Corporate | 2 May 2011 06:55

WILEX AG grants exclusive US commercialisation rights for RENCAREX(R) to Prometheus

WILEX AG / Key word(s): Strategic Company Decision/Alliance

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.

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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

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