Heidelberg Pharma AG

Legal Proceedings Report • Nov 21, 2011

News Details

Ad-hoc | 21 November 2011 19:18

WILEX AG: ARISER Independent Data Monitoring Committee (IDMC) recommends conducting the final analysis of the pivotal Phase III trial with RENCAREX(R)

WILEX AG / Key word(s): Research Update

21.11.2011 19:18

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

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WILEX AG: ARISER Independent Data Monitoring Committee (IDMC) recommends
conducting the final analysis of the pivotal Phase III trial with
RENCAREX(R)

Munich, Germany, 21 November 2011. WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today announced that the IDMC has recommended
cancelling the interim analysis and performing the final DFS analysis of
the Phase III ARISER trial with RENCAREX(R) in clear cell renal cell
carcinoma (ccRCC) now. This decision follows discussions with the Medical
Advisory Board, the Food and Drug Administration (FDA) in the USA and the
Swedish regulatory authority as well as WILEX's EU and US commercialisation
partners Esteve, S.A., Barcelona, and Prometheus Laboratories Inc., San
Diego, CA, USA.

Over the last year the recurrence rate has further declined leading the
advisors to conclude that the trial has matured such that the final
analysis can be conducted now instead of after 512 events as originally
planned. WILEX therefore plans to complete the final analysis immediately
following the necessary approvals from the regulatory authorities. In the
meantime the trial remains blinded.

The process of formal protocol amendment will start immediately. Upon
approval by the regulatory authorities the final analysis will take place
and full results may be expected in Q4 2012.

Further information in the press release.

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Information and Explaination of the Issuer to this News:

About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the company has a broad portfolio of near-to-market
therapeutic and diagnostic products for the targeted treatment and specific
detection of various types of cancer. The company's therapeutic product
candidates are based on antibodies and small molecules. Through its US
subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of
research use only and in vitro diagnostic tests under the brand Oncogene
Science(R). These diagnostic tests could be developed as companion
diagnostics in clinical trials and for therapy monitoring. The wholly owned
subsidiary Heidelberg Pharma AG gives WILEX access to an attractive and
highly promising antibody drug conjugate technology platform and a
pre-clinical service business. The business model of WILEX covers the
entire value chain in the oncology market and comprises research,
technology, development collaboration as well as sales and marketing.
WILEX's customers and partners include leading international pharmaceutical
companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6

Contact
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors@wilex.com

This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will', 'should', 'future', 'potential' or similar expressions or by
a general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.

21.11.2011 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart

End of Announcement DGAP News-Service

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