8th Dec 2005 07:02
Protherics PLC08 December 2005 Protherics and AstraZeneca Announce Late Stage Licensing Agreement On CytoFab(TM) For Treatment Of Sepsis London, UK, Nashville, TN 8 December 2005 - Protherics, the biopharmaceuticalcompany focused on critical care and oncology, today announces an agreement withAstraZeneca for the global development and commercialisation of Protherics'anti-sepsis product CytoFab(TM). CytoFab(TM) is currently being prepared for asingle phase III registration study in severe sepsis in line with guidancereceived 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-alphapolyclonal antibody fragment (Fab) product, as a treatment for TNF-alphamediated diseases in man, with an initial target indication of severe sepsis.Sepsis is a life-threatening condition resulting from uncontrolled severeinfections which affects an estimated three million people a year worldwide.Under the terms of the agreement, AstraZeneca will undertake all clinicaldevelopment work for CytoFab(TM) and Protherics will be primarily responsiblefor bulk drug manufacturing, including the supply of clinical trial material. The agreement will become effective upon the expiration of the Hart-Scott-Rodinowaiting period in the US, which is anticipated early in 2006. The agreement has a potential total deal value, excluding royalties, ofapproximately £195 million to Protherics, including an initial payment of £16.3million. In addition, AstraZeneca will make a £7.5 million equity investment inProtherics to be paid in cash, at 68.24 pence per share, being a 30 percentpremium to the average middle market closing price of Protherics shares over thethree months prior to the date of the agreement. AstraZeneca will ownapproximately 4.3 percent of Protherics' enlarged share capital. Protherics will receive additional payments worth up to £171 million payableupon the achievement of milestones. A significant proportion of these paymentsare contingent on pre-approval milestones being achieved. There are nomilestone payments related to sales performance. Protherics will also receiveroyalties on global product sales of 20 percent of net sales which reflect thelate stage development status and market potential of CytoFab(TM). Prothericswill also receive additional payments in return for the commercial supply of theproduct and will invest to expand its manufacturing capacity accordingly. AstraZeneca plans to start the pivotal phase III study for CytoFab(TM) in the USand EU in 2007 following completion of improvements to the current manufacturingprocess. Protherics has previously demonstrated in a phase IIb study thatCytoFab(TM) caused a marked reduction in TNF-alpha in the blood and lung tissuesof 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 comparedto placebo and a favourable side-effect profile. Approximately one third of patients with severe sepsis die from major organfailure. Patients typically require mechanical ventilation and intensive care.There is only one product currently available for the treatment of severe sepsisand there remains a considerable unmet need for treatment of thislife-threatening condition. Dr Andrew Heath, Chief Executive of Protherics, said: "We are delighted toannounce a major licensing deal with AstraZeneca for CytoFab(TM). AstraZenecahas proven to be a focused and agile partner and as one of the leadingpharmaceutical companies in the world, it has the clinical, regulatory andmarketing 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 infectionfranchise. By working together with Protherics, we now have the opportunity tobuild on the excellent phase IIb data already generated. Our goal is to makeCytoFab(TM) the standard of care for patients with sepsis, improving theirchances of recovery and reducing their length of stay in intensive care. Wehope it will provide clinicians with a new means of addressing this devastatingcondition and ultimately, help save lives." -Ends- 8th December 2005 A conference call and webcast for analysts will be held at 13.00 GMT/08.00 ESTon Thursday 8th December. Journalists can listen in ONLY by dialling, 0800 5593282 (UK) or +44(0)20 7365 1832 (outside UK). This will be followed by a presentation to analysts on Protherics' interimresults at 15.00 GMT/10.00 EST at the offices of Financial Dynamics, HolbornGate, 26 Southampton Buildings, London WC2A 1PB. Webcast details can be foundon http://www.protherics.com or please call Mo Noonan for further details on +4420 7269 7116. For further information contact: Protherics PLC +44 (0) 20 7246 9950 +44 (0) 7919 480510Andrew Heath, CEOBarry Riley, Finance DirectorNick Staples, Corporate Affairs Protherics Inc +1 615 327 1027Saul Komisar, President Financial DynamicsLondon: David Yates/Ben Atwell +44 (0) 20 7831 3113New 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. Polyclonalantibody 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 antibodyfragments to bind TNF-alpha and thus achieve greater neutralisation of TNF-alphacompared to monoclonal antibodies. Secondly, antibody fragments (Fabs) are muchsmaller than whole antibody Immunoglobulin G molecules (IgG). This means thatthey have a much greater volume of distribution, with more rapid tissuepenetration 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 ofsepsis patients, and patients required, on average, five days' less mechanicalventilation than when treated with placebo, achieving statistical significanceon this endpoint. In addition, CytoFab(TM) showed an encouraging trend towardsdecreased mortality compared to placebo and a favourable side effect profile. CytoFab(TM) is based on the same technology platform, sheep raised polyclonalFabs, as Protherics CroFab(TM) (pit viper antivenom) and DigiFab(TM) (digoxinantidote) 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 companyfocused on the development and marketing of products for critical care andoncology. With headquarters in London, the Company has approximately 190employees across its operations in the UK, US and Australia. The Company's leadprogrammes are Voraxaze(TM), for the control of high dose methotrexate therapyin cancer, where discussions are on-going with the US and EU regulatorsregarding marketing approvals, and CytoFab(TM), for severe sepsis, which isbeing prepared for a pivotal phase 3 trial. Protherics' strategy is to use the revenues generated from its marketed productsto help fund the advancement of its development pipeline. With a proven trackrecord in drug development, biopharmaceutical manufacturing and regulatoryaffairs, Protherics' goal is to develop and attract additional oncology andcritical care products for its sales and marketing teams to distribute in the USand Europe. The majority of the Company's revenues are derived from two critical careproducts, CroFab(TM) (pit viper antivenom) and DigiFab(TM) (digoxin antidote)which were developed in-house and are sold in the US through Fougera Inc, adivision of Altana AG. Additional products in the development pipeline includeProlarix(TM) (a selective prodrug based chemotherapy), currently in phase I; andan Angiotensin Vaccine (treatment of hypertension), where encouraging phase IIaresults 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 theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of over $21.4 billion and leadingpositions in sales of gastrointestinal, cardiovascular, respiratory,neuroscience, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. Forfurther information visit: www.astrazeneca.com This document contains forward-looking statements that involve risks anduncertainties including with respect to the approval of Protherics' products formarketing and distribution in the US. Although we believe that the expectationsreflected in such forward-looking statements are reasonable at this time, we cangive no assurance that such expectations will prove to be correct. Given theseuncertainties, readers are cautioned not to place undue reliance on suchforward-looking statements. Actual results could differ materially from thoseanticipated in these forward-looking statements due to many important factors,including the factors discussed in Protherics' Annual Report on Form 20-F andother reports filed from time to time with the U.S. Securities and ExchangeCommission. We do not undertake to update any oral or written forward-lookingstatements that may be made by or on behalf of Protherics. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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