Sun Pharma and Samsung BioLogics announce strategic manufacturing tie-up for tildrakizumab.
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 the novel investigational biologic was accepted for review by the U.S. Food and Drug Administration (FDA) in May and the European Medicines Agency (EMA) in March. The agreement was signed at Samsung BioLogics’ headquarters in Incheon, South Korea. The approximate value of the contract will be $55.5 million. Other financial details of the agreement were confidential.
“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,” Kirti Ganorkar, global head—portfolio management and business development at Sun Pharma, 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.
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.
A Sun Pharmaceutical Industries Ltd. wholly owned subsidiary received worldwide rights to tildrakizumab from Merck, known as MSD outside the United States and Canada, in 2014. Funded by a Sun Pharma subsidiary, Merck is responsible for the completion of Phase-3 trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a Biologics License Application to the United States Food and Drug Administration (FDA). Merck is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch.
Post-approval in the U.S., Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck is eligible to receive milestone payments and royalties on sales of tildrakizumab.
(Source: PR Newswire)
