Possibility of earlier pimavanserin approval boosts Acadia
The FDA’s revelation that it would accept data from Acadia Pharmaceuticals’ ongoing trial of its Parkinson's psychosis candidate pimavanserin as sufficient for an approval application has allowed the company to shelve its plans for a confirmatory study and could permit the project's approval a year earlier than expected, towards the end of 2015.
The sooner pimavanserin is on the market for Parkinson's psychosis the sooner Acadia can work towards approval in other, more lucrative indications. Speedier approval could also help the Californian firm nab a partner for the drug – and even raises the possibility of a buyout.
Et in Acadia ego
The San Diego group’s share price was boosted 64% yesterday, and no wonder: using EvaluatePharma’s My NPV Editor tool to remove the risk of the FDA turning pimavanserin down – after all, the FDA has signalled its willingness to look on it favourably – and slightly advance the launch date sends the project’s NPV through the roof, nearly doubling it to $1.7bn.
The longer-term share price jump looks a little stranger. The shares nearly doubled back in November when the ACP-103-020 trial of pimavanserin, also called ACP-103, reported positive results (Acadia scores big with pimavanserin data but new trial awaits, November 28, 2012).
There was a second rise, this time of 24%, on March 21 following the presentation of the same results at a conference. It might have been expected that pimavanserin’s chances of success had already priced into the shares back then, but apparently investors’ optimism was not yet worn out.
The combination of clinical success, investor confidence and the FDA’s putative backing suggest that the lack of a partner for ACP-103 so far is simply due to the fact that Acadia does not want one. On 22 March analysts from Roth Capital Partners wrote that Acadia could launch pimavanserin for Parkinson’s psychosis with a 60 to 75-strong neurology sales force at a cost of just under $20m annually.
But an effective antipsychotic with decent tolerability is a rare thing, and ought to have applicability beyond the relatively niche Parkinson’s market. Pimavanserin is in Phase II trials in both schizophrenia and psychosis related to Alzheimer’s disease, and launch in these larger markets would require the muscle of a larger partner.
There is, however, another possibility. Acadia is now a takeover target – Roth analysts gave the company a 20% chance of being bought out even before the news of the possibility of expedited approval.
With some analysts expecting pimavanserin to attain blockbuster status early in the 2020s, a takeover could make sense. US approval in Parkinson’s psychosis is the first step along this path, and is now looking like a reasonably easy one to take.