8-K 1 a2034566z8-k.txt FORM 8-K 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. ------------------------------------------------------------------------------ (Exact Name of Registrant as Specified in its Charter) DELAWARE --------------------------------------------------------------- (State or Other Jurisdiction of Incorporation) 000-21481 04-3027191 ----------------------------- ----------------------------------- (Commission File Number) (IRS Employer Identification No.) 195 ALBANY STREET, CAMBRIDGE, MASSACHUSETTS 02139 ------------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) (617) 349-0200 ------------------------------------------------------------------------------- Registrant's Telephone Number, Including Area Code NOT APPLICABLE ------------------------------------------------------------------------------- (Former Name or Former Address, if Changed Since Last Report) Item 5. OTHER EVENTS. ------------ 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. ------------------------------------------------------------------ (c) Exhibits. 99.1 Press Release -2- 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 ----------------------------------- Daniel E. Geffken Vice President, Finance and Chief Financial Officer -3- EXHIBIT INDEX EXHIBIT NUMBER DESCRIPTION 99.1 Press Release -4-