Neopharmed buys Euro rights to BioCryst's HAE drug Orladeyo

BioCryst has agreed to sell its European business based on hereditary angioedema (HAE) therapy Orladeyo to Italy's Neopharmed Gentili in a deal valued at $250 million upfront.

The transaction – which is due to close in October – will see BioCryst's European sales organisation transferred to Neopharmed and also includes $14 million in additional milestone payments linked to sales of Orladeyo (berotralstat) in central and eastern Europe.

Plasma kallikrein inhibitor Orladeyo was approved in the EU in 2021 as the first oral, once-daily therapy to prevent attacks in patients aged 12 and over with HAE, a very rare genetic condition that is painful and debilitating and can be fatal if left untreated. In attacks, patients experience swelling of the skin and mucous membranes that can cause difficulty breathing and severe pain.

Orladeyo has grown quickly commercially since then, bringing in 2024 sales of around $438 million last year, and BioCryst has predicted that the product's revenues could grow to as much as $550 million in 2025.

The next phase in its growth could come from an attempt by BioCryst to expand its use into younger patients aged two to 11, with a marketing application already filed in the US and others in Europe, Japan, and Canada due this year.

BioCryst said it will use the proceeds from the sale to Neopharmed to retire around $249 million in debt owed to Pharmakon Advisors, which it said will save it around $70 million in interest payments. Meanwhile, the sale of the European commercial organisation will carve an additional $50 million off the company's annual operating costs.

It now expects to end 2027 with $700 million in cash, an increase of $400 million from previous guidance, which will end its reliance on debt and leave the company with "a significantly higher margin business," said chief executive Jon Stonehouse.

For Neopharmed, a privately held company that operates mainly in the Italian market, focusing mainly on generic medicines for chronic diseases, the acquisition will allow it to grow on the international stage and enter the rare disease space.

CEO Alessandro Del Bono, a member of the Del Bono family that owns the company along with private equity firms Ardian and Renaissance Partners, said that the company intends to expand further in the coming years in rare diseases, as well as other specialty medicines.

"This transaction marks the beginning of a new path for Neopharmed Gentili, projecting the company onto the international stage and rare disease field, leveraging its deep Italian roots and welcoming a successful and experienced European team," he said.

The transaction will be funded by a combination of available cash and contributions from Neopharmed shareholders.