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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2000.
PROTHERICS PLC
(Translation of Registrant's Name Into English)
Beechfield House
Lyme Green Business Park
Macclesfield Cheshire SK11 0JL
England
(Address of Principal Executive Offices)
(Indicate by check mark whether the registrant files or will file
annual reports under cover of Form 20-F or Form 40-F.)
Form 20-F [X] Form 40-F [ ]
(Indicate by check mark whether the registrant by furnishing the
information contained in this form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes [ ] No [X]
(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b)): 82-_________________________.
Attached to the Registrant's Form 6-K for the month of May 2000 and
incorporated by reference herein is the Registrant's announcement as reported to
the Company Announcements Office of the London Stock Exchange on May 10, 2000.
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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.
PROTHERICS PLC
Date: May 16, 2000 By: /s/ Andrew J. Heath
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Andrew J. Heath, M.D., Ph.D.
Chief Executive Officer
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[PROTHERICS LOGO]
10 May 2000
PROTHERICS' HIGH BLOOD PRESSURE VACCINE
TO ENTER PHASE II CLINICAL TRIALS
PHASE I STUDY VALIDATES CONCEPT
Protherics' angiotensin vaccine, a unique product under development for the
treatment of high blood pressure (hypertension), has completed Phase I clinical
trials and demonstrated its ability to raise an antibody response in humans. In
addition, there were encouraging indications that these antibodies are capable
of blocking the blood pressure raising effects of angiotensin as intended.
Hypertension is one of the most common medical conditions in developed countries
and while high blood pressure itself usually causes no immediate symptoms, it is
a risk factor for developing heart attacks, heart failure, blood vessel problems
or kidney damage. Current treatments are tablet based and require daily dosing,
often for life. The pharmaceutical market for high blood pressure treatment is
the largest single therapeutic sector, exceeding US $20 billion in sales per
annum world-wide.
The Phase I clinical trial programme for Protherics' angiotensin vaccine
comprised single and two dose studies in a total of more than 50 healthy male
volunteers. In the recently completed two dose study, eight subjects received
injections of the vaccine three weeks apart and eight received control
injections. In all eight vaccine treated subjects, anti-angiotensin antibodies
were present in blood samples taken four weeks after the second injection. All
subjects receiving control injections were negative in the antibody test.
The planned Phase IIa trials will involve testing the vaccine in patients who
have high blood pressure and will initially focus on varying the immunisation
regime to optimise the antibody response prior to undertaking controlled studies
on the effectiveness of the vaccine. The aim of the Phase II programme is to
demonstrate the ability of the vaccine to control blood pressure as effectively
as current leading oral drugs that act on the angiotensin system (ACE inhibitors
or angiotensin receptor antagonists). This programme is expected to take 18
months.
CHIEF EXECUTIVE ANDREW HEATH COMMENTED: "This is a very encouraging result for
our high blood pressure vaccine and gives us an excellent platform to launch the
next stage of development. This vaccine is a unique product with substantial
commercial potential in the
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world's largest pharmaceutical market. It clearly underlines the strength of our
product portfolio."
CROTAB(R) UPDATE
Protherics has now completed and submitted its response to the US Food and Drug
Administration's (FDA) request for supplementary information regarding the
CroTAb(R) product license applications. FDA approval of CroTAb(R), Protherics'
rattlesnake antivenom, is anticipated in the autumn this year.
FOR FURTHER INFORMATION:
Andrew Heath
Chief Executive, Protherics plc +44 (0) 20 7606 8637
Arthur Rushton
Chief Operating Officer, Protherics plc +44 (0) 1625 500555
Laura Frost
The Maitland Consultancy +44 (0) 20 7379 5151
BACKGROUND INFORMATION ON HYPERTENSION
Hypertension affects about 20 per cent of the middle-aged adult population with
the frequency of occurrence increasing with age to 50 per cent in the over 65s.
Current treatment to reduce blood pressure and hence the risk of subsequent
problems is taking tablets on a daily basis, usually for the rest of the
person's life, often combined with lifestyle guidance.
Many patients with high blood pressure fail to reach target levels of reduction
in blood pressure in part due to failure to take prescribed treatment regularly.
Protherics' Angiotensin vaccine would require 2 to 4 injections under medical
supervision and would replace or complement existing treatments by reducing the
number and dose of conventional drugs. This should improve compliance with
existing treatments and thereby increase cost-effectiveness of treatment for
this condition.
Protherics plc
Protherics plc was formed on 15 September 1999 from the merger of Proteus
International plc and Therapeutic Antibodies Inc. Protherics, an international
biopharmaceutical company, has two platform technologies, the development and
production of immunotherapeutics and computer aided molecular design.
The Company's ordinary shares are listed on the London Stock Exchange.
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An electronic version of this will be available today at
http://www.Protherics.com
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',
words of similar meaning, and by the fact that they do not relate strictly to
historical or current facts. Forward-looking statements frequently are
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.
