Samsung Biologics to manufacture Sun Pharma’s new psoriasis drug
Mumbai: Sun Pharmaceutical Industries Ltd on Tuesday said it has entered into a long-term manufacturing agreement with South Korea's Samsung Biologics for Tildrakizumab, the Indian company's new drug for treatment of moderate-to-severe plaque psoriasis.
Samsung Biologics will manufacture Tildrakizumab for Sun Pharma, according to the agreement. The value of the contract is $55.5 million, Sun Pharma said in a stock exchange filing.
“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.
Sun Pharma, India's largest drug maker, had acquired rights for Tildrakizumab from US drug maker Merck in 2014. While Merck was responsible for completion of phase-3 clinical trial and submission of biologics license application to the US Food and Drug Administration (FDA), Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
Applications for Tildrakizumab were accepted for review by the US FDA in May and by the European Medicines Agency in March this year.
For the European market, Sun Pharma signed a licensing agreement with Almirall S.A. in July 2016 for development and commercialisation of Tildrakizumab.
In a conference call with analysts on 26 May, Dilip Shanghvi, managing director of Sun Pharma had said the company plans to launch Tildrakizumab in the US in the beginning of fiscal year 2018-19.