“BioCryst is in an outstanding position, both near-term and long-term, with growing revenue from a strong Orladeyo launch in the U.S. and more approvals and launches of Orladeyo around the globe”, says President and CEO Jon Stonehouse at BioCryst Pharmaceuticals, Inc.‘s presentation of the financial results for the second quarter ended 30 June 2021.
Program Updates and Key Milestones for Orladeyo:
“The Orladeyo launch is off to an excellent start because HAE patients want a safe and effective oral medicine to control their attacks and reduce their burden of therapy, and switching to Orladeyo meets these needs for them,” says Charlie Gayer, Chief Commercial Officer of BioCryst.
- Patient switches continue to drive the launch with 60 percent of patients who were new to Orladeyo in the second quarter switching from other prophylactic medicine to Orladeyo and the remainder from acute-only treatment.
- The number of physicians prescribing Orladeyo grew by approximately 50 percent in second quarter.
- The majority (approximately 70 percent) of HAE patients in the U.S. now have access to Orladeyo through insurance policies.
- Through the launch thus far, patient retention on therapy remains consistent with the one-year patient retention rate observed in the APeX-2 clinical trial.
- On 10 July 2021, the company announced data presented at the European Academy of Allergy and Clinical Immunology Hybrid Congress 2021. HAE patients who were randomized to receive 150 mg of oral, once-daily Orladeyo at the start of the APeX-2 trial had an 80 percent average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline. Median attack rates also decreased from 2.7 attacks/month at baseline to 0.0 attacks per month in 16 of 17 months through the same period. Orladeyo was generally well-tolerated during the treatment period with fewer drug-related adverse events reported in part 3 (weeks 49-96) as compared to part 1 (weeks 0-24) and part 2 (weeks 25-48). Eighty-one percent of the patients who entered part 3 completed the trial.
- On 16 June 2021, the company announced that the Israeli Ministry of Health has accepted the regulatory submission of Orladeyo for the prevention of recurrent attacks in patients with HAE 12 years and older. In addition, BioCryst entered into a distribution and supply agreement granting Neopharm Ltd., the exclusive rights to commercialize Orladeyo in Israel.
- On 3 June 2021, the company announced the launch of Orladeyo in Germany.
- On 12 May 2021, BioCryst announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted marketing authorization for Orladeyo for the routine prevention of HAE attacks in HAE patients 12 years and older.
- On 30 April 2021, the company announced that the European Commission (EC) has approved Orladeyo for the prevention of recurrent HAE attacks in HAE patients 12 years and older. The EC approval of Orladeyo is applicable to all European Union member states plus Iceland, Norway and Liechtenstein.
- On 14 April 2021, the company announced that the Japanese National Health Insurance System (NHI) approved the addition of Orladeyo to the NHI drug price list on April 21, 2021.