Sun Pharma said it has inked a long-term agreement with Samsung BioLogics under which the Korean company will manufacture Tildrakizumab, a potential treatment for plaque psoriasis, for the Indian company.
Plaque psoriasis is an autoimmune condition which results in patches of thick, red, scaly skin.
The approximate value of the contract will be US$ 55.5 million, other financial details of the agreement are confidential, it said.
Commenting on its agreement with Samsung BioLogics, Mr Kirti Ganorkar, Global Head – Portfolio Management & Business Development, Sun Pharma 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.”
TH Kim, President and CEO of Samsung BioLogics 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.”
The filing for the investigational biologic has been accepted for review by the U.S. Food and Drug Administration (FDA) (May 2017) and the European Medicines Agency (EMA) (March 2017), the Indian company said.
Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. With this precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system, Sun Pharma said.
“Phase-3 tildrakizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis,” it said.
The regulatory filings associated with tildrakizumab have been accepted for review by the FDA and EMA.