United Therapeutics fails to expand its Beat

Today’s failure of United Therapeutics’ phase III esuberaprost might not seem like a huge deal. After all, the pulmonary arterial hypertension candidate was only expected to bring in $73m by 2024, according to EvaluatePharma sellside consensus. But esuberaprost was the only United pipeline hope with sales forecasts attached, and it could have reduced the group’s reliance on treprostinil, the active ingredient in most of its marketed products. United is under pressure after the recent US launch of a generic version of its treprostinil injection, Remodulin, by Novartis’s Sandoz division, and more copycats are expected to follow later this year. United called time on esuberaprost after the Beat trial, which had been testing the project in combination with United’s inhaled treprostinil solution Tyvaso, failed to meet its primary endpoint, time to first clinical worsening. Both esuberaprost and treprostinil are prostacyclin analogues, but United thought their different binding profiles might lead to greater efficacy when combined. With esuberaprost gone, United’s pipeline looks even more lacklustre: the company has struck a couple of deals recently, but both were in its tried-and-tested space of PAH. It needs new ideas if it is to escape the generic squeeze in this market.

United Therapeutics' pipeline
Project Indication Description Status
Esuberaprost  Pulmonary arterial hypertension Prostacyclin receptor agonist Discontinued after failing phase III
Ralinepag*  Pulmonary arterial hypertension  Prostacyclin receptor agonist Phase III
Treprostinil Technosphere**  Pulmonary arterial hypertension  Dry powder inhaled treprostinil Phase III
Aurora-GT Pulmonary arterial hypertension  eNOS gene therapy Phase II 
SM04646 Idiopathic pulmonary fibrosis Wnt pathway inhibitor Phase I
RemoPro Pulmonary arterial hypertension  Pain-free subcutaneous Remodulin prodrug Phase I
*Licensed from Arena; **Licensed from Mannkind. Source: company SEC filing 27 Feb, 2019; EvaluatePharma.

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