Semaglutide (Novo Nordisk)

iStock, TheMountBirdStudio Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away. Novo Nordisk’s termination of a weeks-old partnership with telehealth player Hims & Hers Health has shaken up the obesity space, reigniting a row over compounded GLP-1 drugs and the potential for a legal battle. The companies teamed up in late April. Through the alliance, Hims began offering telehealth packages featuring Novo’s Wegovy on its platform starting at $599 a month. The telehealth provider continued to offer compounded semaglutide after the Novo deal, relying on the personalization exemption once the end of the drug shortage prohibited mass compounding. Hims has pitched its ongoing provision of compounded semaglutide as a way to allow clinicians to personalize titration schedules and steady-stage doses for patients who are unable to tolerate Wegovy because of side effects. Novo has railed against compounding, which executives blamed for the decision to cut full-year guidance in May. But the pact was pitched as a way to reach more patients. Aaron DeGagne, senior healthcare analyst at PitchBook, said the two companies “always seemed like strange bedfellows” because of their divergent positions on compounding. Those differences soon scuttled the alliance. Eight weeks after striking the deal, Novo terminated the partnership, accusing Hims of “deceptive promotion and selling of illegitimate, knockoff versions of Wegovy that put patient safety at risk.” According to Novo, Hims “failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of ‘personalization’.” Hims CEO Andrew Dudum hit back quickly, taking to X to say his company was “disappointed to see Novo Nordisk management misleading the public.” According to Dudum, in the weeks leading up to the termination of the deal Novo’s “commercial team increasingly pressured us to control clinical standards and steer patients to Wegovy regardless of whether it was clinically best for patients.” Fallout from the Termination Branded weight-loss drugs such as Wegovy are a small part of Hims’ business, which generated sales of $1.5 billion in 2024. Truist Securities analysts said in a note to investors that personalized compounding accounted for around two-thirds of the $389 million in weight-loss sales they expected Hims to generate in the second half of 2025. Yet, Hims’ stock fell 35% on the day Novo walked away, partly wiping out gains made after disclosing the deal in the first place. The termination could hurt Hims beyond the direct loss of Wegovy sales. Truist analysts said Hims “was likely benefiting from the ‘credibility’ or increased consumer traffic onto their platforms as a result of advertising of branded Wegovy.” The termination could reduce traffic and drug compounding sales. The split from Novo may also open Hims up to lawsuits. Truist analysts named reduced litigation risks as a benefit of the Novo alliance when Hims unveiled the deal in April. The analysts said the “litigation risk is back on the table” after Novo terminated the partnership. “While Hims would argue that its compounding business is not violating any IP..., Novo could make a legal argument around other practices (corporate practice of medicine, deceptive advertising, etc.),” the analysts said. “A litigation, if there is one, could drag on for 18-24 months and could remain an overhang on Hims shares.” Speaking on an earnings call in May, Dudum said the FDA’s personalization exemption rules are “extremely straightforward and clear.” Steven Grossman, a policy and regulatory consultant, discussed the use of the personalization exemption to support “special needs” compounding in a blog post published after Novo terminated the Hims deal. Grossman called for the FDA to urgently address the scope of the exemption to stop compounding from spreading to other drug classes. “If trivial adjustments to a commercially-available product qualifies as ‘special needs,’ then the shift from regulated manufacturers to unregulated compounders will expand to many additional drug products beyond GLP-1’s,” Grossman said. “Compounding would then be far beyond what the law was intended to permit, and far from the consumer protections we now enjoy.” Novo’s Search for Growth Drivers Novo continues to work with the telehealth companies LifeMD and Ro but is cut off from Hims’ platform. The separation limits Novo’s ability to serve a set of patients that David Moore, executive vice president, U.S. operations at the Danish drugmaker, has identified as becoming more and more important. “Increasingly, people living with obesity are seeking healthcare through telehealth companies, and we need to be where patients are and to have an offering for the real Wegovy,” Moore said on an earnings call in May. Novo has severed its link to Hims at a time when it is trying to accelerate growth of semaglutide. Obesity sales grew 67% in the first quarter but the drugmaker cut guidance to reflect “lower-than-planned penetration of branded GLP-1 treatments in the U.S., impacted by compounded GLP-1s.” Competition with Eli Lilly’s tirzepatide, which beat semaglutide in a head-to-head trial, is another factor.

▎药明康德全球首款！诺华创新疗法获瑞士批准今日，诺华（Novartis）宣布其与疟疾药物开发伙伴组织Medicines for Malaria Venture（MMV）合作开发的Coartem（artemether-lumefantrine，蒿甲醚-苯芴醇）Baby已获瑞士监管单位Swissmedic批准上市。根据新闻稿，这是首个专门针对新生儿和婴幼儿的疟疾治疗药物。值得一提的是，在此以前无针对体重低于4.5公斤婴儿的获批疟疾药物，临床上只能通过用于年长儿童的药物进行治疗，存在潜在的剂量不精确和毒性风险。此外，现有疟疾疫苗同样尚未获得对最年幼婴儿的批准。此次批准基于一项名为CALINA的2/3期临床研究，该研究专门评估了蒿甲醚-苯芴醇的新剂量比例，以更好适用于体重不足5公斤婴儿的代谢特点。根据批准信息，Coartem Baby适用于体重2至不足5公斤的新生儿和婴儿，用于治疗由恶性疟原虫（Plasmodium falciparum）单一或混合感染引起的急性、非复杂性疟疾。诺和诺德再递交司美格鲁肽监管申请诺和诺德（Novo Nordisk）今日宣布，已向欧洲药品管理局（EMA）提交其重磅疗法Wegovy（皮下注射司美格鲁肽）7.2毫克新剂量的监管申请。此次申请旨在拓展Wegovy的治疗剂量选项，为肥胖患者（包括合并2型糖尿病者）提供更高剂量的治疗方案，进一步提升体重管理效果。该申请主要基于两项临床研究数据：STEP UP试验和STEP UP T2D试验。前者评估了7.2毫克剂量Wegovy在单纯肥胖成人中的疗效与安全性，结果显示受试者平均体重减轻达21%，其中约三分之一患者体重下降幅度超过25%，显著优于安慰剂对照组。后者则在合并2型糖尿病的肥胖成人群体中验证了该剂量的疗效与耐受性。整体数据显示，该剂量的安全性良好，与此前获批的2.4毫克剂量及其他司美格鲁肽临床研究结果一致。参考资料：[1] Novartis receives approval for first malaria medicine for newborn babies and young infants. Retrieved July 8, 2025 from https://www.novartis.com/news/media-releases/novartis-receives-approval-first-malaria-medicine-newborn-babies-and-young-infants[2] Novo Nordisk A/S: New Wegovy® dose submitted to European Medicines Agency for approval, with 1 in 3 trial participants achieving 25% or more weight loss. Retrieved July 8, 2025 from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916360免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。👇 分享，点赞，在看，聚焦全球生物医药健康创新