BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) transitions to a drug launching company to the patients with Hereditary Angioderma. The company expects approval for its ORLADEYO to treat patients suffering from HAE in Japan, and the US towards the end of this year.
Half a billion in revenues
BioCryst expects to post half a billion in revenues in 2021 because it transitions to a drug manufacturing company. CEO of BioCryst, Jon Stonehouse, said the company will invest in expediting BCX9930, a single molecule, program to address rare disease indications. The company expects to receive additional data by the end of this year in patients with PNH using BCX9930 and 400mg and 200 mg of ORLADEYO. It will also receive clinical data from innovative formulation – galidesivir in patients suffering from COVID-19.
The launch date for ORLADEYO
BioCryst expects to introduce ORLADEYO on December 3, 2020, under PDUFA (Prescription Drug User Fee Act). It undergoes a review under the designation – Sakigake in Japan and expects approval in December 2020.
Validation of MAA for ORLADEYO
BioCryst said EMA (European Medicines Agency) validated MAA (marketing authorization application) for innovative drug ORLADEYO. EMA already commenced a review of MAA under a centralized procedure. After getting through MAA, the company expects to receive an opinion from CHMP (committee for medicinal products for use on humans) within 365 days.
BioCryst attracted the attention of a well established rare diseases team in the US. The company is well-positioned to introduce ORLADEYO worldwide and satisfy demand.
BioCryst expanded access to ORLADEYO in the US on June 9, 2020, to provide treatment to HAE patients. It allows the physicians to request for ORLADEYO to treat patients, who did not get a chance to this drug during a clinical study, suffering from HAE.
Conducts clinical study on BCX4430 in Brazil
BioCryst is carrying a double-blind, randomized, and placebo-controlled clinical study on BCX4430 to assess antiviral effects, clinical impact, and safety in Brazil in response to the ongoing coronavirus crises. It expects to receive meaningful clinical data from this trial in Q3 2020. The company gets grants from BARDA and NIAID for this clinical study.