getting regulatory approvals for future
label extensions of Renvela(TM), the logistical risks associated with
manufacturing and formulating the product, delays or unexpected problems
with commercial launch of Renvela(TM), the medical community's acceptance
of this new product, the transition from Renagel(R) to Renvela(TM), the
ability to get marketing approvals in other countries, the ability to get
favorable pricing and reimbursement for Renvela(TM), the ability to get
approvals of an alternative formulation such as the powder form of
Renvela(TM). There are also 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 of the Genzyme Quarterly Report on Form 10-Q for the quarter ending
June 30, 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 the 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 1-678-999-4572 outside the
United States.
Genzyme(R) and Renagel(R) are registered trademarks and Renvela is a
trademark of Genzyme Corporation. All rights reserved.
Media Contact: Investor Contact:
Erin Emlock Patrick Flanigan
(617) 768-6923 (617) 768-6563
SOURCE Genzyme Corp.
 back to top
Related links:
http://www.genzyme.com
http://www.renvela.com
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media, Erin Emlock, +1-617-768-6923, or
Investor, Patrick Flanigan, +1-617- 768-6563, both of Genzyme
Corp.
|
