Pulmonary Hypertension | Disease Landscape and Forecast | G7 | 2019

Pulmonary hypertension (PH) is a devastating disease with high levels of morbidity and mortality and no cure. Despite the disease’s rarity, the potential commercial opportunities for drugs approved for PH are considerable, driven by premium pricing and the propensity for polypharmacy. Although this market has become congested, commercial interest in PH remains high. The need for more-efficacious and disease-modifying agents fuels this attention, along with the PHpopulations lacking any approved treatments.

Questions answered:

• Novel agents such as United Therapeutics’ ralinepag, Reata Pharmaceuticals’ bardoxolone methyl, and Liquidia/United Therapeutics/MannKind’s dry-powder inhaled treprostinil are in late-phase development for the treatment of PH. What do interviewed thought leaders say about the advantages and disadvantages of these therapies? How will the launch of these agents affect prescribing decisions?
• Actelion is developing Opsumit (macitentan) and Uptravi (selexipag)for the treatment of inoperable CTEPH. How would these therapies be prescribed to these patients? How would their launches impact the sales of Adempas?
• Several key branded therapies are set to lose patent protection/exclusivity during the forecast period. How will the launch of generic formulations affect their market share? What effect will generic launches have on entrenched and emerging branded therapies?
• ·A large unmet need exists for treatments for PHWHO groups 2, 3, and 5. What are the other key unmet needs in PH? How likely are these unmet needs to be fulfilled during the forecast period?
• Pulmonary arterial hypertension (PAH) patients are normally prescribed PDE-5 inhibitors and/or ERAs as first-line therapy. What are the treatment guidelines for later lines of therapy? How do the guidelines vary between geographical regions?

Geographies:

United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Key drugs covered:

Uptravi, Orenitram, Adempas, Opsumit, Adcirca, Tracleer, Revatio, Letairis / Volibris, Remodulin, Flolan, Veletri, Tyvaso, Ventavis, Beraprost, ralinepag, esuberaprost, bardoxolone methyl, inhaled dry powder treprostinil, INOpulse

Key companies mentioned:

Actelion, United Therapeutics, Bayer HealthCare, GlaxoSmithKline, Gilead Sciences, Pfizer, Arena Pharmaceuticals, Mannkind Corporation, Bellerophon Therapeutics, Liquidia Technologies, Reata Pharmaceuticals