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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 October 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 October 1999 and
incorporated by reference herein is the Registrant's announcement as reported to
the Company Announcements Office of the London Stock Exchange on October 13,
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: October 20, 1999 By: /s/ Barrington M. Riley
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Barrington M. Riley
Finance Director
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[PROTHERICS GRAPHIC]
13 October 1999
FDA ACCEPTS DIGITAB(R) FILING FOR REVIEW
Protherics PLC, formed last month through the merger of Proteus International
plc and Therapeutic Antibodies Inc, announces that the US Food and Drug
Administration (FDA) has accepted for review its Product License Application
(PLA) and Establishment License Application (ELA) for DigiTAb(R), a product
designed to treat the effects of digoxin toxicity. The FDA's acceptance of the
filing triggers a milestone payment of US$250,000 from Altana, Inc., the
Company's US marketing partner for DigiTAb(R).
Protherics developed DigiTAb(R) for treating digoxin intoxication. Digoxin, the
most commonly prescribed form of digitalis, 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. The Company estimates that 7,500 cases of
digoxin toxicity occur annually in the US and Europe.
DigiTAb(R) has also been shown to be effective in the treatment of oleander
poisoning. Oleander, a plant commonly found throughout the US coastal states and
Southeast Asia, contains seeds and plant parts which are poisonous when
ingested.
Protherics submitted the DigiTAb(R) PLA and ELA to the FDA this year on 31 July
and 9 August respectively. The FDA's formal review process begins upon
acceptance of the submission for filing. The FDA granted DigiTAb(R) the standard
12-month review indicating that it will complete its review of the applications
within 12 months of the 9 August submission date.
The acceptance of the DigiTAb(R) applications marks the Company's second PLA and
ELA acceptance by the FDA in the last 15 months. License applications for
CroTAb(R), the Company's North American crotalid rattlesnake antivenom, were
accepted by the FDA in July 1998 and are in the final stages of regulatory
review.
Dr. Andrew Heath, Chief Executive of Protherics, commented:
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"Protherics was formed to create a biopharmaceutical business focused
on generating near term revenues to provide support for our ongoing
research. The FDA's acceptance for review of the DigiTAb(R)
applications is a milestone in this strategy. Altana is a strong
marketing partner and, with its support, we are optimistic about the
potential for DigiTAb(R). In addition, if approved for the treatment of
oleander poisoning, DigiTAb(R) would be the only product available for
this indication."
FOR FURTHER INFORMATION, PLEASE CONTACT:
Andrew Heath, Chief Executive Tel: 0171 606 8637
Protherics PLC Mobile: 0468 256 595
Stuart Wallis, Chairman Tel: 0171 553 1483
Protherics PLC
Laura Frost/William Clutterbuck Tel: 0171 379 5151
The Maitland Consultancy
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BACKGROUND INFORMATION
The FDA application contains data from three clinical studies of DigiTAb(R): an
ongoing study of DigiTAb(R) in digoxin overdose patients in the US and Europe, a
trial in healthy volunteers comparing DigiTAb(R) to Digibind(R) and a study
conducted in Sri Lanka in patients with oleander toxicity. Oleander is a plant
commonly found throughout the US coastal states and Southeast Asia. The seeds
and plant parts contain substances (e.g. oleandrin) that are closely related to
digitalis and digoxin and cause similar toxic effects when ingested in
sufficient quantities.
In 1986, Glaxo Wellcome plc introduced Digibind(R), a similar product, for the
treatment of life-threatening digoxin intoxication. DigiTAb(R) will compete
directly with Digibind(R) in the emergency medicine product market. DigiTAb(R)
will have a broader application than Digibind(R) should the FDA approve the
oleander indication.
PROTHERICS PLC
Effective 15 September 1999, Proteus International plc and Therapeutic
Antibodies Inc announced the completion of the merger between the two companies
to form Protherics PLC. Protherics, an international biopharmaceutical company,
has two platform technologies, the development and production of
immunotherapeutics and computer aided molecular design.
Protherics' corporate and research & development headquarters are located in
Macclesfield, Cheshire, England. The Company's US office is located in
Nashville, Tennessee. Laboratories are also located at the Medical College of
St. Bartholomew's Hospital in London. The Company's products are manufactured at
their production facilities in Australia and the United Kingdom for worldwide
distribution. The Company's ordinary shares are listed on the London Stock
Exchange.
An electronic version of this news release, as well as additional information
about Protherics, is available at http://www.protherics.com 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.
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