DGAP-News: WILEX AG regains US rights for RENCAREX(R) from Prometheus
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Agreement
WILEX AG regains US rights for RENCAREX(R) from Prometheus
07.11.2013 / 07:25
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PRESS RELEASE
WILEX regains US rights for RENCAREX(R) from Prometheus
Munich, Germany, 07 November 2013. WILEX AG (ISIN DE0006614720/ WL6 / FSE)
and Prometheus Laboratories Inc. (Prometheus), San Diego, CA, USA, agreed
as of 31 October 2013 on the terms of the termination of the 2011 license
agreement on RENCAREX(R) (Girentuximab). As announced on 3 June 2013,
Prometheus and WILEX decided to finalise the cooperation and to discuss the
formalities and timing regarding the termination.
According to the settlement agreement, WILEX regains the US
commercialisation rights for RENCAREX(R) and will receive a final payment
of USD 1.75 million covering Prometheus' obligations under the
collaboration agreement for the RENCAREX(R) development costs. Prometheus
will no longer participate in the RENCAREX(R) development. The parties have
no further mutual obligations.
WILEX has received upfront and milestone payments of USD 39 million plus
40% of development costs since the beginning of the collaboration.
RENCAREX(R) is a Phase III product candidate for adjuvant therapy of
non-metastatic clear cell Renal Cell Carcinomas (ccRCC). In October 2012,
the Phase III ARISER trial failed to meet its primary endpoint. The final
analysis showed no improvement in median disease-free survival following
treatment with RENCAREX(R) compared to placebo. However, WILEX carried out
an extensive subgroup and biomarker analysis and presented positive
subgroup data at the ASCO Annual Meeting in June 2013. The results of this
retrospective analysis showed that RENCAREX(R) has a therapeutic effect in
the subgroup of patients with a high score of the antigen CAIX.
Disease-free survival in this group showed a clinically and statistically
significant improvement compared to both placebo and patients with a low
CAIX score.
Professor Olaf G. Wilhelm, CEO of WILEX AG, commented: 'We look back on a
very valuable collaboration with Prometheus. Due to the top line data of
RENCAREX(R) and the delay of a marketable product, Prometheus' request to
terminate was not a surprise to us. We are delighted that we came to an
agreement that works for both parties. The return of the US rights for
RENCAREX(R) offers us new and broader options for its commercialisation.'
WILEX has already started discussions with regulatory authorities (FDA and
European agencies) on a confirmatory prospective clinical Phase III trial
with RENCAREX(R) in the subgroup of patients with high CAIX scores. WILEX
has received initial positive feedback from the authorities. In addition,
talks are being held with several parties for the out-licensing of the
global rights (except Southern Europe). WILEX's goal is to find a partner
that will participate in financing, development and commercialisation.
Should RENCAREX(R) receive regulatory approval, the definition of the
subgroup could open up a market with adjusted peak sales potential of over
USD 300 million for RENCAREX(R) as an adjuvant therapy of ccRCC.
About RENCAREX(R)
RENCAREX(R) (Girentuximab) is a highly specific chimeric monoclonal
antibody that binds to a cell surface antigen, the CAIX-antigen, which is
found on 95% of clear cell Renal Cell Carcinomas (ccRCC) and on various
other solid tumours but not on healthy tissue. Renal cell cancer, or RCC,
is the most common type of kidney cancer and accounts for more than 90% of
malignant kidney tumours. Two-thirds of RCC patients with no evidence of
metastases at the time of first diagnosis have a high risk of relapse
within a few years after surgery. WILEX developed the product candidate
RENCAREX(R) with the aim of preventing metastases (adjuvant therapy). There
is no adjuvant treatment approved by the FDA or EMA for patients after
surgery. RENCAREX(R) was tested in the double-blind, placebo-controlled
Phase III trial for adjuvant therapy (Adjuvant RENCAREX(R) Immunotherapy
trial to Study Efficacy in non-metastatic Renal cell carcinoma, 'ARISER
trial') but failed to meet the primary endpoint. However, a retrospective
subgroup analysis showed that RENCAREX(R) has a clear therapeutic effect in
the subgroup of patients with a high CAIX score. Disease-free survival in
this group showed a clinically and statistically significant improvement
compared to both placebo and patients with a low CAIX score.
With the support of the cooperation partner Nuclea Biotechnologies Inc., a
CAIX in-vitro diagnostic test will be developed as a companion diagnostic,
which will be helpful in identifying and stratifying patients who might
benefit from RENCAREX(R) therapy.
About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company develops diagnostic and therapeutic product
candidates for the specific detection and targeted treatment of various
types of cancer based on antibodies and small molecules. The subsidiary
Heidelberg Pharma GmbH offers preclinical contract research services and an
antibody drug conjugate (ADC) technology platform. The business model
comprises research and product development as well as the commercialisation
of its activities. Our customers and partners include leading international
pharmaceutical companies. WILEX AG is listed at the Frankfurt Stock
Exchange. ISIN DE0006614720 / WKN 661472 / Symbol WL6. More information is
available at www.wilex.com.
Contact
WILEX AG MC Services AGThis communication contains certain forward-looking statements relating to
Corporate Communications Katja Arnold (CIRO)
Sylvia Wimmer Tel.: +49-89-210 228-40
Tel.: +49 (0)89-41 31 38-29 Mobil: +49 160 9360 3022
Email: investors[at]wilex.com E-Mail: katja.arnold[at]mc-
Grillparzerstr. 10, 81675 Munich, services.eu
Germany
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.
End of Corporate News
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Language: English
Company: WILEX AGGrillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info(at)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 News DGAP News-Service
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238421 07.11.2013
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