OPB-111077

Novo Nordisk's dealmaking dispute with KBP Biosciences, AstraZeneca's purchase of FibroGen China and Ono's FDA approval for a rare tumor drug made our news this week. Novo Nordisk alleges Singaporean biotech KBP Biosciences made misleading statements before the two firms inked a licensing deal worth up to $1.3 billion. AstraZeneca is buying out its roxadustat partner FibroGen in China. Ono Pharmaceutical's $2.4 billion Deciphera acquisition has borne fruit. And more.1. Novo Nordisk to sue KBP Biosciences over alleged fraudulent claims on kidney disease drugNovo Nordisk is alleging that KBP Biosciences intentionally withheld negative clinical data before the Danish company bought the latter’s hypertension candidate ocedurenone in a potential $1.3 billion deal in 2023. Novo plans to seek $830 million in damages from the Singaporean biotech, which was founded by Huang Zhenhua in China. The Singapore International Commercial Court has ordered a freeze of the assets of KBP and Huang as Novo prepares to launch arbitration proceedings in New York.2. AstraZeneca pays $160M for FibroGen's China unit, regional rights to roxadustatAfter ditching FibroGen’s chronic kidney disease drug roxadustat in the U.S., AstraZeneca has decided to take full control of the HIF-PH inhibitor in China. The British pharma is paying $160 million to buy FibroGen’s China unit. Last year, AZ recorded $336 million in revenue from the drug, sold as Evrenzo in China, a 22% increase despite generic competition.3. FDA approves Ono's rare tumor drug from $2.4B Deciphera buyoutOno Pharmaceutical’s Deciphera Pharmaceuticals has won FDA approval for Romvimza as a competitor to Daiichi Sankyo’s Turalio in symptomatic tenosynovial giant cell tumor. The Japanese pharma bought the U.S. biotech last year for $2.4 billion to expand its targeted oncology portfolio and boost its U.S. footprint. Compared with Turalio, Romvimza holds a convenience edge and does not come with a black box warning.4. Otsuka breaks up with cancer candidates on strategic groundsOtsuka has nixed several clinical cancer programs for “strategic reasons.” Among the candidates, the only one that the company was developing in the U.S. was OPB-111077, an oral STAT inhibitor that entered the clinic in 2012. The drug was mostly recently tested in a lymphoma trial starting in 2019 until enrollment stopped last year. The other three are being tested only in Japan.5. Siemens Healthineers plans 'mega depots' to bolster US supply chain amid 'geopolitical uncertainties'As President Donald Trump’s new tariffs on China and Mexico are expected to impact medical devices, Siemens Healthineers said it’s building new “mega depots” for spare parts and other inventory in New York City and Oakland, California. The company cited “geopolitical uncertainties” as a potential threat to a stable medtech supply chain.6. Radiance rolls into ROR1 race, paying $15M for ADC rival to Merck’s frontrunnerRadiance Biopharma is paying $15 million upfront for rights to a ROR1-directed antibody-drug conjugate from a subsidiary of China’s CSPC Pharmaceutical. The deal could be worth more than $1 billion if the drug reaches certain sales milestones. After reporting a 100% complete response rate, Merck & Co. has moved its ROR1 ADC into phase 3 testing in diffuse large B-cell lymphoma.Other News of Note: 7. Amid Merck supply squeeze, ImmunityBio and Serum Institute snag FDA blessing for BCG expanded access program8. Ascletis' swift surge into obesity continues with competitive oral GLP-1 data9. FDA hits pair of Indian API makers with warning letters, import alerts