RESEARCH TRIANGLE PARK, N.C., July 19, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the company has entered into a collaboration with Er-Kim Pharmaceuticals to commercialize ORLADEYO® (berotralstat) in Turkey.
“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. 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,” said Charlie Gayer, chief commercial officer of BioCryst.
“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. 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,” said Cem Zorlular, chief executive officer of Er-Kim.
Er-Kim is an international pharmaceutical company based in Istanbul, Turkey, which specializes in partnering with biopharmaceutical companies to commercialize new products in global markets. With broad experience in a wide range of areas, including rare disease, Er-Kim has worked with its affiliates to deliver more than 70 innovative treatments, including the latest standards of care, to patients around the world.
About ORLADEYO® (berotralstat)ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
U.S. Indication and Important Safety Information
INDICATIONORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Limitations of useThe safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
IMPORTANT SAFETY INFORMATION
An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.
The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.
A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).
Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.
ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.
The safety and effectiveness of ORLADEYO in pediatric patients