India’s largest drug maker, Sun Pharma, which in 2014, acquired rights to Merck’s psoriasis drug- Tildrakizumab, has now announced a partnership pertaining to the same drug with south-Korean firm Samsung BioLogics.
The $55.5 million contract signed at Samsung BioLogics’ headquarters in Incheon, South Korea, signals the appointment of Samsung Biologics to manufacture Tildrakizumab for Sun Pharma.
“Samsung Biologics is a globally renowned CMO (contract manufacturing organisation). Through this partnership we will leverage Samsung’s manufacturing knowledge and world class quality systems to provide high quality products for the Tildrakizumab pipeline,”said Kirti Ganorkar, global head – portfolio management and business development at Sun Pharma.
According to Sun Pharmas’s deal with Merck for the drug to treat moderate-to-severe plaque psoriasis, the latter was responsible for completion of phase-3 clinical trial and submission of biologics license application to the US Food and Drug Administration (FDA), and the former will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
Sun Pharma intends to launch Tildrakizumab in the US in the beginning of fiscal year 2018-19.
Applications for Tildrakizumab were accepted for review by the US FDA in May and by the European Medicines
Agency in March this year. And for the European market, Sun Pharma has already signed a licensing agreement with Almirall S.A. in July 2016 for development and commercialisation of Tildrakizumab.
