8-K 1 a2031903z8-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): NOVEMBER 22, 2000 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 November 22, 2000, Transkaryotic Therapies, Inc. ("TKT") announced that the U.S. Food and Drug Administration (FDA) has required that data be provided on additional manufacturing runs of Dynepo-TM-. Dynepo Is being developed by Aventis Pharma, the pharmaceutical company of Aventis S.A., in collaboration with TKT. The FDA's requirement is based on a recent change in the Dynepo manufacturing process, an increase in scale from the 2000 liter to 5000 liter bioreactors. Though the product has been successfully manufactured at the 5000 liter scale, additional process validation data will be submitted to the FDA. The amount of new data will necessitate that it be submitted as part of a new Biologics License Application (BLA), which is expected to occur in approximately six months. 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: November 22, 2000 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-