Protherics PLC
AGM and Interim Management Statement
London, UK; Brentwood, TN, US; 22 July 2008 - Protherics PLC
("Protherics" or the "Company"), the international biopharmaceutical
company focused on critical care and cancer, today provides
its Interim Management Statement for the period 31 March to 21
July 2008. This statement summarises comments to be made today by
Stuart Wallis, Chairman of Protherics' at the Annual General Meeting at
midday today.
Highlights for the period:
- Trading and cash position in line with expectations
- Initiation of a phase 2a clinical study of Angiotensin Therapeutic
Vaccine in hypertension
- Results reported from the phase 2b "DEEP" study of Digoxin Immune
Fab in severe
pre-eclampsia
- Headline Prolarix™ phase 1 data, presented by Cancer
Research UK, was awarded a merit at the prestigious American
Society of Clinical Oncology (ASCO) Annual Meeting
Trading update:
On 3 June, Protherics reported a strong cash position of GBP37.7 million
and a strong sales performance with trading revenues of GBP23.5 million
from its marketed products for the year ended 31 March 2008,
representing 27% organic growth year-on-year. Despite the challenging
global economic environment and the weakness of the US dollar, revenues
from DigiFab™, CroFab™ and Voraxaze™ were in line with Company
expectations during the first quarter of the current financial year.
Expenditure and cash are also in line with expectations, as we continue
to make good progress with the Company's development pipeline, one of
the broadest, late-stage development portfolios in the UK
biopharmaceutical industry.
Pipeline progress:
AstraZeneca's phase 2 study of CytoFab™ in severe sepsis is expected
to report towards the end of the calendar year, providing
an important near-term event for one of the Company's key value
drivers. In addition, there has been substantial progress made during
the period to advance the Company's other programmes.
On 24 June we announced the start of a phase 2a proof-of-concept
clinical study of Angiotensin Therapeutic Vaccine (ATV) in 124
patients, with mild to moderate hypertension. The study will assess
the effects of ATV, which includes our promising new proprietary
adjuvant, CoVaccine HT™, on blood pressure and antibody response, in
addition to safety and tolerability. The blood pressure results are
expected in the first half of next year. ATV is a key value driver for
Protherics and, with good data, the Company looks forward to
progressing out-licensing discussions with potential partners.
On 22 April we announced that our placebo-controlled phase 2b Digoxin
Immune Fab (DIF) Efficacy Evaluation in Pre-eclampsia ("DEEP") study in
severe pre-eclampsia met one of its two primary endpoints. The DEEP
study results, along with data from further analyses, are under review
by a potential licensing partner. Data from the study will be presented
at international conferences later in the year, and we expect to
give guidance on the future of the programme before the end of
the calendar year.
In early June, Cancer Research UK presented promising headline data
from the Prolarix™ phase 1 study at the prestigious American Society
of Clinical Oncology (ASCO) Annual Meeting in Chicago, US. Prolarix is
a novel targeted prodrug therapy being developed for the treatment of
hepatocellular carcinoma (primary liver cancer) with the potential to
be used in other selected tumours. We are in the final stages of
preparation for the start of a phase 2a proof-of-concept study of
Prolarix in primary liver cancer.
Outlook:
With the start of the Prolarix phase 2a study anticipated shortly, we
will soon have achieved our goal of having 9 programmes in clinical
development in 2008. Importantly, we plan to start filing our marketing
application for Voraxaze in the US within the next few
months, and expect the results from AstraZeneca's phase 2 study of
CytoFab in severe sepsis around the end of 2008. In addition, in the
first half of 2009 we look forward to the results from the ATV phase 2a
trial in hypertension.
Commenting on today's announcement, Andrew Heath, Chief Executive of
Protherics, said:"We made good progress in the first quarter of our
financial year 2008/
9, with trading in line with expectations and with the start of the
Angiotensin Therapeutic Vaccine phase 2a study in hypertension. We look
forward to receiving important results in the near term for both ATV
and CytoFab, our two key value drivers, which we believe will
demonstrate the value in our diversified pipeline."
/ Ends /
For further information please contact:
Protherics
Andrew Heath, CEO +44 (0) 20 7246 9950
London, UK: Nick Staples, Director of Corporate +44 (0) 7919 480510
Affairs
Brentwood, US: Saul Komisar, President Protherics +1 615 327 1027
Inc
Financial Dynamics - press enquiries
London, UK: Ben Atwell, Lara Mott +44 (0) 20 7831 3113
New York, US: John Capodanno +1 212 850 5600
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 by 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 GBP26.1 million for the year ended 31
March 2008 and a strong cash balance of GBP37.7 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
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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