Almac Group to manufacture Pila Pharma API

The TRPV1 target (also called the “chili-receptor”) has reportedly demonstrated applications across pain and inflammatory diseases

Almac Sciences, a global provider of integrated drug development services, has signed a manufacturing agreement with Swedish biotech company, Pila Pharma, for the production of XEN-D0501, a highly selective and potent API.

From its global headquarter facilities in Northern Ireland, Almac will manufacture the small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has reportedly demonstrated applications across pain and inflammatory diseases and possibly in diabetes as well.

XEN-D0501 was acquired by Pila in March 2016 and the company says it’s now 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.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company said: “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 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.”

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