- Findings Presented at 2003 European Society of Human Genetic Meeting -
BIRMINGHAM, England, May 5 /PRNewswire-FirstCall/ -- TKT Europe - 5S AB
today announced at the European Society of Human Genetics 2003 conference that
participating European physicians of FOS, the Fabry Outcome Survey, reported
data confirming the clinical benefits of Replagal(TM) (agalsidase alfa) in
patients with Fabry disease. FOS is a European multi-center, clinical
outcomes survey, which is designed to monitor the long-term effects of
Replagal. Untreated patients are also followed in FOS, in order to increase
knowledge of the natural history of Fabry disease. Of the 336 patients
enrolled in FOS at the end of last year, 217 patients, or 65%, are receiving
Replagal, with 58% treated for over one year.
"FOS is a remarkable tool for clinicians to gain access to important data
relating to Replagal and in treating Fabry disease," stated Professor Michael
Beck, who is a member of the FOS executive committee. "The findings generated
from FOS are very encouraging as they confirm the benefits of Replagal in
clinical practice. Considering the multi-organ involvement in Fabry patients
and what we know from the natural history of the disease, it is astounding to
see the effects of Replagal on the kidney, pain and quality of life,
particularly over this relatively short period of time."
Long-term Follow-up in FOS Confirms Beneficial Effects of Replagal
At the Human Genetics meeting, Dr. Michael Beck of the University of Mainz
in Germany presented a data analysis of FOS, on behalf of the FOS European
Board, showing treatment with Replagal has positive effects on renal and
neurological manifestations of the disease. The renal findings were based on
an analysis of 285 patients enrolled in FOS, of which 70% have received
Replagal for at least 12 months. Upon entry into FOS, 65% of these patients
had impaired renal function. After 12 months of treatment, renal function, as
assessed by creatinine clearance or glomerular filtration rate, stabilized or
improved in patients with mild to moderate renal impairment. Data on pain was
also presented. At baseline, 85% of men and 63% of women were suffering from
chronic pain and impaired pain related quality of life measured by the Brief
Pain Inventory (BPI). Treatment with Replagal was accompanied by significant
improvement in 8 out of 11 dimensions of the BPI (n=90).
About FOS
FOS is an outcomes database developed to provide further understanding
about Fabry disease as well as to improve the clinical management of patients
with the disorder. Eligible for inclusion in FOS are patients with Fabry
disease who are receiving Replagal or are candidates for enzyme replacement
therapy. Patients not receiving treatment, but who participate in the
database, provide a potential source of matched control data. FOS was
developed in 2001 by TKT Europe - 5S in close collaboration with leading
European experts on lysosomal storage diseases. The FOS European Board is
responsible for the scientific analysis and publications from the database.
About TKT Europe - 5S AB
TKT Europe - 5S AB is a European pharmaceutical company that is dedicated
to develop and market drugs to treat rare genetic diseases. The company has
its headquarters in Stockholm, Sweden and has representation in most countries
in Europe.
The company has a close collaboration with Transkaryotic Therapies, Inc.
(Nasdaq: TKTX) a pharmaceutical company based in Cambridge, MA, US.
The company's first product, Replagal (agalsidase alfa) is a specific
enzyme replacement therapy for patients with Fabry disease. Additional
information on TKT Europe - 5S is available on the Company's website at
http://www.tkt5s.com.
Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.
Contact:
Jacob Kaluski
Senior Vice President, Pharmaceutical Affairs
+46-70-3000-392
SOURCE TKT Europe - 5S AB
 back to top
Related links:
http://www.tkt5S.com
CONTACT:
Jacob Kaluski, Senior Vice President,
Pharmaceutical Affairs of TKT Europe - 5S AB, +46-70-3000-392
|
