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Xenova Group PLC (XEN)

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Thursday 03 October, 2002

Xenova Group PLC

FDA Fast Track Status

Xenova Group PLC
03 October 2002

                                                           FOR IMMEDIATE RELEASE

                             Xenova Group plc

             Xenova's Tariquidar Granted FDA Fast Track Status

Slough, UK, October 3, 2002 - Xenova Group plc (NASDAQ NM: XNVA; London Stock
Exchange: XEN) today announces that the US Food and Drug Administration (FDA)
has granted fast track review status to tariquidar for the treatment of
multi-drug resistance in first-line treatment of non-small cell lung cancer
(NSCLC) patients.

Under the FDA Modernization Act of 1997, designation as a Fast Track Product
means that the FDA will facilitate the development and expedite the review of a
new drug that is intended for the treatment of a serious or a life-threatening
condition, if it demonstrates the potential to address unmet clinical needs for
such a condition.

Xenova and its North American partner, QLT Inc. (NASDAQ: QLTI; TSE: QLT), are
currently evaluating tariquidar in two pivotal Phase III clinical trials as an
adjunctive treatment in combination with first-line chemotherapy for NSCLC

David Oxlade, Chief Executive of Xenova, commented:

'We are delighted with the FDA's decision to grant fast track designation to
tariquidar.   Non-small cell lung cancer is a leading cause of cancer deaths and
our current trials are designed to demonstrate that the use of tariquidar will
improve survival of patients with this condition.'

Current clinical trial programme: In June 2002 it was announced that patient
enrolment has begun in two pivotal Phase III trials for tariquidar. The two
double-blind, randomised, placebo-controlled trials are being carried out on
approximately 1,000 patients at approximately 100 centres located throughout
North America and Europe.  The primary end-point of both trials is overall
survival.  An interim safety analysis is planned for mid-2003.

It is anticipated that, on successful completion of the Phase III programme, QLT
will file for approval of tariquidar in North America for use in combination
with first-line chemotherapy in advanced NSCLC by the end of 2005.

Partnership with QLT Inc: As announced In August 2001, Xenova has entered into
an agreement with QLT for the development and North American marketing of
tariquidar.  This agreement will provide Xenova with funding, in the form of
licence and milestone payments and research and development funding, to gain
product marketing approval.  QLT paid an upfront licence fee of US$10m (£7.1m)
and will provide up to US$45m (£28.9m) in funding for development activities
related to Phase III clinical studies for tariquidar in North America and
Europe.  In addition, milestones of up to US$50m (£32.2m) and royalties in the
range of 15 to 22 per cent depending on the level of North American sales are
also payable to Xenova.

Xenova retains substantially all rights to commercialise tariquidar in Europe
and the Rest of the World and Xenova's directors intend to establish further
collaborations to maximise the value of this potentially first-in-class drug.


UK:                                                 US:
Xenova Group plc                                    Trout Group/BMC Communications
Tel: +44 (0)1753 706600                             Tel: 001 212 477 9007
David A Oxlade, Chief Executive Officer             Press: Brad Miles (Ext 17) Lauren Tortorete (Ext 20)
Daniel Abrams, Group Finance Director               Investors: Jonathan Fassberg (Ext 16) Lee Stern (Ext 22)
Hilary Reid Evans, Corporate Communications

Financial Dynamics
Tel: +44 (0)207 831 3113
Fiona Noblet

Media: Tamara Hicks, Tel 001 604 707 7316
Investors: Therese Crozier or Tamara Hicks

Tel 001 604 707 7000

Notes to Editors

Xenova Group plc is an emerging bio-pharmaceutical company focusing on the
therapeutic areas of cancer and immune system disorders.  Xenova's directors
believe that it has a strong and well balanced portfolio of product candidates
in development, with 8 products in clinical trials and a further 8 in
preclinical development.  The Group has a strong track record in the discovery
and development of novel drug candidates and has established partnerships with
major pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT
and Millennium Pharmaceuticals.

Tariquidar - There is a substantial market opportunity for a drug that overcomes
multi-drug resistance (MDR).  It is estimated that, depending on the type of
cancer, between 30 and 80 per cent of solid tumours develop resistance to
anti-cancer drugs.  In 1999 the total cancer drugs market was around $23 billion
per annum, of which over 30 per cent was made up of cytotoxics.  A drug
resistance modulator such as tariquidar would be used in combination with these
cytotoxics, such as the taxanes, anthracyclines and vinca alkaloids.  The most
common known form of MDR is the result of over-production of a membrane protein,
known as P-gp, which pumps anti-cancer drugs out of cells.  Tariquidar is a drug
candidate which is being developed to restore the sensitivity of MDR cancer
cells to specific cytotoxic drugs by blocking the P-gp pump, thus preventing the
export of cytotoxic drugs from cancer cells.  A series of three Phase IIa trials
for tariquidar have been carried out to study the pharmacokinetic behaviour of
tariquidar when given with a range of marketed cytotoxic agents, namely
vinorelbine, doxorubicin and paclitaxel, comprising some of the world's
best-selling cytotoxic drugs.  The results of the tariquidar/paclitaxel study
were announced in March 2000, the tariquidar/doxorubicin trial in March 2001 and
the tariquidar/vinorelbine trial in May 2001.  The results of these three
studies demonstrated that tariquidar is a potent P-gp inhibitor, without
significant side effects and with less pharmacokinetic interaction than other
inhibitors used previously.  The trial investigator reported that 7 patients
received symptomatic benefit out of a 12 patient sample receiving paclitaxel,
carboplatin and tariquidar.  However, interpretation of these results should
take into account the relatively small number of patients in the trial.

For further information about Xenova and its products please visit the Xenova
website at

QLT Inc is a global biopharmaceutical company dedicated to the discovery,
development and commercialisation of innovative therapies to treat cancer, eye
diseases and immune disorders.  Combining expertise in opthalmopogy, oncology
and photodynamic therapy, QLT has commercialised two products to date, including
Visudyne(R) therapy which is the largest selling ophthalmology product ever
launched.  For more information you are invited to visit QLT's website at

For Xenova: Disclaimer to take advantage of the 'Safe Harbor' provisions of the
US Private Securities Litigation Reform Act of 1995. This press release contains
'forward-looking statements,' including statements about the discovery,
development and commercialisation of products. Various risks may cause Xenova's
actual results to differ materially from those expressed or implied by the
forward looking statements, including: adverse results in our drug discovery and
clinical development programs; failure to obtain patent protection for our
discoveries; commercial limitations imposed by patents owned or controlled by
third parties; our dependence upon strategic alliance partners to develop and
commercialise products and services; difficulties or delays in obtaining
regulatory approvals to market products and services resulting from our
development efforts; the requirement for substantial funding to conduct research
and development and to expand commercialisation activities; and product
initiatives by competitors.  For a further list and description of the risks and
uncertainties we face, see the reports we have filed with the Securities and
Exchange Commission.  We disclaim any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.

                      This information is provided by RNS
            The company news service from the London Stock Exchange                                                                                                                

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