US firm Codexis and Shasun Chemicals and Drugs of India have signed a manufacturing and supply agreement for a pharmaceutical intermediate for a generic drug.
The novel cost-effective process was developed using Codexis' biocatalytic technology platform. This uses a process re-engineering platform to create new biocatalysts that can produce drug intermediates and active pharmaceutical ingredients (APIs) at lower cost and with fewer by-products and impurities than conventional methods, the company claims.
Biocatalysts are used to simplify and lower the cost of a variety of chemical transformations and are of particular interest in manufacturing chiral or single-enantiomer compounds. Earlier this year, Codexis bolstered its activities in this area through the acquisition of Germany's Juelich Fine Chemicals, which offers a range of off-the-shelf specialty enzymes and chiral intermediates.
The agreement is a real milestone for Codexis as it will market the API worldwide to the generic pharmaceutical industry. This agreement marks the start of direct product marketing for Codexis.
The process involves a biocatalytic system that has been specifically developed to function optimally for the synthesis of the pharmaceutical intermediate in Shasun's manufacturing facility, said the firm.
Codexis will provide Shasun with commercial quantities of the novel biocatalyst for use in the production process and the companies will share profits on sales. Under the terms of the agreement, Shasun will manufacture the compound. Additional terms were not disclosed.
Codexis has already signed more than 10 agreements with pharmaceutical partners. One of the more significant of these was with Pfizer last 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. The company has also signed biocatalyst deals with Lonza, Sandoz and Teva, amongst others.
Alan Shaw, president and CEO of Codexis, said the firm "now has the unique opportunity to leverage Shasun's core manufacturing and regulatory competence in combination with our own proprietary protein and strain engineering technologies in order to generate a clear competitive advantage in the generic pharmaceutical market."