The unusual story of Shire’s adult Adderall, SHP465, appears close to reaching a long-delayed climax as the pill has produced positive phase III data a decade after it was first filed with the FDA.
SHP465 had been shelved until two years ago, and it came in handy when the UK-based group needed revenue forecasts to argue that AbbVie’s hostile bid was undervalued. With today’s news that another pipeline prospect has failed in phase II, it only heightens the need for Shire to support the late-stage attention-deficit/hyperactivity disorder drug with a sharp marketing campaign.
The 10-year wait
The strength of SHP465 comes in its long duration, which Shire hopes will allow patients to stop using both an immediate and extended-release version of Adderall to achieve the same control. Shire says 10% of ADHD patients must take two pills.
This project was previously known as SPD465, and appeared on track to hit the market 10 years ago until the FDA sent the application back to Shire for more work. This sat on a shelf until 2014, when the group decided to initiate a new trial just five days before AbbVie bid to take out Shire for $46bn (Shire puts on rose-coloured glasses and outlines defence, June 23, 2014).
The reasons for freezing and resuscitating this agent are not exactly clear. However, the EvaluatePharma consensus of sellside analysts forecasts $323m in sales in 2022; this morning, Bryan Garnier analysts estimated a potential $500m in sales by 2020.
These numbers do not achieve the blockbuster peak sales numbers of Adderall, or the $3bn figure being forecast for Vyvanse, but Shire is eager to point out how launch of ‘465 extends its ADHD franchise – its last patent expires in 2029, six years after Vyvanse loses market exclusivity.
As it has already been in the FDA’s hands ‘465 will be a class 2 resubmission, giving the agency a six-month decision deadline. Shire said launch could come by the end of 2017.
The phase II setback today of one of Shire’s other pipeline hopes, SHP607, in the eye condition retinopathy of prematurity, will heighten the need for ’465 to perform well after launch. It is now reckoned to be Shire’s third-biggest pipeline project after lifitegrast and lanadelumab (DX-2930).
Achieving these sales forecasts will require that Shire persuade stable patients and their physicians to switch from two to one pill a day – a direct-to-consumer campaign could be necessary – and that the group agrees to pricing terms with payers. Express Scripts, for one, lists only generic versions of immediate and extended-release Adderall in its national formulary, and Vyvanse is on a higher tier with increased cost sharing.
In this circumstance, Shire cannot realistically hope to achieve premium pricing. Achieving sales of half a billion dollars, as executives forecast in 2014, looks ambitious. Perhaps money spent prolonging the ADHD franchise would be better focused on rare diseases.