CAMBRIDGE, Mass., July 22 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced that the company and its Former
Chief Executive Officer, Richard Selden, received "Wells" notices from the
staff of the Securities and Exchange Commission, in connection with the SEC
investigation previously announced by the company. The Wells notices state
that the SEC staff has preliminarily determined to recommend that the
Commission bring a civil action for possible violations of the federal
securities laws in which it may seek an injunction and civil penalties against
TKT, and an injunction, disgorgement, and an officer and director bar as to
Dr. Selden.
As previously disclosed, the SEC's investigation relates to the company's
disclosures and public filings with regard to Replagal(TM) and the status of
the Food and Drug Administration's approval process for Replagal, as well as
transactions in the company's securities.
Under the SEC's procedure, recipients of Wells notices have the
opportunity to respond to the SEC staff before the staff makes a formal
recommendation regarding whether any action should be taken. TKT intends to
respond promptly and thoroughly in writing before the SEC staff formally
decides what action, if any, to recommend, and to continue to cooperate fully
in the investigation.
Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily
focused on researching, developing and commercializing treatments for rare
diseases caused by protein deficiencies. Within this focus, the company
markets Replagal(TM), an enzyme replacement therapy for Fabry disease, and is
developing treatments for Hunter syndrome and Gaucher disease. In addition to
its focus on rare diseases, TKT intends to commercialize Dynepo(TM), its Gene-
Activated(R) erythropoietin product for anemia related to kidney disease, in
the European Union. TKT was founded in 1988 and is headquartered in Cambridge,
Massachusetts, with additional operations in Europe, Canada and Latin America.
Additional information about TKT is available on the company's website at
http://www.tktx.com.
This press release contains forward-looking statements, including
statements regarding the Wells notices received from the SEC and the
investigation being conducted by the SEC and other statements containing the
words "believes," "anticipates," "plans," "expects," "estimates," "intends,"
"should," "could," "will," "may," and similar expressions. These forward-
looking statements are subject to risks and uncertainties. There are a number
of important factors that could cause the company's actual results to differ
materially from those indicated by such forward-looking statements, including
what action, if any, the SEC will recommend to the Commission; what action, if
any, the Commission will take against the company; whether the company will be
able to successfully defend any such action; and other factors set forth under
the caption "Risk Factors" in the company's Current Report on Form 8-K filed
April 29, 2004, which is on file with the Commission and are incorporated
herein by reference. While the company may elect to update forward-looking
statements at some point in the future, the company specifically disclaims any
obligation to do so, even if its expectations change.
Gene-Activated(R) is a registered trademark and Replagal(TM) is a
trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of
Aventis Pharmaceuticals, Inc.
For More Information Contact:
Justine E. Koenigsberg
Senior Director, Corporate Communications
(617) 349-0271
Daniella M. Lutz
Corporate Communications Manager
(617) 349-0205
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
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Company News On-Call:
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CONTACT:
Justine E. Koenigsberg, Senior Director,
Corporate Communications, +1-617-349-0271, or Daniella M. Lutz,
Corporate Communications Manager, +1-617-349-0205, both of
Transkaryotic Therapies, Inc.
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