Acorda Therapeutics made some noise at last week’s JP Morgan conference about the growing importance of Parkinson’s disease to its future, and just days later it has paid $363m for Finland’s Biotie in a deal focused squarely on this therapy area.
For a relatively modest price Acorda has picked up the phase III project tozadenant – but then European biotech valuations typically trail the US by some margin. Biotie had lost UCB as a tozadenant partner two years ago, though this setback actually meant it was simpler for Acorda to acquire the asset than had it been encumbered by a licensee.
Of course, this is little solace for Biotie investors, as even the 95% premium at which their company is being bought out today is some 30% below where the stock stood before UCB pulled the plug. Then again they are pretty used to disappointment, and appear to have realised that accepting Acorda is the best they can get under the circumstances.
This is actually Acorda’s second foray into Parkinson’s R&D; in September 2014 the group paid $525m in cash for the Alkermes spin-out Civitas Therapeutics on the day the private company was set to float.
With Civitas came CVT-301, a dry-powder formulation of levodopa that is in phase III for treating off episodes in Parkinson’s patients. At JP Morgan Acorda indicated that it was increasingly focusing on the Civitas assets, and Evercore ISI’s Mark Schoenebaum noted investor relief that this shifted attention away from Acorda’s troubled multiple sclerosis drug, Ampyra.
Ampyra was approved on mixed clinical data, and has since been hit with a US patent challenge; EvaluatePharma sellside consensus indicates sales of $419m last year. Another MS project, rHIgM22, which targets remyelination, has generated a lot of interest but is very early.
On an investor call today Acorda’s chief executive, Ron Cohen, said Biotie brought him a fourth phase III asset, resulting in three possible US filings by the end of 2018, worth over $1bn in combined peak revenue. Biotie also brings a phase II Parkinson’s project, SYN120, which Roche turned down, and thus “creates a centre of excellence in Parkinson’s at Acorda”.
While Biotie is a pure CNS player it has not always worked on Parkinson’s; its initial focus was on the binge drinking treatment Selincro, which is now marketed in the EU by Lundbeck, though insufficient patent protection means that it has not been developed for the US.
Tozadenant is no dead-cert, however, and its mechanism, A2A antagonism, has failed to live up to the promise. Merck & Co’s preladenant failed two phase III trials, Kyowa Hakko Kirin’s Nouriast was knocked back by the FDA, and Biogen pulled out of a deal for Vernalis’s V81444 (Biotie mulls second chance for Parkinson’s drug, September 22, 2014).
However, tozadenant did generate promising phase II data, with two of four doses, 120mg and 180mg twice daily, reducing daily off-time with statistical significance versus placebo. On the strength of this Biotie began the phase III TOZ-PD trial, having raised €33m ($36m) in debt and €50m in a secondary float on Nasdaq.
Edison analysts estimated that the raise would fund Biotie until an initial readout, but more money would be needed to complete TOZ-PD. Whether it was ethical for Biotie to begin a study it could not afford to complete is now a moot point, and tozadenant becomes Acorda’s binary outcome.
For Acorda tozadenant is a risky bet to make, but at least the group can boast that it did not break the bank.
|TOZ-PD||450 pts, measures hours spent in off state vs placebo as primary endpoint||NCT02453386|