Glide Technologies, the development company focused on solid dose formulations of therapeutics and vaccines and non-invasive diagnostics, today announced that it has appointed Albany Molecular Research (Glasgow) Limited (AMRI) to manufacture the company’s novel solid dose injection (SDI) formulation of octreotide, for use in a human bioequivalence study to be conducted in Q4 2015. The appointment follows successful pre-clinical proof-of-concept results, which compared the solid formulation with the currently marketed liquid product (Sandostatin®).
Under the terms of the manufacturing agreement, AMRI will install the clinical production line developed by Glide into its GMP facility, and will produce sterile octreotide solid doses for clinical study. Glide’s clinical trial planned for later this year is designed to confirm that the company’s solid dose formulation has an equivalent pharmacokinetic profile to Sandostatin®. AMRI will produce the novel formulation at its state-of-the art facility in Glasgow, UK.
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. The Glide SDI® offers comfort, 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 several serious disorders, including acromegaly and certain neuroendocrine tumours, and the market for immediate release liquid formulations is estimated to be in excess of $150 million.
“We have been extremely impressed by AMRI’s experience in GMP manufacture of novel sterile products and their flexible, collaborative approach, and we look forward to working with the team to produce our unique solid formulation,” said Dr Mark Carnegie-Brown, Glide’s CEO. “The appointment of AMRI as our chosen manufacturer is an important step towards confirming the clinical promise of the Glide SDI® platform, following the positive proof-of-concept equivalence data we announced last year.”
David Stevens, Senior Director and Site Head of AMRI Glasgow, commented, “AMRI is thrilled to work with Glide on the GMP manufacture of their octreotide formulation. 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, and we are delighted to have been selected to support Glide’s programme.”