BioCryst, Swixx BioPharma Partner on Orladeyo in Europe

Swixx BioPharma Selected to Commercialize the HAE Therapy

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by Mary Chapman |

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BioCryst Pharmaceuticals has tapped Swixx BioPharma to commercialize the hereditary angioedema (HAE) treatment Orladeyo (berotralstat) in central and Eastern Europe.

Agreement terms call for Swixx, a Switzerland-based biopharmaceutical company, to handle commercialization of the oral therapy in 15 markets.

“We continue to build partnerships with companies that have deep expertise in commercializing rare disease therapies as we advance our mission of bringing Orladeyo to patients living with hereditary angioedema around the world,” Charlie Gayer, BioCryst’s chief commercial officer, said in a press release.

“The team at Swixx is highly skilled at launching rare disease therapies in Central and Eastern Europe, and we are thrilled to work alongside them to bring our oral, once-daily prophylactic treatment for HAE to patients in this region,” he added.

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The U.S. Food and Drug Administration (FDA) approved Orladeyo in 2020 to be used as a preventive treatment against HAE attacks in adults and children  12 and older. The once-daily oral therapy also has been granted approval by the European Commission, the U.K., Israel, Canada and Switzerland, United Arab Emirates, Saudi Arabia, and regulators in Japan for the same indication.

In HAE, defects in C1 inhibitor — a protein that participates in the body’s immune response, regulates blood clotting, and other important functions — lead to the excessive production of an inflammatory molecule called bradykinin, which can cause sudden swelling and pain attacks.

BioCryst developed Orladeyo to prevent these swelling attacks by suppressing the activity of plasma kallikrein, a bradykinin precursor. Through this mechanism of action, the medication is expected to prevent bradykinin levels from rising too high and triggering an attack.

Data from an international Phase 2 clinical trial called APeX-1 (NCT02870972) showed that treatment with Orladeyo was generally safe and resulted in a significant drop in HAE attacks, compared with a placebo.

These findings supported the launch of the global Phase 3 APeX-2 study (NCT03485911) and the open-label Phase 2/3 APeX-S trial (NCT03472040), which assessed the medicine’s safety and effectiveness in preventing angioedema attacks in adults and adolescents with HAE.

Data from these studies showed that about a year of treatment with Orladeyo sustainably lowered monthly HAE attacks and reduced the need for other standard treatments. Compared with patients receiving a placebo, those treated with Orladeyo had more symptom-free days, better quality of life, and treatment satisfaction.

Last fall, real-world data presented by BioCryst showed that HAE patients who switched to Orladeyo from other preventive therapies generally had fewer swelling attacks.

“Based on our unrivaled understanding of the rare disease landscape in [central and Eastern Europe], we believe we are best suited to help BioCryst bring Orladeyo to patients living with HAE in the countries within this region,” said Jean-Michel Lespinasse, Swixx’s CEO. “It goes without saying that there are significant unmet needs among HAE patients in [central and Eastern Europe], and our experienced commercial team is well equipped to bring this important long-term prophylactic therapy to the people who need it most.”

North Carolina-based BioCryst Pharmaceuticals is a commercial-stage biotech company that is developing novel oral medicines for rare diseases.