Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, and Samsung BioLogics, an Incheon, Korea-based contract biologics manufacturer, have formed a $55.5-million strategic long-term manufacturing agreement for tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.

The agreement was entered into by Sun Pharma’s wholly owned subsidiary and Samsung BioLogics. Sun Pharma has appointed Samsung BioLogics to manufacture tildrakizumab.

Filings for this investigational biologic have been accepted for review by the US Food and Drug Administration as of May 2017 and the European Medicines Agency in March 2017.

Sun Pharma’s wholly owned subsidiary received worldwide rights to tildrakizumab from Merck & Co. in 2014. Funded by a Sun Pharma subsidiary, Merck was responsible for the completion of Phase III trials in patients with mild-to-moderate plaque psoriasis and submission of the biologics license application to the FDA. Merck is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch.

Post approval in the US, 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, and manufacturing and commercialization of approved products for all non-US markets. Merck is eligible to receive milestone payments and royalties on sales of tildrakizumab.

In Europe, Sun Pharma and its wholly owned subsidiary and Almirall, a Spanish pharmaceutical company, formed a licensing agreement on the development and commercialization of tildrakizumab for psoriasis. Under the license agreement, Almirall is able to lead European studies and participate in larger global clinical studies for the psoriasis indication subject to the terms of the Sun Pharm–Merck agreements as well as certain cost-sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck & Co.

Source: Sun Pharmaceutical Industries and Samsung BioLogics