Tafamidis Meglumine

上周五，爆出诺和诺德不讲“武德”加价竞购辉瑞看上的肥胖治疗公司Metsera（详情回顾），上周辉瑞已对诺和诺德、Metsera提起诉讼。就在昨天，战火再次升级。在辉瑞发布三季度财报之际，诺和诺德再次加价竞购Metsera。据Metsera周二发布的新闻显示，诺和诺德已将报价提高至100亿美元，超过了辉瑞周一经修订后的81亿美元。此前，分析师认为，Metsera的药物数据与其他公司的在研发资产水平相当，这一切都不足以引发竞标战，更谈不上旷日持久的法律纠纷。 辉瑞在财报电话会议上示：我们看不出诺和诺德的交易方案有何优势。这是一家外国公司利用美国政府停摆之机，试图绕过反垄断法的非法行为。况且，诺和诺德此次恶意竞购，意在“围猎并扼杀”竞争对手，并非有意收购并推进Metsera的产品研发。基于竞争方面的考量，诺和诺德的收购案恐难通过审查。 辉瑞CEO布尔拉为提价持续竞购Metsera进行了辩护：我清楚我们将获得什么，辉瑞在决定竞购Metsera一事上信息充分。我们已经查看了相关数据，开展了全面的调查，并为该资产设定了我们能为双方带来最大价值价格。尽管美国联邦政府正处于停摆状态，一旦Metsera 股东在11月13日投票通过，这笔交易便有望完成。此外，辉瑞在商业运营和研发基础设施方面具备独特优势。尽管辉瑞内部开发的多个项目未能达到临床预期，目前暂无在研的肥胖症资产，但有Eliquis和 Vyndaqel等产品的相关经验，我们计划以类似的方式运营 Metsera，以重振辉瑞在心脏代谢领域的影响力。 辉瑞最初在9月向 Metsera 提出收购要约：首付约49亿美元，外加一项或有价值权（CVR），潜在总金额达72.7亿美元。但上周四杀出个诺和诺德，提出了总额为85亿美元的报价。 周五下午，辉瑞对 Metsera 和诺和诺德提起诉讼，指控其“侵权干扰”；周一上午，辉瑞又提起另一项诉讼，状告Metsera的主要股东。 在接到诺和诺德的竞标通知后，辉瑞需在四天内提出更优报价，否则将失去 Metsera 的收购权。周一，辉瑞回应以 81 亿美元的报价，但在周二就被诺和诺德100亿美元的报价超越。目前，Metsera认为诺和诺德的新报价更具优势，给了辉瑞两天时间作出回应。 尽管陷入Metsera竞价风波，辉瑞仍如期发布了三季度业绩。得益于 Eliquis、Comirnaty和 Xeljanz等产品的贡献，辉瑞三季度营收再达 166.5 亿美元。 财报显示，辉瑞正实施大规模成本削减计划，预计到 2027 年实现 72亿美元的净成本节约。 对辉瑞而言，另一积极消息是抗凝血药物Eliquis的出色表现。据蒙特利尔银行数据，Eliquis 全球营收达 20 亿美元，同比增长 22%。 不过，古根海姆（Guggenheim）指出，辉瑞营收超出预期的部分，很大程度上来自投资者关注度较低的产品。投资者原本期望看到心脏疾病药物 Vyndaqel 以及赛 agen（Seagen）旗下老牌膀胱癌药物 Padcev 等较新资产的更好表现，但这两款药物的业绩均未达预期。其中，Vyndaqel 系列（包括老款 Vyndaqel 和新款 Vyndamax）三季度全球营收为 16 亿美元，较去年同期变化 10%；Padcev 同期营收仅为 4.64 亿美元。 参考消息： https://www.pfizer.com/news/press-release/press-release-detail/pfizer-files-federal-antitrust-claims-second-lawsuit 本文旨在行业资讯和知识分享，无任何商业用途。文章仅代表作者观点，不代表本站立场。   往期推荐 1.诺和诺德、辉瑞“撕破脸”！诺和高报价截胡辉瑞收购案，是真急了 2.贺建奎前妻成立新公司，冲到Nature头条！大张旗鼓站台“CRISPR baby” 3.默沙东与卫材宣布：贝组替凡+仑伐替尼达晚期肾癌PFS主要终点 4.国产自研新标杆！玛仕度肽头对头赢得司美格鲁肽，III期临床数据优异 5.罗氏宣布裁员，本年第三轮！涉及上百人 Being科学公众号目前已经有多个交流群（好学，有趣的生物医药人才在这里聚集）。进群请扫描下方二维码，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。 发现“分享”和“赞”了吗，戳我看看吧

Addressing the performance of Pfizer’s vaccines business Tuesday, CEO Albert Bourla indicated an interest in opportunities outside the U.S. Even without accounting for the COVID declines that have punctuated Pfizer’s earnings in recent years, the company’s vaccines business appeared to be on the back foot in the third quarter, brought low by a U.S. market that is currently proving unfavorable for immunizations.Among the shots that receive top billing in Pfizer’s earnings reports, only Pfizer’s tick-borne encephalitis shot TicoVac posted sales gains (PDF) for the three months that ended in September.Meanwhile, Pfizer’s Prevnar family of pneumococcal vaccines, its respiratory syncytial virus (RSV), shot Abrysvo, its COVID-19 prevention shot, Comirnaty, all suffered sales declines compared to the same period in 2024, according to a Nov. 4 earnings announcement.Notably, in the case of Prevnar and Abrysvo, ex-U.S. sales of the vaccines increased—and in Abrysvo’s case at a significant 75%—but revenues in the U.S. brought down their overall performance.Taking a closer look at the numbers, Comirnaty sales slipped 19% globally to $1.15 billion, the Prevnar franchise experienced a 3% global sales decline to $1.7 billion, and Abrysvo’s performance decreased 22% to sales of $279 million in Q3. Slipping COVID-19 vaccine sales are nothing new for Pfizer, which has struggled to meet tough COVID-era revenue comparisons ever since the market for its vaccine and coronavirus antiviral, Paxlovid, transitioned from pandemic to endemic. Nevertheless, the company grappled with a new constraint in the third quarter, noting in a press release that Comirnaty has struggled of late thanks to a “narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population.”Pfizer won an FDA nod for an updated version of its BioNTech-partnered COVID vaccine in late August. But unlike with past FDA endorsements, the new nod carries restrictions on the vaccine’s use in many age groups, to include only people with underlying health conditions.Addressing the performance of Pfizer’s vaccines business more broadly Tuesday, CEO Albert Bourla indicated an interest in opportunities outside the U.S. The company’s roster of immunizations is a “key area of focus in international markets,” the chief executive said on a call with analysts.Speaking to Abrysvo’s recent struggles in the U.S. specifically, Bourla admitted that Pfizer is “experiencing the headwind of a more difficult-to-activate population as we enter the third season of RSV.”