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Trevyent? for pulmonary arterial hypertension (PAH)
• Combination of treprostinil and our PatchPump? platform technology
- Goal - to overcome the limitations of market leader Remodulin? (treprostinil)
- Expected NDA filing in Q3 2016
• Potential high revenue, high margin ~$180,000 per patient per year
• Potential >$4 Billion addressable market opportunity in U.S.
Bio-waiver confirmed – No clinical studies required for approval
• 505(b)(2) NDA in the U.S.
• Hybrid 10(3) Application in the E.U. - granted Centralized Review by EMA
NDA submission anticipated Q3 2016 and E.U. MAA H2 2016
Remodulin safety and efficacy data to be included in Trevyent prescribing
information
Example of FDA product approvals through bio-waiver
• Parenteral epoprostenol reformulation (Veletri?, Actelion) for PAH
Pipeline of two At-Home Patient Analgesia (AHPA) product candidates
• SMT – 201 (Ketorolac). Anticipate pivotal / registration trial H2 2016
• SMT – 301 (Bupivacaine.) Formulation development and technical feasibility ongoing
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