DGAP-News: WILEX AG / Key word(s): Strategic Company Decision/Alliance
WILEX AG grants exclusive US commercialisation rights for RENCAREX(R)
to Prometheus
02.05.2011 / 06:55
---------------------------------------------------------------------
PRESS RELEASE
WILEX grants exclusive US commercialisation rights for RENCAREX(R) to
Prometheus
Munich, Germany, 2 May 2011: WILEX AG (ISIN DE0006614720, Frankfurt Stock
Exchange) announced the granting of US commercialisation rights for
RENCAREX(R) (Girentuximab) to Prometheus Laboratories Inc. (Prometheus),
San Diego, CA, USA. Prometheus is an established specialty pharmaceutical
and diagnostics company with a proven track record in gastroenterology and
oncology.
In return, WILEX will receive $39 million, $19 million upon signing and
either $20 million after twelve months or alternatively the European
commercial rights for an undisclosed product from Prometheus. In addition
WILEX will receive milestone payments and royalties on US net sales of
RENCAREX(R). Furthermore Prometheus will co-fund a portion of the ongoing
development of RENCAREX(R). This potentially values the deal at over $145
million plus royalties on net sales in the United States.
RENCAREX(R) is a Phase III product candidate for adjuvant use in
non-metastatic clear cell Renal Cell Cancer (ccRCC). The deal includes the
potential development in further indications. Prometheus markets
Proleukin(R), an oncology product indicated for metastatic renal cell
carcinoma and metastatic melanoma, in the US. If RENCAREX(R) receives
approval in the USA Prometheus would be able to offer a treatment for both
adjuvant and metastatic kidney cancer.
Professor Olaf G. Wilhelm, CEO of WILEX AG, commented: 'This is the deal we
have been looking for, not only in financial, but also in commercial and
strategic terms. We are very excited about WILEX's new partnership with
Prometheus since Prometheus has a proven track record in commercialising
pharmaceutical and diagnostic products.'
'We are very pleased to enter into this partnership with WILEX as we
continue to build our oncology franchise,' said Joseph M. Limber, President
and Chief Executive Officer of Prometheus. 'RENCAREX(R) is a great
strategic fit with our current oncology portfolio in renal cell carcinoma.
There is no product currently approved in the United States for patients
who could have recurrence of ccRCC after a kidney resection. We look
forward to working with WILEX to complete the development process and
commercialise RENCAREX(R) in the United States.'
Invitation to the conference call:
On 2 May, WILEX 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
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 RENCAREX(R)
RENCAREX(R) (girentuximab) is a highly specific chimeric monoclonal
antibody that binds to a cell surface antigen, the CA IX-antigen, which is
found on 95% of clear cell Renal Cell Carcinomas (ccRCC) and on various
other solid tumours but not on healthy tissue. Approximately 208,500 new
cases of kidney cancer are diagnosed each year worldwide and the most
prevalent form is ccRCC. Roughly one third of the patients will die from
RCC. Standard therapy for non-metastatic RCC is resection of the affected
kidney (nephrectomy) followed by observation. Nevertheless, there is a high
risk of disease recurrence. There is no adjuvant treatment approved by the
FDA or EMA for patients after surgery. RENCAREX(R) is currently tested in a
Phase III trial versus placebo in the adjuvant setting in 864 patients with
non-metastatic clear cell renal cell cancer at high risk of recurrence
after nephrectomy. WILEX expects the results from the interim analysis for
efficacy of RENCAREX(R) in the second half of 2011. This analysis will
provide critical information regarding the trial endpoint - disease-free
survival - which could form the basis for the European application for
marketing approval.
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 biomarker tests under the brand Oncogene Science. These
biomarkers can be used as companion diagnostics in clinical trials and for
therapy monitoring. Furthermore, the acquisition of Heidelberg Pharma AG,
Ladenburg, Germany, is set to give WILEX access to an attractive and highly
promising antibody drug conjugate technology platform (ADC) 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
About Prometheus
Prometheus Laboratories Inc. is committed to improving lives through the
development and commercialisation of novel pharmaceutical and diagnostic
products that enable physicians to provide greater individualised patient
care. Prometheus is a leader in applying the principles of personalised
medicine to the diagnosis and treatment of gastrointestinal diseases and is
applying these principles to oncology. Its strategy includes the marketing
and delivery of pharmaceutical products complemented by proprietary
diagnostic testing services. By integrating therapeutics and diagnostics,
Prometheus believes it can provide physicians with more targeted solutions
to optimise care for their patients. Prometheus' corporate offices are
located in San Diego, California. Website: http://www.prometheuslabs.com/
Contact WILEX AG
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Phone: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors [at] wilex.com
Raimund Gabriel
Phone: +49 (0)89-210 228 0
Email: raimund.gabriel [at] mc-services.eu
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.
End of Corporate News
---------------------------------------------------------------------
02.05.2011 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
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 News DGAP News-Service
---------------------------------------------------------------------
122366 02.05.2011
DGAP-News: WILEX AG grants exclusive US commercialisation rights for RENCAREX(R) to Prometheus
| Source: EQS Group AG