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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): JANUARY 3, 2001
TRANSKARYOTIC THERAPIES, INC.
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(Exact Name of Registrant as Specified in its Charter)
DELAWARE
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(State or Other Jurisdiction of Incorporation)
000-21481 04-3027191
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(Commission File Number) (IRS Employer Identification No.)
195 ALBANY STREET, CAMBRIDGE, MASSACHUSETTS 02139
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(Address of Principal Executive Offices) (Zip Code)
(617) 349-0200
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Registrant's Telephone Number, Including Area Code
NOT APPLICABLE
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(Former Name or Former Address, if Changed Since Last Report)
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Item 5. OTHER EVENTS.
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On January 3, 2001, Transkaryotic Therapies, Inc. ("TKT") announced
that it has received a complete review letter from the U.S. Food and Drug
Administration (FDA) concerning its Biologics License Application (BLA) for
Replagal(TM) (agalsidase alfa), an investigational enzyme replacement therapy
for the treatment of Fabry disease. In the letter, the FDA has asked for further
explanation in several areas and requested additional data. TKT has initiated
the collection of these data, but until there is an opportunity for further
discussion with the FDA, TKT cannot make projections about the timing of future
FDA decisions concerning the approval of Replagal.
The full text of TKT's press release issued in connection with the
foregoing matter is filed as Exhibit 99.1 to this Current Report on Form 8-K and
is incorporated herein by reference.
Item 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
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(c) Exhibits.
99.1 Press Release
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: January 4, 2001 REGISTRANT
TRANSKARYOTIC THERAPIES, INC.
By: /s/ DANIEL E. GEFFKEN
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Daniel E. Geffken
Vice President, Finance and
Chief Financial Officer
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EXHIBIT INDEX
EXHIBIT NUMBER DESCRIPTION
99.1 Press Release
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