Chikungunya Vaccine, Recombinant (Bavarian Nordic)

丹麦疫苗大厂 Bavarian Nordic 最近上演了一出 “捡钱” 大戏！周三突然官宣，把自家疫苗 Vimkunya 获批后薅来的优先审评券（PRV），以 1.6 亿美元的天价卖给了神秘买家。这张 PRV 可是 FDA 看在热带病计划的面子上发的 “通关文牒”，直接让 Bavarian Nordic 原地喜提 “财务自由体验卡”！说起来这疫苗 Vimkunya 也有段 “奇妙身世”。2023 年，Bavarian 大手一挥，豪掷 2.7 亿美元收购 Emergent BioSolutions 的旅行健康业务，顺道把这 “潜力股” 疫苗收入囊中。不过这疫苗的 “出身” 有点复杂，最初是从美国国立卫生研究院（NIH）拿的许可，所以这次卖券赚了钱，还得给 NIH 分走 20%，妥妥的 “合伙做生意，分红不能少”！PRV：生物制药界的 “硬通货”，价格一路狂飙在生物制药这个 “江湖” 里，PRV 绝对是行走的 “香饽饽”！它就像游戏里的“加速道具”，能把 FDA 药物申请的审评时间从漫长的 10 个月，直接砍到 6个月。关键是这玩意儿价格还一路猛涨，简直比房价涨得还离谱！2024 年，PRV 市场那叫一个热闹！2 月，Valneva 刚以 1.03 亿美元卖了自家PRV，当时大家还觉得这价格挺香，结果转头就被市场打脸 ——PRV 价格直接开启 “火箭模式”！8 月，Ipsen 以 1.58 亿美元卖掉 PRV；11 月和 2 月，PTC Therapeutics、Acadia Pharmaceuticals 和 Zevra Therapeutics 齐刷刷以 1.5 亿美元的价格 “出货”。这价格走势，简直是 “没有最高，只有更高”！PRV 江湖风云：供应告急，计划终止引争议PRV 价格涨得欢，背后却藏着 “大危机”！FDA 的罕见儿科疾病 PRV 计划直接“凉凉”，因为国会没给续上 “续命符”，2024 年 12 月正式宣布终止。这下好了，以后 FDA 只有在特定条件下才发 PRV，而且 2026 年 9 月 30 日后彻底 “断供”！虽然月初有人在 FDA 细胞与基因治疗圆桌会议上大声疾呼重启计划，但目前一点动静都没有。还有人吐槽，现在 PRV 卖这么贵，早就偏离了当初激励罕见儿科疾病疗法开发的初心，妥妥的 “变味了”！专业机构一分析，发现 2009 年以来 70% 的 PRV 都用在了罕见儿科疾病疗法上，所以这个计划一停，市场上的 PRV 供应直接 “大跳水”。有律师甚至预言，热带病 PRV 的价格可能要飙到 2015 年 AbbVie 创下的 3.5 亿美元天价，这是要让 PRV 变成 “生物制药界的比特币” 吗？美国食品药品监督管理局（FDA）罕见儿科优先审评券（PRV）计划的结束可能会导致热带疾病优先审评券的价值增加，Hyman, Phelps & McNamara律师事务所的律师们最近提出了这一观点。新旧交替：FDA 推出 “超级加速卡”，但有 “使用限制”这边旧计划凉凉，那边 FDA 火速上线新玩法 ——“局长国家优先审评券”（CNPV），号称能把药物审评时间压缩到 1 - 2 个月，简直是 “光速通道”！不过这新券有个大 bug，不能转让！这就好比给了你一辆超跑，但规定只能自己开，不能转手卖，多少有点 “扫兴”！疫苗界的 “神仙打架”：Bavarian Nordic vs Valneva再回头看看 Bavarian Nordic 和老对手 Valneva，简直是 “冰火两重天”！同样是靠疫苗拿 PRV，Bavarian Nordic 卖券赚得盆满钵满，Valneva 却因为疫苗出问题被 “泼冷水”。5 月，FDA 和 CDC 直接叫停了 Valneva 的 Ixchiq 疫苗，原因是接种者出现严重不良事件，甚至还有两例死亡，这波直接 “翻车现场”！反观 Bavarian Nordic 的 Vimkunya，4 月就被 CDC 推荐给 12 岁及以上的特定人群，而且 FDA 批准的适用范围更广，疫苗技术路线也不一样。这对比，妥妥的 “别人家的孩子” 既视感！参考资料：https://www.fiercepharma.com/pharma/bavarian-nordic-sells-priority-review-voucher-chikungunya-vaccine-approval-160m识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

The end of the FDA's rare pediatric PRV program could lead to increased value of the tropical disease PRVs, lawyers at Hyman, Phelps & McNamara recently suggested. The FDA approval of Vimkunya has given the chikungunya vaccine’s owner, Bavarian Nordic, an extra financial windfall.Bavarian Nordic has reached an agreement to sell a priority review voucher (PRV) gained from Vimkunya’s approval to an unnamed buyer for $160 million, the Danish company said Wednesday. The FDA awarded the PRV under its tropical disease program.Bavarian got the shot in 2023 as part of the company’s acquisition of Emergent BioSolutions’ travel health business for $270 million upfront. As the vaccine was originally licensed from the National Institutes of Health, the government research agency will receive 20% of the proceeds from the PRV sale.Gains from the PRV sale will be recorded as operating income, so Bavarian expects an increase in its projected profits for 2025.PRVs are coveted commodities in the biopharma industry because they can slash the FDA’s review time of drug applications from the standard 10 months to six months. And the price of PRVs seems to be on the rise.It was only in February 2024 that Valneva monetized a PRV obtained from the FDA approval of the U.S.’s first approved chikungunya