BioCryst Selects Swixx BioPharma as Commercial Partner for ORLADEYO® (berotralstat) in Central and Eastern Europe
RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the company has entered into a collaboration with Swixx BioPharma AG to commercialize ORLADEYO® (berotralstat) in Central and Eastern Europe (CEE).
“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. 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,” said Charlie Gayer, chief commercial officer of BioCryst.
“Based on our unrivaled understanding of the rare disease landscape in CEE, we believe we are best suited to help BioCryst bring ORLADEYO to patients living with HAE in the countries within this region. It goes without saying that there are significant unmet needs among HAE patients in CEE, and our experienced commercial team is well equipped to bring this important long-term prophylactic therapy to the people who need it most,” said Jean-Michel Lespinasse, chief executive officer of Swixx.
Under the terms of the agreement, Swixx will be responsible for commercializing ORLADEYO in 15 markets within CEE.
Swixx is a Swiss-based biopharmaceutical company that has extensive experience with providing end-to-end services to its partner companies to bring therapies for rare diseases to patients living in CEE, with a strategic business unit focused on rare and ultra-rare diseases.
About ORLADEYO® (berotralstat)
U.S. Indication and Important Safety Information
Limitations of use
IMPORTANT SAFETY INFORMATION
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 ptients 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 <12 years of age have not been established.
There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.
To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
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