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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 SECTION 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 1999.
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 November 1999
and incorporated by reference herein is the Registrant's announcement as
reported to the Company Announcements Office of the London Stock Exchange on
November 18, 1999.
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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: November 19, 1999 By: /s/ Andrew J. Heath, M.D., Ph.D.
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Andrew J. Heath, M.D., Ph.D.
Chief Executive Officer
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[PROTHERICS LOGO]
18 November 1999 For immediate release
PROTHERICS PRODUCT DEVELOPMENT UPDATE
CROTAB(R) APPROVAL DELAY
Protherics PLC announces that, following recent contact with the US Food and
Drug Administration (FDA), supplemental information regarding the manufacturing
process for CroTAb(R) will be requested in support of its Establishment License
Application (ELA). The issues relate to the validation of certain parts of the
manufacturing process for CroTAb(R), the Company's rattlesnake antivenom, and
are not related to the efficacy or safety of the product or the Product License
Application (PLA). The Company anticipates no difficulty in responding to the
issues which have been raised. However, final approval by the FDA may not take
place until the second half of 2000.
The delay in obtaining approval for CroTAb(R) will impact the Company's cash
flow. Initiatives commenced earlier this year to further reduce the Company's
administrative costs are continuing and there will now also be a reduction in
pre-production costs. In the absence of further licensing agreements for the
products in its portfolio, the Company will need to have secured additional
financing by the latter part of next year.
Protherics has previously stated its intention to pursue a strategy of further
mergers and acquisitions, to expand and develop its business over and above its
own internal growth. The Directors have identified a number of potential
business combinations which they are pursuing actively. The Directors expect
that a development in this area is likely within the coming months.
Andrew Heath, Chief Executive of Protherics, commented:
"While the delay in the CroTAb(R) review is not unusual for a product in
the final stages of an approval process, it is disappointing and we are
working with the FDA to resolve the remaining manufacturing issues. In
other product areas, good progress continues to be made and we remain
confident of both the potential of CroTAb(R) and the future development of
the Company."
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PRODUCT DEVELOPMENT UPDATE
Protherics' other antibody products have made progress in clinical and
regulatory stages in the USA. The acceptance of the DigiTAb(R) marketing
applications for review by the FDA was recently announced (13 October). In
addition, supported by encouraging results in a pilot clinical trial, the
application (IND) for FDA clearance to proceed with a pivotal Phase III clinical
trial of the tricyclic antidepressant overdose treatment, TriTAb(R), was
submitted at the end of October. One of the first cases of tricyclic
antidepressant overdose treated with TriTAb(R) was recently published in The
Lancet (6 November), a leading medical journal.
Results of the Phase IIb study of CytoTAb(R), which has been developed to
neutralise tumor necrosis factor alpha (TNF(alpha)), were recently presented at
the 65th Annual Scientific Assembly of the American College of Chest Physicians
in Chicago, Illinois. Dr. Gordon Bernard, Professor of Medicine at Vanderbilt
University, presented the results from this study which looked at the use of
CytoTAb(R) in patients with life-threatening infections. In this study,
CytoTAb(R) was shown to significantly reduce the amount of time a patient spends
on assisted ventilation and in intensive care. Given the positive results, the
Company is now seeking a partner to pursue Phase III trials.
In clinical trials in the UK, Protherics' high blood pressure vaccine is
progressing towards proof of concept studies first in healthy volunteers (Q1
2000) and subsequently in patients with high blood pressure (Q4 2000).
Significant progress has been made in developing drugs targeted against the
Factor Xa (thrombosis) and tryptase (asthma/allergy) enzymes using the Company's
proprietary computer aided molecular design software (CAMD).
FOR FURTHER INFORMATION, PLEASE CONTACT:
Andrew Heath, Chief Executive Tel: 0171 606 8637
Protherics PLC
Laura Frost Tel: 0171 379 5151
The Maitland Consultancy
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.
An electronic version of this news release is available 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,"
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.
