Teva turns to Codexis for process improvement

The news highlights the development of the generics sector, which after a spate of mergers is becoming less fragmented and more competitive on an international scale. As a consequence, the major players are now turning to technologies that can lend a competitive advantage, in this case by improving the production of an active pharmaceutical ingredient (API).

Teva is the second major generics players to sign up for Codexis' technology after Switzerland's Sandoz.

Teva wants Codexis to apply its proprietary MolecularBreeding directed evolution platform, which relies on the rapid selection of bacterial strains that have improved biosynthetic properties. The aim is to improve fermentation-based processes in a fraction of the time and cost associated with traditional strain improvement.

Codexis said the collaboration would improve the productivity of manufacturing process for the unnamed product, as well as reduce the overall capital expenditures necessary to produce each unit of a product.

"Furthermore, the use of Codexis' MolecularBreeding directed evolution platform will generate novel intellectual property around the synthesis of a product,"​ said the firm.

The fermentation strains can be used to improve the characteristics of currently marketed pharmaceutical chemicals, for example decreasing unwanted by-products and enhancing the purity of the molecule. The resulting processes are often proprietary and can serve to extend the life of the existing intellectual property potentially increasing the value of the molecule for traditional pharmaceutical companies, according to Codexis. The technique is also being explored as a way to enable generic companies to access the active ingredient market.

Teva will have exclusive commercialization rights for the process and will provide R&D funding for the project and Codexis will also be eligible for milestone and royalty payments if the project comes to fruition.

Codexis has made significant progress in the two years since it was founded, and already has 10 agreements in place with pharmaceutical partners. The most significant of these was with Pfizer earlier this year, which saw the adoption of Codexis DNAShuffling technology - used to generate libraries of novel genes or genomes and recombine the DNA - across its process R&D for small molecule drugs.

This deal represented a shift in the way drug companies use this type of technology.

"As a rule, pharmaceutical companies use classical chemistry to pull together a process and get a drug to market,"​ said Alan Shaw, Codexis' CEO, at the CPhI meeting. Afterwards, he continued, the firm must seek regulatory approval for any changes in the process that might be adopted to drive down costs.

Pfizer is seeking to build in this cost saving at an early-stage, with the added benefit of greater intellectual property protection and generally a more environmentally friendly production process from the outset. And doing away with supplemental filings also represents a significant opportunity to save money, he noted.