London, UK, Nashville, TN 8 December 2005 - Protherics, the biopharmaceutical company focused on critical care and oncology, today announces an agreement with AstraZeneca for the global development and commercialisation of Protherics’ anti-sepsis product CytoFab(TM). CytoFab(TM) is currently being prepared for a single phase III registration study in severe sepsis in line with guidance received at an end of phase II meeting with the US Food and Drug Administration (FDA).
AstraZeneca will be responsible for developing CytoFab(TM), an anti-TNF-alpha polyclonal antibody fragment (Fab) product, as a treatment for TNF-alpha mediated diseases in man, with an initial target indication of severe sepsis. Sepsis is a life-threatening condition resulting from uncontrolled severe infections which affects an estimated three million people a year worldwide. Under the terms of the agreement, AstraZeneca will undertake all clinical development work for CytoFab(TM) and Protherics will be primarily responsible for bulk drug manufacturing, including the supply of clinical trial material. The agreement will become effective upon the expiration of the Hart-Scott-Rodino waiting period in the US, which is anticipated early in 2006.
The agreement has a potential total deal value, excluding royalties, of approximately GBP195 million to Protherics, including an initial payment of GBP16.3 million. In addition, AstraZeneca will make a GBP7.5 million equity investment in Protherics to be paid in cash, at 68.24 pence per share, being a 30 percent premium to the average middle market closing price of Protherics shares over the three months prior to the date of the agreement. AstraZeneca will own approximately 4.3 percent of Protherics’ enlarged share capital.
Protherics will receive additional payments worth up to GBP171 million payable upon the achievement of milestones. A significant proportion of these payments are contingent on pre-approval milestones being achieved. There are no milestone payments related to sales performance. Protherics will also receive royalties on global product sales of 20 percent of net sales which reflect the late stage development status and market potential of CytoFab(TM). Protherics will also receive additional payments in return for the commercial supply of the product and will invest to expand its manufacturing capacity accordingly.
AstraZeneca plans to start the pivotal phase III study for CytoFab(TM) in the US and EU in 2007 following completion of improvements to the current manufacturing process. Protherics has previously demonstrated in a phase IIb study that CytoFab(TM) caused a marked reduction in TNF-alpha in the blood and lung tissues of patients with severe sepsis, and that patients required on average five days’ less mechanical ventilation than when treated with placebo. In addition, CytoFab(TM) showed an encouraging trend suggesting a survival benefit compared to placebo and a favourable side-effect profile.
Approximately one third of patients with severe sepsis die from major organ failure. Patients typically require mechanical ventilation and intensive care. There is only one product currently available for the treatment of severe sepsis and there remains a considerable unmet need for treatment of this life-threatening condition.
Dr Andrew Heath, Chief Executive of Protherics, said: “We are delighted to announce a major licensing deal with AstraZeneca for CytoFab(TM). AstraZeneca has proven to be a focused and agile partner and as one of the leading pharmaceutical companies in the world, it has the clinical, regulatory and marketing strength to maximize the potential of CytoFab(TM). "
Dr John Patterson, Executive Director of Development, AstraZeneca, said: " CytoFab(TM) is an exciting opportunity for AstraZeneca to extend its infection franchise. By working together with Protherics, we now have the opportunity to build on the excellent phase IIb data already generated. Our goal is to make CytoFab(TM) the standard of care for patients with sepsis, improving their chances of recovery and reducing their length of stay in intensive care. We hope it will provide clinicians with a new means of addressing this devastating condition and ultimately, help save lives.”
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8th December 2005
A conference call and webcast for analysts will be held at 13.00 GMT/08.00 EST on Thursday 8th December. Journalists can listen in ONLY by dialling, 0800 559 3282 (UK) or +44(0)20 7365 1832 (outside UK).
This will be followed by a presentation to analysts on Protherics’ interim results at 15.00 GMT/10.00 EST at the offices of Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Webcast details can be found on http://www.protherics.com or please call Mo Noonan for further details on +44 20 7269 7116.
For further information contact:
Protherics PLC +44 (0) 20 7246 9950 +44 (0) 7919 480510 Andrew Heath, CEO Barry Riley, Finance Director Nick Staples, Corporate Affairs
Protherics Inc +1 615 327 1027 Saul Komisar, President
Financial Dynamics London: David Yates/Ben Atwell +44 (0) 20 7831 3113 New York: Jonathan Birt/John Capodanno +1 212 850 5600
Notes for Editors:
About CytoFab(TM)
CytoFab(TM) is an anti-TNF-alpha polyclonal antibody fragment (Fab) product, which is being developed for the treatment of severe sepsis. Polyclonal antibody fragments are well suited to the in situ neutralisation of TNF-alpha, an inflammatory mediator implicated in sepsis, an inflammatory syndrome. Firstly, polyclonal antibodies are polyvalent, allowing multiple antibody fragments to bind TNF-alpha and thus achieve greater neutralisation of TNF-alpha compared to monoclonal antibodies. Secondly, antibody fragments (Fabs) are much smaller than whole antibody Immunoglobulin G molecules (IgG). This means that they have a much greater volume of distribution, with more rapid tissue penetration and clearance from the body.
In an 81 patient, randomised, placebo-controlled phase IIb severe sepsis study, CytoFab(TM) significantly reduced TNF-alpha in the blood and lung tissues of sepsis patients, and patients required, on average, five days’ less mechanical ventilation than when treated with placebo, achieving statistical significance on this endpoint. In addition, CytoFab(TM) showed an encouraging trend towards decreased mortality compared to placebo and a favourable side effect profile.
CytoFab(TM) is based on the same technology platform, sheep raised polyclonal Fabs, as Protherics CroFab(TM) (pit viper antivenom) and DigiFab(TM) (digoxin antidote) which have been approved and are currently marketed in the US. Protherics is the commercial manufacturer of these products.
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is an integrated biopharmaceutical company focused on the development and marketing of products for critical care and oncology. With headquarters in London, the Company has approximately 190 employees across its operations in the UK, US and Australia. The Company’s lead programmes are Voraxaze(TM), for the control of high dose methotrexate therapy in cancer, where discussions are on-going with the US and EU regulators regarding marketing approvals, and CytoFab(TM), for severe sepsis, which is being prepared for a pivotal phase 3 trial.
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 in drug development, biopharmaceutical manufacturing and regulatory affairs, Protherics’ goal is to develop and attract additional oncology and critical care products for its sales and marketing teams to distribute in the US and Europe.
The majority of the Company’s revenues are derived from two critical care products, CroFab(TM) (pit viper antivenom) and DigiFab(TM) (digoxin antidote) which were developed in-house and are sold in the US through Fougera Inc, a division of Altana AG. Additional products in the development pipeline include Prolarix(TM) (a selective prodrug based chemotherapy), currently in phase I; and an Angiotensin Vaccine (treatment of hypertension), where encouraging phase IIa results have led to an improved formulation entering pre-clinical testing.
For further information visit: www.protherics.com
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, neuroscience, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For further information visit: www.astrazeneca.com
This document contains forward-looking statements that involve risks and uncertainties including with respect to the approval of Protherics’ products for marketing and distribution in the US. 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
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-------------------------------------------------------------------------------- Source: Protherics PLC
