Pursues Additional Approvals Globally for Dialysis and Earlier Stage
Chronic Kidney Disease Patients
CAMBRIDGE, Mass., March 6 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) today announced the U.S. launch of the phosphate binder
Renvela(R) (sevelamer carbonate) for dialysis patients, as well as
significant progress in its international efforts to secure additional
approvals for the product.
Genzyme has submitted a marketing authorization application to the
European Medicines Agency seeking approval of Renvela for the control of
serum phosphorus in chronic kidney disease patients regardless of whether
they are on dialysis. This application, which includes both tablet and
powder formulations, must be validated before it will be accepted for
review.
Genzyme anticipates that the application will be validated by the end
of this month, and the review period is expected to take approximately 15
months. The first E.U. launch of Renvela is anticipated in the third
quarter of 2009. Genzyme also applied for approval of Renvela tablets for
dialysis patients in the key South American market of Brazil late last
year, and will continue to pursue additional approvals internationally.
In the United States, Genzyme is engaged in active discussions with the
Food and Drug Administration to expand Renvela's labeling to include
chronic kidney disease patients with hyperphosphatemia who are not on
dialysis. At the FDA's request, the three companies that currently market
phosphate binders for dialysis patients are working collaboratively to
provide information that will assist the agency in defining the appropriate
earlier stage chronic kidney disease patient population.
Genzyme had previously anticipated filing a supplemental New Drug
Application for Renvela's use in non-dialysis patients during the first
half of 2008. Given the current discussions with the FDA, it will not be
necessary for the company to file an sNDA for this indication. However,
Genzyme anticipates the Renvela label expansion will take place within a
similar timeframe had it gone a more traditional route. During the second
quarter, Genzyme also plans to file for U.S. approval of the powder
formulation of the product, which may make it easier for patients to comply
with their prescribed treatment program.
"We are very pleased with the progress we've made to date on our
comprehensive global plan for Renvela," stated John P. Butler, president,
Genzyme Renal. "The U.S. launch in dialysis, the E.U. and Brazil filings,
and the positive nature of our current conversations with the FDA represent
significant steps forward as we work to make this important product
available to all patients who can benefit from it."
Renvela is a next-generation version of Renagel(R) (sevelamer
hydrochloride), the most-prescribed phosphate binder in the United States.
It is a calcium-free, metal-free, non-absorbed phosphate binder and is
available in the U.S. as 800mg tablets. Renvela offers all of the
advantages of Renagel with the 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.
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 (sevelamer carbonate) and Renagel (sevelamer hydrochloride) are
indicated for the control of serum phosphorus in patients with chronic
kidney disease (CKD) on dialysis. Sevelamer 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.
Common adverse events reported with sevelamer include vomiting, nausea,
diarrhea, dyspepsia, abdominal pain, and constipation. Other events
reported include pruritus, rash, fecal impaction, and intestinal
obstruction. Drug- drug interactions may occur with some medications and
should be taken into consideration when instructing patients how to take
sevelamer. Patients should be informed to take sevelamer with meals and to
adhere to their prescribed diets. For more information on Renvela or
Renagel, please see Full Prescribing Information, call Genzyme Medical
Information at 1-800-847-0069 or visit http://www.renagel.com or
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 more than 10,000 employees in locations
spanning the globe and 2007 revenues of $3.8 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.
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,
without limitation, statements about the potential approval and launch of
Renvela(R) in the E.U. and internationally and plans for, and the potential
approval of, new indications and formulations of Renvela(R) in the U.S.
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 regulatory authorities regarding the
approval of Renvela(R); the timing and content of submissions to and
decisions made by regulatory authorities relating to Renvela(R); further
analysis of clinical trial data; the results of other studies and whether
such results are consistent with this data; the actual efficacy and safety
of the powder formulation of Renvela(R); the outcome of discussions with
the FDA regarding the approval of Renvela(R) for use in non-dialysis
chronic kidney disease patients and the timing of such discussions; the
availability and extent of third-party reimbursement for Renvela(R); 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 Annual
Report on Form 10-K for the year ended December 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 1-678-999-4572 outside the
United States.
Genzyme(R), Renagel(R) and Renvela(R) are registered trademarks of
Genzyme Corporation. All rights reserved.
Media Contact: Investor Contact:
Erin Emlock Patrick Flanigan
(617) 768-6923 (617) 768-6563
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com
http://www.renvela.com http://www.renagel.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Media Contact, Erin Emlock, +1-617-768-6923,
or Investor Contact, Patrick Flanigan, +1-617-768-6563, both of
Genzyme Corporation
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