- Reference code :
- wf5197
- Published date :
-
08 December 2005
- Expired date :
-
25 April 2033
AstraZeneca today announced a global development and commercialisation agreement for Protherics anti-sepsis product CytoFab™. CytoFab™ 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 CytoFab™, 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 CytoFab™ 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 CytoFab™. 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 CytoFab™ 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 CytoFab™ 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, CytoFab™ 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: “ CytoFab™ 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 CytoFab™ 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 CytoFab™. 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 CytoFab™. ”
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
Notes for Editors:
About CytoFab™
CytoFab™ is an anti-TNF-alpha polyclonal antibody fragment (Fab) product, which is being developed for the treatment of severe sepsis. Polyclonal antibody 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 antibody fragments to bind TNF-alpha and thus achieve greater neutralisation of TNF-alpha compared to monoclonal antibodies. Secondly, antibody fragments (Fabs) are much smaller than whole antibody Immunoglobulin G molecules (IgG). This means that they have a much greater volume of distribution, with more rapid tissue penetration and clearance from the body.
In an 81 patient, randomised, placebo-controlled phase IIb severe sepsis study, CytoFab™ significantly reduced TNF-alpha in the blood and lung tissues of sepsis patients, and patients required, on average, five days’ less mechanical ventilation than when treated with placebo, achieving statistical significance on this endpoint. In addition, CytoFab™ showed an encouraging trend towards decreased mortality compared to placebo and a favourable side effect profile.
CytoFab™ is based on the same technology platform, sheep raised polyclonal Fabs, as Protherics CroFab™ (pit viper antivenom) and DigiFab™ (digoxin antidote) which have been approved and are currently marketed in the US. Protherics is the commercial manufacturer of these products.
About AstraZeneca
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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, neuroscience, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For further information visit: www.astrazeneca.com
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is an integrated biopharmaceutical company focused on the development and marketing of products for critical care and oncology. With headquarters in London, the Company has approximately 190 employees across its operations in the UK, US and Australia. The Company’s lead programmes are Voraxaze™, for the control of high dose methotrexate therapy in cancer, where discussions are on-going with the US and EU regulators regarding marketing approvals, and CytoFab™, for severe sepsis, which is being prepared for a pivotal phase 3 trial.
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 in drug development, biopharmaceutical manufacturing and regulatory affairs, Protherics’ goal is to develop and attract additional oncology and critical care products for its sales and marketing teams to distribute in the US and Europe.
The majority of the Company’s revenues are derived from two critical care products, CroFab™ (pit viper antivenom) and DigiFab™ (digoxin antidote) which were developed in-house and are sold in the US through Fougera Inc, a division of Altana AG. Additional products in the development pipeline include Prolarix™ (a selective prodrug based chemotherapy), currently in phase I; and an Angiotensin Vaccine (treatment of hypertension), where encouraging phase IIa results have led to an improved formulation entering pre-clinical testing.
For further information visit: www.protherics.com
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 CytoFab™. 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 CytoFab™ 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 CytoFab™ 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, CytoFab™ 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: “ CytoFab™ 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 CytoFab™ 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 CytoFab™. 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 CytoFab™. ”
Further enquiries to:
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
Notes for Editors:
About CytoFab™
CytoFab™ is an anti-TNF-alpha polyclonal antibody fragment (Fab) product, which is being developed for the treatment of severe sepsis. Polyclonal antibody 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 antibody fragments to bind TNF-alpha and thus achieve greater neutralisation of TNF-alpha compared to monoclonal antibodies. Secondly, antibody fragments (Fabs) are much smaller than whole antibody Immunoglobulin G molecules (IgG). This means that they have a much greater volume of distribution, with more rapid tissue penetration and clearance from the body.
In an 81 patient, randomised, placebo-controlled phase IIb severe sepsis study, CytoFab™ significantly reduced TNF-alpha in the blood and lung tissues of sepsis patients, and patients required, on average, five days’ less mechanical ventilation than when treated with placebo, achieving statistical significance on this endpoint. In addition, CytoFab™ showed an encouraging trend towards decreased mortality compared to placebo and a favourable side effect profile.
CytoFab™ is based on the same technology platform, sheep raised polyclonal Fabs, as Protherics CroFab™ (pit viper antivenom) and DigiFab™ (digoxin antidote) which have been approved and are currently marketed in the US. Protherics is the commercial manufacturer of these products.
About AstraZeneca
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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, neuroscience, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For further information visit: www.astrazeneca.com
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is an integrated biopharmaceutical company focused on the development and marketing of products for critical care and oncology. With headquarters in London, the Company has approximately 190 employees across its operations in the UK, US and Australia. The Company’s lead programmes are Voraxaze™, for the control of high dose methotrexate therapy in cancer, where discussions are on-going with the US and EU regulators regarding marketing approvals, and CytoFab™, for severe sepsis, which is being prepared for a pivotal phase 3 trial.
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 in drug development, biopharmaceutical manufacturing and regulatory affairs, Protherics’ goal is to develop and attract additional oncology and critical care products for its sales and marketing teams to distribute in the US and Europe.
The majority of the Company’s revenues are derived from two critical care products, CroFab™ (pit viper antivenom) and DigiFab™ (digoxin antidote) which were developed in-house and are sold in the US through Fougera Inc, a division of Altana AG. Additional products in the development pipeline include Prolarix™ (a selective prodrug based chemotherapy), currently in phase I; and an Angiotensin Vaccine (treatment of hypertension), where encouraging phase IIa results have led to an improved formulation entering pre-clinical testing.
For further information visit: www.protherics.com
Not signed in
Page tools
Share price
- London
-
26.95 GBP - New York
-
44.82 USD
- Stockholm
-
310.10 SEK
At 21-Nov-2009 07:01 GMT
Detailed share priceIntroduction to AstraZeneca
Our responsibility
We continue to communicate openly on a range of issues, including:
