Almirall gets in on the eczema action

Sanofi’s Dupixent has shown there is a market for biologic drugs to treat eczema, and now Spain’s Almirall wants a piece of the action. The company’s head of external innovation and licensing Josep-Maria Casanovas spoke with Richard Staines to discuss its strategy in dermatology.

Two years ago, Sanofi and Regeneron broke new ground by getting their Dupixent (dupilumab) approved for atomic dermatitis – otherwise known as eczema.

Previously treated with lotions and creams, this was the first time that a company had managed to get a biologic injected drug approved that aims to treat the underlying cause of the disease.

Dupixent works by inhibiting the inflammatory response caused by a protein known as interleukin 4 (IL-4), which is overactive in people with the condition. The drug is breaking through the billion dollars a year barrier after amassing sales of 496 million euros ($551 million) in the second quarter.

With Dupixent looking like it is going to fulfil expectations commercially, dermatology rivals such as Almirall and LEO Pharma are looking to tap into this growing market.

Almirall does not have its own in-house biologics development operation and has decided to in-licence an eczema drug, lebrikizumab, from Dermira. Lebrikizumab also works in a different way from Dupixent, targeting IL-13, and Almirall hopes that Sanofi’s innovation has cleared the way for other injected rivals.

Almirall’s strategy for now means that it is reliant on third parties to develop biologic treatments as it does not have the expertise in-house. This is not altogether different from Sanofi – its big selling antibodies have come through a long-established partnership with Regeneron.

In the same way, Almirall has already partnered with Sun Pharmaceutical in 2016 to develop and market the psoriasis drug tildrakizumab in Europe. The latest deal with Dermira builds on this arrangement, said Almirall’s head of external innovation and licensing, Josep-Maria Casanovas.

All of the company’s R&D is now based in dermatology and the deal with Dermira fits with the pipeline focused on diseases such as acne, actinic keratosis, androgenic alopecia, and fungal nail infections.

“The Dermira deal has been a very important one for the future of the company,” Casanovas said. “Almirall has a strong science presence. In order to get access to innovation based on biologics we have to go to third parties.”

Almirall is already launching tildrakizumab in Europe under the brand name Ilumetri, and has the atopic dermatitis market in its sights following the initial success in psoriasis. “The fit within our R&D is perfect,” said Casanovas.

An obvious question is whether Almirall plans to bring biologic R&D in-house through an acquisition – and Casanovas gave the standard pharma answer that if the right opportunity comes along then Almirall will take it.

He told pharmaphorum: “What we are doing is assessing all potential opportunities, not only licensing but from an M&A perspective.

“So as long as it makes sense this has to be taken into account – it is something that is under review.”

Market opportunity

Lebrikizumab has had a convoluted development. It was originally intended to treat non-Hodgkin’s lymphoma but has been repurposed as a skin care drug due to its interaction with inflammatory pathways.

Originally developed by the US biotech Tanox, the drug came into the hands of Genentech through an acquisition in 2007.

After Roche’s acquisition of Genentech the Swiss pharma decided to license lebrikizumab to Dermira.

Almirall thinks there is considerable potential for lebrikizumab in this niche, with the drug so far demonstrating good efficacy and safety in mid-stage trials.

Casanovas said that Almirall has identified eczema as a section of the market where there is a “tangible medical need”, making lebrikizmab one of the most important products in the company’s pipeline.

“I think there are enough grounds for us to find differentiation versus other therapies. We have the possibility to have flexibility in the dose ranging, the data show that it is effective every two weeks or every four weeks.”

This could give a convenience advantage over Dupixent, which patients inject themselves every two weeks.

The company is also looking at measuring other patient-centred goals in later stage trials such as sleep loss

“We think that this could have a very good profile in terms of quality of life endpoints,” said Casanovas.

At the time of writing, Dermira and Almirall are still drawing up phase 3 trial design, and Casanovas has not ruled out head-to-head trials against rivals.

“We are still in discussions with Dermira and will disclose the phase 3 trials we are planning for this product.”

Encouraged by Dupixent

Almirall is understandably coy about its plans for pricing at such an early stage in development, but is nevertheless encouraged by the Dupixent’s performance in the European market.

Sales are mounting, especially in Germany where there is free pricing in the first year of a product’s life, and the drug has even been recommended by NICE, albeit at a commercially secret discount.

Casanovas said: “Dupilumab is paving the way in pricing for other biologics to enter the market. The strategy that Dermira will follow is under internal discussion but I think we will take an approach that will ensure we are accessing the countries with a good price and reimbursement strategy.”

He said that lebrikizumab could generate sales of around 450 million euros per year at peak in Europe where Almirall has marketing rights.

“The performance we expect from dupilumab is high and the investors are also predicting a good level in sales.

“What I am saying is that it will pave the way for others to hit the market. Companies like LEO, companies like Almirall would benefit from that.”

Almirall acknowledges that LEO could also come into play as a competitor but Casanovas said that the Spanish firm is seen as a “partner of choice” in dermatology.

“Our relationship with LEO is good. I think that they will start commercialising biologics.”

Casanovas notes that he expects LEO’s tralokinumab to hit the market sometime before lebrikizumab as LEO’s drug is ahead of Almirall’s drug in the pipeline, with several phase 3 trials already started.

But he is confident that despite the increasingly competitive nature of the market there will be room for more drugs as long as they can show improved performance over their competitors.

Casanovas’ comments suggest a scenario such as that seen in psoriasis, where a number of manufacturers have different products that are vying to outperform each other.

It’s also important for patients to have a range of drugs to choose from depending on their individual preferences.

He concluded: “It is a very underserved market with high potential and with differentiating factors such as efficacy, safety and convenience we can have a very nice market share.”