India’s Sun Pharmaceutical Industries acquired the rights to the anti-IL-23p19 candidate from Merck & Co. in 2014 and today announced it has selected Korean contract manufacturing organisation (CMO) Samsung Biologics to make the monoclonal antibody.
Tildrakizumab – which has been accepted for review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in March and May, respectively – is being developed to control the pathogenic cells responsible for the inflammatory process of psoriasis by selectively blocking the cytokine IL-23.
Production will take place at Samsung Biologics’ mammalian manufacturing site in Incheon, South Korea which currently houses 180,000L of stainless steel capacity across two plants, with a third plant set to double capacity expected to come online next year.
The deal is worth around $55.5m (€49m), though when contacted neither Sun Pharma nor Samsung Biologics divulged any further details.
From conception to one-stop-shop in six years
However, the Korean CMO – which was only conceived in 2011 – has not been shy of ambition.
As well as constructing three facilities, the firm has won contracts with Big Pharma firms including Bristol-Myers Squibb and Roche, and last year launched on the Korea Composite Stock Price Index (KOSPI) through a $2bn initial public offering (IPO).
And speaking last week at the first Biopharma Expo, held in Tokyo alongside Interphex Japan, CEO TH Kim said in the six months since going public the CMO’s value had doubled from $8bn to $16bn.
Furthermore, he told delegates the firm has branched out into offering development services to its clients. Since earlier this year, the CMO now offers cell line development services, process development services, preclinical and clinical materials, QC services, formulation ad fill/finish.
By becoming a “one-stop CDMO service provider,” Samsung Biologics can support its vision of reducing its costs, reducing its prices and increasing its value, Kim said.