Novartis has unveiled a major clinical trial programme for Entresto as it tries to kick-start sales of the heart failure drug.
Described as the "largest global clinical programme in the heart disease area", the FortiHFy initiative includes more than 40 ongoing or planned trials of Entresto (sacubitril/valsartan), which has seen sluggish sales since its first launch in the US last year.
Prescribing hurdles levied by US insurers in particular have resulted in a switch-around from the usual sales pattern for new pharma launches, with sales in Europe running ahead of those in the world's largest pharma market.
Novartis has attributed the phenomenon to 'step -edits' imposed by US payers - requiring that other treatment options are exhausted before Entresto can be used - which are not so common in the European market.
Entresto costs around $4,500 per year in the US, but has to compete with established drugs such as ACE inhibitors and angiotensin II receptor antagonists (AIIRA) that are now available as generics and cost cents per dose.
Armed with clinical data showing it can reduce deaths and hospitalisations compared to ACE inhibitor enalapril in patients with reduced ejection fraction heart failure (HFrEF), Novartis has predicted Entresto has the potential to become a $5bn product. However, sales in the first quarter of the year were $17m and the company is suggesting they will rise to just $200m for 2016 as a whole.
Hoping to make prescribing the drug a compelling proposition, Novartis' new clinical programme will be aimed at providing new insights into "symptoms reduction, efficacy, quality of life benefits and real-world evidence" for the drug, which adds a first-in-class neprilysin inhibitor to an AIIRA.
Among the larger trials highlighted in FortiHFy is the PARAGON-HF trial comparing Entresto to valsartan in HF patients with preserved ejection fraction (HFpEF), a group with few treatment options that accounts for around half of all HF cases, with data expected in 2019.
Novartis is also conducting the TRANSITION trial in post-discharge HFrEF patients, and the PIONEER trial looking at starting Entresto treatment in hospital in HFrEF patients who experience a sudden worsening of symptoms. Results of both these studies are expected in 2018.
Meanwhile, the PARADISE-MI study will examine the use of the drug to prevent heart failure in patients who have suffered a myocardial infarction (MI), with results due in 2020.