Munich, 17 June 2011. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that the Pre-BLA Meeting with the American Food and Drug Administration planned for the second quarter has taken place. The aim of this type of meeting is to discuss the application for approval and the approval process for a product in advance of filing. Two issues remain to be resolved by WILEX and its partner Ion Beam Applications SA, Louvain-la-Neuve, Belgium (IBA Reuters IBAB.BR and Bloomberg IBAB.BB).
During the pre-BLA discussions the FDA confirmed that the trial provides reasonable evidence for the diagnostic efficacy and safety of REDECTANE® and stated that three hypotheses were confirmed. In order to strengthen the position for approval, the FDA suggested that WILEX and IBA might consider an outcomes based study to provide additional evidence of clinical benefit before BLA filing. Such an outcomes based study demands that a doctor determines patient management based on the diagnostic result with REDECTANE® and PET/CT. During the Phase III REDECT trial, and in accordance with the trial design agreed in the SPA, doctors did not utilise the REDECTANE® PET/CT results to influence the decision for or against surgery. For the completed Phase III trial, the diagnostic results of CT or PET/CT had to be confirmed by an histological analysis post-surgery under the terms of the trial design. WILEX and IBA agree with the FDA that a trial with a clinical benefit outcome could represent the next logical step in REDECTANE’s development. WILEX, IBA and external medical advisors however are of the opinion that such a trial should be conducted as a Phase IV trial after market approval. WILEX and IBA will first discuss the trial design and strategy with the Medical Advisory Board and subsequently with the FDA. Following agreement a further announcement will be made.
The second issue discussed with the FDA concerns the manufacturing of REDECTANE®. WILEX has successfully completed two consecutive consistency lots for process validation of the naked antibody Girentuximab at the manufacturer Avid Bioservices, Inc., Tustin, CA, USA. The third production run was started before the pre-BLA meeting and will be completed shortly. Process validation data from this third run were to be submitted to the FDA by WILEX during the approval process. The FDA has made clear that all necessary process validation data from all three consistency lots must be delivered as part of BLA filing.
Furthermore, the FDA has requested from IBA (responsible for radioactive labelling of the antibody) data pertaining to the commercial production of REDECTANE®, in particular product characterisation and process validation. By building a new manufacturing facility with central manufacturing and quality assurance, IBA has created an infrastructure in which REDECTANE® can be produced not only as study medication but also as a marketable product. WILEX and IBA will provide the FDA with the necessary data in the next few months.