Cheshire, UK--(Marketwire - July 26, 2007) -
Protherics PLC
AGM and Interim Management Statement
London, UK; Brentwood, TN, US; 26 July 2007 - Protherics PLC ("Protherics" or
the "Company"), the international biopharmaceutical company focused on critical
care and cancer, provides its Interim Management Statement ahead of the
Company's AGM at midday today.
Protherics reported strong financial results for its financial year ended 31
March 2007, with losses for the year reduced from the prior year and a solid
financial position. Trading for the first quarter of the current financial year
was in-line with expectations. Sales of CroFab™ and DigiFab™ by our US
distributor, Fougera, have been strong and our shipments of product to them over
the remainder of the year are anticipated to be ahead of the previous year, also
in-line with expectations. We continue to increase our investment in R&D across
our expanded pipeline as planned and G&A expenditure will also increase, as
previously indicated, reflecting the acquisition of MacroMed in January 2007.
We plan these increased expenditures from a strong financial base: unaudited
cash balances at 30 June 2007 were USD45m, following the USD10m AstraZeneca
milestone payment received in April 2007 and ongoing expenditure is in-line with
expectations.
We have also made excellent progress since our preliminary results with our
development portfolio:
CytoFab™
Protherics has produced CytoFab™ clinical trial material at commercial scale
as planned, and AstraZeneca is now preparing to start its additional 480 patient
Phase II programme in severe sepsis in the fourth quarter of the 2007.
Digoxin Immune Fab
The Phase IIb DEEP study to investigate the use of Digoxin Immune Fab in severe
pre-eclampsia remains on track to report in the first half of 2008. Awareness
of the study in the US has increased following recent press coverage.
Voraxaze™
Protherics has commenced the additional manufacturing work requested by the FDA
to support a Voraxaze™ marketing application in the US. We have also agreed
the design of a small study to address the interaction of Voraxaze™ with
leucovorin, and are preparing the final protocol.
Named patient sales of Voraxaze™ in the US have started strongly and are
currently ahead of our expectations. This follows FDA approval at the end of
May for the supply of Voraxaze™ in the US under a Treatment Protocol.
Protherics is permitted to charge the commercial price for Voraxaze™ to
recover some of the costs associated with the programme. Protherics intends to
request a meeting with the EMEA in the next few months regarding the potential
re-submission of a Marketing Authorisation Application for Voraxaze™ in the
EU.
OncoGel™
Following the encouraging OncoGel™ Phase IIa data in oesophageal cancer
reported in June, and following discussions with our Clinical Advisory Board, we
have decided to prioritise the development of OncoGel™ in combination with
pre-operative chemoradiotherapy to improve patient survival. We have met with
the EMEA and have a meeting scheduled with the FDA to agree on the protocol for
a Phase IIb study, which is planned to start in the US and Europe later in the
year.
In March, we initiated a Phase I/II study of OncoGel™ in primary brain cancer
and we continue recruiting patients into the first dose cohort. We also recently
presented encouraging preclinical data for the use of OncoGel™ in primary
brain cancer at a major scientific conference.
Prolarix™
We recently reported that Cancer Research UK has determined the maximum
tolerated dose (MTD) for Prolarix™, our prodrug based selective cancer
therapy for the treatment of primary liver cancer. Two patients have already
been recruited into an additional cohort of 6 patients who will receive up to
six cycles of Prolarix at the MTD. Protherics expects Cancer Research UK to
report the study in the first half of 2008. Meanwhile, we are planning to start
a Phase II study in primary liver cancer in the first half of 2008 to
investigate the efficacy of this promising cancer therapy in its lead
indication.
Acadesine
We are now close to completing the preclinical testing of acadesine, our
selective therapy for the treatment of B-cell Chronic Lymphocytic Leukaemia
(B-CLL), which will allow us to commence a proof of concept Phase I/II study in
B-CLL patients in the coming months.
Angiotensin Therapeutic Vaccine and CoVaccine HT
We continue preparing for the start of a proof of concept Phase IIa study of our
Angiotensin Therapeutic Vaccine, which includes our new proprietary adjuvant,
CoVaccine HT, in hypertensive patients in the first half of 2008. We are
receiving significant external interest in our adjuvant for use in third party
vaccines.
Andrew Heath, Chief Executive of Protherics commented:
"Since the year end, Protherics has made good progress with its portfolio and
trading has been strong. We are on track to commence four Phase 2 clinical
studies in the current financial year, including AstraZeneca's Phase 2 programme
for CytoFab™. With these trials commencing and with the Phase 2b
pre-eclampsia study reporting, we expect to see significant pipeline progress in
the current financial year."
| Ends |
For further information please contact:
Protherics
Andrew Heath, CEO +44 (0) 20 7246 9950
Nick Staples, Director of Corporate Affairs +44 (0) 7919 480510
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 Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading biopharmaceutical company
focused on the development, manufacture and marketing of specialised products
for critical care and cancer.
Protherics has developed and manufactures two biologics for critical care which
are FDA approved and currently sold in the US: CroFab™, a pit viper antivenom
and DigiFab™, a digoxin antidote. The Company's strategy is to use the
revenues generated from its marketed and out-licensed products to help fund the
advancement of its broad, late stage pipeline.
Protherics has two major development opportunities in its critical care
portfolio. CytoFab™ is being developed by AstraZeneca, for the treatment of
severe sepsis, after a major USD195 million ($340 million) licensing deal with
AstraZeneca in December 2005. An additional, expanded phase 2 programme is
planned to start in the second half of 2007. In addition, Protherics is
currently undertaking a phase 2b study with Digoxin Immune Fab for the treatment
of pre-eclampsia. This study is expected to report in the first half of 2008.
Protherics has a pipeline of four novel cancer products in clinical development,
and intends to undertake the sales and marketing of these products in the US and
or the EU. Protherics is preparing to resubmit a BLA for Voraxaze™, an
adjunct to high dose methotrexate therapy, under a rolling submission in the US
starting in early 2008.
Protherics has a strong cash position, with unaudited cash balances at 30 June
2007 of USD45m, having completed a USD38 million equity fundraising in January 2007
and received a USD10 million milestone payment from AstraZeneca in April 2007.
With headquarters in London, the Company has approximately 270 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 future growth, product development and
clinical studies, product sales and regulatory approval of Protherics' products
for marketing and distribution. 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 market for the Company's products, the timing and receipt of
regulatory approvals, the progression and results of clinical studies and other
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