Drug substance ready for production

August 25, 2015

Drug substance ready for production

Follicum announce today that the synthesis of the peptide has been completed.  The peptide is the active ingredient of the product planned to be used in the clinical Phase I/IIa study.

Production of product for the clinical Phase I/IIa study
Follicum announced in early June that the company had signed an agreement with the peptide producing PolyPeptide Group AB to produce the peptide, which will be used in the product in the planned clinical Phase I/IIa study. The peptide, which is produced according to GMP standard (“Good Manufacturing Practice”), is now ready and has been produced in generous amount which means that Follicum have the required resources to continue the development, should the clinical Phase I/IIa study be successful. The peptide has undergone a number of studies and showed good stability and customization for large-scale production.

Recipharm AB takes over to development and produce the actual product for the clinical Phase I/IIa study, which is planned to start around year-end 2015/early 2016.

CEO Jan Alenfall comments:
– Reporting that the peptide now is ready means that we continue to keep the communicated time plan and that we are one step closer to initiate the planned clinical Phase I/IIa study. The production of the peptide has given us plenty of material of very high quality, which means that we now are ready to continue the development of the product beyond completion of the clinical Phase I/IIa study.