Cook to make Biolex' Locteron API for Ph III trials
Under the deal Cook will use Biolex’s Lex gene expression system to produce the active pharmaceutical ingredient (API), namely interferon alpha 2b, in preparation for planned Phase III trials.
The Lex expression system uses a genetically modified version of the aquatic plant lemna, also known as duck weed, to generate large quantities of medically important proteins.
BioLex CEO Jan Turek said that the firm was “extremely impressed with the personnel and infrastructure assembled by Cook Pharmica,” and added that “utilizing the advanced GMP capabilities and systems established at Cook Pharmica [is] more efficient than building this fixed infrastructure in-house.”
Turek also said that the deal and the installation of the necessary Lex knowhow at Cook is a milestone for the platform.
He explained that the “ability to transfer this manufacturing platform outside of Biolex demonstrates the robustness and scalability that has been achieved as a result of extensive experience with the system, including five years of GMP manufacturing to support our interferon clinical trials.”
Locteron, which was co-developed by Biolex and Dutch drug delivery firm OctPlus, is expected to enter Phase III testing sometime next year, depending on the results of on-going Phase II trials.
Prior to the deal with Cook, Biolex had been making the Locteron API at its manufacturing facility in facility in Pittsboro, North Carolina.
As a result of the new agreement Biolex plans to halt the majority of manufacturing operations in Pittsboro and focus on using the site as a base for its R&D and process development operations.
