EC approval of DuoCort’s Plenadren® (hydrocortisone modified release tablet) therapy for adrenal insufficiency in adults marks the go-ahead for ViroPharma to acquire the Swedish specialty pharma firm. The definitive agreement for ViroPharma to acquire DuoCort, announced in October, was dependent on EC approval of Plenadren, and the drug’s clearance by the regulator means the firms now expect to complete the acquisition in November. On closing, ViroPharma will pay $33 million up front, and could in addition pay another $130 million, associated with manufacturing, sales thresholds, and territory expansion.
The EC’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on Plenadren in July. Final approval means the drug is now cleared for marketing in all countries of the EU, plus Iceland, Norway, and Lichtenstein.
Plenadren is a once-daily, dual-release oral glucocorticoid therapy that combines both rapid release and extended release characteristics in a single tablet.