- Belgian Ablynx announced Thursday morning that big pharma partner AbbVie has ditched their development partnership, leaving the biotech to finish development of its rheumatoid arthritis drug on its own.
- Ablynx says it will pursue an end-of-Phase 2 meeting with the U.S. Food and Drug Administration and hopes to start a Phase 3 trial of vobarilizumab in early 2017.
- In the original deal, signed in September 2013, AbbVie paid $175 million for the option to the anti-inflammatory drug and agreed to $665 million in development, regulatory and commercial milestones. AbbVie is still tied to the drug in another indication.
Despite Phase 2 data that Ablynx says proves vobarilizumab is superior to Roche's already approved Actemra (tocilizumab), the IL-6R drug is of no interest to AbbVie any longer.
The company reported the vobarilizumab arm of the Phase 2b trial in rheumatoid arthritis had 60% more patients reaching remission by 12 weeks. A previous Phase 2 trial showed a high placebo response which prevented the drug from showing a statistically significant response.
"These are very encouraging data," said Chief Medical Officer Robert Zeldin on a call with investors Thursday morning.
"We couldn’t have asked for better differentiation from voba and any other suggestion of that is clearly ignoring the facts," added CEO Edwin Moses, who pointed out that vobarilizumab performed 43% better than Actemra (the only approved drug in the class) and 233% better than Humira, in a placebo-adjusted comparison of trials.
Yet the company will now be tasked with moving the drug into expensive late-stage trials on its own. The company said it "has enough cash allowing for flexibility."
Ablynx also indicated it will now look for a new partner for commercialization. "We look forward to sharing these developments with potential partners," said Moses.
The company said it hopes to find a partner that will co-finance late-stage trials and that it is open to a range of deal structures.
"AbbVie still has an rights to opt-in to development for SLE following Phase 2 data in 2018E," wrote Jefferies analyst Peter Welford in a note to investors.
"We understand AbbVie did not express any specific concerns relating to voba when relaying its decision. It is possible thatAbbVie would prefer to concentrate on its oral JAK inhibitor, ABT-494, which is currently in Phase 3 development, in our view."
Welford estimates peak sales for vobarilizumab of $750 million in RA and $300 million in lupus.