vaccine, Ixchiq, for $103 million. The general understanding at that time was that PRVs could sell for about $100 million.A notable uptick in PRV prices started later in 2024. In August, Ipsen said it would receive $158 million from selling its PRV tied to the FDA approval of the company’s rare disease drug Sohonos.In three transactions unveiled in November and February, PTC Therapeutics, Acadia Pharmaceuticals and Zevra Therapeutics all sold their PRVs for $150 million.The rise in the monetary value of PRVs came as concerns mounted over declining supplies. The future of the FDA’s rare pediatric disease PRV program, which was designed to incentivize the development of therapies for rare pediatric diseases, came into serious question as the program was sunset in December 2024 after a lapse in its Congressional reauthorization. As a result, the FDA may only award PRVs under this pathway for drugs that have already received a rare pediatric disease designation before Dec. 20, 2024, and the agency may not award any such PRVs after Sep. 30, 2026.There have been calls for the renewal of the program, including at an FDA cell and gene therapy roundtable earlier this month. Still, there’s no clear sign that the initiative will be revived, and critics have raised concerns that the ability to sell PRVs at high prices distorted the original purpose of the program.The impact of the loss of the rare pediatric disease PRV program on the market supply of PRVs is significant. About 70% of all PRVs that have been awarded since 2009 were for therapies against rare pediatric diseases, according to a recent analysis by the law firm Hyman, Phelps & McNamara.In an article published in February, lawyers at HPM suggested the end of the rare pediatric PRV program could lead to increased value of the tropical disease PRVs, potentially to a level that’s on par with the record $350 million that AbbVie paid United Therapeutics in 2015.Meanwhile, the FDA just introduced a new PRV program, which is designed to shorten the drug review time to as little as one or two months. Called the “Commissioner’s National Priority Voucher” (CNPV), the coupon will be given to “companies aligned with U.S. national priorities,” the FDA said Tuesday. But unlike existing PRVs, CNPVs are non-transferrable, according to the FDA. As for Bavarian Nordic, the vaccine specialist is differentiating itself from rival Valneva not only when it comes to PRV sale prices. In May, the FDA and the CDC recommended a pause in the use of Valneva’s Ixchiq in people 60 years of age and older following postmarketing reports of some serious adverse events, including two deaths, in those who had received the vaccine.Before that, Bavarian’s Vimkunya in April picked up a recommendation from the CDC’s Advisory Committee on Immunization Practices for individuals aged 12 and older traveling to places where there is a chikungunya outbreak, as well as for people who plan extended stays in areas at elevated risk and for certain lab workers.Vimkunya was approved in April with a broader FDA label reaching individuals as young as 12 years of age, whereas Ixchiq is only cleared in adults. Ixchiq is a live-attenuated vaccine, compared with Vimkunya’s virus-like particle construct.