Why four months is worth $350m to AbbVie and filgotinib

AbbVie’s $350m cheque to United Therapeutics for a priority review voucher ought to pique observers’ curiosity about which of its pipeline assets is worth accelerating by four months.

The Illinois-based group has seven novel agents in phase III for which it could invoke a six-month review, but a more likely candidate seems to be the phase II rheumatoid arthritis (RA) agent filgotinib. With the sun setting on Humira’s dominance, AbbVie may be eager to push this kinase inhibitor onto the market as early as possible to close the gap between it and a competing project from Eli Lilly and beat the entry of biosimilars poised to storm this space in the next few years.

License it and prioritise it

Filgotinib is still technically in the hands of its originator, the Belgian biotech Galapagos. But compelling late phase II results make it a near certainty that AbbVie will execute an option deal it signed in 2012, a decision that would trigger a $200m fee to Galapagos (AbbVie’s filgotinib opt-in could be a no-brainer, August 4, 2015). A janus kinase (JAK) inhibitor, the drug trails Lilly’s baricitinib into late-stage trials by a year or more, as the Indiana-based group put that project into phase III at the end of 2012.

If approved, they would follow Pfizer’s Xeljanz, which became the first JAK inhibitor to enter the market but has disappointed because of infection and cancer risk. European authorities rejected Xeljanz on its first try – 2018 sales forecasts have sunk by more than half in the past two years.

Like Xeljanz, baricitinib hits both the JAK 1 and 2 kinase; Galapagos hopes its more selective blockade of JAK 1 can help avoid the safety issues of Xeljanz, and some of the clinical data compiled so far supports that hypothesis.

However, filgotinib remains at a launch disadvantage to baricitinib. EvaluatePharma models a launch for the Lilly candidate in 2016 and filgotinib in 2018. The 2020 consensus for the former is $899m and the latter is $481m.

Without a major misstep from Lilly, filgotinib could risk looking like a “me-too” agent if it launches two years later, even if it turns out to have best-in-class efficacy and safety data. Pushing it up the approval timeline could help it avoid that label. In addition, in a chronic disease like RA, where physicians and patients are reluctant to switch medications if symptoms are under control, the value of an earlier launch is substantial.

The big kahuna

Equally as important to AbbVie’s RA outlook is the entrance of biosimilars to Humira, the world’s biggest-selling drug, and other biological agents acting on the tumour necrosis factor-alpha (TNF) pathway. Xeljanz’s growth has been constrained in part because physicians typically try two TNF agents before switching to Xeljanz, and payers seldom cover treatment before third line.

A biosimilar version of Johnson & Johnson and Merck & Co’s Remicade has been submitted to the FDA, and Novartis has queued up its own version of Amgen and Pfizer’s Enbrel, with a possible 2016 launch. These will be logical priority choices for newly diagnosed patients.

Then there is one of the biggest events for AbbVie and the entire pharma sector when Humira, the world’s biggest-selling branded drug, faces likely biosimilar competition in 2018. This could blow a big hole in AbbVie’s earning power. It will undoubtedly want a replacement for its RA flagship at that point, and filgotinib could fit that bill.

AbbVie has obviously not disclosed its plans for the voucher, and late-stage assets currently judged as more valuable could take priority. The trouble with that hypothesis is that projects like venetoclax, veliparib and duvelisib already have orphan drug designation and should receive swift review; elagolix is launching into the rather stable endometriosis space; and atransentan has a decent lead in diabetic nephropathy. Its hepatitis C assets, meanwhile, stand a good chance of qualifying for priority review on their own.

Look for AbbVie to follow through on its license on filgotinib and apply the priority review voucher to the project. It has hundreds of millions of reasons to do so.

To contact the writer of this story email Jonathan Gardner in London at [email protected] or follow @ByJonGardner on Twitter

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