Endo allies on hybrid drugs
Asubsidiary of Endo is allying with US-based ophthalmics and injectables specialist Nevakar to develop and market five “differentiated” sterile injectable products in the US and Canada. Nevakar will take charge of developing and filing the products, using in the US the 505(b)(2) hybrid new drug application (NDA) pathway.
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Endo maintains that it will continue to drive revenue and EBITDA growth via business development opportunities, after the advent of generic competition to its lucrative Vasostrict injectable led the firm to disclose potentially catastrophic Q2 profitability guidance.
Endo’s Par has announced the first launch under a longstanding US collaboration with 505(b)(2) specialist Nevakar, in the form of pre-mixed ephedrine sulfate injection in a ready-to-use 50mg/10ml single-use vial.
With Endo’s CEO Paul Campanelli intending to step down for personal reasons, the US brands and generics player’s board has started to look for external and internal candidates to take over.