Psoriasis is a common skin condition with no known cure at the moment, however India’s largest drug manufacturer, Sun Pharmaceutical, and South Korea-based Samsung BioLogics have recently signed an agreement regarding the manufacture of Tildrakizumab in experimental treatment of this frustrating condition.
According to news reports, the FDA (U.S. Food & Drug Administration) and EMA (European Medicines Agency) are reviewing Tildrakizumab. The contract between the two companies is said to be valued at about $55.5 million, however additional financial details of the long-term agreement have not been revealed according to a statement made by Sun Pharma, and they remain confidential.
Samsung BioLogics will manufacture the drug, designed to treat those with moderate to severe plaque psoriasis. In 2014 Sun Pharma acquired rights for the drug from U.S. pharmaceutical company Merck, who remained liable for phase-3 clinical trial completion and submitting the biologics license application to the FDA.
While Tildrakizumab will be manufactured by CMO (contract manufacturing organization), Samsung BioLogics, who is globally renowned, Sun Pharma will be in control of subsequent submissions to the FDA, post approval studies, pharmacovigilance, commercialization following approval of the drug, and all remaining regulatory activities.
The new psoriasis drug is Sun Pharmaceutical’s entry into the innovation drug sector, as it seeks to prove its fortitude to regulators.
Psoriasis is a highly common condition in the U.S., with about 7.5 million people affected, according to the American Academy of Dermatology. Hopefully Tildrakizumab will prove to be effective in treating the uncomfortable, and often embarrassing, condition.
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