Therapeutic Antibodi - Re Licences Application
August 09 1999 - 3:36AM
UK Regulatory
RNS No 7128a
THERAPEUTIC ANTIBODIES INC
9 August 1999
THERAPEUTIC ANTIBODIES INC
SUBMITS DIGITAb FOR FDA APPROVAL
London, 9 August 1999 - Therapeutic Antibodies announces that it
has submitted a Product License Application (PLA) and
Establishment License Application (ELA) to the US Food and Drug
Administration (FDA), seeking approval of its product, DigiTAb,
which is designed to treat the effects of digoxin toxicity. The
FDA's acceptance of the filing for review will trigger a
milestone payment from Altana Inc., Therapeutic Antibodies' US
marketing partner for DigiTAb.
The submission of the DigiTAb PLA and ELA marks Therapeutic
Antibodies' second PLA and ELA submission to the FDA in the last
15 months. The Company anticipates the FDA will grant the same
standard 12 month review period for DigiTAb as it granted for
the Company's rattlesnake antivenom, CroTAb. The CroTAb PLA and
ELA were submitted to the FDA in April 1998 and are in the final
stages of review.
Therapeutic Antibodies developed DigiTAb for treating digoxin
intoxication. Digoxin is the most commonly prescribed form of
digitalis, which has been in use worldwide for many years to
treat a range of heart conditions. However, digoxin has a
narrow therapeutic range and can cause life-threatening toxicity
as a result of both acute overdose and chronic poisoning. It is
estimated that 7,500 cases of digoxin toxicity occur annually in
the US and Europe, with the majority in the US. DigiTAb has
also been shown to be effective in the treatment of oleander
poisoning. Oleander, a common plant found throughout the US
coastal states and Southeast Asia, contains seeds and plant
parts which are poisonous when ingested.
Andrew J. Heath, MD, Therapeutic Antibodies' CEO, commented,
'the submission of the DigiTAb filing within 15 months of the
CroTAb submission is evidence of management's focus in meeting
product development milestones. With CroTAb approaching the US
marketplace and the merger with Proteus moving ahead, we are
well on the way to creating a self-sustaining biopharmaceutical
business.'
For further information, please contact:
Stuart Wallis, Chairman - tel: 0171 553 1483
Therapeutic Antibodies Inc
Saul Komisar - tel: 615-327-1027
Therapeutic Antibodies Inc
Nick Freer - tel: 0171 379 5151
The Maitland Consultancy
BACKGROUND INFORMATION
The FDA application contains data from three clinical studies of
DigiTAb: an ongoing study of DigiTAb in digoxin overdose
patients in the US and Europe, a trial in healthy volunteers
comparing DigiTAb to Digibind and a study conducted in Sri Lanka
in patients with oleander toxicity.
In 1986, Glaxo Wellcome introduced Digibind, a similar product,
for the treatment of life-threatening digoxin intoxication.
DigiTAb will compete directly with Digibind in the emergency
medicine product market. DigiTAb will have a broader
application than Digibind if the FDA approves the oleander
indication.
Therapeutic Antibodies is an international biopharmaceutical
company specialising in research, development and production of
highly-purified polyclonal antibodies for treatment of diseases
and other life-threatening conditions for which satisfactory
therapies have generally not previously existed.
The Company is headquartered in Nashville, Tennessee, adjacent
to the Vanderbilt University Medical Center. The Company's
research laboratories are located at the Medical College of St.
Bartholomew's Hospital in London. Therapeutic Antibodies'
products are manufactured at the Company's production facilities
in Australia and the UK for worldwide distribution. The
Company's common stock is listed on the London Stock Exchange.
On 20 May 1999, the Boards of Proteus International plc and
Therapeutic Antibodies Inc announced that they had executed an
agreement providing for the merger of Proteus and Therapeutic
Antibodies, accompanied by a conditional non pre-emptive placing
of 23,325,000 new Proteus ordinary shares at 40p per share to
raise approximately #7.0 million net of expenses for the
enlarged group, which at the placing price has a value of
approximately #63.1 million. Upon the merger becoming
effective, Therapeutic Antibodies' shareholders will receive
1.163 Proteus ordinary shares for each share of Therapeutic
Antibodies common stock. The merger is subject to the approval
of shareholders of both Proteus and Therapeutic Antibodies.
Shareholders' meetings of both companies are expected to be held
as soon as practical following regulatory approvals.
An electronic version of this news release, as well as
additional information about Therapeutic Antibodies Inc is
available at http://www.tab.co.uk on the Company's home page.
This release, and oral statements made from time to time by
Company representatives concerning the subject matter hereof,
may contain so-called 'forward looking statements'. These
statements can be identified by introductory words such as
'expects', 'plans', 'will', 'estimates', 'forecasts', 'projects'
or words of similar meaning, and by the fact that they do not
relate strictly to historical or current facts. Forward-looking
statements frequently are used in discussing the Company's
growth strategy, operating and financial goals, plans relating
to regulatory submissions and approvals and development
programs. Many factors may cause actual results to differ from
the Company's forward-looking statements, including inaccurate
assumptions and a broad variety of risks and uncertainties, some
of which are known and others of which are not. Those and other
risks are described in the Company's filings with the Securities
and Exchange Commission, copies of which are available from the
SEC or may be obtained upon request from the Company. No
forward-looking statement is a guarantee of future results or
events, and one should avoid placing undue reliance on such
statements.
END
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