Heidelberg Pharma AG

Regulatory Filings • Apr 3, 2007

News Details

Corporate | 3 April 2007 10:22

WILEX gives positive update of current pivotal Phase III trial of RENCAREX®

WILEX AG / Research Update

Release of a Corporate-announcement, transmitted by DGAP - a company of
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The issuer is solely responsible for the content of this announcement.

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WILEX gives positive update of current pivotal
Phase III trial of RENCAREX®

• Over 420 patients enrolled in the Phase III trial
• Milestone payment from Esteve received
• Publication of the results of the 'futility analysis' expected for H2 /
  2007
• Results expected in H2 / 2008

Munich, April 3, 2007 – The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced
today that, in its pivotal Phase III study of RENCAREX® (the data of which
are required for European and US filing for approval) over 420 of 856
patients planned have been enrolled. The international, multicentre,
randomised trial, called ARISER (Adjuvant Rencarex Immunotherapy trial to
Study Efficacy in non-metastasized Renal cell carcinoma), examines the
efficacy of the antibody RENCAREX® in comparison to placebo for the
treatment of clear cell renal cell cancer patients after complete or
partial surgical removal of the affected kidney in patients with no
detectable metastases. This cancer belongs to one of the particularly
aggressive indications. RENCAREX® aims to inhibit these malignant kidney
tumours from further growth and recurrence and to help to kill cancer cells
and thereby prolong the disease-free survival of patients.

Dr. Paul Bevan, Head of Research and Development and member of the
executive management board of WILEX, commented: 'Patient recruitment is
outstanding with the numbers increasing quarter on quarter. Furthermore,
the drop-out rate, at roughly 3%, is very low and suggests that the
treatment regimen of weekly injections is well tolerated. We are on track
and can expect the results of the trial in the second half of 2008'.

The next important milestone of the ARISER study is the so-called 'futility
analysis' as per the statistical analysis plan. An Independent Data
Monitoring Committee will analyse the data after 100 patients have
relapsed. This is expected in H2 2007. No-one outside the Committee will
have access to the data. The Committee will inform WILEX of the outcome and
its expectation as to whether the study is likely to deliver the result
expected.

WILEX expects results of the study for European filing in the second half
of 2008. The FDA requires a higher statistical significance which demands
higher number of relapses and, therefore, filing for approval at the FDA is
planned for 2009.

About WILEX
WILEX is a biopharmaceutical Company based in Munich, which was founded in
1997 by a team of physicians and oncologists from the Technical University
of Munich. WILEX is focused on the development of new cancer therapies
based on antibodies and small molecules. The therapeutic approach of WILEX
targets the prevention of growth, spread and the metastasis of malignant
tumours and the destruction of malignant tumours in the body. The portfolio
includes both drug and medical product candidates ranging from research to
late stage clinical development. Currently the following compounds are in
clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1
and CA9-SCAN.
WILEX has a license agreement with the Spanish pharmaceutical Company
Laboratorios del Dr. Esteve S.A. Barcelona (Spain) for the marketing of
RENCAREX® in particular countries in Southern Europe. Pursuant to the
agreement, the Company has a claim for payments upon attainment of
particular development milestones.
The company’s strategy is to develop WILEX into a commercially successful
biopharmaceutical company with a broad portfolio of new drugs and medical
products for the treatment of cancer. Since November 13, 2006 WILEX AG is
listed at the Frankfurt Stock Exchange on the Official Market Segment
(Amtlicher Markt) / Prime Standard.
ISIN DE0006614720 / WKN 661472 / Stock market symbol WL6

Contact
Juliane Giese
Manager Public Relations
Tel.: +49 (0)89-41 31 38-29
Email: investors@WILEX.com

DGAP 03.04.2007

Language: English
Issuer: WILEX AG
Grillparzerstr. 16
81675 München Deutschland
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
www: www.wilex.de
ISIN: DE0006614720
WKN: 661472
Indices:
Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin-Bremen, Düsseldorf, München, Stuttgart

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