Cheshire, UK -- (MARKET WIRE) -- March 12, 2007 --
Protherics PLC
Protherics to receive GBP10 million milestone from AstraZeneca
London, UK; Brentwood, TN, US; 12 March 2007 - Protherics PLC
("Protherics" or the "Company"), the international
biopharmaceutical company focused on critical care and cancer,
today announces that a GBP10 million milestone payment from
AstraZeneca has been triggered as a result of the successful
scale-up of the CytoFabTM manufacturing process to a 600 litre
batch size. This milestone will be included in the Company's
results for the financial year ending 31 March 2007 and is
expected to be received in April.
On receipt of this manufacturing related milestone, Protherics
will have received a total of GBP26.3 million in milestone
payments from AstraZeneca since the deal was signed in December
2005. Under the licensing agreement, Protherics may receive up
to a further GBP161 million in milestone payments, in addition
to a 20% royalty on global net product sales of CytoFabTM.
Andrew Heath, Chief Executive of Protherics commented:
"Scaling-up the CytoFab manufacturing process has been a major
focus for Protherics since signing the deal with AstraZeneca in
December 2005. We are extremely pleased to have met this key
milestone and are excited about the prospect of AstraZeneca
continuing the clinical development of CytoFab."
John Rex, Vice-President, Medical Director for Infection,
AstraZeneca, said:
"We are delighted with the progress that has been made with
CytoFab to date, and we are all looking forward to starting the
expanded phase 2 programme with CytoFab in the second half of
this year as planned."
Ends
For further information please contact:
Protherics
Andrew Heath, CEO +44 (0) 20 7246 9950
Nick Staples, Director of Corporate
Affairs +44 (0) 7919 480510
Saul Komisar, President Protherics Inc +1 615 327 1027
Financial Dynamics - press enquiries
London: Ben Atwell, Anna Keeble +44 (0) 20 7831 3113
New York: John Capodanno, Jonathan Birt +1 212 850 5600
Or visit
www.protherics.com
Notes for Editors:
About CytoFabTM
CytoFabTM is a first in class anti-TNF-alpha polyclonal
antibody fragment (Fab) product, which is being developed for
the treatment of severe sepsis.
Effective neutralisation of TNF-alpha
TNF-alpha is an inflammatory mediator strongly implicated in
sepsis, an inflammatory syndrome. Polyclonal antibody fragments
are well suited to the in situ neutralisation of TNF-alpha for
two main reasons. Firstly, polyclonal antibodies are
polyvalent, allowing multiple antibody fragments to bind
TNF-alpha and thus achieve greater neutralisation compared to
monoclonal antibodies. Secondly, antibody fragments (Fabs) are
much smaller than whole antibody Immunoglobulin G molecules
(IgG). As a result, they have a much greater volume of
distribution, with more rapid tissue penetration and clearance
from the body than monoclonal antibodies.
Encouraging phase 2b data
A phase 2b study was conducted in 19 centres in North America
and was coordinated by the leading sepsis investigator,
Professor Gordon R. Bernard, M.D., Director, Division of
Allergy, Pulmonary and Critical Care, Vanderbilt University.
The trial was a double blind placebo controlled randomised
study involving 81 patients with either septic shock or sepsis
with multiple organ dysfunctions.
Two hours after initiation of treatment, TNF-alpha became
undetectable in all patients receiving CytoFabTM who had
detectable levels pre-treatment whereas levels in the placebo
group remained at baseline. TNF-alpha remained significantly (p
< 0.050) lower in the CytoFabTM group throughout the 120 hour
infusion period. CytoFabTM also significantly decreased TNF-
alpha in bronchoalveolar lavage (BAL) fluid (p < 0.001).
Patients who received CytoFabTM had more shock-free days than
those who received placebo (10.7 vs 9.4, p = 0.259), by day 14,
and spent significantly more time off a ventilator (15.6 vs 9.8
ventilator-free days, p = 0.021) and 5 days less in an ICU
(12.6 vs 7.6 ICU-free days, p = 0.030) by day 28. There was an
encouraging trend to lower mortality at 28-days in the
CytoFabTM group relative to the placebo group (26% vs 37%, p =
0.274). There were no differences in the incidence of adverse
events or in laboratory or vital sign abnormalities, between
groups.
