BeiGene lost its TIGIT inhibitor collaboration with Novartis but signed an antibody-drug conjugate deal with Duality Biologics. Takeda has pulled the FDA filing for its dengue vaccine after the FDA requested more data. Eisai's Alzheimer's chief Ivan Cheung is handing the baton to group CEO Haruo Naito's son. And more.
1. Novartis retreats from TIGIT, handing $300M candidate back to BeiGene
Novartis has decided to leave BeiGene alone fighting the TIGIT battle. The two companies have terminated their ociperlimab licensing deal, which Novartis paid $300 million to enter in 2021. BeiGene will carry on with a phase 3 trial of the drug in combination with its other Novartis-partnered drug, PD-1 inhibitor tislelizumab, in non-small cell lung cancer. The TIGIT field has seen several setbacks lately.
2. UPDATED: Takeda yanks FDA filing for dengue vaccine, citing data disagreement with regulator
Takeda has withdrawn an application for dengue vaccine TAK-003 after the FDA sought additional data that weren’t captured by a phase 3 trial. The vaccine is approved as Qdenga in Europe and several endemic countries. Takeda said it needs time to fully evaluate the requirements for a resubmission. The company had previously projected up to $2 billion in peak sales for the vaccine.
Just days after Leqembi got its full FDA approval, Eisai’s global Alzheimer’s disease chief Ivan Cheung is hanging up his harness. Keisuke Naito, the 34-year-old son of Eisai’s longtime CEO Haruo Naito, will take over the Alzheimer’s reins. Eisai’s chief financial officer Tatsuyuki Yasuno will pick up Cheung’s U.S. CEO position.
4. BeiGene links future to DualityBio, inking backloaded $1.3B deal for solid tumor ADC
After making a name with an antibody-drug conjugate pact with BioNTech, China’s Duality Biologics has attracted another company. BeiGene has signed up for a preclinical asset from Duality in a deal worth up to $1.3 billion. BeiGene will have a chance to exercise its option to take in the asset, and the undisclosed ADC will need to pass multiple milestones for the deal to realize its full value.
5. WuXi Bio telegraphs spinoff of its bioconjugate subsidiary XDC
WuXi Biologics has unveiled a plan to spinoff its bioconjugate business, WuXi XDC, into a separate entity listed on the Hong Kong Stock Exchange. The unit handles CDMO business around antibody-drug conjugates, peptide conjugates and other biologics. As ADCs start to gain popularity, WuXi figured some of this market is beyond the scope of WuXi Biologics.
6. Astellas paves backloaded biobucks deal to test 4DMT's eye disease gene therapy vector
Astellas is still investing in gene therapy despite past setbacks. In a new deal, the Japanese pharma is shelling out $20 million upfront to tap 4D Molecular Therapeutics’ intravitreal retinotropic R100 vector initially for one target in rare eye diseases. Astellas could later add up to two more targets, and the deal could eventually swell to nearly $1 billion.
7. Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
How will the price of Eisai and Biogen's Leqembi impact Medicare? Sen. Sanders wants to know
Doctors are still navigating the entire procedure of treating patients with Leqembi, including testing, administration, reimbursement and monitoring. But two experts told Leerink Partners that the drug’s brain side effect is manageable and its efficacy clear. Meanwhile, it’s not clear whether or when patients can stop treatment, and U.S. Sen. Bernie Sanders wants more information on the financial impact of the drug on Medicare.
Other News of Note
8. Samsung Biologics, after expanding Pfizer collab, inks Novartis production deal worth $391M
9. Lupin gets off light after FDA inspection at Indian manufacturing plant
10. South Korean biotech group spies US SPAC as route to Nasdaq
11. Buoyed by preclinical success, Chinese and Korean biotechs expand ADC collaboration
12. FDA slams Intas, Ipca over manufacturing shortfalls at 3 Indian plants
13. Cipla pulls 6 batches of asthma med albuterol after inhaler leak complaint
14. ObsEva regains China rights to pregnancy drug after partner misses deadlines