“Still,” he continued, “we are continuing to strengthen our position with a 59% market share in the U.S.”And despite the sales slump in the U.S. this past quarter, Pfizer’s Prevnar dynasty still leads in pediatric pneumococcal vaccination worldwide and among conjugated pneumococcal vaccines for adults in the U.S., Bourla emphasized.Beyond Comirnaty, Pfizer’s COVID treatment Paxlovid endured a precipitous sales decline in the third quarter, falling a staggering 55% to $1.2 billion. The antiviral took a one-two punch in the period stemming from “reduced demand from lower levels of disease incidence,” as well as an unfavorable comparison to a government stockpiling order for the drug that Pfizer booked last year, the company’s chief financial officer, Dave Denton, said on the earnings call.Speaking to Pfizer’s overall performance in the quarter and through the rest of the year, Denton admitted that there is currently some “softness in our COVID products due to lower vaccination rates and COVID infection rates.”The low end of the drugmaker’s 2025 forecast “would assume that the COVID franchise continues a very modest uptake for the balance of this year, particular in the U.S.,” Denton said in response to an analyst question about Pfizer’s ability to meet its financial guidance, which sits in a range between $61 billion and $64 billion for the full year.“However, as you know, the COVID franchise is subject to peaks and valleys,” he added. “If there happens to be a wave of COVID in the next several months, you can see utilization spike up.”Removing COVID from the equation, Pfizer’s innovative drug franchises performed better overall in the third quarter. Without the negative effects from Comirnaty and Paxlovid, Pfizer’s portfolio of branded medicines grew sales 4% for the period.In particular, the drugmaker spotlighted the momentum behind Bristol Myers Squibb-partnered anticoagulant Eliquis, which grew 22% in Q3 to $2 billion; Nurtec ODT in migraine, which was up 22% to $412 million; and the company’s Vyndaqel family of drugs for amyloidosis, which increased revenues by 7% globally to nearly $1.6 billion.Vyndaqel is now facing fresh competition in the shape of Alnylam’s Amvuttra, which passed muster at the FDA in March. While Pfizer’s drug has continued to hold its own for the time being, analysts on the company’s call were curious to hear how the competitive dynamics in the transthyretin amyloid cardiomyopathy (ATTR-CM) market are evolving.“There’s obviously new competition in the category,” Aamir Malik, Pfizer’s chief U.S. commercial officer, admitted. That said, the Vyndaqel franchise “is still the only ATTR-CM product that has statistically significant reductions in both mortality and [cardiovascular]-related hospitalizations together and as a standalone,” the commercial chief stressed.“And it’s also the only product where there is a once-daily capsule, placebo-like safety and near complete [transthyretin] TTR stabilization, and we’ve got 90% access for Vyndamax across the U.S. now,” Malik added. Vyndamax is a single-capsule presentation of Pfizer’s drug that uses the same active ingredient as Vyndaqel.In Q3 specifically, Pfizer’s Vyndaqel franchise benefited from “very strong demand growth,” reinforced by the medicine’s “continued market share leadership,” Malik explained.Nevertheless, that volume growth was offset by a pair of “gross-to-net headwinds,” Malik pointed out, spotlighting IRA manufacturer rebates and “payer contracting” during the earnings period.“So Vyndamax is performing exactly where we thought it would, and consistent with what we guided,” Malik said. “And performance continues to reflect strong diagnosis, broad access, improving affordability dynamics—and that’s going to continue to grow our volume.”Even though the Vyndaqel franchise is now facing some competition among treatment-naïve patients, “Amvuttra has driven minimal switching to date,” Malik added, calling out Alnylam’s ATTR-CM rival by name. Pfizer reported its earnings as it grapples with Novo Nordisk over the companies’ competing efforts to purchase obesity biotech Metsera. While Pfizer’s planned $4.9 billion purchase of the company appeared solidly in the books as of late September, Novo Nordisk swooped in last week with a $6.5 billion counterbid.Pfizer has launched legal efforts to scupper Novo’s offer and has also raised its initial bid for Metsera, which Novo countered again with its own higher proposal Tuesday morning. For now, leadership at Pfizer appears steadfast in their belief that Novo’s attempt to cut in on the deal will fail on legal grounds, accusing their Danish rival of violating U.S. antitrust laws to stymie an emerging obesity rival.“Novo Nordisk's offer is illusory and cannot constitute a superior proposal under the terms of our merger agreement with Metsera, because it violates antitrust law and there is a high risk it will never be consummated,” Bourla said of the situation Tuesday.