Bristol Myers Squibb and BeiGene have settled their Abraxane feud by terminating their three-drug licensing deal altogether. Sumitomo Pharma's Otsuka-partnered schizophrenia candidate ulotaront filed in a pair of phase 3 trials. AstraZeneca CEO responded to a report about the company's plan to spin out its China business. And more.
1. Bristol Myers, BeiGene end legacy Celgene deal with settlement years after China ban
Bristol Myers Squibb and BeiGene have decided to terminate their China licensing deal originally signed in 2017 by Celgene around the cancer drugs Revlimid, Abraxane and Vidaza. The settlement puts an end to a feud that stemmed from a Chinese import and sale ban on Abraxane. Chinese authorities placed the ban in 2020 after noticing manufacturing problems at a BMS contract manufacturing facility in the U.S.
2. Sumitomo-Otsuka schizophrenia drug flunks pair of phase 3 trials amid 'high placebo response'
A pair of phase 3 studies for Sumitomo Pharma and Otsuka’s schizophrenia candidate ulotaront missed their primary endpoints. Compared with placebo, the AAR1 agonist showed slightly better results on improving schizophrenia symptoms on a severity scale. But the results failed to meet statistical significance. The pair suggested that placebo overperformance may have masked the drug’s therapeutic effect.
3. AstraZeneca forecasts stronger China sales as CEO tries to clear the air on spinoff report
In response to a question about a recent Financial Times report that AstraZeneca has crafted plans to spin out its China operations in case of rising geopolitical tensions, AstraZeneca CEO Pascal Soriot said the company studies many business scenarios. The company studies many potential situations that never become reality, he explained during a press call. The British pharma also dialed up its revenue projection for its China business for the year.
4. Biogen looks at selling biosims unit to longtime ally Samsung Bioepis: reports
It wasn’t long ago that Biogen sold its stake in Samsung Bioepis to joint venture partner Samsung Biologics but kept rights to some biosimilars. Now, Biogen is reportedly in talks to offload the remaining biosimilar portfolio to Samsung Bioepis. Biogen CEO Chris Viehbacher had previously said that the company was examining strategic options for the biosimilar business.
5. Takeda's Exkivity sputters in lung cancer trial, with accelerated approval on the line
Takeda’s targeted non-small cell lung cancer drug Exkivity has failed as a monotherapy in a phase 3 trial in newly diagnosed patients whose tumors bear EGFR exon 20 insertion mutations. The first-line flop puts Exkivity’s second-line accelerated approval in danger. News of Exkivity’s phase 3 flop came just days after Johnson & Johnson touted a win for its rival drug Rybrevant also in new patients.
6. Lupin Pharma recalls birth control pills deemed possibly ineffective
Lupin is recalling two lots of the birth control drug Tydemy because they missed the mark on a 12-month stability test, suggesting they may not be effective in preventing pregnancy. Testing on one of the lots found low levels of an essential inactive ingredient, ascorbic acid, and high levels of an impurity. The affected lots were distributed from June 3, 2022, to May 31, 2023.
Other News of Note
7. Lundbeck, Otsuka target Alzheimer's caregivers in ad for expanded Rexulti label
8. Daiichi Sankyo wins Japanese nod for homegrown mRNA COVID vaccine (Reuters)