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Celltrion and Eli Lilly's U.S. plant transaction, the FDA complete response letter for Lundbeck and Otsuka's PTSD drug application and an ADC deal between Hengrui and Glenmark made our news this week. Celltrion is buying an Eli Lilly drug substance plant in the U.S. for $330 million. The FDA has declined to approve Lundbeck and Otsuka's Rexulti in PTSD. Hengrui Pharma has out-licensed certain rights to its HER2 antibody-drug conjugate to Glenmark. And more.1. Celltrion snaps up Lilly's NJ drug substance plant for $330M in tariff mitigation move, pledges to retain employeesCelltrion is paying 460 billion Korean won (about $330 million) to buy Eli Lilly’s drug substance plant in Branchburg, New Jersey. Once the deal is closed by the end of the year, Celltrion plans to retain all employees and start operations immediately with existing CDMO contracts at the site. The purchase is meant to protect the company from tariffs, the company said.2. FDA turns down Lundbeck, Otsuka's Rexulti in PTSD on lack of efficacy dataThe FDA has declined to approve Lundbeck and Otsuka’s application for Rexulti as part of a combination with Viatris’ Zoloft in post-traumatic stress disorder. The FDA cited a lack of substantial evidence of effectiveness and asked the partners to run additional trials should they wish to pursue an approval again, according to the companies.3. In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to EnhertuHengrui Pharma is licensing certain rights in emerging markets around its HER2 antibody-drug conjugate, trastuzumab rezetecan, to Glenmark. The deal features $18 million in upfront payment and up to $1.09 billion in milestones. The drug was approved in China in May in second-line non-small cell lung cancer with HER2-activating mutations.4. Generics makers to sell Gilead's Yeztugo at $40 a year under deals with Gates Foundation, othersIndia's Dr. Reddy’s Laboratories and Hetero Lab have signed deals with charity organizations to provide generic versions of Gilead Sciences' long-acting HIV PrEP injection Yeztugo at $40 a year in 120 low- and middle-income countries starting in 2027. The deals were enabled by licensing agreements with Gilead.5. FDA hands warning letter to J&J subsidiary over stopper issues, spotty reporting at Korean plantJohnson & Johnson's Janssen Vaccines in South Korea was hit with an FDA warning letter. The regulator criticized the company’s manufacturing site in Incheon, South Korea, for inconsistent quality control procedures and failure to follow up thoroughly on product complaints. The site no longer performs any vaccine development, a spokesperson said.Other News of Note:6. Fujifilm Biotechnologies cuts ribbon on $3.2B antibody facility in N.C.7. Fujifilm, argenx expand partnership to bring Vyvgart production to the US8. Italy's Angelini inks $550M-plus pact for preclinical brain condition asset9. Takeda scientists tackle Mount Fuji to advocate for patients in need of plasma-derived therapies10. Japan biotech inks research pact in effort to develop new RNA meds11. Lantheus hands GE HealthCare the rights to its blockbuster prostate cancer PET tracer in Japan

Rexulti’s PTSD snub was largely expected after an overwhelmingly negative vote on the drug’s approvability at an FDA advisory committee meeting in July. Following a negative FDA advisory committee vote earlier this year, the other shoe has dropped for Lundbeck and Otsuka Pharmaceutical’s post-traumatic stress disorder (PTSD) hopeful.The FDA has issued a complete response letter to the partners, scuppering their ambition to launch the atypical antipsychotic Rexulti—in combination with Viatris’ Zoloft (sertraline)—as a novel treatment for PTSD, Lundbeck and Otsuka said in a Sept. 20 press release.In the regulator’s letter, the FDA said it completed its review of the Rexulti application but could not currently approve it, citing a lack of substantial evidence of effectiveness in PTSD, according to Lundbeck and Otsuka.The partners used three separate phase 3 trials to support their application, which the FDA accepted for review last June.After its review, the FDA indicated to the companies that “not all of these studies are capable of contributing to the substantial evidence of the submission,” Lundbeck and Otsuka said in their release. Should the partners wish to continue pursuing a PTSD nod for Rexulti, they have been told they will need to run additional trials to establish stronger efficacy data.Both companies appear committed to Rexulti’s potential in the trauma-induced mental health condition, which is estimated to affect around 5% of the U.S. population, according to the National Center for PTSD.“While we respect the FDA’s decision, we continue to believe in the potential of Rexulti in combination with sertraline to help address this serious unmet need,” John Kraus, M.D., Ph.D., Otsuka’s EVP and chief medical officer, said in a statement. “Otsuka and Lundbeck will take time to review the contents of the letter with the FDA to determine the appropriate path forward.” The current treatment landscape for PTSD largely consists of the selective serotonin reuptake inhibitors (SSRIs) Zoloft and Paxil (paroxetine), both of which have had generic versions on the market for years.Rexulti’s PTSD snub was largely expected after an overwhelmingly negative vote on the drug’s approvability at an FDA advisory committee meeting in July. The panel of outside experts voted 10 to 1 against greenlighting Rexulti plus Zoloft in PTSD, arguing that the existing clinical data don't support the combo’s efficacy.In materials prepared ahead of the meeting, the FDA suggested that a “clearly and convincingly negative” phased 3 study had sewn doubts in reviewers' minds about the ability of the combination to demonstrate improvements over Zoloft alone.Otsuka and Lundbeck argued that Rexulti and Zoloft showed comparable reductions in the severity of PTSD symptoms across the three studies, while acknowledging that one of the trials failed to reach statistical significance. Rexulti holds approvals in three other psychiatric indications: major depressive disorder, schizophrenia and agitation associated with Alzheimer’s disease dementia.Lundbeck in February reported (PDF) total 2024 sales of Rexulti at 5.2 billion Danish kroner (about $822 million), an increase of 16% at constant currencies. The molecule was originally discovered by Otsuka before the Japanese pharma entered a co-marketing and development collaboration with its now longtime partner Lundbeck.