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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): NOVEMBER 22, 2000
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.
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
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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: November 22, 2000 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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