Having moved early on a promising phase II monoclonal antibody, Almirall is inching closer to entering the Sanofi-dominated European market for eczema after posting, along with Eli Lilly, positive phase III results for Lebrikizumab. The Catalan company says it is on track for a 2023 launch on the continent; Lilly has the rights for the US and the rest of the world.
The Barcelona-based company placed an early bet on Lebrikizumab in 2019, acquiring the rights to develop and commercialize the product for dermatology indications in Europe from Dermira just six months before Lilly snatched the whole company for USD 1.1 billion. Lilly’s CEO David Ricks has mentioned the asset as a top five drug in its late-stage pipeline.
Lebrikizumab is being evaluated for the treatment of moderate-to-severe atopic dermatitis and was granted Fast Track designation from the FDA. In a statement announcing positive phase III results, Almirall’s chief scientific officer, Karl Ziegelbauer, stated that lebrikizumab has the potential “to be a leading treatment for a new generation of biologics.”
If approved by regulators – Almirall and Eli Lilly intend to submit regulatory applications in 2022 – it will challenge Sanofi’s top drug by sales, Dupixent.
One of the things we decided to do last year when rethinking our future strategy was to own the European market
Almirall, led by Italian CEO Gianfranco Nazzi who the company hired last year from Teva, has been putting the pieces in place for what promises to be one of its top products ever. “The main interest of the company, according to the strategy we revisited last year, is to focus on Medical Dermatology, including all our research and development… One of the things we decided to do last year when rethinking our future strategy was to own the European market. Owning Europe is one of the most important parts of our strategy,” Nazzi recently told PharmaBoardroom.
Some analysts have given the drug a peak global sales prospect of about USD 600 million, “but Almirall insists European rights alone would open up a USD 500 million market,” according to Endpoints News. Other analysts have been slightly more optimistic, projecting lebrikizumab as the third biggest seller in eczema with a forecast 2026 sales of USD 990 million.
Almirall-Lilly vs Sanofi
By Sanofi’s own admission, a substantial share of its future depends on the performance of Dupixent which generated EUR 5.2 billion globally last year, making it their top product. In Europe, the drug brought in EUR 649 million driven by atopic dermatitis – the condition that Almirall will tackle if Lebrikizumab gets the green light from the EMA – according to Sanofi’s latest financial disclosures,
The key in Almirall’s possible European battle with Sanofi could be the narrow scope of the licensing agreement that the former signed with Dermira, which is limited to dermatological conditions, while Sanofi is commercializing Dupixent for multiple indications and has the ambition of reaching EUR ten billion in annual sales.
For his part, Nazzi remains unmoved by the prospect of a marketing authorisation that would put Almirall face-to-face with what Sanofi considers a flagship product. “While the market will be very crowded, if [phase III data] confirms what we saw in phase II, Almirall is set to compete with a strong product,” he said.
Nazzi even took the opportunity to praise his French competitors. “Dupixent is a good product, is performing very well and covers multiple indications. The company has done well with lifecycle management,” he said, making the distinction that Dupixent has two types of targets, IL-4 and IL-13, while lebrikizumab is very selective and focuses on IL-13, “which is a central mediator for atopic dermatitis.”
The market analysis for atopic dermatitis given by the Italian exec is quite revealing: “The market for atopic dermatitis is growing double digits, at a 22 percent compound annual growth rate, and indeed the market leader today is Dupixent from Sanofi. LEO Pharma also launched its own product at the beginning of the year, called Tralokinumab, in Germany and the UK and are waiting for price approval in France.”
“Nevertheless, the atopic dermatitis market remains unsatisfied in terms of unmet medical needs, and we truly believe that lebrikizumab will play a very important role; Almirall will submit its application to the regulatory agency by the end of 2022 and the goal is to have the first launches by the end of 2023.”
Outside of Europe, in the US, where Lilly holds the rights for Lebrikizumab, the battle is poised to be more intense. As Endpoints’ John Carroll summarises, “Eli Lilly is no little biotech. It is a global powerhouse noted for a series of steps forward — and back. On the other hand, Sanofi plus Regeneron has turned out to be the power player to beat for the biologics share of atopic dermatitis. Both are intensely sales-focused on the marketing side, and Dupixent has now had five long years to establish itself with physicians and patients.”
Per Lilly’s latest annual report, the American giant has the right to receive tiered royalty payments on future net sales in Europe ranging in percentages from low double digits to low twenties if the product is successfully commercialized: “We are eligible to receive additional payments of USD 85 million from Almirall contingent upon the achievement of success-based regulatory milestones and up to USD 1.25 billion in a series of sales-based milestones, contingent upon the commercial success of lebrikizumab.”
For Almirall’s Nazzi, a European market focus could be both a limitation and advantage: “Doing business in the US is a completely different ballgame than in Europe. In the US, Almirall’s strategy is to serve patients in niche markets where we can add value for them… We need to think carefully about the geographic expansion, since being an organisation with a little less than EUR one billion in sales, we cannot spread out too thin across the globe.”