Leo Pharma is continuing its push to expand its pipeline this year, agreeing to pay up to $435 million for worldwide rights to a rare dermatology treatment from Tanabe Pharma that is currently awaiting an FDA decision for green light.
The therapy, dersimelagon, is an oral melanocortin-1 receptor agonist being developed for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). These uncommon inherited disorders can cause intense, painful skin reactions after exposure to sunlight and, in some cases, certain sources of artificial light.
How Dersimelagon Works
Dersimelagon works by activating melanocortin-1 receptors to promote melanin production in the skin. The resulting increase in pigmentation is intended to act as a protective barrier, potentially allowing patients to spend more time outdoors without experiencing painful reactions, according to Leo Chief Scientific Officer Jacob Pontoppidan Thyssen.
Under the agreement, Tanabe will receive as much as $435 million through a combination of upfront and near-term milestone payments for the global rights to dersimelagon. The deal also includes the possibility of payments related to additional development and commercial milestones, along with tiered royalties on future sales, although the companies have not disclosed the detailed financial structure.
Tanabe’s Yearly Performance So Far
Tanabe reported Phase 3 success for dersimelagon in both EPP and XLP earlier this year. Subsequent analyses showed that treatment extended the time before patients developed their first prodromal symptoms – including stinging, itching, burning and tingling caused by sunlight exposure – to almost 30 minutes at the 16th week. Tanabe submitted the therapy to the FDA for approval in June following those results.
The asset fits Leo’s strategy of expanding its dermatology pipeline through external deals. Chief Executive Officer Christophe Bourdon previously said the company was actively seeking additional partnership opportunities. Leo’s marketed portfolio includes Adbry for eczema, Enstilar foam for plaque psoriasis and Spevigo for pustular psoriasis.
How Dersimelagon Helps Leo
Dersimelagon also fills a gap in Leo’s portfolio because the company does not currently have an EPP treatment. The only therapy approved by the FDA for the condition is Scenesse, marketed by Australia’s Clinuvel Pharmaceuticals. Like dersimelagon, Scenesse works by stimulating melanin production, but it is administered as a subcutaneous implant once every eight weeks, whereas dersimelagon is taken orally.
Bourdon said the transaction strengthens Leo’s innovation pipeline and gives the company an opportunity to introduce a therapy that could significantly improve the lives of people affected by EPP.
Leo’s broader business development campaign has included a $105 million upfront payment to Boehringer Ingelheim last year to acquire rights related to Spevigo. Four months ago, the company also paid $50 million to Replay Therapeutics for access to its preclinical gene therapy platform targeting dystrophic epidermolysis bullosa, a rare inherited skin disorder.
This has been a busy week for Leo. A few days ago, the firm’s Vice President of Rare Disease, Lukasz Jarzyna, said the company and the National Psoriasis Foundation (NPF) spearheaded the yearly awareness campaign aiming to amplify the perspectives of people living with the uncommon condition and draw greater attention to the potentially life-threatening skin disorder.
Leo Pharma Lands a Major Dermatology Deal
Leo Pharma has agreed to acquire worldwide rights to dersimelagon from Tanabe Pharma in a deal worth up to $435 million in upfront and near-term milestone payments, with additional potential milestones and tiered royalties.
For Leo Pharma, the agreement adds a late-stage oral therapy to its rare dermatology pipeline and strengthens its position in treatments for serious genetic skin diseases.
Leo Pharma Targets Rare Skin Diseases
The acquired drug, dersimelagon, is being developed for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). These rare inherited conditions can cause severe pain and other skin reactions after exposure to sunlight.
For Leo Pharma, the program represents an opportunity to address an area with significant unmet medical need while expanding its focus beyond more common dermatological conditions.
Leo Pharma Expands Its Rare Dermatology Strategy
The transaction fits Leo Pharma‘s broader strategy of building its rare dermatology portfolio. The company has also expanded into genetic skin disease through its acquisition of Replay and its development of next-generation gene therapy capabilities.
By adding a late-stage asset that is already under regulatory review, Leo Pharma can potentially strengthen its pipeline without starting development from an early stage.
Leo Pharma and the Future of Dersimelagon
The success of the deal will ultimately depend on regulatory approval and the medicine’s ability to demonstrate meaningful benefits for patients. For Leo Pharma, acquiring worldwide rights gives the company responsibility for advancing and potentially commercializing dersimelagon globally.
The transaction highlights the growing interest in rare dermatology and shows how Leo Pharma is using strategic licensing and acquisitions to expand its pipeline with potentially differentiated treatments.
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