Leo Pharma, a small, century-old Danish drugmaker, has spent the past few years tailing Sanofi on their franchise drug Dupixent, betting that an antibody they licensed from AstraZeneca coupled with a few decades of expertise in dermatology could compete with one of Big Pharma’s biggest drugs. They got a huge boost in that regard in December, with positive Phase III results in atopic dermatitis, and last week, when they announced the FDA had accepted their BLA for the drug.
Under the direction of Thomas Hultsch, a former Sanofi exec who now runs translational medicine for Leo, the company has been developing a suite of other experimental dermatology drugs. Now, though, with new partnerships in the mix, they’re offloading their second most developed compound to another company.
In an up-to $200 million deal, Leo has agreed to give global rights to their psoriasis and atopic dermatitis candidate LP0058 to fellow Danish drugmaker Union Therapeutics. Leo will also receive single-digit royalties.
LP0058, now renamed UNI500, is an oral PDE4 inhibitor. That’s a class of drugs that has long been used to treat skin conditions, among other inflammatory conditions. Most notably Otezla, the Celgene psoriasis drug that Bristol Myers Squibb sold off to Amgen for $13.4 billion last year after the two companies merged, is a PDE4 inhibitor.
Leo can be circumspect when it comes to trial results — the company didn’t announce its Phase III results for about a year after the data were complete — and they’ve yet to disclose the results of Phase II trials on the drug. But the company said in a press release that it had “demonstrated superior effect over placebo in randomized, double-blinded, placebo-controlled clinical studies.”
For Leo, the out-licensing deal comes as the company is focusing on commercialization for its lead drug and new partnerships that have shored up much of its earlier pipeline with newer approaches. In April, the company agreed to an up-to $570 million deal with Oneness Biotech in Taiwan and Microbio Shanghai in China for FB825, a new drug that tries to tackle eczema and asthma by depleting a kind of B cell called IgE. It’s a similar approach to the Roche and Novartis drug Xolair, which is already approved for asthma and now being tested for atopic dermatitis.
Social/tile: News Øresund – Johan Wessman (Flickr, Creative Commons)