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WILEX and IBA enter into worldwide marketing, distribution and
sales agreement on REDECTANE®* (CA9-SCAN)
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.
* temporary name while under development
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
D-81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
e-mail: press@WILEX.com |
Contact
Paul-Emmanuel Goethals
Director, Corporate Business Development
& Investor Relations
IBA
Tel.: +32 10 47 58 16
paul-emmanuel.goethals@iba-group.com
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.
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