The last few days of 2023 and the beginning of 2024 featured a flurry of dealmaking by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies. Big Pharma companies are also increasingly entrusting commercialization of some products in China to domestic firms. And more.
1. AstraZeneca pays $1B to take the wheel of Gracell’s CAR-T ‘fast car’
AstraZeneca is paying $1 billion to acquire CAR-T specialist Gracell Biotechnologies in the first full buyout of an innovative Chinese biotech by a Big Pharma company. Gracell’s FasTCAR platform is designed to reduce manufacturing time and enhance T cell fitness. The company’s lead candidate, a BCMA and CD19 dual CAR-T coded GC012F has delivered some impressive early results in multiple myeloma.
2. A Christmas deal spree: See what J&J, Roche and more had in their stockings
AstraZeneca picks up a friend for Tagrisso in $40M upfront deal
GSK heads back to Hansoh, paying $185M upfront for another ADC
Avenzo, Merck KGaA and AbbVie each ink new deals to fortify cancer pipelines
A wave of cancer drug licensing deals with Asian companies were unveiled in the past few weeks. Johnson & Johnson paid $100 million upfront and promised $1.7 billion in milestones for LegoChem Biosciences’ TROP2 antibody-drug conjugate. Roche in-licensed MediLink Therapeutics’ c-MET ADC in a deal potentially worth $1 billion. Astellas penned a $1.7 billion biobuck pact for two bispecific macrophage engagers from Elpiscience Biopharma.
AstraZeneca laid out $40 million in upfront and near-term milestones to take in Allorion Therapeutics’ EGFRL858R allosteric inhibitor as a potential lung cancer treatment. Allorion also out-licensed ex-Greater China rights to an early-stage CDK2 inhibitor and a preclinical asset to Avenzo Therapeutics for $40 million upfront. Just two months after buying rights to Hansoh’s B7-H4-targeted ADC, GSK has picked up a B7-H3 ADC from the Chinese biotech for $185 million upfront and up to $1.5 billion in potential milestones.
3. Boehringer bets $2B in biobucks to unlock siRNA targets for MASH treatments
Outside oncology, Boehringer committed more than $2 billion in biobucks to tap Ribo Life Science’s small interfering RNA technology to treat metabolic-associated steatohepatitis, also known as nonalcoholic steatohepatitis. The Chinese biotech and its Swedish subsidiary have a platform that produces RNAi drugs that target genes specifically in liver cells.
4. 2024 forecast: Big Pharma reworks China strategy, and job cuts are part of it
In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen tasked local companies to commercialize some of their products in China. Increased pricing pressure and competition, especially for mature products, makes in-house commercial buildup less cost-effective for foreign pharmas, L.E.K. Consulting’s China practice leader, Justin Wang, said. The moves also come amid companies’ global cost-cutting initiatives.
5. Merck, Astellas and Pfizer bring down the house with Keytruda-Padcev FDA nod in bladder cancer
The combination of Astellas and Pfizer’s Padcev and Merck’s Keytruda has won full FDA approval as a first-line treatment for bladder cancer. The go-ahead came way ahead of the FDA’s target decision date and was backed by impressive overall survival data that sparked a standing ovation when they were presented in October. The nod doubled the scope of a previous accelerated approval to now include patients who are eligible for cisplatin-based chemotherapy.
6. J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk
The FDA has upgraded a warning about secondary cancers following the use of J&J and Legend Biotech’s Carvykti. The risk is now highlighted in the black box warning section of the BCMA CAR-T’s label. In the CARTITUDE-1 study, 10 of 97 Carvykti takers later developed myelodysplastic syndrome and acute myeloid leukemia. The update also comes as the FDA is investigating a new safety signal of secondary T-cell malignancies for all marketed CAR-Ts.
7. Nexletol partners Esperion and Daiichi Sankyo patch up milestone dispute with $125M settlement
With a $125 million payment, Daiichi Sankyo has settled a milestone dispute with Esperion Therapeutics around the latter’s bempedoic acid products. The two companies previously clashed over a $300 million milestone payment because of different views of a cardiovascular trial’s endpoints. With the new deal, the two companies will work together to develop a triple formulation product.
8. FDA slams trio of Indian drugmakers with Form 483 filings after December inspections
The FDA issued Form 483 letters to Dr. Reddy’s Labs, Torrent Pharma and Laurus Synthesis over lapses found at their plants in India. Dr. Reddy’s Bachupally R&D campus had deficient records-keeping or control procedures and lacked employee training, the FDA said. Torrent’s three-observation citation centered on its quality system.
Other News of Note:
9. Olympus lung scope recall details risks of fires, internal burns
10. Takeda’s gene therapy pivot leaves JCR behind after proof-of-concept preclinical test
11. AstraZeneca, Sanofi win nod in China for RSV antibody Beyfortus
12. After issuing Form 483, FDA classifies Aurobindo plant as only needing 'voluntary' action
13. Otsuka pays $65M cash for European rights to Ionis’ phase 3 rare disease med
14. After Xiidra deal with Bausch, Novartis divests Indian eye care brands to J.B. Pharma for $116M
15. Sciwind blows into GLP-1 contention with pivotal data on Chinese rival to Novo, Lilly
16. AGC extends CDMO expansion spree, plans second manufacturing facility in Japan
17. WuXi CRDMO spinoff WuXi XDC inks partnership with IntoCell