Codexis has granted GSK a license to install its Codevolver platform at an R&D centre in Upper Merion, Pennsylvania, US in a deal that CEO John Nicols said was “very significant” for the Californian biocatalyst supplier.
Nicols told in-Pharmatechnologist.com “We are working very differently with GSK. This deal sets them up to do the biocatalyst development work without us,” adding that the agreement was “driven by GSK’s enthusiasm for biocatalysis.”
Under the license – for which GSK is paying $6m (€4.4m) upfront and up to $19m in milestones – the drugmaker will use Codexis' tech to develop biocatalysts for both new and established pharmaceuticals according to Mark Buswell who heads the UK firm's advanced manufacturing technologies team.
Buswell told us “GSK intends to use the enzymes developed with Codevolver on both the new chemical entity portfolio and the established products portfolio through lifecycle management” adding that any resulting changes will not impact supply continuity.
“As with any life cycle process improvements, modifications to established product manufacturing processes will only be implemented with the appropriate regulatory approvals. Internal GSK governance mechanisms would ensure that any lifecycle modifications do not cause interruptions to supply of established products.”
GSK’s use of the tech is limited to human healthcare products and the UK drugmaker is not allowed to let the contract manufacturing organisations (CMOs) it works with use the system according to Nicols, who said Codexis would consider similar deals.
“This is a very significant deal that is likely to generate $25m in two years,” he said, adding that “it is a model from which to approach other Big Pharmas” and confirming that Codexis is in talks with an unnamed pharma customer that is also interested in bringing the Codevolver system in-house.
Pharma business
Codexis has been trying to expand its pharma business to compensate for the termination of its biofuel accord with Royal Dutch Shell in 2012. In addition to GSK, the firm’s roster of pharmaceutical customers includes Pfizer, Exela and Merck & Co.
The Merck deal saw the US drugmaker apply Codexis developed biocatalysts to several products, including: the diabetes treatment Januvia; and various active ingredients for its hepatitis C portfolio.
Previously, Codexis has cited hepatitis C as a key driver both as a result of the Merck deal and its work with Vertex Pharmaceuticals (page 15). However, changing market dynamics mean this is no longer the case according to Nicols.
“The hepatitis C world has changed” he said, adding that “Gilead [which makes Sovaldi] has taken the market and customers have told us not to expect more roll out [of Codexis’ biocatalysts at manufacturing sites].”