New Therapy Helps Lower Cholesterol in Primary Hypercholesterolemia
Patients
CAMBRIDGE, Mass., Oct. 23 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) today announced the launch of Cholestagel(R) (colesevelam
hydrochloride), Genzyme's first commercially available cardiovascular
product, in Europe. Cholestagel is a new, non-absorbed,
cholesterol-lowering agent aimed at treating patients with primary
hypercholesterolemia who cannot meet their targeted cholesterol levels with
standard therapies alone.
"Cholestagel offers patients at high risk of life-threatening
cardiovascular disease a new way to manage their cholesterol," said Genzyme
Senior Vice President James A. Geraghty, who oversees the company's
cardiovascular activities. "Most of these high-risk patients are seen at
specialized treatment centers, and the launch of Cholestagel in Europe is
consistent with our efforts to provide treatments for patients with serious
unmet medical needs. We intend to do so with a small and highly-focused
field organization that leverages Genzyme's existing country
organizations."
Developed by Genzyme, Cholestagel is a polymer in tablet form that
lowers LDL (or "bad") cholesterol. It can be taken in combination with
other cholesterol-lowering medications, such as statins, or alone. When
combined with various statins, fibrates or ezetimibe, current standard
treatments for cholesterol control, Cholestagel was shown to have an
additive LDL-cholesterol lowering effect in the range of 10 to 16 percent.
A post-approval study launched in August 2007 by Genzyme aims to
specifically demonstrate the efficacy of Cholestagel as an add-on therapy
in patients with familial hypercholesterolemia (FH) -- an inherited
disorder that causes exceptionally high levels of LDL-cholesterol -- who
cannot reach their target LDL- cholesterol levels with a maximum regimen of
statins and ezetimibe alone.
This double-blind, randomized "TRIPLE" study will involve 80 patients
with FH enrolled in six European centers (including in the UK, Netherlands,
Sweden and France) and preliminary results are expected in Q3 2008.
"Patients with genetic conditions like familial hypercholesterolemia
are at particularly high risk of early coronary heart disease," said Dr.
Anthony Wierzbicki, from London's St. Thomas' Hospital and a board member
and chairman of the Medical Scientific and Research Committee of FH patient
association 'Heart UK'. "Patients have to take multiple
cholesterol-lowering therapies and yet still often require further
cholesterol reduction to reach target lipid levels recommended for patients
at risk of cardiovascular events. New non-systemic agents are a welcome
addition for these patients to help them achieve these targets."
Unlike most other cholesterol-lowering treatments, Cholestagel is non-
systemic, and therefore is not absorbed into the bloodstream. Cholestagel
binds bile acids in the intestine, impeding their reabsorption. This
process -- called bile acid sequestration -- results in an increased
clearance of LDL cholesterol from the blood. Cholestagel is also well
tolerated, with minimal gastrointestinal side effects similar to those seen
in placebo, and has limited drug-interaction.
Colesevelam has been approved for use in the United States since 2000,
where it is marketed by Daiichi Sankyo Inc. under the trade name
WelChol(R). Genzyme plans to launch Cholestagel in the United Kingdom, the
Netherlands and the Scandinavian region this quarter, and in additional
European countries next year. Genzyme also intends to pursue regulatory
approvals for Cholestagel in Latin America, Canada, and the Asia Pacific
region.
Genzyme has been conducting innovative research in the field of
cardiovascular disease for several years. The company is currently running
a Phase 2 gene therapy trial with the intention of forming new blood
vessels to improve the flow of oxygen in the legs of patients with
peripheral arterial disease.
About Primary Hypercholesterolemia
Primary hypercholesterolemia comprises a range of disorders in which
LDL cholesterol blood levels are above normal (usually above 200mg/dl or
5mmol/l) due to a number of possible genetic mutations such as familial
hypercholesterolemia, where patients inherit a gene that prevents them from
metabolizing LDL cholesterol properly. These patients face a markedly
increased risk of premature cardiovascular disease and CVD-related death.
For more information about Cholestagel, please visit
http://www.cholestagel.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 9,500 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
statements about the timing and geographies of Cholestagel's launch, as
well as statements concerning Genzyme's plans to seek regulatory approval
for Cholestagel in additional geographies. 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 size of the market for
the therapy in any particular geography, the sufficiency of reimbursement
for the therapy in any particular geography; actions by governmental
authorities related to Cholestagel, and the other 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 Cholestagel(R) are registered trademarks of Genzyme
Corporation and WelChol(R) is a registered trademark of Daiichi Sankyo Inc.
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 Leah Rosenberger
(617) 768-6923 (617) 768-6602
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
http://www.cholestagel.com
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media: Erin Emlock, +1-617-768-6923, or
Investors: Leah Rosenberger, +1-617-768-6602, both of Genzyme
Corp.
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