Mumbai: Sun Pharma and Samsung BioLogics announced a strategic long-term manufacturing agreement for Tildrakizumab. The agreement was entered into by Sun Pharma’s wholly-owned subsidiary and Samsung BioLogics.
According to the agreement, Sun Pharma has appointed Samsung BioLogics to manufacture Tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis.
Filings for this novel 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 agreement was signed at Samsung BioLogics’ headquarter in Incheon, South Korea. The approximate value of the contract will be US$ 55.5 million, other financial details of the agreement are confidential.
Commenting on the development, Dr. TH Kim, President and CEO of Samsung
BioLogics said, “Samsung BioLogics is pleased to join hands with Sun Pharma and is looking forward to delivering best-in-class manufacturing services with global quality standards. 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.”
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.”
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. Phase-3 tildrakizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis. The regulatory filings associated with tildrakizumab have been accepted for review by the FDA and EMA.