SBA Member, 04.06.2018
In May, Cosmo’s key pipeline product MethyleneBlue suffered a setback with the FDA issuing a Complete Response Letter (non-approval) and surprisingly requiring a second phase III trial to gain US approval. We conservatively push back US approval by ~3 years. EU filing remains unchanged for Q4 2018 with approval expected at the end of 2019. MethyleneBlue, with unchanged global peak sales of USD 700+ mn, should be transformational for Cosmo. Rifamycin SV/Rifafalk is likely the most underestimated pipeline product with US and EU approval in its first indication for travelers’ diarrhea expected in Q4 2018.
Key catalysts include:
• Rifamycin SV/Rifafalk US & EU approval travelers’ diarrhea (Q4 2018)
• MethyleneBlue EU filing colonoscopy (Q4 2018)
• Remimazolam US filing procedural sedation (Q4 2018/Q1 2019)
Read the full report below.