Biocryst sells European rights to HAE therapy Orladeyo for $250M
Price paid by Neopharmed about 5 times last year's sales of drug in Europe
Biocryst Pharmaceuticals has sold the European rights to Orladeyo (berotralstat), its approved oral therapy for preventing swelling attacks in people with hereditary angioedema (HAE), to the Italian pharmaceutical company Neopharmed Gentili.
Under the terms of the deal, according to a Biocryst press release, the company “will focus on driving Orladeyo sales in the U.S. while Neopharmed Gentili will lead commercialization across Europe.”
Neopharmed will make an upfront payment of $250 million to Biocryst, with the potential for an additional $14 million in future milestones based on sales in Central and Eastern Europe. Per Biocryst, this price tag is about 5.4 times the sales of Orladeyo in Europe over the last year ending in June. Both Neopharmed and Biocryst will pay into royalties already owed to other stakeholders for global sales of Orladeyo.
“We are pleased to work with Neopharmed Gentili, a highly capable partner, and we look forward to the continued commercial success of Orladeyo in Europe and around the globe,” said Charlie Gayer, president and chief commercial officer of Biocryst.
Orladeyo deal focuses developer on ‘core US opportunity’
A genetic disorder, HAE is marked by recurrent swelling attacks driven by the overproduction of a signaling molecule called bradykinin. Orladeyo, sold as oral capsules, works to block the activity of kallikrein, an enzyme that helps produce bradykinin. This, in turn, lowers bradykinin levels in the body, reducing the risk of swelling attacks.
Orladeyo was approved in the European Union in 2021 as a prophylactic treatment to prevent HAE attacks in patients ages 12 and older. It has also been approved for the same indication in the U.S. and several other countries, namely Argentina, Brazil, Chile, Mexico, Peru, and, earlier this year, Colombia.
“This strategic deal is an important milestone for Biocryst that unlocks significant value for the company. It focuses our business on our core U.S. opportunity, immediately improves our operating margin, enhances cash flow generation, and provides enormous strategic optionality for BioCryst,” Gayer said.
He added: “Even when excluding European revenue after the close, we remain on track to reach the upper half of our 2025 guidance range of $580 million to $600 million.”
This strategic deal is an important milestone for Biocryst that unlocks significant value for the company. … It … provides [the company] enormous strategic optionality.
Regulatory approvals of Orladeyo were based largely on data from the Phase 3 APeX-2 clinical trial (NCT03485911), which demonstrated that the therapy worked better than a placebo at reducing the rates of HAE swelling attacks. Additionally, its effects were sustained after multiple years.
Real-world data have consistently confirmed that Orladeyo treatment can lead to a long-lasting reduction in the number of swelling attacks experienced by people with HAE, as well as in the number of hospitalizations.
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