The centerpiece of Gonzalez’s year––closing the Allergan deal––has met some hiccups at the U.S. Federal Trade Commission (FTC), but that logjam could be cleared by May even with the ongoing novel coronavirus pandemic slowing operations.
Last week, AbbVie and Allergan signed an FTC consent decree to divest late-stage gastrointestinal candidate brazikumab and two pancreatic replacement enzymes in a move to ease antitrust concerns. The pair closed that sale in the EU earlier in the month after regulators required the divesture of brazikumab alone for the merger’s approval.
AbbVie said it expects the transaction to close in May after the FTC’s final review of the drug sale.
However, the FTC warned that operational challenges posed by COVID-19 could limit drugmakers’ ability to confirm or challenge its decisions––potentially setting the stage for AbbVie and Allergan to request an extension to close their deal. If the merger passes FTC muster, it would make the new AbbVie the fourth-largest drugmaker in the world, the company has said.
Meanwhile, AbbVie has had to contend with the declining sales in Europe of immunology med Humira, the world’s bestselling drug that faced biosimilar challenges for the first time in 2019.
With a 31.3% sales decrease on the year in Europe, Humira’s steep decline and expected stabilization abroad at about two-thirds market share has given AbbVie hope that the U.S. falloff won’t be as bad previously expected, Gonzalez told investors during an earnings call in early February.
“I’m feeling pretty good about how the strategy played out,” Gonzalez told analysts. “Our strategy was to make sure that we could maintain as much share as possible and maintain it as profitable as possible. The strategy that we’ll put in place (in the U.S.) is the exact same as we put in the international market.”
Globally, Humira posted $4.9 billion in sales during the fourth quarter, which came in flat compared with the same period in 2018. Worldwide, the drug pulled in $19.17 billion, a 4% decline. Biosimilars launched in Europe in late 2018, meaning 2019 was the first full year of competition for the drug.
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But any Humira contribution is good for AbbVie as it works to make Gonzalez’s sky-high, $20-billion-per-year combined estimate for Skyrizi and Rinvoq come to fruition.
In January, Gonzalez told investors at the J.P. Morgan Healthcare Conference that Skyrizi––launched in April––had already scooped up about 25% of the “in-play” market share, referring to new patients and patients switching treatments. Rinvoq, which hit the market later in August, had gained about 9% of the “in-play” share, Gonzalez said.
But that’s just the start: Over time, Rinvoq and Skyrizi “will have all of the major indications that Humira has when fully built out, plus one that Humira doesn’t have, which is atopic dermatitis,” Gonzalez said, throwing down a gauntlet to Sanofi and Regeneron, who have $10 billion hopes for their entry in that field, Dupixent.
Rinvoq and Skryrizi sales reached $33 million and $216 million in the fourth quarter, respectively. Rinvoq sales were slightly lower than expected, but Gonzalez said an uptick in market access in January would likely translate into a big bump in sales in the current quarter.
