Semaglutide (Novo Nordisk)

Pfizer is suing to stop Novo Nordisk from throwing a wrench in its acquisition of Metsera, the next-gen obesity biotech that Pfizer said it would buy for $4.9 billion upfront . The lawsuit against both parties comes a day after Metsera told Pfizer that Novo’s higher upfront proposal was “superior” to Pfizer’s. It’s the latest turn in what could become a high-stakes bidding war as Pfizer looks to gain ground in the obesity drug race and Novo seeks to maintain a dominant position once semaglutide hits a patent cliff. “This action seeks to halt Novo Nordisk’s plot to catch and kill Metsera before Pfizer can possibly nurture its products into healthy competition — a plot that is being facilitated by a brazen breach of the Pfizer-Metsera Merger Agreement and disloyal, bad faith actions by Metsera’s directors,” Pfizer said in a complaint filed Friday in the Delaware Court of Chancery. Pfizer said it’s asking the court to “issue a temporary restraining order to block Metsera from terminating the merger agreement to allow Pfizer time to be heard on this important matter.” In a statement Friday, Novo called the claims “meritless, and we will vigorously defend ourselves in any litigation.” Metsera said it disagreed with the allegations and will address them in court. Last month, Metsera and Pfizer agreed to a $47.50 per share upfront buyout. Then, on Oct. 25, Novo submitted a $56.50 per share upfront deal. Both offers came with varying milestone payment structures, with the overall deal value being about $9 billion from Novo and about $7.3 billion from Pfizer. Novo revealed its bid on Thursday morning. Pfizer threatened legal action an hour later. Pfizer claimed Novo’s offer is not superior and that it’s an “attempt by a company with a dominant market position to suppress competition.” Minutes before the markets closed on Friday, Pfizer said it got early clearance from the Federal Trade Commission, meaning the regulatory review requirements have been satisfied prior to the Nov. 7 expiration. Novo, in search of follow-up obesity drugs to Wegovy, tried acquiring Metsera earlier this year. But Metsera went with Pfizer because of risks that the deal could drag on for as long as two years, according to a regulatory filing outlining the deal . Metsera’s notice to Pfizer on Thursday morning triggered a four-day window for Pfizer to decide whether to submit a matching offer or a more compelling bid than Novo’s. Pfizer claimed the notice was a breach of their agreement. Metsera said Thursday morning that it disagreed . Pfizer, in its lawsuit, said it wants the court to prevent Metsera from “improperly terminating the deal,” enforce its bargained-for agreement, and stop Novo from unlawfully “interfering in and scuttling the transaction.” Editor’s Note: This story was updated with information from the complaint, and to add statements from Novo and Metsera.

Takeda's third-quarter pipeline cull, a head-to-head win against Novo Nordisk's semaglutide and a potential $1 billion-plus licensing deal by Roche made our news this week. Takeda tightened its pipeline in the third quarter. Innovent Biologics reported a head-to-head win against semaglutide in a Chinese phase 3 trial. Roche licensed a respiratory bispecific candidate in a potential $1 billion-plus deal. And more.1. Takeda drops AstraZeneca-partnered neurological program after phase 2 failureTakeda’s AstraZeneca-partnered alpha-synuclein antibody, TAK-341/MEDI1341, has failed in a phase 2 study in multiple system atrophy. The Japanese pharma also stopped developing the orexin-2 receptor agonist danavorexton (TAK-925) for narcolepsy “due to strategic considerations,” while phase 2 development in respiratory conditions remains ongoing.2. Innovent, Lilly's mazdutide trumps Novo's semaglutide in head-to-head diabetes, weight loss studyInnovent Biologics’ China-approved mazdutide has topped Novo Nordisk’s 1-mg semaglutide in a Chinese phase 3 trial conducted in patients with early-stage Type 2 diabetes and obesity. A 6-mg dose of the first-in-class GLP-1/glucagon dual receptor agonist outperformed semaglutide on the proportion of patients who met certain blood sugar and body weight benchmarks. The drug is partnered with Eli Lilly in the country.3. Roche pens $1B biobucks deal for Chinese company's respiratory disease bispecificRoche is paying $75 million upfront and committing up to $995 million in milestones to license a long-acting TSLPxIL-33 bispecific from China’s Qyuns Therapeutics. Coded QX031N, the drug holds promise for chronic obstructive pulmonary disease and asthma, according to Qyuns. The long-acting TSLP mechanism last year attracted GSK to a $1 billion buyout of Aiolos, which got its candidate from China’s Jiangsu Hengrui Pharma.4. Merck, Eisai scrap ambitions for Keytruda-Lenvima pairing in liver cancer subtype after survival missMerck & Co. and Eisai’s Keytruda and Lenvima failed to significantly extend patients’ lives when added to standard transarterial chemoembolization in unresectable, non-metastatic liver cancer. The overall survival miss at an interim analysis has led the pair to close the phase 3 Leap-012 trial. While an FDA expansion appears unlikely, the regimen was recently approved in China based on a positive progression-free survival readout.5. Boehringer returns to Kyowa Kirin with €640M pact for preclinical autoimmune moleculeIn a deal worth up to 640 million euros ($743 million), Boehringer Ingelheim has licensed a preclinical program from Kyowa Kirin that the German pharma hopes could become a “first-in-class … treatment of autoimmune diseases.” No details on the drug’s target or specific indications were given.6. WuXi AppTec sharpens focus by selling off China-based clinical research unitsWuXi AppTec is selling its China-based CRO WuXi Clinical and site management organization WuXi MedKey to Hillhouse. With the divestments, the company aims to emphasize its drug discovery, laboratory testing, process development and manufacturing services, according to a securities filing.7. BIO’s John Crowley urges ‘strategic action’ to strengthen FDA amid China’s biotech rise (Testimony before Congress)In a testimony before the Senate Health, Education, Labor, and Pensions Committee, Biotechnology Innovation Organization chief John Crowley called for “proactive, strategic action” to strengthen the FDA to secure “America’s biotech future” amid China’s rapid rise in biotech. His long list of recommendations includes reducing the time, cost and complexity of early drug development and improving the agency’s first-cycle review success rate.Other News of Note:8. Birds, lizards and cats, oh my: FDA blasts generic drug maker Hetero in scathing Form 4839. Roche's Chugai strikes $200M M&A deal to take over IgAN asset in several Asian countries10. Biogen boosts sales outlook on 'resilient' legacy MS franchise as new launches build momentum11. Astellas taps social media star Babs Costello to promote Izervay for geographic atrophy12. Samsung Bioepis gains full rights to Lucentis, Eylea biosimilars from Biogen in Europe (release)