RESEARCH TRIANGLE PARK, N.C. - BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced the company has entered into an exclusive collaboration with Pint Pharma GmbH to register and promote ORLADEYO (berotralstat) in the pan-Latin America (LATAM) region.

'We are pleased to join forces with Pint Pharma to bring our oral, once-daily therapy to hereditary angioedema patients in LATAM who are in need of a new treatment option. Pint Pharma is the ideal partner for BioCryst based on the team's deep experience in rare diseases that spans multiple aspects of commercialization and their established network across this important region,' said Charlie Gayer, chief commercial officer of BioCryst.

'Our partnership with BioCryst is significant for Pint Pharma given the critical unmet need among HAE patients in LATAM who are seeking an innovative treatment option for this serious disease. ORLADEYO has successfully launched in multiple markets across the globe, and we are privileged to leverage our expertise to support BioCryst in introducing this prophylactic therapy to the region,' said David Munoz, chief executive officer and co-founder of Pint Pharma.

Under the terms of the agreement, Pint Pharma will be responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in the pan-LATAM region.

Pint Pharma is an Austria-based pharmaceutical company that has extensive experience developing, registering and commercializing rare disease and specialty treatments throughout Latin America and Europe.

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

INDICATION

ORLADEYO (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 use

The 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

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