Angelini seizes the initiative with Arvelle takeout

Two years after licensing cenobamate from SK, Arvelle gets a nice payday.

Deals

Any deal bankers hoping that the flurry of biopharma acquisitions in late 2020 bodes well for this year already have cause for further optimism: the first takeover of 2021 has been struck, with a biodollar value of $960m.

But if the cash on offer is simple the deal is anything but: Italy’s Angelini Pharma has bought Switzerland’s Arvelle Therapeutics, giving it European rights to cenobamate, an epilepsy project that Arvelle had licensed from South Korea’s SK Biopharmaceuticals two years ago.

The transaction also gives Angelini another crack at Gaba-A modulation. Angelini had licensed European rights to Ovid Therapeutics' Gaba-A modulator OV101 last July, but this project failed in Angelman syndrome last month.

Dual mechanism

However, the two projects work quite differently, Agnese Cattaneo, Angelini’s chief medical officer, told Evaluate Vantage: OV101 is a straight Gaba-A agonist, while cenobamate is both a positive modulator of Gaba-A and a sodium channel blocker.

She believes that this dual mechanism could bolster cenobamate’s efficacy versus currently marketed anti-epileptic drugs. Mark Altmeyer, Arvelle’s chief executive officer, added that cenobamate could stop the initiation and spread of seizures.

Ms Cattaneo noted that, while there were several epilepsy drugs with one or the other mechanism, cenobamate was the only project with both actions.

Angelini’s bet on OV101 was small, at just $20m up front, but the Italian group is going much bigger on cenobamate, pledging $610m on approval in Europe and another $350m if certain sales targets are met.

This seems to be a reflection of cenobamate’s better chances of making it to market: the drug is already approved for partial-onset seizures in adults in the US, where it is sold by its originator SK under the brand name Xcopri.

In Europe Arvelle had been preparing for the same type of seizures in treatment-resistant adults – those who had already tried two anti-seizure medications. A decision from the EMA is due this year; if approved, cenobamate will be branded there as Ontozry, according to Mr Altmeyer.

SK is also studying cenobamate in primary generalised tonic-clonic seizures, in phase III. Arvelle had planned to use this trial as the basis for European approval in this indication, something that Angelini now hopes to do. Data are due in 2022.

SK stake

As part of the deal, SK is selling its 12% stake in Arvelle to Angelini for up to $55m, and the South Korean group is still eligible for $430m in milestones, under the original deal. Another company cashing in today is Sio Gene Therapies, which is offloading its stake in Arvelle for up to $20m.

Apart from the immediate $32m windfall, not much has changed for SK, which is effectively swapping one Europe licensee for another. The real winner is Arvelle, which has made a healthy return on the $100m up-front fee it had originally paid for cenobamate.

Mr Altmeyer accepted that Arvelle did not have to do any of its own studies, but said it had had to carry out work with the EMA around filing and manufacturing requirements, as well as building its organisation to prepare for launch.

Arvelle's presence in northern European countries – in which Angelini currently does not have a high profile – might have helped drive the deal. Indeed, in its press release Angelini stated that the acquisition would make it a leading European player with direct affiliates in France, the UK, the Nordic countries and Switzerland by 2022.

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