Galapagos Turns the Tables on Abbvie, Courtesy of Gilead

December 17, 2015 Galapagos turns the tables on AbbVie, courtesy of Gilead

Jacob Plieth

A year that started with AbbVie’s overpriced takeout of Pharmacyclics is ending with the group likely ruing its decision to can a deal with Galapagos over the Jak inhibitor filgotinib.

That’s because Gilead today stepped in with a knockout transaction to license filgotinib from Galapagos. Not only has the Belgian group scored an even better deal than it had before – less than three months after AbbVie pulled the plug – but its former partner has to develop its own Jak inhibitor ABT-494 in the face of a daunting new competitor.

It was the presence of ABT-494 in Abbvie’s in-house pipeline that prompted the scrapping of the filgotinib deal with Galapagos in September. Opting in to full development would have cost AbbVie another $200m; while there would have been no logic to having two Jaks in late-stage development, the decision to turn down Galapagos now looks shortsighted.

$725m cash injection

The Gilead deal gives Galapagos an immediate $300m up front, plus a $475m equity investment, with an obligation on the junior party to fund just 20% of filgotinib’s phase III programme.

The Belgian group had received $150m from AbbVie back in 2012, though it still had to fund phase II. At the time the $1.35bn biodollar value made that deal one of the biggest ever for a phase II asset; now Galapagos has got much more up front from Gilead than it stood to receive from AbbVie under the phase III opt-in.

It is likely that recently released phase II data in Crohn’s disease, supplementing the earlier readout of studies in the lead indication of rheumatoid arthritis (RA), helped turn deal talks in Galapagos’s favour (Galapagos goes with its gut to attract new filgotinib partner, December 8, 2015).

However, Gilead was not one of the names the sellside had mentioned in a speculated new filgotinib deal, instead focusing on big pharmas like Johnson & Johnson or Sanofi. It is inconceivable that these were not also involved in the bidding, which would have pushed up the transaction’s price for Gilead.

One clue, however, was that almost precisely three years ago Gilead had bought YM Biosciences – developer of the Jak inhibitor momelotinib. That agent has progressed without fanfare, and in any case it does not seem to have potential beyond myelodysplastic syndromes.

Either way AbbVie now faces a headache on multiple fronts, and one of the few advantages it still has is an established RA sales force – something that Gilead has yet to set up. But recent events have left AbbVie’s top- selling drug, Humira, looking precarious.

Biological challenger

In addition to progress being made by the oral agent filgotinib, a biological RA contender has also taken a step towards approval: GlaxoSmithKline yesterday said topline phase III results with its anti-IL-6 MAb sirukumab were positive, though it did not reveal any of the data.

The full results will be eagerly awaited to see whether sirukumab lives up to the best-in-class promise shown in phase II. It will need a clinical edge if it is to take market share from Roche’s Actemra, the only anti-IL-6 approved in RA, and Sanofi’s rival agent sarilumab, which is expected to get the go-ahead next year.

Three pivotal trials of sirukumab are ongoing: Sirround-H, versus Humira, and Sirround-T and Sirround-D, versus placebo in patients who have not responded to other RA drugs (Upcoming events: Sirukumab and serelaxin face phase III readouts, October 30, 2015).

And the triple whammy of bad news for AbbVie was completed today with AstraZeneca’s $2.5bn purchase of a majority stake in Acerta Pharma. With all the caveats of across-study comparisons and investigator assessments of disease remission, Acerta’s acalabrutinib looks like a strong challenger to Imbruvica, the CLL drug AbbVie owns half of through its $21bn Pharmacyclics takeover.

It is true that hindsight is 20/20, but AbbVie’s business development people should be asking themselves some pretty searching questions today.

To contact the writers of this story email Jacob Plieth or Madeleine Armstrong in London at [email protected] or follow @JacobPliethor @medtech_ma on Twitter