Takeda is bracing for two important patent expirations this year. AstraZeneca has in-licensed an antibody-drug conjugate from Chinese company LaNova Medicines. Astellas' menopause drug fezolinetant has won a delayed FDA approval. And more.
1. Takeda braces for impact as Vyvanse edges toward the patent cliff
A pair of patent expirations will make fiscal 2023 a “challenging” year for Takeda, CEO Christophe Weber said. The company expects that hypertension med Azilva and ADHD therapy Vyvanse will lose protections in Japan and the U.S., respectively. As a result, Takeda expects to collect 4.7% less revenue than it did in fiscal 2022.
2. AstraZeneca, spying post-BCMA big bucks, pays $55M for ADC to join peers in hot cancer space
AstraZeneca has once again reached out to an Asian company for an antibody-drug conjugate. For $55 million upfront and $545 million in potential milestones, AZ licensed a preclinical GPRC5D-directed candidate from China’s LaNova Medicines. Companies such as Bristol Myers Squibb, Johnson & Johnson and Roche are developing GPRC5D-targeted agents for multiple myeloma.
3. Astellas' menopause drug crosses FDA finish line after costly delay
After a short FDA delay, Astellas has won FDA approval for Veozah, or fezolinetant, for moderate to severe menopause-related hot flashes. As a non-hormonal treatment, Veozah can help some women who can’t take hormone therapies, the FDA noted. Astellas expects Veozah to be a potential blockbuster and one of the company’s main growth drivers.
4. Otsuka, Lundbeck's Rexulti nabs new use in Alzheimer's disease agitation
In another FDA approval, Otsuka and Lundbeck’s atypical antipsychotic Rexulti became the first drug in the U.S. for dementia-associated agitation in Alzheimer’s disease patients. The drug showed a 31% improvement from baseline agitation symptoms compared with placebo in two studies.
5. Takeda puts $510M on the line to expand KSQ cancer collaboration
Takeda has expanded its partnership with KSQ Therapeutics after their original immuno-oncology tie-up in 2021. This time, for “double-digit millions of dollars” upfront and up to $510 million in milestones, Takeda is tapping KSQ’s CRISPRomics platform to identify novel tumor-intrinsic targets.
6. Philips reaches $62M SEC settlement over alleged violations of anti-bribery law in China
Philips is shelling out $62 million to settle foreign bribery charges with the U.S. Securities and Exchange Commission under the Foreign Corrupt Practices Act. The agency accused Philips’ Chinese operations of colluding with government-owned hospitals to tailor public tenders to match the Dutch company’s products.
7. Next-gen Lilly obesity drug slashes weight in Innovent study—but is it enough to rival Mounjaro?
Innovent Biologics reported positive phase 2 data from a Chinese study for Eli Lilly’s dual GLP-1/glucagon receptor agonist mazdutide in weight loss. At a 9-mg dose, the drug induced placebo-adjusted weight loss of 15.4% after 24 weeks. A previous 6-mg cohort saw 11.6% weight loss on average. Innovent now plans to take the higher dose into phase 3.
8. Pfizer puts kibosh on 4 antibiotics in India after contractor's manufacturing issues
Pfizer is asking doctors in India to stop using its antibiotic drugs Magnex, Zosyn, Magnamycin and Magnex Forte because of deviations at a third-party manufacturing facility operated by Astral Steritech. While the contractor is still investigating the matter, it has advised Pfizer to halt use of those drugs as an “abundant precautionary measure.”
Other News of Note
9. After string of setbacks, FibroGen and AstraZeneca's anemia drug Evrenzo finally chalks up a win
10. FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists
11. BeiGene, Max Foundation team up to provide free Brukinsa to CLL patients in 29 low-income countries
12. Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type