Heidelberg Pharma AG

Regulatory Filings • Jun 17, 2011

News Details

Ad-hoc | 17 June 2011 00:13

WILEX AG reports on the Pre-BLA Meeting with the FDA and the next steps in the REDECTANE(R) approval process

WILEX AG / Key word(s): Regulatory Admission

17.06.2011 00:13

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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Ad-hoc release pursuant to § 15 Wertpapierhandelsgesetz
(German Securities Trading Act)

WILEX reports on the Pre-BLA Meeting with the FDA and the next steps in the
REDECTANE(R) approval process

Munich, Germany, 17 June 2011. WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today announced that the Pre-BLA Meeting with the
American Food and Drug Administration planned for the second quarter has
taken place. The aim of this type of meeting is to discuss the application
for approval and the approval process for a product in advance of filing.
Two issues remain to be resolved by WILEX and its partner Ion Beam
Applications SA, Louvain-la-Neuve, Belgium (IBA Reuters IBAB.BR and
Bloomberg IBAB.BB).

During the pre-BLA discussions the FDA confirmed that the trial provides
reasonable evidence for the diagnostic efficacy and safety of REDECTANE(R)
and stated that three hypotheses were confirmed. In order to strengthen the
position for approval, the FDA suggested that WILEX and IBA might consider
an outcomes based study to provide additional evidence of clinical benefit
before BLA filing. Such an outcomes based study demands that a doctor
determines patient management based on the diagnostic result with
REDECTANE(R) and PET/CT. During the Phase III REDECT trial, and in
accordance with the trial design agreed in the SPA, doctors did not utilise
the REDECTANE(R) PET/CT results to influence the decision for or against
surgery. For the completed Phase III trial, the diagnostic results of CT or
PET/CT had to be confirmed by an histological analysis post-surgery under
the terms of the trial design. WILEX and IBA agree with the FDA that a
trial with a clinical benefit outcome could represent the next logical step
in REDECTANE's development. WILEX, IBA and external medical advisors
however are of the opinion that such a trial should be conducted as a Phase
IV trial after market approval. WILEX and IBA will first discuss the trial
design and strategy with the Medical Advisory Board and subsequently with
the FDA. Following agreement a further announcement will be made.

The second issue discussed with the FDA concerns the manufacturing of
REDECTANE(R). WILEX has successfully completed two consecutive consistency
lots for process validation of the naked antibody Girentuximab at the
manufacturer Avid Bioservices, Inc., Tustin, CA, USA. The third production
run was started before the pre-BLA meeting and will be completed shortly.
Process validation data from this third run were to be submitted to the FDA
by WILEX during the approval process. The FDA has made clear that all
necessary process validation data from all three consistency lots must be
delivered as part of BLA filing.

Furthermore, the FDA has requested from IBA (responsible for radioactive
labelling of the antibody) data pertaining to the commercial production of
REDECTANE(R), in particular product characterisation and process
validation. By building a new manufacturing facility with central
manufacturing and quality assurance, IBA has created an infrastructure in
which REDECTANE(R) can be produced not only as study medication but also as
a marketable product. WILEX and IBA will provide the FDA with the necessary
data in the next few months.

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

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Information and Explaination of the Issuer to this News:

Invitation to the conference call:
On 17 June, WILEX and IBA will hold a public conference call for media,
analysts and investors in English at 3:00 p.m. CET. Please dial in ten
minutes before the conference call using the following dial-in numbers:

1. Germany: +49 69 6677 75756
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. Belgium: +32 (0) 2 789 8603

You will be welcomed by an operator taking your name and company. The
presentation for the conference will be available for download at the
website http://www.wilex.de/IR/Presentations.php at 2:00 p.m. CET. A replay
will be available after the conference on the website.

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
oncological diagnostic tests under the brand Oncogene Science. These
diagnostic tests can be used as companion diagnostics in clinical trials
and for therapy monitoring. Furthermore, the acquisition of Heidelberg
Pharma AG is set to give 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

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.

17.06.2011 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
Deutschland
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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