The full phase 2b data has been published in Critical Care
Medicine (2006; 34(9):2271-2281).
Important safety data
In clinical studies of CytoFabTM in sepsis to date, there have
been no adverse events that were considered definitely,
possibly or probably related to treatment with CytoFabTM.
However, out of 110 sepsis patients who received CytoFabTM,
there were 7 patients who experienced events of uncertain
causality that are consistent with adverse events experienced
by patients receiving other ovine Fab products, including 1
episode of pruritis, 2 episodes of wheezing, and 4 episodes of
rash.
Approved technology platform
CytoFabTM is based on the same technology platform, ovine
polyclonal Fabs, as Protherics' CroFabTM (pit viper antivenom)
and DigiFabTM (digoxin antidote) which have been approved and
are currently marketed in the US. Protherics is the commercial
manufacturer of these products.
AstraZeneca licensing deal
CytoFabTM has been out-licensed to AstraZeneca, which is
responsible for its global development and commercialisation in
an agreement worth up to GBP187.3 million ($340 million) to
Protherics in upfront and milestone payments; Protherics will
receive an additional 20% royalty on global net product sales.
Protherics is responsible for the supply of CytoFabTM bulk drug
substance and will receive additional supply payments. On
payment of this manufacturing related milestone payment,
Protherics will have received a total of GBP26.3 million in
milestone payments since the agreement was signed in December
2005.
On 3 November 2006, AstraZeneca announced its intention to
undertake an additional phase 2 programme in the second half of
2007 with CytoFabTM prior to the initiation of the Phase 3
study in the US, EU and Japan.
About Sepsis
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 world wide incidence of about 3 million and a
30% mortality rate.
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading
biopharmaceutical company focused on the development,
manufacture and marketing of specialist products for critical
care and cancer.
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.
Protherics potentially has two blockbuster opportunities in its
critical care franchise. CytoFabTM is being developed by
AstraZeneca for the treatment of severe sepsis, and is expected
to start an expanded phase 2 study in 2007. In addition the
Company has in-licensed intellectual property relating to the
use of anti-digoxin polyclonal antibody fragments such as
DigiFabTM and GSK's Digibind® in the treatment of
pre-eclampsia and eclampsia. Protherics is currently
undertaking a phase 2b study with Digibind® which is expected
to report in 2007.
Protherics has four cancer products in development: VoraxazeTM
which is an adjunct to high dose methotrexate therapy currently
in pre-registration in the US and Europe; OncoGelTM, a
formulation of paclitaxel in phase 2a development for the
treatment of oesophageal and a brain cancer study about to
commence; ProlarixTM, a targeted cancer therapy for primary
liver cancer and other select tumours which is currently in
phase 1 with a phase 2a study planned for 2007; and acadesine,
which is being jointly developed with Advancell for the
treatment of B-cell chronic lymphocytic leukaemia and a phase 1
/2 study is planned to start mid 2007.
The Company is also developing its Angiotensin Therapeutic
Vaccine for the treatment of hypertension, where encouraging
phase 2a results have been demonstrated and another phase 2a is
planned with an improved formulation in 2007.
The majority of the Company's sales revenues (GBP17.7m in the
year ended 31 March 2006) are derived from two critical care
products, CroFabTM (pit viper antivenom) and DigiFabTM (digoxin
antidote) which were developed by Protherics and are sold, in
the US, through Fougera Inc, a division of Altana AG.
With headquarters in London, the Company has approximately 260
employees across its operations in the UK, US and Australia.
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 $26.47 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 FTSE4 Good Index.
Disclaimer
This document contains forward-looking statements that involve
risks and uncertainties, including with respect to Protherics'
product pipeline and anticipated development and clinical
trials for product candidates. 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
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