Belgium benefits from AbbVie’s biz dev spree

AbbVie’s business development people are keeping busy, and Belgium has been the beneficiary. Two deals in two days have seen the US pharma major strike joint development alliances, first with Ablynx and now with Galapagos.

The latter deal targets cystic fibrosis (CF), and it is interesting that AbbVie still thinks it worth pursuing a space on which Vertex Pharmaceuticals has a virtual stranglehold. Still, as AbbVie’s outlay is relatively modest perhaps the group is simply placing a cautious bet on an opportunity that might materialise should Vertex stumble.

And, although Galapagos boasts a $45m signing fee, this is not a pure up-front payment; much of it will go towards funding R&D under the tie-up. This is similar to AbbVie’s rheumatoid arthritis partnerships with Ablynx and Galapagos, both of which comprised big up-front payments that would largely have to be committed to development (Ablynx another beneficiary of AbbVie’s pay-to-fund approach, September 23, 2013).

Partners since 2012

The AbbVie/Galapagos RA deal, signed in February 2012, probably helped set up yesterday’s CF alliance. Like in Monday’s Ablynx tie-up, AbbVie will only assume full control at phase III.

While Galapagos would not specify precisely how much of the $45m fee would be swallowed up in R&D spending, it gave a clue in raising its forecast 2013 year-end cash balance by only €25m ($33m), to €125m.

The Belgian group’s involvement in CF actually began some years ago in a collaboration with the US CF Foundation, and has so far resulted in discovery of series of CFTR potentiators and correctors. The hope is to name a lead for the former this year.

CF is a rare condition caused by a mutation in a gene on chromosome 7 that codes for the CFTR protein, and the treatment strategy depends on the type of mutation. The F508del mutation, which causes misfolding of the protein, is the most common; the idea is to treat it with a combination of a corrector and potentiator.

Meanwhile, the G551D mutation, accounting for 3% of cases, results in defective channel regulation, and might be treated with a CFTR potentiator alone, as might certain other mutations that together account for the remaining 7% of CF cases.

Unfortunately for Galapagos, Vertex is way ahead here, having already launched its own CFTR potentiator Kalydeco – forecast to hit blockbuster sales in 2015 – for G551D patients. The US group has a combination of Kalydeco and VX-809 (a corrector) in phase III for the 50% of patients with homozygous F508del mutations, and plans a triple combo for F508del heterozygotes.

Clear superiority

While Galapagos says it is too early to speculate on the design of possible head-to-head studies, it admits that the clear aim is to achieve superiority versus Kalydeco. It hopes to identify a potentiator and one or two correctors, but a phase I study will not begin until late next year.

AbbVie will contribute in kind to the initial discovery stages, while preclinical and phase I and II studies will be funded by Galapagos, possibly through milestones that it stands to receive under the deal.

As such, despite AbbVie’s reluctance to commit significant cash at this stage, the deal can be seen as another clear vote of confidence in Galapagos. But even in a best-case scenario a marketed drug is still many years away, and by that time Vertex could have the entire CF market sewn up.

To contact the writer of this story email Jacob Plieth in London at [email protected] or follow @JacobEPVantage on Twitter

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