CAMBRIDGE, Mass., July 6 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced top-line data today from the first of two Phase 3
clinical studies to assess the safety and efficacy of tolevamer liquid, an
investigational, non-antibiotic, polymer therapy for patients with
Clostridium difficile associated diarrhea (CDAD). The second Phase 3 study
of tolevamer liquid is fully enrolled and results are expected later this
year.
In this first Phase 3 study known as the Polymer Alternative for CDAD
Treatment (PACT) study, tolevamer liquid did not meet its primary endpoint
of non-inferiority to the standard prescribed oral dose of the antibiotic
vancomycin, as measured by the percent of patients with resolution of CDAD.
This result contrasts with the findings from Genzyme's earlier Phase 2
study of a solid oral dosage formulation of tolevamer that met its primary
endpoint of non-inferiority compared to vancomycin.
Consistent with recent published studies, high rates of CDAD
recurrences were observed in patients treated with either vancomycin or
metronidazole. High CDAD recurrence rates were not observed in patients
treated with tolevamer liquid. Tolevamer liquid was generally well
tolerated with no unanticipated safety concerns. Data from this first Phase
3 study is expected to be presented at a future medical conference.
"These are disappointing results that alter our expectations about the
potential for commercializing tolevamer in the near future," stated Henri
A. Termeer, chairman and chief executive officer of Genzyme Corp. "The
results of our second Phase 3 study will be available later this year and
will help us determine what contribution tolevamer might be able to make in
addressing this serious unmet medical need."
C. difficile has become one of the most significant infection control
concerns in healthcare today. Physicians worldwide are confronting a
worsening epidemic, with an alarming rise in the incidence of disease,
higher numbers of patients with complications and more frequent failures of
standard antibiotic therapy.
Tolevamer is designed to bind and neutralize the toxins released by C.
difficile that damage the intestine. A non-antibiotic approach has the
potential to treat CDAD and reduce the number of disease recurrences,
resulting in improved quality of life for the patient and significant
savings to the healthcare system.
About the PACT Study
The PACT study, which involved more than 1,100 patients at
approximately 300 sites in North America, Europe, and Australia, is the
largest of its kind ever to be conducted for CDAD. In this trial, tolevamer
was compared to metronidazole and vancomycin. Aside from testing
tolevamer's efficacy, this was also the first large, rigorously designed,
multi-center clinical study that will compare the efficacy of the current
standards of care.
About Clostridium difficile
C. difficile proliferates in the setting of altered normal colonic
bacterial flora, most commonly due to the administration of broad-spectrum
antibiotics. Once established in the colon, C. difficile produces toxins
that disrupt the intestinal lining, causing cell death and inflammation
that result in diarrhea and colitis.
Earlier studies have shown that even after successful treatment with
the current standard of care, approximately 20 percent of patients
experience a recurrence of CDAD potentially requiring repeat
hospitalization. In addition, a subset of patients with CDAD develop
multiple recurrences of the disease, with symptoms that may persist for
years.
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.
This press release contains forward-looking statements, including
statements regarding the potential for commercializing tolevamer in the
future, when data from this Phase 3 study of tolevamer will be presented
and when the results of the second Phase 3 study of tolevamer will be
available. 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 actual safety and efficacy of tolevamer; the outcome of
discussions with regulatory authorities regarding clinical studies and the
approval of tolevamer for CDAD and the timing of such discussions;
additional analysis of the data from the first Phase 3 study; the results
of the second Phase 3 study and whether such results are consistent with
this data; the timing of the second Phase 3 study; 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 of the Genzyme Quarterly Report on Form
10-Q for the quarter ending 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(R) is a registered 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:
Maria Cantor Sally Curley
(617) 768-6690 (617) 768-6140
SOURCE Genzyme Corp.
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CONTACT:
Media, Maria Cantor, +1-617-768-6690;
Investors, Sally Curley, +1-617-768-6140, both of Genzyme Corp.
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