8th Dec 2005 07:02
AstraZeneca PLC08 December 2005 AstraZeneca and Protherics Announce Late Stage Licensing Agreement On CytoFabTM For Treatment Of Sepsis AstraZeneca today announced a global development and commercialisation agreementfor Protherics anti-sepsis product CytoFabTM. CytoFabTM is currently beingprepared for a single phase III registration study in severe sepsis in line withguidance received at an end of phase II meeting with the US Food and DrugAdministration (FDA). AstraZeneca will be responsible for developing CytoFabTM, 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 CytoFabTM and Protherics will be primarily responsible forbulk drug manufacturing, including the supply of clinical trial material. Theagreement 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 CytoFabTM. 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 CytoFabTM in the USand EU in 2007 following completion of improvements to the current manufacturingprocess. Protherics has previously demonstrated in a phase IIb study thatCytoFabTM 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,CytoFabTM showed an encouraging trend suggesting a survival benefit compared toplacebo 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 John Patterson, Executive Director of Development, AstraZeneca, said: "CytoFabTM 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 makeCytoFabTM the standard of care for patients with sepsis, improving their chancesof recovery and reducing their length of stay in intensive care. We hope itwill provide clinicians with a new means of addressing this devastatingcondition and ultimately, help save lives." Dr Andrew Heath, Chief Executive of Protherics, said: "We are delighted toannounce a major licensing deal with AstraZeneca for CytoFabTM. AstraZeneca hasproven 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 CytoFabTM. " A conference call and webcast for analysts will be held at 13.00 GMT on Thursday8th December. Full details are available on www.astrazeneca.com -Ends- 8th December 2005 Media Enquiries Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries: Mina Blair, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 Ed Seage, Tel: +1 302 886 4065 Jorgen Winroth, Tel + 1 212 579 0506 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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