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
November 20, 2008
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.
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PROTHERICS PLC
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Date: November 20, 2008
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By:
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/s/ Rolf Soderstrom
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Rolf Soderstrom
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Finance Director
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Protherics PLC
Voraxaze™ rolling BLA submission initiated with the US
FDA
London, UK; Brentwood, TN, US;
20
November
20
08 -
Protherics PLC (“Protherics” or the “Company”), the international
biopharmaceutical company focused on critical care and cancer,
today
announces that it
has commenced the submission of a rolling Biologics License Application (BLA) for
Voraxaze
with the Food and Drug Administration
(FDA)
in the US. This marketing application is being
made for the interventional use of Voraxaze for the rapid and sustained reduction of
methotrexate (MTX) in patients who have toxic MTX levels due to impaired renal
function.
Voraxaze contains an enzyme that breaks down MTX, a commonly used cancer drug. It is an
investigational new drug that is available in the US under a Treatment Protocol for
patients receiving high dose MTX (
≥
1g/m
2
) who are
experiencing, or at risk of, MTX toxicity. High dose MTX is used to treat or prevent the
recurrence of certain types of cancer. Patients are considered at risk of MTX toxicity if
they have impaired renal function, which can lead to a delay in MTX elimination, or have
evidence of delayed elimination based on MTX levels. Voraxaze is also available in Europe
and elsewhere outside the US on a named patient basis.
The development program for interventional use of Voraxaze has
been granted Fast Track designation by the FDA, enabling the
submission of the
licensing application in sections rather than all components simultaneously. The Voraxaze
rolling BLA commenced today with the submission of a pre-clinical data module. The
remaining two modules containing the CMC (chemistry, manufacturing and control) and
clinical data are scheduled for submission within the next 12 months, as stipulated by the
FDA. Protherics intends to seek a Priority Review, reducing the time for the BLA review
from 10 to 6 months from submission of the final part of the application. This would allow
a potential marketing approval in US in 2010. Protherics estimates that the global market
potential for Voraxaze, for interventional use, is approximately $25-50m per annum.
Andrew Heath, Chief Executive of Protherics, commented:
“The initiation of the
Voraxaze BLA
submission
represents a
significant milestone towards enhancing our portfolio of niche, specialty pharmaceutical
products.
Approval by the FDA would provide an
excellent opportunity for us to promote and sell this important product in the US,
alongside CroFab™ and DigiFab™ when their US marketing rights are returned to
us in 2010."
| Ends |
F
or f
urther
i
nformation
please
contact
:
Protherics
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Ashley Tapp, Communication Manager
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+44 (0) 7790 811 554
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Saul Komisar, President Protherics Inc
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+1 615 327 1027
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Financial Dynamics
– press
enquiries
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London:
Ben
Atwell, Lara Mott
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+44 (0) 20 7831 3113
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New York:
John
Capodanno
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+1 212 850 5600
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Or visi
t
www.protherics.com
Notes for Editors:
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading international biopharmaceutical company
focused on specialist products for critical care and cancer.
The Company has two critical care products, CroFab™ and DigiFab™, approved for
sale in the US. The Company has the opportunity to sell these products in the US from
October 2010 together with Voraxaze™, a supportive cancer care product, following
anticipated approval in the US in 2010. Protherics is also developing a number of other
products in the cancer arena that it can commercialise in-house.
In addition, Protherics has several potential blockbuster products that require development
and commercialisation partners. These include CytoFab™ which has been partnered by
AstraZeneca in a major licensing deal, and also Angiotensin Therapeutic Vaccine and Digoxin
Immune Fabs for which licensing partners will be sought in 2008-2009. These products
have the potential to be high value products that can provide additional funding for the
Company.
Protherics reported revenues of £26.1 million for the year ended 31 March 2008 and a
strong cash balance of £37.7 million. With headquarters in London, the Company has
approximately 300 employees across its operations in the UK, US and Australia.
On Thursday, 18th September Protherics announced a proposed merger with BTG through a
recommended share offer.
For further information visit
www.protherics.com
About Methotrexate
Methotrexate (MTX) is a widely used anti-cancer drug which is often used in high-doses
(>1g/m
2
) in certain types of cancer. However, MTX 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 and
increased risk of sepsis and in some instances death.
Disclaimer
This document contains
forward-looking statements that involve risks and uncertainties including with respect
to
products under
development and the progress and completion of clinical trials.
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 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.
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