Pharmaceutical Industry Roundup: Major Acquisitions, FDA Decisions, and Global Partnerships

Celltrion Acquires Eli Lilly Plant in Strategic $330M Deal

In a significant move to bolster its U.S. presence and mitigate tariff impacts, South Korean biopharmaceutical company Celltrion has announced the acquisition of Eli Lilly's drug substance plant in Branchburg, New Jersey. The deal, valued at approximately $330 million, is set to close by the end of the year. Celltrion plans to retain all current employees and continue existing CDMO contracts at the site, signaling a smooth transition and immediate operational readiness.

This strategic purchase not only expands Celltrion's manufacturing footprint in the United States but also serves as a protective measure against potential tariffs. The company's decision to maintain the workforce and honor existing contracts demonstrates a commitment to continuity and could potentially strengthen its position in the competitive biopharmaceutical landscape.

FDA Decisions Shape Drug Development Landscape

The U.S. Food and Drug Administration (FDA) has made two notable decisions impacting major pharmaceutical players:

1. Lundbeck and Otsuka faced a setback as the FDA declined to approve their application for Rexulti in post-traumatic stress disorder (PTSD). The regulatory body cited insufficient evidence of effectiveness and recommended additional trials for potential future approval. This decision underscores the rigorous standards maintained by the FDA in evaluating new drug applications, particularly for complex mental health conditions.

2. Johnson & Johnson's subsidiary, Janssen Vaccines, received an FDA warning letter regarding its manufacturing site in Incheon, South Korea. The regulator highlighted concerns over inconsistent quality control procedures and inadequate follow-up on product complaints. While the site no longer performs vaccine development, this warning serves as a reminder of the importance of maintaining stringent quality standards in pharmaceutical manufacturing.

Global Partnerships and Licensing Deals

The pharmaceutical industry continues to see significant collaboration and licensing activity:

Hengrui Pharma has entered into a licensing agreement with Glenmark for its HER2 antibody-drug conjugate, trastuzumab rezetecan. The deal, potentially worth up to $1.1 billion, grants Glenmark certain rights in emerging markets. This partnership comes on the heels of the drug's approval in China for second-line non-small cell lung cancer with HER2-activating mutations, positioning it as a potential competitor to established treatments in the space.

In a separate development, generics manufacturers Dr. Reddy's Laboratories and Hetero Lab have signed agreements with charitable organizations to provide generic versions of Gilead Sciences' long-acting HIV PrEP injection, Yeztugo. The deal aims to make the treatment available at $40 per year in 120 low- and middle-income countries starting in 2027, significantly improving access to critical HIV prevention medication in underserved regions.

These collaborations highlight the industry's ongoing efforts to expand global access to innovative treatments and address unmet medical needs across diverse markets.