CAMBRIDGE, Mass., Oct. 16 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) today participated in the FDA's Cardiovascular and Renal
Products Advisory Committee meeting, during which the committee voted 8 to
4, with one abstaining, to recommend that the FDA extend the indications
for phosphate binders to use in pre-dialysis patients with
hyperphosphatemia.
Genzyme markets Renagel(R) (sevelamer hydrochloride), the most
prescribed phosphate binder in the United States, and is pursuing approval
for Renvela(TM) (sevelamer carbonate), a next-generation, buffered form of
sevelamer. The FDA is expected to act this month on a New Drug Application
seeking marketing approval for the use of Renvela in patients on dialysis.
Genzyme also plans to pursue approval of Renvela for hyperphosphatemic
patients with CKD who are not on dialysis. The company has successfully
completed studies of Renvela in both dialysis and pre-dialysis patients.
"We are pleased that the committee recognizes that there is a benefit
to treating hyperphosphatemic patients prior to the initiation of
dialysis," said Genzyme Chief Medical Officer Richard Moscicki. "Genzyme
has always been committed to continuing clinical studies on sevelamer, and
this is evidenced by our strong post-marketing research investment in the
product to date. We remain focused on making this product available to all
patients who can benefit from it, and we look forward to working
collaboratively with the FDA to determine the most appropriate pathway for
doing so."
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 9,500 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
Genzyme's expectations regarding the timing for FDA action on its NDA
seeking approval for the use of Renvela in dialysis patients, its plans to
pursue approval of Renvela for treatment of CKD patients who are not on
dialysis in the US and for dialysis and pre-dialysis patients globally,
including expected filings in Europe and Latin America in 2008, and its
clinical study plans. 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 possibility that the FDA action
with respect to the Renvela NDA is not favorable or is delayed, the
possibility that Genzyme's plans for Renvela use in pre-dialysis patients
will not be successful, and the possibility that regulatory authorities
outside the US do not grant marketing authorization for the use of Renvela
in dialysis and/or pre-dialysis patients. 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(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 1-678-999-4572 outside the
United States.
Media Contact: Investor Contact:
Erin Emlock Patrick Flanigan
(617) 768-6923 (617) 768-6563
SOURCE Genzyme
 back to top
Related links:
http://www.genzyme.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Media, Erin Emlock, +1-617-768-6923, or
Investors, Patrick Flanigan, +1-617-768-6563, both of Genzyme
|
