Almac Group and Pila Pharma Sign Manufacturing Agreement

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

According to an August 10, 2021 press release, Almac Sciences, a member of the Almac Group, has signed a manufacturing agreement with Swedish biotech company, Pila Pharma, for the production of the API XEN-D0501— a highly selective and very potent small molecule TRPV1 antagonist. Almac Sciences will manufacture XEN-D0501 from its global headquarters in Northern Ireland. The API was previously in development by Bayer Healthcare and Xention/Ario Pharma and was acquired by Pila Pharma in March 2016.

The TRPV1 target has demonstrated applications across pain and inflammatory diseases and possibly in diabetes. After being acquired by Pila Pharma, XEN-D0501 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).

“The availability of new API is key for us to be able to conduct planned three-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,” said Dorte X. Gram, CEO of Pila Pharma, in a press release.

“Almac Sciences is delighted to be working with Pila Pharma and supporting their API manufacture,” said Tom Moody, VP technology development and commercialization, Almac Sciences and Arran Chemical Company, in a press release. “The project showcases deployment of our technology platforms including integration of green chemistries and we look forward to further opportunities in this space.”

Source: Almac Group