Drugmaker Sun Pharmaceutical Industries Ltd has entered into a long-term manufacturing agreement with Samsung BioLogics for biological drug Tildrakizumab.
Tildrakizumab is Sun Pharma's investigational drug being evaluated for the treatment of moderate to severe plaque psoriasis, a skin ailment. And filings for this product have been accepted for review by the US Food and Drug Administration (May 2017) and the European Medicines Agency (March 2017), Sun Pharma said.
The agreement was signed at Samsung BioLogics’ headquarters in Incheon, South Korea. And the approximate value of the contract will be $ 55.5 million, the note said, adding that other financial details of the agreement were confidential.
TH Kim, President and CEO of Samsung BioLogics, said in the statement that the collaboration with Sun was important for it as it was a “testament” to its ability to provide reliable supplies through its GMP-certified (Good Manufacturing Practices) facility to pharmaceutical companies.
Other deals on Tildrakizumab
Sun Pharma's wholly-owned subsidiary had received worldwide rights for tildrakizumab from Merck (through a Merck subsidiary), known as MSD outside the United States and Canada, in 2014. Funded by a Sun Pharma subsidiary, Merck was responsible for the completion of Phase-3 or late trials in patients with mild-to-moderate plaque psoriasis.
Merck was also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch. Post-approval in the US, Sun Pharma would be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product.
Sun Pharma was also responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialisation of approved products for all non-US markets, Sun Pharma said.
Merck was also eligible to receive milestone payments and royalties on sales of tildrakizumab.
Meanwhile, Sun Pharma also closed a licensing agreement with Almirall last July, involving the development and commercialisation of tildrakizumab for psoriasis in Europe.
Almirall was to lead the Europe studies and participate in larger global clinical studies for psoriasis indication subject to the terms of the Sun Pharma-Merck agreements, as well as certain cost sharing agreements. Sun Pharma was eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales.
Sun Pharma added that it would continue to lead the development of tildrakizumab for other indications, where Almirall would have a right of first negotiation for certain indications in Europe. The agreement between Sun Pharma and Almirall, however, remained subject to the exclusive license agreement between Sun Pharma and Merck, it added.