Company chosen to commercialize HAE medicine Orladeyo in Turkey

BioCryst partnering with Istanbul-based Er-Kim as part of new agreement

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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BioCryst Pharmaceuticals is teaming up with Er-Kim Pharmaceuticals to commercialize Orladeyo (berotralstat) in Turkey. Orladeyo is an oral therapy, taken once a day, to prevent swelling attacks with hereditary angioedema (HAE).

Er-Kim, based in Istanbul, partners with pharma companies to bring new therapies to markets around the world.

“We have a shared commitment with BioCryst to bring life-changing medicines to patients living with rare disease and we are excited to deliver Orladeyo to patients living with HAE in Turkey,” Cem Zorlular, CEO of Er-Kim, said in a press release. “Our commercial team is adept at distributing therapies to patients with unmet needs, and we look forward to helping BioCryst achieve its goal of bringing Orladeyo to patients around the world.”

“We continue our mission to make Orladeyo available to as many patients living with hereditary angioedema around the world as possible by partnering with companies that have deep expertise in commercializing rare disease therapies,” said Charlie Gayer, the chief commercial officer for BioCryst.

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Orladeyo approvals for treating HAE

Orladeyo blocks the activity of kallikrein, an enzyme that controls the production of the signaling molecule bradykinin. In HAE, swelling attacks are triggered by the excessive production of bradykinin. By blocking kallikrein, Orladeyo prevents its levels from rising too high and triggering swelling attacks.

The therapy has been shown to effectively prevent swelling attacks in HAE patients ages 12 and older in clinical trials, and real-world studies have supported its effectiveness.

Orladeyo has been approved to treat HAE patients ages 12 and older in many countries and regions, including the U.S.EuropeJapan, Israel, and Saudi Arabia. More recently, it won approval in Chile, its first in Latin America.

The collaboration with Er-Kim is the sixth official partnership BioCryst has formed to distribute Orladeyo. In Chile and other markets in Latin America, the therapy is being commercialized with Pint Pharma. Earlier this year, BioCryst announced it would join with Swixx BioPharma to commercialize the therapy in central and eastern Europe.

“We are pleased to enter into this agreement with Er-Kim, our sixth global distribution partner for Orladeyo, as their wealth of experience delivering novel therapies to patients in Turkey makes them the ideal partner to bring our oral, once-daily prophylactic treatment to HAE patients in this important market,” Gayer said.

BioCryst is conducting a Phase 3 trial called APeX-P (NCT05453968) to test Orladeyo’s safety and effectiveness in children ages 2-11 with HAE. The open-label trial is recruiting participants in Canada, Israel, and throughout Europe.