SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
6 August 2008
PROTHERICS PLC
(Translation of Registrant’s Name Into
English)
The Heath Business & Technical Park
Runcorn, Cheshire, W47 4QF 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 if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is
submitting the Form 6-K in paper as permitted by Regulation S-T Rule 191(b)(7):
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-
.
The Registrant is furnishing a copy of its
announcements as reported to the Company Announcements Office of the London Stock
Exchange.
Protherics PLC
DEEP results in pre-eclampsia to be presented at
leading conference
London, UK; Brentwood, TN,
US; 6 August 2008 -
Protherics PLC ("Protherics" or the
"Company"), the international biopharmaceutical company focused on critical care and
cancer, today announces that data from the "DEEP" study has been
selected as one of the key presentations at the
16
th
World Congress of The International Society for
the Study of Hypertension in Pregnancy (ISSHP) in Washington DC, US 21-25
September 2008.
On 22 April Protherics announced
that its placebo-controlled phase
2b Digibind
®
Efficacy Evaluation in Pre-eclampsia
("DEEP") study in severe pre-eclampsia met one of its two primary endpoints. An
abstract of the study results prepared by Protherics and other stakeholders in the
programme has been selected by ISSHP for presentation at the opening plenary session
on 22 September 2008. In addition, two abstracts describing research data
supporting the mechanism of action of Digoxin Immune Fabs (DIFs) in
pre-eclampsia have also been
accepted for presentation. Please see the ISSHP's website for more
details: http://www.isshp2008-washington.org/
Dr Garrett K. Lam, lead clinical investigator on the
DEEP study commented,
"The opportunity to present the
results of the DEEP study at the ISSHP's World Congress reflects the considerable
scientific and medical interest in this important study
in pre-eclampsia, as this is the first time a drug has shown a clinical
benefit towards improving an end organ function in pre-eclamptic patients. This study
will advance efforts to identify the underlying cause(s) of this life-threatening
condition."
Andrew Heath, CEO commented: "We are delighted that the DEEP study results
will be one of the leading presentations at this prestigious
meeting. Discussions with key stakeholders about how to progress this
important programme continue, and we are encouraged by the interest shown in the
programme to date. We expect to give a further update on next
steps towards the end of the year."
Protherics also announces today that a patent has been granted in
the US covering the use of DIFs, including
Digibind
®
(GlaxoSmithKline) and DigiFab™, as a method
for controlling pre-eclampsia and eclampsia.
| Ends |
For further information please contact:
Protherics
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London, UK: Nick Staples, Director of Corporate
Affairs
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+44 (0) 7919 480510
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Brentwood, US: Saul Komisar, President Protherics
Inc
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+1 615 327 1027
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Financial Dynamics
- press enquiries
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London, UK: Ben Atwell, Lara Mott
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+44 (0) 20 7831
3113
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New York, US: John Capodanno
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+1 212 850 5600
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Or visit
www.protherics.com
Notes for Editors:
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a
leading international biopharmaceutical company focused on specialist products
for critical care and cancer.
The Company has two critical care products, CroFab™ and
DigiFab™, approved for sale in the US. The Company has the
opportunity to sell these products in
the US from October 2010 together with Voraxaze™,
a supportive cancer care product, following anticipated approval
in the US in 2010. Protherics is also developing a number of other
products in the cancer arena that it can commercialise in-house.
In addition, Protherics has several potential blockbuster
products that require development and commercialisation partners. These include
CytoFab™ which has been partnered with AstraZeneca in a major
licensing deal, and also Angiotensin Therapeutic Vaccine and
Digoxin Immune Fabs for which licensing partners will be sought in
2008-2009. These products have the potential to be high value products that can
provide additional funding to help grow the Company.
Protherics reported revenues of £26.1 million for the year
ended 31 March 2008 and a strong cash balance of £37.7
million. With headquarters in London, the Company has approximately 300 employees
across its operations in the UK, US and Australia.
For further information visit www.protherics.com
About Digoxin Immune Fabs
Digibind
®
and DigiFab™ are
intravenously administered polyclonal antibody fragments (Fab) designed to bind and
neutralise digoxin. These products are used in the treatment of patients
with life-threatening or potentially life-threatening digoxin toxicity or
overdose.
Digoxin is the most commonly used cardiac glycoside in the treatment of
congestive heart failure, and is also used to slow heart rate in some cardiac
disturbances. Digoxin toxicity can cause potentially life-threatening heart rhythm
disturbances, ranging from very slow to rapid ventricular rhythms.
About Pre-eclampsia
Pre-eclampsia is a life-threatening disorder occurring in 10% of pregnancies
worldwide per year. It is characterised by high blood pressure and can lead to renal
failure and seizures. It typically results in the early delivery of the baby, with
potential developmental abnormalities and the possible death of the mother and/or baby. By
conservative estimates, pre-eclampsia and other hypertensive disorders of pregnancy are
responsible for 76,000 deaths each year in the US. Pre-eclampsia is also a major cause
of admission of babies into Neonatal Intensive Care Units (NICU). Currently there are no
approved therapies available to treat pre-eclampsia and few products in development. The
cause of pre-eclampsia has not been conclusively identified but several vasoactive
substances called endogenous digoxin-like factors (EDLFs) have been identified in the blood
and placenta of women with pre-eclampsia. These EDLFs rapidly disappear following delivery
of the baby, coincident with the disappearance of the symptoms of pre-eclampsia.
Both Digibind
®
and DigiFab™ (Protherics), which
have been found to bind to EDLFs in vitro, may have potential application in the
treatment of pre-eclampsia.
Disclaimer
This document contains forward-looking
statements that involve risks and uncertainties including with respect to products
under development and the progress and completion of clinical trials. Although
we believe that the expectations reflected in such forward-looking statements are
reasonable at this time, we can give no assurance that such expectations will prove to be
correct. Given these uncertainties, readers are cautioned not to place undue reliance on
such forward-looking statements. Actual results could differ materially from those
anticipated in these forward-looking statements due to many important factors
discussed in Protherics' Annual Report on Form 20-F and other reports filed from time
to time with the U.S. Securities and Exchange Commission. We do not undertake to update any
oral or written forward-looking statements that may be made by, or on behalf of,
Protherics.
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.
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PROTHERICS PLC
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Date: 6 August 2008
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By:
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/s/ Rolf Soderstrom
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Rolf Soderstrom
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Finance Director
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