ASTRAZENECA UPDATES CYTOFABTM DEVELOPMENT PROGRAMME
AstraZeneca today announced its intention to expand the development plan for CytoFabTM, a treatment for severe sepsis, with the addition of a
480 - patient Phase II study programme.
The company has recently completed consultations with regulators in the US and EU. These consultations confirmed that a single Phase III study could be sufficient for regulatory approval. Furthermore, to meet the regulatory needs of both agencies, it is required that AstraZeneca implement a Phase II study programme to support the single global Phase III study.
Data from Phase II will be used to more accurately estimate the number of patients required, and confirm the appropriate dose, for the Phase III study, as well as providing further supporting efficacy and safety data. This may enable a shorter timetable for the Phase III programme than originally anticipated by AstraZeneca.
The Phase II programme will start in the second half of 2007 and is expected to last up to 21 months. It will be immediately followed by the initiation of the Phase III study in the US, EU and Japan.
Under the terms of the licensing agreement, AstraZeneca is responsible for conducting and funding the global development of CytoFabTM and Protherics is responsible for product supply.
John Rex, Vice-President, Medical Director for Infection, AstraZeneca, said:
“Our goal is to optimise the chances of showing a statistically and clinically meaningful result with CytoFabTM, in a single, global Phase III study, while ensuring an acceptable time to market. To increase the likelihood of success in this complex disease and reflecting the changing regulatory environment for biologics, we have made the decision to undertake additional clinical work. We hope that this will help to reduce the size of and the time needed to complete the Phase III study. We believe that this development plan will give us the best chance of successful registration for this exciting treatment.”
Andrew Heath, Chief Executive of Protherics, said: “CytoFabTM represents a major market opportunity and AstraZeneca’s proposed development programme provides the treatment with the best route to registration. We now have a clear view of the steps needed to make this important new treatment available to sepsis patients worldwide.”
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Chris Major, Tel: +44 (0) 207 304 5028
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Jörgen Winroth, Tel: +1 (212) 579 0506
Ed Seage, Tel: +1 302 886 4065
Andrew Heath CEO, Tel: +44 (0) 20 7246 9950
Nick Staples, Director of Corporate Affairs, Tel: +44 (0) 7919 480510
Saul Komisar, President Protherics Inc, Tel: +1 615 327 1027
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Notes for Editors:
CytoFabTM is a first in class, anti-TNF-alpha polyclonal antibody fragment (Fab) product, which is being developed for the treatment of severe sepsis.
CytoFabTM licensing deal
CytoFabTM has been licensed in by AstraZeneca, which is responsible for its global development and commercialisation in an agreement worth up to £195M ($340M) to Protherics in upfront and milestone payments; Protherics will receive an additional 20 per cent royalty on global net product sales. Protherics is responsible for the supply of CytoFabTM bulk drug substance and will receive additional supply payments.
Sepsis occurs when the body’s immune system sets off a chain reaction and “overreacts” to an infection. Rather than being localized to the site of infection, the severe immune response develops throughout the body. A person suffering from sepsis can rapidly deteriorate, with the systemic response to an infection distorting the body’s natural balance and damaging one or more vital organs. A patient can continue to deteriorate into septic shock, where blood pressure falls dangerously low and many organs malfunction because of inadequate blood flow. Sepsis remains a significant problem in medical management, with an annual worldwide incidence of about 3 million and a 30 per cent mortality rate.
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 $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
Protherics (LSE: PTI, NASDAQ: PTIL) is an integrated biopharmaceutical company focused on the development, manufacture and marketing of specialist products for critical care and oncology.
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, Protherics’ goal is to develop and attract additional critical care and cancer products for its sales and marketing teams to distribute in the US and Europe.