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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities and Exchange Act of 1934
Date of Report: (Date of earliest event reported): February 22, 2000
TEXAS BIOTECHNOLOGY CORPORATION
(Exact name of registrant as specified in its charter)
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<S> <C> <C>
Delaware 1-12574 13-3532643
(State of Incorporation) (Commission File Number) (IRS Employer Identification No.)
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7000 FANNIN, SUITE 1920
HOUSTON, TEXAS 77030
(Address of Registrant's principal executive offices)
(713) 796-8822
(Registrant's telephone number, including area code)
(NOT APPLICABLE)
(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
THE FOLLOWING STATEMENT WAS RELEASED TO THE PRESS ON FEBRUARY 22, 2000 REGARDING
A U.S. FDA APPROVABLE LETTER TO TEXAS BIOTECHNOLOGY CORPORATION FOR NOVASTAN(R)
Texas Biotechnology Corporation (AMEX:TXB) announced today that it has received
an approvable letter from the U.S. Food & Drug Administration for NOVASTAN(R)
(argatroban) as an anticoagulant for prophylaxis or treatment of thrombosis in
patients with heparin-induced thrombocytopenia.
NOVASTAN is a synthetic direct thrombin inhibitor that prevents clot formation
and has been developed as anticoagulant therapy for patients who can no longer
receive heparin. In clinical trials, the rapid onset of action of NOVASTAN,
together with its short half-life and lack of immunogenicity, resulted in
predictable anticoagulation levels as well as a safe and relatively easy drug to
use.
Under the agreement with SmithKline Beecham (SB) in August 1997, SB has the
rights to market and co-develop NOVASTAN in the United States and Canada as
anticoagulant therapy in patients with heparin-induced thrombocytopenia (HIT).
David M. Stout, President North America of SB, stated, "With the positive action
of the approvable letter for NOVASTAN from FDA, NOVASTAN now has the opportunity
of ultimately fulfilling an unmet need and providing benefits to patients
requiring this life-saving drug."
Currently, preparations for the marketing and commercialization of NOVASTAN are
underway. Commercial-scale manufacturing of NOVSTAN has been initiated and
several medical education initiatives as well as the presentation of the
NOVASTAN Phase III clinical trail results are planned for the upcoming American
College of Cardiology meeting in March. TBC believes that it will take
approximately 60 days to satisfy FDA requirements for securing the final
approval letter for NOVASTAN.
John G. Kelton, M.D., a recognized expert in the area of heparin-induced
thrombocytopenia, noted, "HIT is a serious and life-threatening adverse reaction
to heparin. The condition is caused by a complex immune reaction characterized
by a strong tendency to clot that puts the patient at risk of major
complications such as heart attack and stroke which can, in turn, lead to
amputation or even death. I believe that the approval of argatroban, NOVASTAN,
will increase the awareness, diagnosis and successful treatment of this
condition." Dr. Kelton is Professor and Chairman of Medicine, McMaster
University Faculty of Health Sciences, Ontario, Canada.
According to an analysis of 34 million hospitalizations from the U.S. Health
Care Financing Administration database, over 10 million patients received
heparin in the U.S. annually, making heparin one of the most widely used drugs
in the hospital. The literature suggests that HIT occurs in approximately
300,000 to 400,000 heparin patients in the U.S. per year although it is widely
believed to be under-diagnosed. The literature also suggests that approximately
30 to 60% of cardiac surgery patients exposed to heparin will form the
antibodies to heparin, which causes HIT.
Dr. Bruce Lewis, Associate Professor of Medicine, Loyola University Medical
Center and Chief, Section of Cardiology, Catholic Health Partners, and the
principal investigator for the NOVASTAN clinical program in HIT, stated, "I have
used NOVASTAN in over 140 patients and have found it to be a very effective,
easy to use anticoagulant that offers a much needed alternative to heparin." Dr.
Lewis is the lead author on the
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presentation of the Phase III clinical trial results to be presented at the
Annual Meeting of the American College of Cardiology which will be held in
March.
Texas Biotechnology Corporation (TBC) is a biopharmaceutical company focused on
the development and commercialization of small molecule drugs to treat a variety
of diseases including thrombosis, chronic heart failure and asthma. In addition
to NOVASTAN, the Company has two compounds in Phase II development. Sitaxsentan
(TBC11251), is an endothelin receptor antagonist that is being developed as a
treatment for pulmonary arterial hypertension and chronic heart failure. TBC1269
is a selectin antagonist that is currently being developed for asthma.
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 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: February 22, 2000 TEXAS BIOTECHNOLOGY CORPORATION
/s/ Stephen L. Mueller
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Stephen L. Mueller
Vice President, Finance and Administration,
Secretary and Treasurer
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