WILEX grants exclusive US commercialisation rights for RENCAREX® to Prometheus
ENGLISH DEUTSCH
Ad-hoc release pursuant to § 15 Wertpapierhandelsgesetz (German Securities Trading Act)
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Munich, 29 April 2011. WILEX AG (ISIN DE0006614720, Frankfurt Stock Exchange) today announced the granting of US commercialisation rights for RENCAREX® (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®. Furthermore Prometheus will co-fund a portion of the ongoing development of RENCAREX®. This potentially values the deal at over $145 million plus royalties on net sales in the United States.
Contact
WILEX AG
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-mail: investors [at] wilex.com
Additional information to this release:
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 from http://www.wilex.de/press-investors/presentations/ at 2:00 p.m. CET. A replay will be available after the conference on the website.
About RENCAREX®
RENCAREX® (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® 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® 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 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
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/
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.
