REDECTANE Preliminary data of the Phase III trial 30 November 2009

Transcription

1 REDECTANE Preliminary data of the Phase III trial 30 November 2009

2 Forward looking statements 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, performa ance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursem ment and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing i arrangements, currency fluctuations, ti adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other factors referenced in this communication. 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. RENCAREX, REDECTANE und MESUPRON, WX-554 and WX-037 are temporary development names. This material is not intended as an offer or solicitation for the purchase or sale of shares of WILEX AG. This material may not be distributed within countries where it may violate applicable law. 2

3 Portfolio Product Indication Pre-clinical Phase I Phase II Phase III Market Partner REDECTANE (WX-G250 antibody for diagnostic use) RENCAREX (WX-G250 antibody for therapeutic use) MESUPRON (small molecule, upa inhibitor) Renal mass ccrcc* Pancreatic cancer Breast cancer (ww**) (Southern Europe) (award) WX-554 (small molecule, MEK inhibitor) WX-037 (small molecule, PI3K inhibitor) 3 antibody programmes Cancer Cancer Cancer (ww) (ww) (ww) *clear cell Renal Cell Carcinoma, non-metastatic, ** worldwide 3

4 REDECTANE : commercialisation partner Commercialisation agreement with Ion Beam Applications Signed in June 2008 WILEX responsible for antibody manufacture and clinical development IBA responsible for manufacturing of finished radio-labelled antibody, distribution, sales & marketing Worldwide co-promotion rights for WILEX WILEX received upfront payment, rece eives development milestones and royalties up to 45% on ex-factory sales 4

5 REDECTANE (INN: 124I-girentuximab) Radio-labelled antibody targeting CAIX for diagnostic use

6 REDECTANE : First in class diagnostic imaging agen t Today Tomorrow Symptomatic patients Urologist CT Scan REDECTANE PET-CT* PET-CT: Positron-Emission Tomography - Computer Tomography Positive ccrcc? Positive ccrcc Negative Renal mass Surgery No surgery 6

7 REDECTANE : Proof of concept data Antibody targets CAIX** antigen Radio-labelled with 124 I for PET-CT* Antigen abundantly expressed in clear cell Renal Cell Carcinoma (ccrcc), bladder, head & neck and colon cancers Proof of concept data 2006 Specificity 100%; Sensitivity 94% 24 samples were accurately predicted PET-CT Positive Negative Total Positive Sensitivity 94% Negative Specificity 100% Total PET-CT: Positron-Emission Tomography - Computer Tomography, ** Carbonic Anhydrase IX 7

8 REDECTANE : US Phase III trial Phase III trial of 226 patients with renal masses in 14 US sites IND* and SPA** granted from the FDA Patient recruitment completed in Septe ember 2009 Inclusion criteria: Suspected kidney cancer Scheduled for complete or partial removal of affected kidney REDECTANE (PET-CT) and Standard CT Primary Endpoint: Improvement of diagnosis using REDECTANE over standard CT Truth standard: histology *IND Investigation New Drug Application, **SPA Special Protocol Assessment 8

9 Preliminary results of phase III trial REDECTANE outperformed CT REDECTANE pre-surgery as good as th he truth standard histology (post-surgery) in predicting ccrcc and non ccrcc In order to avoid unnecessary surgery of renal masses in future a diagnostic agent sho ould show when clear cell renal cell cancer is not present (Specificity) 9

10 REDECTANE : Study results Study endpoints Specificity: the correct diagnosis that clear cell renal cell cancer is not present Sensitivity: the correct diagnosis of clear cell renal cell cancer Study results Specificity: achieved with a highly statistical value (p value, p) (p<0.001) Sensitivity: with p=0.052 very close to the requested p value (p<0.050) Reasons for Sensitivity p=0.052: CT performed better with respect to sensitivity in the study than expected and tha an generally observed in clinical practise 10

11 REDECTANE : next steps Next milestones Final report including additional safety data expected in Q Discussion with external experts and consultation of the process going forward with FDA 11

12 Feedback from Dr Divgi, principle investigator of the Phase III trial This study confirms the ability of REDECT PET/CT to accurately identify the clear cell renal cancer phenotype. Imaging patients with renal masses using this technique will help guide approp riate management, with consequent implications for patient comfort as well as enhancing surgical treatment. In particular, of course, the study underscores the unique ability of REDECTANE PET/CT to provide a reproducible and relatively straightforward method for identification of the clear cell phenotype. Congratulations. C. Divgi 12

13 Thank you! WILEX AG Grillparzerstr Munich, Germany Tel.: +49 (0) Fax: +49 (0) Website: Investor & Public Relations Katja Arnold (CIRO) Tel.: +49 (0) ISIN: Symbol: DE WL6 Reuters: WL6G.DE Bloomberg: WL6G.GR GR 13