Pharmaceutical Industry Roundup: Major Deals, Approvals, and Legal Challenges

In a flurry of activity across the pharmaceutical landscape, several major players have made significant moves in drug development, acquisitions, and regulatory approvals. From allegations of fraud to strategic buyouts and FDA nods, the industry continues to evolve at a rapid pace.

Novo Nordisk Alleges Fraud in $1.3 Billion Deal

Danish pharmaceutical giant Novo Nordisk has leveled serious accusations against Singaporean biotech KBP Biosciences, claiming the company intentionally withheld negative clinical data prior to a licensing deal worth up to $1.3 billion in 2023. The deal centered around the hypertension candidate ocedurenone. Novo Nordisk is now seeking $830 million in damages and has initiated legal proceedings in the Singapore International Commercial Court, which has ordered a freeze on KBP's assets and those of its founder, Huang Zhenhua.

Strategic Moves: AstraZeneca and Ono Pharmaceutical

AstraZeneca has made a decisive move in China, paying $160 million to acquire FibroGen's China unit and regional rights to roxadustat, a chronic kidney disease drug. This acquisition comes after AstraZeneca distanced itself from the drug in the U.S. market. Despite facing generic competition, roxadustat, marketed as Evrenzo in China, generated $336 million in revenue for AstraZeneca last year, marking a 22% increase.

In another strategic play, Ono Pharmaceutical's $2.4 billion acquisition of Deciphera Pharmaceuticals has yielded its first major success. The FDA has approved Romvimza for the treatment of symptomatic tenosynovial giant cell tumor, positioning it as a competitor to Daiichi Sankyo's Turalio. Romvimza boasts a convenience advantage and lacks the black box warning associated with its competitor.

Regulatory Approvals and Clinical Developments

The FDA's approval of Ono's Romvimza marks a significant milestone in rare tumor treatment. Meanwhile, Radiance Biopharma has entered the ROR1-directed antibody-drug conjugate (ADC) race, paying $15 million upfront for rights to a candidate from a CSPC Pharmaceutical subsidiary. This deal could potentially exceed $1 billion based on sales milestones. The move comes as Merck & Co. advances its own ROR1 ADC into phase 3 testing for diffuse large B-cell lymphoma, following impressive early results.

In contrast to these advancements, Otsuka has discontinued several clinical cancer programs for strategic reasons, including OPB-111077, an oral STAT inhibitor that had been in development since 2012.