Will install the clinical production line developed by Glide into its newly acquired GMP facility in Glasgow
Albany Molecular Research (AMRI) has won a contract to manufacture a solid dose injection (SDI) formulation of octreotide for Oxford, UK-based Glide Pharmaceutical Technologies, a UK development company focused on solid dose formulations of therapeutics, vaccines and non-invasive diagnostics.
The drug will be used in a human bioequivalence study to be conducted in the fourth quarter of this year.
The appointment follows pre-clinical proof-of-concept results, which compared the solid formulation with the currently marketed liquid product (Novartis' Sandostatin).
Under the terms of the manufacturing agreement, AMRI will install the clinical production line developed by Glide into its GMP facility in Glasgow, and produce sterile octreotide solid doses for clinical study.
Glide’s delivery system, the Glide SDI, is an innovative approach for the parenteral administration of drugs, which uses a novel solid dose formulation delivered using the company’s proprietary injector. It is said to offer comfort and ease-of-use for self-administration and improved product stability.
Octreotide is Glide’s lead pipeline programme. Currently approved octreotide products are used for the treatment of acromegaly and certain neuroendocrine tumours, and the market for immediate release liquid formulations is estimated to be in excess of $150m.
David Stevens, Senior Director and Site Head of AMRI Glasgow, acquired last month from Aptuit, said: 'We anticipate that the combination of Glide’s innovative delivery system and AMRI Glasgow’s lyophilisation development and clinical GMP expertise will help accelerate clinical development of the Glide SDI. The Glide delivery technology offers patients the possibility of game changing enhancements to the way their medication is administered.'