Biotechnology, Business, Drug Development

UPDATED: AbbVie preps franchise decision after Ablynx’s IL-6 drug goes head-to-head against Actemra

AbbVie was willing to bet up to $840 million that Ablynx’s nanobody tech could help it protect and expand its $14 billion megafranchise for Humira. Today, AbbVie $ABBV is getting a look at new Phase IIb data for their partnered IL-6 drug vobarilizumab (ALX-0061) that measures up against Roche’s Actemra as it moves closer to its decision on whether or not it will take it into Phase III.

But there’s no clear cut win here. In fact, on key efficacy measures, a lower dose failed to measure up to Actemra.

A high dose of vobarilizumab provided every two weeks did just manage to edge out Actemra in two out of three standard efficacy measures, though not by a significant amount. But Ablynx $ABLX also highlighted an edge on safety data and dropouts among the patients with moderate to severe rheumatoid arthritis that is resistant to methotrexate. And there’s evidence of lower disease activity and an easier treatment regimen to consider as well, with the most effective high dose provided every two weeks compared to Actemra’s weekly schedule.

“We’re getting really stand-out data, which is great, and it is the first step for us in providing a data package to AbbVie, who will decide later in the year whether to take up their option and license the product,” Ablynx CEO Edwin Moses told Reuters in an interview. And Moses claims the drug has blockbuster potential.

But is that going to fly with AbbVie?

When AbbVie struck the deal with Ablynx in 2013, they were looking to see if an IL-6 antibody could provide an alternative to Humira when patients generated antibodies against their anti-TNF drug. But now AbbVie is fighting against a host of biosimilar manufacturers looking to muscle in on their big U.S. franchise. And in this marketing environment, anything that doesn’t measure up as a big gain for patients can be hard to sell.

There’s also a preferred late-stage program at AbbVie to consider. Last fall, AbbVie axed a collaboration it has in place with Galapagos for their JAK1 inhibitor filgotinib (GLP0634), saying it preferred to take their in-house program for ABT-494 into Phase III for arthritis.

“We believe ABT-494 has the potential to become a best-in-class therapy, particularly in the most challenging patient population of TNF-inadequate responders,” AbbVie CSO Michael Severino noted after the Phase II data came out in September. The Phase III started in January.

Ablynx still has data on a methotrexate combination coming up in a matter of weeks.

AbbVie has shown no reluctance from walking away from any partnered program that doesn’t measure up to expectations. AbbVie proved that when it recently dropped its collaboration with Infinity Pharmaceuticals after their blood cancer drug duvelisib posted positive but relatively weak data on indolent non-Hodgkin disease.

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