Form 6-K

6-K 1 pti200512086k.htm RE AGREEMENT WITH ASTRAZENECA Form 6-K

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

08 December 2005

PROTHERICS PLC

(Translation of Registrant’s Name Into English)

The Heath Business & Technical Park
Runcorn, Cheshire, W47 4QF England

(Address of Principal Executive Offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F X Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 191(b)(7):

Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes No X

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- .

The Registrant is furnishing a copy of its announcements as reported to the Company Announcements Office of the London Stock Exchange.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


		PROTHERICS PLC

Date: December 08, 2005	By:	/s/ Barrington M. Riley
		Barrington M. Riley
		Finance Director

Protherics and AstraZeneca Announce Late Stage Licensing Agreement On CytoFab™For Treatment Of Sepsis

London, UK, Nashville, TN 8 December 2005 - Protherics, the biopharmaceutical company focused on critical care and oncology, today
announces an agreement with AstraZeneca for the global development and commercialisation of 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 GBP195 million to Protherics, including an
initial payment of GBP16.3 million. In addition, AstraZeneca will make a GBP7.5 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 GBP171 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 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™."

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."

-Ends-

8th December 2005

A conference call and webcast for analysts will be held at 13.00 GMT/08.00 EST on Thursday 8th December. Journalists can listen in
ONLY by dialling, 0800 559 3282 (UK) or +44(0)20 7365 1832 (outside UK).

This will be followed by a presentation to analysts on Protherics' interim results at 15.00 GMT/10.00 EST at the offices of Financial
Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Webcast details can be found on http://www.protherics.com or
please call Mo Noonan for further details on +44 20 7269 7116.

For further information contact:

Protherics PLC +44 (0) 20 7246 9950
+44 (0) 7919 480510
Andrew Heath, CEO
Barry Riley, Finance Director
Nick Staples, Corporate Affairs

Protherics Inc +1 615 327 1027
Saul Komisar, President

Financial Dynamics
London: David Yates/Ben Atwell +44 (0) 20 7831 3113
New York: Jonathan Birt/John Capodanno +1 212 850 5600

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 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

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

This document contains forward-looking statements that involve risks and uncertainties including with respect to the approval of
Protherics' products for marketing and distribution in the US. Although we believe that the expectations reflected in such
forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct.
Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Actual results
could differ materially from those anticipated in these forward-looking statements due to many important factors, including the
factors discussed in Protherics' Annual Report 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 or written forward-looking statements that may be made by or on behalf
of Protherics.
END