12th Jan 2006 13:00
Protherics PLC12 January 2006 CYTOFABTM LICENSING AGREEMENT BETWEEN PROTHERICS AND ASTRAZENECA BECOMES EFFECTIVE FOLLOWING HART-SCOTT-RODINO CLEARANCE London, UK, Nashville, TN, 12 January 2006 - Following the announcement on 8December 2005, of the licensing agreement between Protherics and AstraZeneca forthe global development and commercialisation of Protherics' anti-sepsis productCytoFabTM, it is further announced that the agreement has become effectivefollowing the expiry of the Hart-Scott-Rodino waiting period in the US. This triggers an immediate initial payment to Protherics of £16.3 million and a£7.5 million equity investment by AstraZeneca in Protherics. The agreement hasfurther potential milestone payments worth up to £171 million and Prothericswill also receive a 20 percent net royalty on the net global sales of CytoFabTM. For further information contact: Protherics PLCAndrew Heath, CEO +44 (0) 20 7246 9950Barry Riley, FD +44 (0)1928 518000Nick Staples, Corporate Affairs +44 (0) 7919 480510Protherics IncSaul Komisar, President +1 615 327 1027 Financial DynamicsLondon: David Yates/Ben Atwell +44 (0) 20 7831 3113New York: Jonathan Birt/John Capodanno +1 212 850 5600 Notes for Editors: About CytoFabTM CytoFabTM is an anti-TNF-alpha polyclonal antibody fragment (Fab) product, whichis being developed for the treatment of severe sepsis. Polyclonal antibodyfragments are well suited to the in situ neutralisation of TNF-alpha, aninflammatory mediator implicated in sepsis, an inflammatory syndrome. Firstly,polyclonal antibodies are polyvalent, allowing multiple antibody fragments tobind TNF-alpha and thus achieve greater neutralisation of TNF-alpha compared tomonoclonal antibodies. Secondly, antibody fragments (Fabs) are much smallerthan whole antibody Immunoglobulin G molecules (IgG). This means that they havea much greater volume of distribution, with more rapid tissue penetration andclearance from the body. In an 81 patient, randomised, placebo-controlled phase 2b severe sepsis study,CytoFabTM 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, CytoFabTM showed an encouraging trend towardsdecreased mortality compared to placebo and a favourable side effect profile. In clinical studies of CytoFabTM in sepsis to date, there have been no adverseevents that were considered definitely, possibly or probably related totreatment with CytoFabTM. However, out of 110 sepsis patients who receivedCytoFabTM, there were 7 patients who experienced events of uncertain causalitythat are consistent with adverse events experienced by patients receiving otherovine Fab products, including 1 episode of pruritis, 2 episodes of wheezing, and4 episodes of rash. CytoFabTM is based on the same technology platform, sheep raised polyclonalFabs, as Protherics CroFabTM (pit viper antivenom) and DigiFabTM (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 VoraxazeTM, for the control of high dose methotrexate therapy incancer, where discussions are on-going with the US and EU regulators regardingmarketing approvals, and CytoFabTM, for severe sepsis, which has beenout-licensed to AstraZeneca and is being prepared for a pivotal phase 3 trial. Protherics' strategy is to use the revenues generated from its marketed products(£18.2m in the year ending Mar 2005) to help fund the advancement of itsdevelopment pipeline. With a proven track record in drug development,biopharmaceutical manufacturing and regulatory affairs, Protherics' goal is todevelop and attract additional oncology and critical care products for its salesand marketing teams to distribute in the US and Europe. The majority of the Company's revenues are derived from two critical careproducts, CroFabTM (pit viper antivenom) and DigiFabTM (digoxin antidote) whichwere developed in-house and are sold in the US through Fougera Inc, a divisionof Altana AG. Additional products in the development pipeline include ProlarixTM (selective prodrug based chemotherapy), currently in phase 1; and anAngiotensin Vaccine (treatment of hypertension), where encouraging phase 2aresults 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 Protherics' product pipeline andanticipated development and clinical trials for product candidates. Although webelieve that the expectations reflected in such forward-looking statements arereasonable at this time, we can give no assurance that such expectations willprove to be correct. Given these uncertainties, readers are cautioned not toplace undue reliance on such forward-looking statements. Actual results coulddiffer materially from those anticipated in these forward-looking statements dueto many important factors, including the factors discussed in Protherics' AnnualReport 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 orwritten forward-looking statements that may be made by or on behalf ofProtherics. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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