Pharma, R&D

Anxious to fill Humira-sized revenue hole ahead of US patent cliff, AbbVie hits the ground running with FDA approval for Skyrizi

With the looming cloud of losing US patent protection for its mega-blockbuster Humira, AbbVie needs all the help it can get to fill the gaping $20 billion hole the flagship autoimmune disease drug will leave in its coffers. On Tuesday, the company secured the FDA approval of an IL-23 inhibitor, Skyrizi, that is expected to go some way in replenishing that revenue stream: $4 billion to $5 billion in peak annual sales by AbbVie’s estimate — although that may be difficult in the intensely competitive field it is set to enter.

AbbVie paid Boehringer Ingelheim $595 million upfront to license rights to the drug, known chemically as risankizumab, in early 2016. In the fall of 2017, the injected drug was evaluated against J&J’s Stelara and its own Humira in a psoriasis study — and emerged victorious, handsomely outpacing the rival drugs in clearing psoriasis. Japan became the first region to sanction the use of Skyrizi last month.

More than 8 million Americans have psoriasis — making it one of the most prevalent autoimmune diseases in the United States, according to the National Psoriasis Foundation. The disease is characterized by an unbridled immune system and widespread inflammation that causes painful, itchy plaques anywhere on the skin.

Set for US launch in early May, Skyrizi will enter a crowded market. Humira continues to dominate despite the introduction of newer biologics, including Novartis’ $NVS anti-IL17 Cosentyx, J&J’s $JNJ anti-IL23 Tremfya and anti-IL12/23 Stelara, as well as Lilly’s $LLY anti-IL17 Taltz.

Skyrizi is not the first pure IL-23 inhibitor to be approved — Tremfya was approved in 2017 and Ilumya in 2018. But the AbbVie drug has a dosing advantage over Tremfya — it is administered every 12 weeks, versus once every two months for Tremfya, SVB Leerink’s Geoffrey Porges said on Wednesday, noting that other psoriasis biologics in addition to the oral Otezla generated a combined $11.1 billion in 2018 sales.

This does not include sales of anti-TNFs in psoriasis, which should decrease as patients move to these new, more efficacious therapies. These products also all achieved $500 million – $1 billion in the second year of launch, which is likely to also be achieved by Skyrizi. Overall biologics are still used in only 30% of the moderate to severe psoriasis population, (per JNJ in 2017), and AbbVie’s Skyrizi should benefit from both best-in-category efficacy (i.e. market share gains) and the continued rapid market expansion.”

The maintenance dose for Skyrizi will carry a list price of $59,000, which is lower than the most widely-prescribed biologic treatments for moderate-to-severe plaque psoriasis, an AbbVie spokesperson told Endpoints News.

The drug is expected to win EU approval later this year, and is also being evaluated for Crohn’s disease, psoriatic arthritis and ulcerative colitis.

“(D)espite being positioned as a best-in-class option, risankizumab failed in a proof-of-concept ankylosing spondylitis study, raising additional questions over its profile” Barclays analysts said in March.

Boehringer will receive undisclosed royalties on sales of the product, and in addition is eligible to get up to $1.6 billion for development and regulatory milestones, a portion of which has likely been paid already, Porges noted.

Evaluate has pegged Skyrizi as the number 3 blockbuster on its list of heavyweight drugs launching in 2019, estimating the drug could earn more than $2 billion in 2024 — a far cry from AbbVie’s homegrown estimate of $4 billion to $5 billion in peak sales. Porges has forecast adjusted peak annual sales of $3 billion.

The other candidate expected to fill the Humira gap is AbbVie’s oral JAK1 inhibitor upadacitinib for rheumatoid arthritis. The company $ABBV has high hopes for the treatment, projecting peak sales of $6.5 billion, which was rewarded priority review by the FDA in February. The agency is expected to make its decision by the third quarter of 2019.

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Skyhawk Therapeutics Waltham, MA
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Elektroki Boston, MA
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Elektroki Boston, MA
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Recursion Pharmaceuticals Salt Lake City, UT

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