AMRI to make Glide's solid dose injectable candidate from ex-Aptuit site
The agreement will see contract development and manufacturing organisation (CDMO) AMRI install a clinical production line for Glide’s candidate drug, an SDI formulation of octreotide, from its sterile manufacturing facility in Glasgow, Scotland, recently bought from Aptuit for $24m (€20m).
According to a company spokesman, Glide had begun discussions with the Glasgow site last year under its previous owners, Aptuit, as part of an assessment of sterile manufacturers. “Our preference was with a UK-based CMO in order to ease the technology transfer,” this publication was told.
Glide’s CEO Mark Carnegie-Brown added in a statement: “We have been extremely impressed by AMRI’s experience in GMP manufacture of novel sterile products and their flexible, collaborative approach. The appointment of AMRI as our chosen manufacturer is an important step towards confirming the clinical promise of the Glide SDI platform.”
The company is using the technology across its pipeline, including in collaboration with Pfenex to develop an anthrax vaccine, funded by the National Institute of Allergy and Infectious Diseases (NIAID), but its lead candidate is the octreotide solid dose formulation.
Last year the candidate completed a preclinical proof-of-concept study which showed positive comparison to Sandostatin, the liquid injectable brand marketed by Novartis.
AMRI will manufacture the materials for the clinical trial designed to confirm that the solid dose formulation has an equivalent pharmacokinetic profile to Sandostatin planned for later this year.
