Cheshire, UK -- (MARKET WIRE) -- January 11, 2007 --
Protherics PLC
Voraxaze(TM) Update
London, UK; Brentwood, TN, US; 11 January 2007 - Protherics PLC, the
international biopharmaceutical company focused on critical care and cancer,
today provides an update on progress with Voraxaze™ in the United States and
Europe. Voraxaze™ is an adjunctive therapy for patients experiencing, or at
risk of, toxicity from methotrexate ("MTX"), a widely used anti-cancer agent.
On 7 November 2006, Protherics announced that it was proposing to resubmit its
Biologics License Application ("BLA") for Voraxaze™ to the Food and Drug
Administration ("FDA") in the US, following the FDA's request for additional
manufacturing data. Protherics also announced that it believed that
Voraxaze™ would be eligible for Priority Review, thus reducing the time for
the BLA review from 10 to 6 months. Protherics announces today that the FDA has
now granted Voraxaze™ a Fast Track Designation, which supports our
expectations of an expedited approval process, with possible approval from the
second half of 2008.
In Europe, Protherics submitted a Marketing Authorisation Application ("MAA")
for Voraxaze™ to the European Medicines Evaluation Agency ("EMEA") in June
2005. The EMEA has now also identified the need for further information on
manufacturing in its Day 150 Assessment Report. In addition, the EMEA has
requested further work assessing the potential of Voraxaze™ to interact with
leucovorin, which is currently administered in conjunction with high dose MTX
therapy.
Pending successful generation of this additional data, Protherics now
anticipates that approval in the EU could be granted from the second half of
2008, in line with the current expectations for approval in the US.
Protherics will continue supplying Voraxaze™ on a named patient basis in
Europe and the rest of the world, and on a compassionate basis in the US for
intervention use in patients at risk of severe or life-threatening methotrexate
toxicity due to delays in their elimination of MTX following high dose MTX
therapy. The FDA has approved the first planned use study which is due to start
at the prestigious MD Anderson Cancer Center in the US in 2007 and Medicines and
Healthcare products Regulatory Agency approval has been obtained for a study in
the UK.
Andrew Heath, Chief Executive of Protherics, said:
"The granting of Fast Track Status for Voraxaze™ in the US underlines the
importance of this emergency intervention therapy. We continue to work together
with the EMEA and FDA to bring this important product to market as swiftly as
possible. In the meantime, we will continue to make Voraxaze™ available on a
named patient basis in Europe and the rest of the world, and in the US on a
compassionate use basis, for cancer patients experiencing delayed MTX
elimination following high dose methotrexate therapy."
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For further information please contact:
Protherics
Andrew Heath, CEO +44 (0) 20 7246 9950
Barry Riley, Finance Director +44 (0)1928 518 003
Carol Clark-Evans, Head of Regulatory Affairs +1 615 327 1027
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 Voraxaze™
Voraxaze™ is a unique drug that allows clinicians to control the removal of
methotrexate (MTX) from the body and thereby reduce the risk of serious
toxicities and death which can result from prolonged exposure to MTX following
high dose methotrexate therapy (HDMTX).
Voraxaze™ contains a recombinant enzyme (glucarpidase) which acts by rapidly
and markedly reducing MTX concentrations in the blood, which can sometimes be at
dangerously elevated levels. In one pivotal and two supportive studies,
Voraxaze™ was able to achieve a clinically important reduction (CIR) in MTX
to less than or equal to 1 micromol/L in the majority of patients treated. This
is a generally accepted threshold below which the risk of severe MTX toxicity is
considered to be reduced. Voraxaze™ consistently reduced plasma or serum MTX
concentrations by an average of > 98% within an hour of administration in each
of the three studies.
In clinical studies, a total of 25/329 (8%) patients reported 50 adverse events
with a possible relationship to Voraxaze™; about a third of these were
allergic reactions (burning sensation, flushing, hot flush, allergic dermatitis,
feeling hot, pruritis, hypersensitivity). Two of the adverse events were
considered serious, hypertension and arrhythmia, but neither was definitively
associated with use of Voraxaze™ and the latter was considered more likely to
be associated with MTX.
Protherics currently supplies Voraxaze™ on a named patient basis directly or
for certain EU countries through IDIS World Medicines. For more information,
please visit:
http://www.protherics.com/products/oncology.aspx
Methotrexate
Methotrexate is a widely used anti-cancer drug which is often used in high-doses
(>1g/m2) in certain types of cancer. However, methotrexate can result in reduced
kidney function, particularly when used in high doses. This further delays the
elimination of methotrexate from the body leading to mucositis, increased
haematological toxicity, increased risk of sepsis and in some instances death.
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is an integrated 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. CytoFab™ is being developed by AstraZeneca for the treatment of
severe sepsis, and is expected to start an additional phase 2 study in 2007. In
addition the Company has in-licensed the intellectual property from Glenveigh (a
small private US based company) relating to the use of anti-digoxin polyclonal
antibody fragments such as DigiFab™ and GSK's Digibind® in the treatment of
pre-eclampsia and eclampsia. Glenveigh is currently undertaking a phase 2b
study with Digibind® which Protherics expects to report in 2007.
Following the recently announced acquisition of MacroMed (a US based drug
development and manufacturing company) Protherics has three further cancer
products in development, in addition to Voraxaze™; including OncoGel, a
formulation of paclitaxel in development for the treatment of oesophageal and
brain cancers; Prolarix™, a targeted cancer therapy for primary liver cancer
and other select tumours (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.
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, CroFab™ (pit viper
antivenom) and DigiFab™ (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
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.
This information is provided by RNS
The company news service from the London Stock Exchange