Heidelberg Pharma AG

Regulatory Filings • Jun 6, 2008

News Details

Corporate | 6 June 2008 07:55

WILEX and IBA enter into worldwide marketing, distribution and sales agreement on REDECTANE® (CA9-SCAN)

WILEX AG / Alliance

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Louvain-la-Neuve & Munich, June 6, 2008. The Munich-based biopharmaceutical
company, WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime
Standard), has signed a licensing agreement with IBA (Ion Beam Applications
S.A.: Reuters IBAB.BR and Bloomberg IBAB.BB / Brussels, Belgium) for the
worldwide marketing, distribution and sales of its diagnostic product
candidate REDECTANE® (CA9-SCAN). The agreement gives IBA the exclusive
global rights and licenses required for manufacturing and marketing the
product.

REDECTANE® is an imaging diagnostic designed to support physicians in
diagnosing clear cell renal cell cancer prior to surgery. REDECTANE® is a
radiolabelled antibody visualized by Positron Emission Tomography (PET) and
is currently in a pivotal phase III registration trial. REDECTANE® should
improve cancer diagnostics and the follow-up monitoring of patients. The
peak sales potential of REDECTANE® is estimated to reach over US$100
Million in the diagnosis of clear cell renal cell cancer alone.

According to the agreement, WILEX will manufacture the cold antibody and be
responsible for clinical development. IBA will be responsible for
manufacturing by labeling the antibody and will be responsible for
distribution, sales and marketing of REDECTANE®. WILEX will receive an
upfront payment, milestone payments and certain contributions-in-kind.
After the planned market approval, WILEX will get 20% on ex-factory sales
until a sales volume of EUR 7 million is reached. After that WILEX will get
45% on total ex-factory sales.

WILEX retains worldwide co-promotion rights and may use these to co-promote
REDECTANE® amongst urologists and oncologists. The companies agreed not to
disclose any further details of the agreement. IBA and WILEX had already
entered into a manufacturing agreement for the ongoing Phase III
registration trial in December 2006.

'We are very pleased about this commercial partnership as IBA is the ideal
partner for REDECTANE®', said Professor Olaf G. Wilhelm, Chief Executive
Officer of WILEX AG. 'IBA possesses both the know-how and the
infrastructure necessary for developing the market for REDECTANE® rapidly
and comprehensively following the product's approval. IBA already markets
globally its other products to radiologists, the potential customers of
REDECTANE®. We will support marketing by co-promoting the product to
urologists and oncologists within our worldwide network'.

Pierre Mottet, Chief Executive Officer of IBA explains: 'This agreement is
an important milestone in the expansion of our leading position in the
field of radiopharmaceutical products. We are already the leading supplier
of PET radiopharmaceuticals worldwide and this partnership agreement with
WILEX confirms our strategy of offering technology, materials and services
to medical imaging centers from a single source. We very much look forward
to our enhanced cooperation'.

About REDECTANE® (CA9-SCAN)
REDECTANE® is the diagnostic candidate CA9-SCAN, which is one of two
product candidates from WILEX’s late stage multi-product portfolio which is
in a pivotal registration trial. REDECTANE® is a radioactively labeled form
of the antibody WX-G250 and is being developed for the pre-surgical
diagnosis of clear cell renal cell cancer. The labeled antibody accumulates
in the tumor tissue and can be visualized by means of Positron Emission
Tomography (PET). An earlier feasibility study found that a positive result
with REDECTANE® was confirmed as clear cell renal cell carcinoma in 100% of
the cases (positive predictive value). REDECTANE® could determine whether
the patient had clear cell renal cell carcinoma before surgery and the
subsequent pathology. Therefore, REDECTANE® could significantly improve and
simplify treatment planning for patients suspected of having renal cancer.

About WILEX
WILEX is a biopharmaceutical Company based in Munich and is listed at the
Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s
mission is to develop drugs and diagnostic agents with a low side effect
profile and targeted treatment of different types of cancer as well as for
early detection of tumors. WILEX’s product candidates are based on
antibodies and small molecules. WILEX possesses an attractive pipeline
which includes both drug and diagnostic product candidates: The substances
RENCAREX® and REDECTANE® are currently undergoing a Phase III registration
trial. The substance WX-671 is currently in a Phase II program. Based on
this pipeline, WILEX’s aim is to achieve profitability within a few years
through the commercialization of its products and in the long term to
finance its research and development programs from its operating business.
Website: http://www.wilex.com

About IBA
IBA delivers solutions of exceptional precision in the fields of cancer
diagnosis and therapy. The company also provides sterilization and
ionization solutions to improve the hygiene and safety of everyday life.
IBA is listed on the pan-European stock exchange EURONEXT and belongs to
the BelMid index.

IBA’s leading role in the field of Molecular Imaging continues to grow
through the constant innovation its technology is built upon, as well as
through its worldwide radiopharmaceuticals distribution network. With an
ever-increasing number of sites in North America, Europe and Asia, IBA
continues to make radiopharmaceuticals, today mostly FDG, more accessible
to hospitals and imaging centers across the world.
Website: http://www.iba-worldwide.com.

Contact
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
email: press@wilex.com

Contact IBA
Paul-Emmanuel Goethals
Director, Corporate Business Development & Investor Relations
Tel.: +32 10 47 58 16
paul-emmanuel.goethals@iba-group.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
general discussion of strategy, plans or intentions of the Company. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial condition, performance, or achievements, or industry results, to
be materially different from any future results, performance 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.

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.
06.06.2008 Financial News transmitted by DGAP

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Language: English
Issuer: 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

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