The Board of Directors of MolMed S.p.A. (MLM.MI), chaired by Professor Claudio Bordignon, today reviewed and approved the draft financial statements at 31 December 2012. The most relevant elements concerning product development and activity progress were.
- TK: started registrative procedures and dossier preparation to file a market authorization application through an accelerated procedure (Conditional Marketing Authorisation) with the European Medicines Agency, based on efficacy and safety data obtained in more than 120 patients treated so far;
- NGR-hTNF: completed enrolment in the registrative Phase III trial in relapsed malignant pleural mesothelioma (NGR015); moreover significant efficacy results have been obtained from the randomised Phase II studies in non-small cell lung cancer with squamous histology and in soft tissue sarcomas;
- Production for third parties: increased revenues from the development of new cell and gene therapy treatments to € 4.6 million, up 71% compared to fiscal year 2011.
Claudio Bordignon, Chairman and CEO of MolMed, commented: “2012 saw important progress in the development of the Company’s products and activities. In particular, the long-term analysis of safety and efficacy data obtained so far in the clinical development of TK persuaded us to prepare a request for an accelerated marketing authorisation, to be submitted to the European regulatory authority. Meanwhile, the clinical development of NGR-hTNF for the treatment of solid tumours saw the completion of patient enrolment in the Phase III trial in malignant pleural mesothelioma, the first pivotal trial conducted by the Company for this molecule. Important efficacy data for this investigational drug were also obtained in randomised Phase II trials in soft tissue sarcomas and in the squamous variant of non-small cell lung cancer.
Finally, the increase in activities and revenues in the field of new gene and cell therapy treatments highlights the growing interest in the field and acknowledges MolMed’s role in the development of these highly innovative products.”
Source: MolMed