Almac Group and PILA PHARMA Ink Manufacturing Agreement
August 10, 2021
Availability of API is a key factor in progressing ongoing type 2 diabetes clinical studies
Craigvon, U.K.- 10 August 2021- – Almac Sciences, global provider of integrated drug development services and member of the Almac Group, is delighted to announce that the company has signed a manufacturing agreement with Swedish biotech company, PILA PHARMA, for the production of XEN-D0501 active pharmaceutical ingredient (API).
From its global headquarter facilities in Northern Ireland, Almac Sciences will manufacture XEN-D0501, a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and possibly in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, and subsequently, PILA PHARMA has demonstrated good safety results as well as efficacy, i.e. a statistically improved endogenous insulin response to oral glucose versus placebo in patients with type 2 diabetes, thus demonstrating proof of principle of XEN-D0501.
Commented by Professor Tom Moody, VP Technology Development and Commercialization, Almac Sciences and Arran Chemical Company, “Almac Sciences is delighted to be working with PILA PHARMA and supporting their API manufacture. The project showcases deployment of our technology platforms including integration of green chemistries and we look forward to further opportunities in this space.”
Dorte X. Gram, CEO, PILA PHARMA states, “The availability of new API is key for us to be able to conduct planned 3-month toxicology studies, that are in turn a prerequisite for initiating our main goal, conducting a clinical phase 2b study with XEN-D0501 in type-2 diabetics. I am, therefore, very pleased to have signed off this agreement and we look forward to the collaboration with Almac on timely delivery of new API.”
The global company has proven expertise in small and large molecule analytics, API supply, stable & 14C radiolabeling, formulation development & solid-state services and earlier this year announced the completion of its £5 million two-storey center for biocatalysis, flow chemistry technologies and peptide research and development.