MBiotec received a positive opinion on orphan designation for MALP-2S for the treatment of pancreatic cancer from FDA´s Office of Orphan Products Development
MBiotec presentation at BioConnect Day in Basel, Switzerland
MBiotec presentation at Bio@venture Hannover, Germany
MBiotec presentation at Seed4 Money Frankfurt, Germany
MBiotec assigned SME (small-medium enterprise) status by the EMEA
Presentation at the Venture.Med 2009 in Essen, Germany
Meet MBiotec at the Biovaria in Munich, Germany
MBiotec received a positive opinion on orphan status from COMP/EMEA
COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
April 2009 Plenary Meeting - Monthly Report
MBiotec received two questions regarding the EMEA orphan application for MALP-2S
EMEA application to register as a "Small or Medium Enterprise (SME)"
Orphan application with FDA
The 90-day review period was started. A similar application will be made to the FDA in February 2009.
MBiotec applied for Orphan Drug Designation, after successful validation of the dossier on MALP-2S by the EMEA.
MBiotec concluded a license and development agreement for MALP-2S with Ascenion GmbH, Germany. MBiotec received worldwide rights for the development of MALP-2S in cancer.
MBiotec GmbH was founded as a limited company under German law and started
operation in October 2008. MBiotec is based in Munich, Germany. Present shareholders are
6 private investors and Ascenion GmbH.
Its aim is to develop a new substance, MALP-2S, for the treatment of pancreatic cancer,
which is known to be particularly difficult to treat.