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
22 July 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
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:
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Trading and cash position in line with expectations
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Initiation of a phase 2a clinical study of Angiotensin
Therapeutic Vaccine in hypertension
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Results reported from the phase 2b "DEEP" study of Digoxin Immune Fab
in severe
pre-eclampsia
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Headline Prolarix(TM) 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 £37.7 million and a strong
sales performance with trading revenues of £23.5 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(TM), CroFab(TM) and Voraxaze(TM) 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(TM) 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(TM), 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(TM) 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
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Andrew Heath, CEO
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+44 (0) 20 7246 9950
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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(TM) and DigiFab(TM),
approved for sale in the US. The Company has the opportunity to
sell these products in the US from October 2010 together
with Voraxaze(TM), 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(TM) 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 £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
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: 22 July 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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