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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
AUGUST 26, 1999
TEXAS BIOTECHNOLOGY CORPORATION
(Exact name of registrant as specified in charter)
DELAWARE
(State or Other Jurisdiction of Incorporation)
NO. 1-12574
(Commission File Number)
13-3532643
(I.R.S. Employer Identification No.)
7000 FANNIN, SUITE 1920
HOUSTON, TEXAS 77030
(Address of Principal Executive Offices)
(713) 796-8822
(Registrant's Telephone Number, Including Area Code)
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ITEM 5. OTHER EVENTS
THE FOLLOWING STATEMENT WAS RELEASED TO THE PRESS ON AUGUST 23, 1999 REGARDING
A CORRECTED AMENDMENT TO THE NOVASTAN(R) NEW DRUG APPLICATION
Houston, TX , August 23, 1999 -- Texas Biotechnology Corporation (AMEX:
TXB) today announced that, following discussions with the U.S. Food & Drug
Administration (FDA), the Company has corrected the amendment to the
NOVASTAN New Drug Application (NDA). The corrected amendment replaces the
submission on March 19 of this year.
The changes in this amendment involved correcting the coding of patient
endpoint data and dates on which they occurred, and involved 33 of 304
patients in the pivotal Phase III trial that, when corrected, improved one
of the efficacy analyses for NOVASTAN. In the Phase III follow-up trial, 6
of 264 patient endpoints were miscoded and, when corrected, had no
clinically substantive effects on the efficacy results.
Overall, the corrected analyses do not change the positive clinical
interpretation of the efficacy endpoints and have no effect on the safety
analysis of NOVASTAN.
NOVASTAN has been developed by Texas Biotechnology in collaboration with
SmithKline Beecham as an anticoagulant for use in patients with
heparin-induced thrombocytopenia (HIT) syndrome who in the opinion of their
physician require anticoagulation.
Based on FDA correspondence received August 23, 1999, a response from the
FDA on the amended NDA is expected by February, although the Company is
optimistic of an earlier response. The original date for an FDA decision
had been September 19, 1999.
David B. McWilliams, president and chief executive officer of TBC, stated,
"It is our understanding, based on discussions with FDA, that the review is
essentially complete. We believe this corrected submission remains clearly
supportive of the safety and efficacy of NOVASTAN." McWilliams continued,
"As you would expect, we have taken additional steps, through the use of
outside statisticians and a consultant specializing in FDA matters, Jur Strobos,
M.D, JD, to assure that our submission is of high quality."
Dr. Strobos stated, "While the discovery of these data errors causes a delay,
I view the corrected submission as positive and believe that the data supports
the proposed labeling."
This press release contains forward-looking information that is subject to
certain risks; trends and uncertainties that could cause actual results to
differ materially from those projected. Among those risks, trends and
uncertainties are attainment of research and clinical goals of product
candidates, attainment of required governmental approval and availability
of financing and revenues sufficient to fund development of product
candidates and operations. In particular, careful consideration should be
given to cautionary statements made in the various reports Texas
Biotechnology has filed with the Securities and Exchange Commission.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the Registrant has duly caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: August 26, 1999 TEXAS BIOTECHNOLOGY CORPORATION
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(Registrant)
By: /s/ STEPHEN L. MUELLER
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Stephen L. Mueller
Vice President,
Finance and Administration,
Secretary and Treasurer
