Protherics PLC Announces AGM and Interim Management Statement

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(TM) and DigiFab(TM) 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(TM)

Protherics has produced CytoFab(TM) 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(TM)

Protherics has commenced the additional manufacturing work requested by the FDA to support a Voraxaze(TM) marketing application in the US. We have also agreed the design of a small study to address the interaction of Voraxaze(TM) with leucovorin, and are preparing the final protocol.

Named patient sales of Voraxaze(TM) 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(TM) in the US under a Treatment Protocol. Protherics is permitted to charge the commercial price for Voraxaze(TM) 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(TM) in the EU.

OncoGel(TM)

Following the encouraging OncoGel(TM) 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(TM) 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(TM) 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(TM) in primary brain cancer at a major scientific conference.

Prolarix(TM)

We recently reported that Cancer Research UK has determined the maximum tolerated dose (MTD) for Prolarix(TM), 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(TM). 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."

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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(TM), a pit viper antivenom and DigiFab(TM), 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(TM) 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(TM), 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.

Source:money.cnn.com