Seagen is licensing a HER2-targeted antibody-drug conjugate from China's RemeGen in a deal potentially worth $2.6 billion. AstraZeneca and Daiichi Sankyo showed their HER2 ADC Enhertu works better than Roche's Kadcyla in previously treated breast cancer. Takeda's head of global development office talks about how the company navigated its clinical trial activities during the COVID-19 pandemic. And more.
1. In $2.6B cancer deal, Seagen bets China's first homemade ADC can challenge Roche, AZ-Daiichi
Antibody-drug conjugate leader Seagen is paying $200 million upfront for rights to Chinese biotech RemeGen’s disitamab vedotin, with up to $2.4 billion committed for milestones. The hope is that the HER2-targeted ADC, which bears a conditional nod in China to treat stomach cancer, could carve out a piece of the HER2 market from Roche’s Kadcyla and AstraZeneca and Daiichi Sankyo’s Enhertu.
Meanwhile, AstraZeneca and Daiichi Sankyo's Enhertu is trumpeting an important clinical win on its way to blockbuster land. In patients with HER2-positive, metastatic breast cancer following initial treatment, Enhertu outperformed Roche's Kadcyla at preventing tumor progression or death in the phase 3 DESTINY-Breast03 trial. In addition to efficacy, industry watchers will also examine Enhertu’s side effect of interstitial lung disease to gauge its overall opportunity.
3. 'Forced into a virtual world': Takeda hunts for COVID's silver linings
At the beginning of the pandemic, Takeda quickly halted all ongoing trials and studies except for a few in rare diseases and cancer. In Fierce Biotech’s “Forced into a virtual world” series, Jeremy Chadwick, head of the Japanese pharma’s global development office, shares how the company is incorporating the learnings from navigating the public health crisis into a project dubbed Silver Linings.
4. I-Mab thinks cytokine storm drug can take on Humanigen's lenzilumab in sickest COVID-19 patients
I-Mab said its plonmarlimab helped patients with severe COVID-19. In a U.S. phase 2/3 trial, the drug outperformed placebo at keeping patients off mechanical ventilation. It was also linked to a lower death rate by Day 30 as well as higher recovery rates, the company said. The improvements are comparable to what Humanigen’s lenzilumab showed in a similar patient population, I-Mab said.
AstraZeneca, Bayer, Eli Lilly, Merck & Co., Novartis, Novo Nordisk and Sanofi are among Western drugmakers that reported pharma sales growth from China during the first half of 2021. But as Chinese authorities mull over a round of price-lowering procurement for insulins, concerns grow that the program could tap into more complex biologics and their biosimilars.
Sanofi is recalling three brands of hypertension drugs in South Korea as a precautionary measure following reports of azido impurities in certain sartan products in multiple countries. Regulators consider azido a mutagen, which means it may cause changes to the DNA and increase the risk of cancer.
Merck and Eisai have won an FDA nod for the combination of Keytruda and Lenvima in newly diagnosed advanced kidney cancer. The approval marks the second indication for the pairing and the fifth FDA go-ahead for an immunotherapy regimen in front-line kidney cancer. Other players in the field include Bristol Myers Squibb, Exelixis, Pfizer and Merck KGaA.
8. Teva, Glenmark accuse U.S. government of improperly expanding price-fixing case
Teva and Glenmark are pushing back on drug price-fixing charges from the U.S. Department of Justice. The two firms now accuse the feds of broadening the lawsuit to include conspiracies that weren’t part of the original indictment. Glenmark has also opposed to how the federal attorneys contacted its execs in India without notifying the company’s lawyers.
Other news of note:
9. Takeda takes the lead on Finch-partnered microbiome drug for IBD
10. Oyster Point sells China rights to nasal sprays for eye disease
11. Eyevensys bags $12M to test non-viral gene therapy delivery tech