Heidelberg Pharma AG

Legal Proceedings Report • Dec 13, 2006

News Details

Corporate | 13 December 2006 09:39

WILEX enters into manufacturing and distribution agreement with IBA Molecular for the upcoming pivotal registration trial with CA9-SCAN

Corporate News transmitted by DGAP – a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. —————————————————————————— WILEX enters into manufacturing and distribution agreement with IBA Molecular for the upcoming pivotal registration trial with CA9-SCAN Munich, December 13, 2006 – The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today signed a contract with IBA Molecular N.A., Sterling, Virginia, USA. IBA delivers radiopharmaceuticals and isotopes for radiotherapy and radiodiagnosis and is one of the leading companies in this field worldwide. IBA will label the WILEX antibody WX-G250 with 124Iodine and will deliver it to the study centres participating in the pivotal trial for approval of the WILEX imaging diagnostic CA9-SCAN. ‘We are delighted to have signed this agreement with a major partner in order to conduct the trial for the approval of the diagnostic imaging agent CA9-SCAN’, commented Dr. Paul Bevan, Head of R&D of WILEX AG. ‘We are planning to start this pivotal trial in 2007 and subsequently to apply for marketing approval at the earliest in 2008’, Dr. Bevan continued. It is planned to enrol patients suspected of having kidney cancer in approximately 10 study centres in the USA and image them with CA9-SCAN prior to surgery. CA9-SCAN is a radioactively labelled form of the antibody WX-G250. The labelled antibody WX-G250 targets clear cell renal cell carcinoma and will accumulate in the tumour tissue. This accumulation can be visualised by means of Positron Emission Tomography (PET). An earlier feasibility study found that a positive result with CA9-SCAN could be confirmed as clear cell renal cell carcinoma in 100 % of the cases (positive predictive value). CA9-SCAN could determine whether the patient had clear cell renal cell carcinoma before the surgery and subsequent pathology. Therefore, CA9-SCAN should significantly improve and simplify treatment planning for patients suspected of having kidney cancer. The company is not aware of imaging techniques available with comparable specificity and sensitivity. A market study commissioned by WILEX forecasts a peak sales potential of approximately US-$ 100 million per annum for this product. About WILEX WILEX is a biopharmaceutical Company based in Munich, which was founded in 1997 by a team of physicians and oncologists from the Technical University of Munich. WILEX is focused on the development of new cancer therapies based on antibodies and small molecules. The therapeutic approach of WILEX targets the prevention of growth, spread and the metastasis of malignant tumours and the destruction of malignant tumours in the body. The portfolio includes both drug and medical product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. The company’s strategy is to develop WILEX into a commercially successful biopharmaceutical company with a broad portfolio of new drugs and medical products for the treatment of cancer. Since November 13, 2006 WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard. ISIN DE0006614720 WKN 661472 Stock market symbol WL6 Contact Juliane Giese Manager Public Relations WILEX AG Grillparzerstr. 16 81675 München Germany Tel.: +49 (0)89-41 31 38-29 Fax: +49 (0)89-41 31 38-99 Email: juliane.giese@WILEX.com Website: http://www.WILEX.com (c)DGAP 13.12.2006 ————————————————————————— Language: English Issuer: WILEX AG Grillparzerstr. 16 81675 München Deutschland Phone: +49 (0)89 41 31 38 – 0 Fax: +49 (0)89 41 31 38 – 99 E-mail: info@wilex.com WWW: www.wilex.de ISIN: DE0006614720 WKN: 661472 Indices: Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin-Bremen, Düsseldorf, München, Stuttgart End of News DGAP News-Service —————————————————————————