<PAGE>
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): April 16, 1998
Transkaryotic Therapies, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-21481 04-3027191
(State or Other (Commission File (I.R.S. Employer
Jurisdiction of Number) Identification No.)
Incorporation)
195 Albany Street 02139
Cambridge, Massachusetts
(Address of principal executive offices) (Zip Code)
(617) 349-0200
(Registrant's telephone number, including area code)
<PAGE>
Item 5. Other Events.
On April 16, 1998, Transkaryotic Therapies, Inc. ("TKT") announced that
the United States District Court in Boston had granted TKT and Hoechst Marion
Roussel's Motion for Summary Judgment of Non-infringement in Amgen Inc.'s patent
infringement action against TKT and Hoechst Marion Roussel. A press release
announcing the court's decision is attached hereto as Exhibit 99.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits.
The exhibits listed in the Exhibit Index filed as part of this report
are filed as part of or are included in this report.
-2-
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
TRANSKARYOTIC THERAPIES, INC.
Date: April 17, 1998 By: /s/ Daniel E. Geffken
-------------------------------
Daniel E. Geffken
Vice President, Finance and
Chief Financial Officer
-3-
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit Number Description
- -------------- ------------
<S> <C>
99 Press Release, dated April 16, 1998,
relating to the United States
District Court's decision.
</TABLE>
-4-
<PAGE>
EXHIBIT 99
For Release at 6:00 a.m. EDT on April 16, 1998
CONTACT:
Beverly A. Holley
Director, Corporate Communications
(617) 349-0271
TKT AND HOECHST MARION ROUSSEL MOTION FOR SUMMARY
JUDGMENT GRANTED BY DISTRICT COURT
GA-EPO(TM) Clinical Development Program Proceeds
CAMBRIDGE, MA, April 16, 1998 -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX)
and Hoechst Marion Roussel, Inc. announced today that the United States District
Court in Boston has granted TKT and Hoechst Marion Roussel's Motion for Summary
Judgment of Non-infringement in Amgen Inc.'s patent infringement action. The
Court held that Amgen's patent infringement action was inconsistent with the
Waxman-Hatch Act, which precludes patent infringement litigation while drug
products are being developed for FDA approval. The Court stated that "(a)ll of
the activities Amgen has identified in the papers before the Court fall within
the protection afforded by section 271 (e) (1) [the Waxman-Hatch Act] because
they are solely for uses reasonably related to the production of information for
submission to the FDA for regulatory approval. As such, they are not infringing
activities, and the Defendants are entitled to judgment."
In tandem with this decision, the Court has denied Amgen's pending Motion for
Summary Judgment of Infringement with respect to each of the patents involved in
the lawsuit brought by Amgen against TKT and Hoechst Marion Roussel in April
1997. Furthermore, TKT and Hoechst Marion Roussel's clinical development program
for Gene Activated(TM) erythropoietin (GA-EPO), which is scheduled to enter a
Phase III clinical trial later this year, will continue to proceed as planned.
Commenting on these rulings, Richard F Selden, President and Chief Executive
Officer of TKT, stated, "We are immensely gratified. The Court's rulings give
TKT and Hoechst Marion Roussel everything we requested. From the beginning of
this case, we believed that Amgen's goal in filing an early suit was to disrupt
the GA-EPO development program. That effort has now been defeated. This is most
<PAGE>
likely not the end of litigation between Amgen and TKT/Hoechst Marion Roussel.
However, we believe that GA-EPO and the process used to manufacture it represent
important technological advances, and that we can meet successfully any legal
challenge brought by Amgen."
Founded in 1988, Transkaryotic Therapies, Inc. (TKT) has three proprietary
product development platforms, Gene Activation, gene therapy and Niche
Proteins(TM). The Company's Gene Activation technology is a proprietary approach
to the large scale production of therapeutic proteins which does not require the
cloning of genes and their subsequent insertion into non-human cell lines. The
Company's gene therapy technology is focused on the commercialization of
non-viral, ex vivo gene therapy products for the long-term treatment of a broad
range of human diseases. TKT believes that its gene therapy system is
well-suited to the treatment of chronic protein deficiency states such as
hemophilia, diabetes and hypercholesterolemia. TKT's Niche Protein platform is
based on protein replacement for the treatment of rare genetic diseases, a group
of disorders characterized by the absence of certain metabolic enzymes.
This press release contains forward-looking statements. For this purpose, any
statements contained herein that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the foregoing, the
words "believes", "anticipates", "plans", "expects", "intends" and similar
expressions are intended to identify forward-looking statements. 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 whether any of the Company's product candidates will advance in the
clinical trial process, the timing of such clinical trials, whether the clinical
trial results will warrant continued product development, the timing of making
required regulatory filings such as Investigational New Drug applications, and
additional risks set forth in the Company's periodic reports and registration
statements filed with the Securities and Exchange Commission (the "SEC"),
including those factors set forth under the caption "Certain Factors That May
Affect Future Results" in the Company's Annual Report on Form 10-K, filed with
the SEC on March 30, 1998.
###
