Production & Manufacturing

Samsung Biologics to manufacture Sun Pharma’s psoriasis drug Tildrakizumab

PBR Staff Writer Published 05 July 2017

Indian drug major Sun Pharma has signed a manufacturing agreement with South Korea-based Samsung BioLogics for psoriasis experimental drug Tildrakizumab.

As part of the $55.5m deal, Samsung BioLogics will manufacture Tildrakizumab, which is an investigational IL-23p19 inhibitor that is being assessed for the treatment of moderate to severe plaque psoriasis.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the applications for assessing the novel investigational biologic.

Tildrakizumab is an anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23, enabling to control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system.

According to Sun Pharma, the phase-3 tildrakizumab offer further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis.

In 2014, Sun Pharmaceutical Industries wholly owned subsidiary secured worldwide rights to tildrakizumab from Merck.

Under the deal, Sun Pharma subsidiary will provide funding for Merck to complete phase 3 trials in patients with mild-to-moderate plaque psoriasis.

In July 2016, Sun Pharma along with its wholly owned subsidiary signed a development and commercialization agreement with Almirall for tildrakizumab to be used for psoriasis in Europe.

Samsung BioLogics president and CEO Dr TH Kim said: “Our collaboration with Sun Pharma is an important milestone for Samsung as it is a testament of our ability to provide reliable supply through its GMP-certified manufacturing facility to pharmaceutical companies, which aim to expand their global market.”

Sun Pharma portfolio management and business development head Kirti Ganorkar said: “Samsung BioLogics is a globally renowned CMO. Through this partnership we will leverage

Samsung’s manufacturing knowledge and world class quality systems to provide high quality products for the Tildrakizumab pipeline.”

Image: Sun Pharma’s manufacturing unit. Photo: courtesy of Sun Pharmaceutical Industries Ltd.