Almac, PILA PHARMA Enter API Manufacturing Pact


Almac will manufacture XEN-D0501, a highly selective and very potent small molecule TRPV1 antagonist for ongoing type 2 diabetes clinical studies.

Almac Sciences, a global provider of drug development services and member of the Almac Group, has signed a manufacturing agreement with Swedish biotech company, PILA PHARMA, for the production of XEN-D0501 active pharmaceutical ingredient (API).
Almac Sciences will manufacture XEN-D0501, a highly selective and very potent small molecule TRPV1 antagonist, from its global headquarters in Northern Ireland. The TRPV1 target was previously in development by Bayer and Xention/Ario Pharma and has demonstrated applications across pain and inflammatory diseases and possibly in diabetes.
PILA acquired XEN-D0501 in March 2016, and subsequently, it has demonstrated good safety results and 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.
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 Gram, CEO, PILA PHARMA said, “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.”