CAMBRIDGE, Mass., May 14 /PRNewswire-FirstCall/ --
Transkaryotic Therapies, Inc. (Nasdaq: TKTX) announced that it received
today a copy of a formal order of investigation by the Securities and Exchange
Commission. The order of investigation relates to TKT's disclosures and
public filings with regard to its Replagal(TM) (agalsidase alfa) product and
the status of the FDA's approval process for Replagal, as well as transactions
in the company's securities. TKT will fully cooperate with the SEC in the
investigation.
About TKT
TKT is a biotechnology company developing therapeutics for the treatment
of rare genetic diseases caused by protein deficiencies. TKT currently
markets one product, Replagal(TM) (agalsidase alfa) for the treatment of Fabry
disease in the European Union and certain other countries. TKT is
headquartered in Cambridge, Massachusetts and has a majority owned subsidiary
in Sweden, TKT Europe-5S AB, which is responsible for European sales and
marketing activities of Replagal. Additional information on TKT is available
on the company's website at http://www.tktx.com.
This press release contains forward-looking statements, including
statements regarding a pending SEC investigation, and other statements
containing the words "believes," "intends," "anticipates," "plans," "expects,"
"will" and similar expressions. These forward-looking statements are subject
to risks and uncertainties that could cause actual results to differ
materially. Important factors that could cause results to differ include, but
are not limited to: when the FDA and other equivalent regulatory agencies
will approve Replagal on a timely basis or at all; whether Replagal clinical
data will be deemed sufficient to support regulatory approval of Replagal in
the U.S.; whether the orphan drug exclusivity of Fabrazyme will prevent
approval of Replagal in the U.S]; the impact of competing products on the
market for the treatment of Fabry disease, including with respect to the
market acceptance of Replagal; and other factors set forth under the caption
"Certain Factors That May Affect Future Results" in the Company's Annual
Report on Form 10-K for the quarter ended December 31, 2002 which is on file
with the Securities and Exchange Commission and are incorporated herein by
reference. The Company does not undertake any obligation to update any
forward-looking statements
Replagal is a trademark of Transkaryotic Therapies, Inc.
Investor Contact:
Justine E. Koenigsberg
Director, Corporate communications
(617) 349-0271
Media Contact:
Doug Bailey
Rasky Baerlein Group
(617) 443-9933 x339 or
(617) 335-8136
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO
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Company News On-Call:
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CONTACT:
Investor Contact: Justine E. Koenigsberg of
TKT, Director, Corporate communications, +1-617-349-0271, or
Media Contact: Doug Bailey of Rasky Baerlein Group,
+1-617-443-9933 ext 339 or +1-617-335-8136
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