AstraZeneca PLC
08 December 2005
AstraZeneca and Protherics Announce Late Stage Licensing Agreement On CytoFabTM
For Treatment Of Sepsis
AstraZeneca today announced a global development and commercialisation agreement
for Protherics anti-sepsis product CytoFabTM. CytoFabTM 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 CytoFabTM, 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 CytoFabTM 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 £195 million to Protherics, including an initial payment of £16.3
million. In addition, AstraZeneca will make a £7.5 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 £171 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 CytoFabTM. 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 CytoFabTM 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
CytoFabTM 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,
CytoFabTM 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 John Patterson, Executive Director of Development, AstraZeneca, said: '
CytoFabTM 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
CytoFabTM 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.'
Dr Andrew Heath, Chief Executive of Protherics, said: 'We are delighted to
announce a major licensing deal with AstraZeneca for CytoFabTM. 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 CytoFabTM. '
A conference call and webcast for analysts will be held at 13.00 GMT on Thursday
8th December. Full details are available on www.astrazeneca.com
-Ends-
8th December 2005
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