Cheshire, UK -- (MARKET WIRE) -- January 8, 2007 --
Protherics PLC
Protherics submits DigiFabTM New Drug Submission in Canada
London, UK; Brentwood, TN, US: 8 January 2007 - Protherics PLC ("Protherics" or
the "Company"), the international biopharmaceutical company focused on critical
care and cancer, today announces that it has submitted a New Drug Submission to
the Health Products and Food Branch of Health Canada for DigiFabTM. DigiFabTM
is the leading digoxin antidote in the US where it is approved for the treatment
of life-threatening or potentially life-threatening digoxin toxicity or
overdose.
DigiFabTM is an ovine derived antibody fragment (Fab) preparation for the
treatment of digoxin intoxication, which can produce severe effects on the heart
and central nervous system, sometimes leading to death. Protherics is seeking
to expand DigiFabTM into markets outside of the US, including Canada and Europe.
Subject to regulatory review, Protherics expects to receive marketing approval
in the UK in the first half of 2007, in other European countries in the
following six to twelve months and in Canada in 2008. In addition, Protherics
recently announced an agreement with Roche to replace its digoxin antidote,
Digitalis-Antidot®, with DigiFabTM to facilitate its withdrawal from the
market. Protherics estimates that the market opportunity for digoxin antidotes
outside of the US is approximately $5 to $10 million per annum.
Andrew Heath, Chief Executive of Protherics said:
"DigiFab is now the established market leader in the digoxin antidote market,
worth an estimated $30 million per annum, and we are consolidating this position
by making our product more widely available outside of the US. It is important
to maximise our revenue generating opportunities from our niche marketed
products, in parallel with delivering value from our recently expanded
development pipeline."
Ends
For further information please contact:
Protherics
Andrew Heath, CEO +44 (0) 20 7246 9950
Saul Komisar, President Protherics Inc +1 615 327 1027
Financial Dynamics - press enquiries
London: Ben Atwell, Anna Keeble +44 (0) 20 7831 3113
New York: John Capodanno, Jonathan Birt +1 212 850 5600
Or visit www.protherics.com
Notes for Editors:
About DigiFabTM
DigiFabTM contains purified ovine polyclonal antibody fragments and each vial of
DigiFabTM, which contains 40 mg of digoxin immune Fab, will bind approximately
0.5 mg digoxin.
DigiFabTM is indicated in the US for the treatment of patients with
life-threatening or potentially life-threatening digoxin toxicity or overdose.
Clinical conditions requiring administration of DigiFabTM include known suicidal
or accidental consumption of fatal doses of digoxin, chronic overdoses or any
ingestion leading to life-threatening manifestations of toxicity, such as
ventricular arrhythmia.
In clinical studies, DigiFabTM reduced digoxin in the blood to undetectable
levels in all subjects and digoxin toxicity was resolved in 14 out of 15 (93%)
patients 20 hours after receiving DigiFabTM.
Adverse reactions that could occur with the use of DigiFabTM include
exacerbation of low cardiac output states and congestive heart failure due to
the withdrawal of the inotropic effect of digitalis, hypokalemia due to
reactivation of the sodium-potassium ATPase, rapid ventricular response in
patients with atrial fibrillation due to withdrawal of the effects of digitalis
on the atrioventricular node and rare allergic reactions.
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is an integrated biopharmaceutical company
focused on the development, manufacture and marketing of specialist products for
critical care and oncology.
Protherics' strategy is to use the revenues generated from its marketed products
to help fund the advancement of its development pipeline. With a proven track
record, Protherics' goal is to develop and attract additional critical care and
cancer products for its sales and marketing teams to distribute in the US and
Europe.
The majority of the Company's sales revenues (GBP17.7m in the year ended 31 March
2006) are derived from two critical care products, CroFabTM (pit viper
antivenom) and DigiFabTM (digoxin antidote) which were developed by Protherics
and are sold, in the US, through Fougera Inc, a division of Altana AG.
Protherics potentially has two blockbuster opportunities in its critical care
franchise. CytoFabTM is being developed by AstraZeneca for the treatment of
severe sepsis, and is expected to start an additional phase 2 study in 2007. In
addition the Company has in-licensed the intellectual property from Glenveigh (a
small private US based company) relating to the use of anti-digoxin polyclonal
antibody fragments such as DigiFabTM and GSK's Digibind® in the treatment of
pre-eclampsia and eclampsia. Glenveigh is currently undertaking a phase 2b
study with Digibind® which Protherics expects to report in 2007.
Following the recent acquisition of MacroMed, a US based drug development and
manufacturing company, Protherics has four cancer products in development,
including VoraxazeTM. VoraxazeTM is expected to be approved, subject to
regulatory reviews, in the EU in H1 2007 and in the US from H2 2008, as an
intervention when methotrexate blood levels remain dangerously elevated
following high dose therapy for the treatment of cancer. Protherics is planning
to build its own sales force to undertake the sales and marketing of VoraxazeTM.
In addition, the Company is developing its Angiotensin Therapeutic Vaccine for
the treatment of hypertension.
With headquarters in London, the Company has about 260 employees across its
operations in the UK, US and Australia.
For further information visit:
www.protherics.com
Disclaimer
This document contains forward-looking statements that involve risks and
uncertainties, including with respect to Protherics' product pipeline and
anticipated development and clinical trials for product candidates. 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, including the 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.
This information is provided by RNS
The company news service from the London Stock Exchange