New Delhi : Drug major Sun Pharmaceutical Industries said Spain-based Almirall S.L has sought regulatory approval from the European Medicines Agency for a new drug, tildrakizumab.
The drug is being evaluated for the treatment of moderate-to-severe plaque psoriasis, the two companies said in a statement.
In July 2016, Almirall entered into a licensing agreement with Sun Pharma for the development and commercialisation of tildrakizumab in Europe, it added.
The filing includes efficacy and safety data from the pivotal Phase III clinical trials that included over 1,800 patients across more than 200 clinical sites, the statement said.
“The filing of tildrakizumab in Europe is a significant step forward for healthcare providers as many patients are still suffering from the disease,” Almirall CEO Eduardo Sanchiz said.
Tildrakizumab adds a novel biologic treatment option to “our extensive and innovative portfolio, strengthening our position as a leading dermatology player,” he added.
Under the terms of the pact, Sun Pharma will continue to lead other indications, for which Almirall will have the right to primary negotiation. In addition, Almirall will be able to lead European studies, and participate in larger global clinical studies for psoriasis, the statement said.
Shares of Sun Pharma were trading 0.23 per cent higher at Rs 705.45 per scrip in afternoon trade on BSE.