02/03/2014 | 04:20pm US/Eastern

PRESS RELEASE

MolMed provides an update on the registration strategy for its gene therapy TK in Europe and in the United States

Milan (Italy), 3 February 2014 - MolMed S.p.A. (Milan:MLM) today provided an update on the registration strategy for its gene therapy TK in Europe and in the US.

With regard to the Conditional Approval procedure in EU, after two meetings with the national agencies from rapporteur and co-rapporteur member states designated by the European Medicines Agency (EMA), the Company confirms the expected filing date of the application in the first quarter of 2014. As far as the Breakthrough Therapy submission is concerned, the U.S. Food and Drug Administration (FDA) has not - at this time - granted the designation for the cell therapy TK as adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for adult patients affected by high risk acute leukaemia. However, the FDA indicates that the Company can submit a new request once new clinical evidence becomes available. According to this suggestion, MolMed intends to re-apply for Breakthrough Therapy designation in the US since new evidence is now becoming available, including initial efficacy data from the ongoing Phase III clinical trial. These data will be submitted for presentation at next meeting of the American Society of Clinical Oncology (ASCO).

About Breakthrough Therapy

Breakthrough Therapy designation is a new regulatory option available at FDA and is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features as well as more intensive FDA guidance on an efficient drug development program. Details of these regulatory processes can be found at this link: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantA mendmentstotheFDCAct/FDASIA/ucm341027.htm The last update provided by the FDA on Dec 31st 2013 shows that only 2 requests have been granted out of the 22 submitted.

About TK

TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a "suicide gene". These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high risk leukaemia. TK therapy allows to eliminate the post-transplant immunosuppression treatment thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic differences with the donor, known as Graft versus Host Disease (GvHD).

About Phase III trial TK008

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Molecular Medicine SpA : Update on the registration ...