Astellas shelled out $5.9 billion to join the complement inhibitor battle in geographic atrophy. Hoping to write another successful CAR-T story, Johnson & Johnson put down $245 million upfront to partner with a China-U.S. biotech. Sun Pharma's JAK inhibitor hit a partial clinical hold in alopecia. And more.
1. Astellas keeps the big buyouts rolling, inking $5.9B Iveric takeover ahead of FDA eye disease ruling
Astellas has agreed to pay $5.9 billion to acquire Iveric Bio, which is close to the market with avacincaptad pegol, a C5 inhibitor that’s awaiting an FDA decision in the eye disease geographic atrophy. If approved, the drug will go up against Apellis’ Syfovre. Other companies including AstraZeneca, Johnson & Johnson, Novartis and Roche are all eyeing the same field.
2. J&J refuels CAR-T ambitions with $245M upfront to Cellular Biomedicine for pair of therapies
After the success of Legend Biotech-partnered Carvykti, Johnson & Johnson has struck another CAR-T deal with a China-U.S. biotech. J&J is paying $245 million upfront to Cellular Biomedicine for rights to two CAR-T therapies under testing in non-Hodgkin lymphoma. The two candidates, one targeting CD20 and the other a CD19xCD20 bispecific, have shown promising results in phase 1 studies in China.
3. Sun's Concert hits bum note as FDA imposes partial hold 2 months after $576M buyout
Just two months after closing its $576 million acquisition of Concert Pharma, Sun Pharma has run into a clinical hold for the deal’s key asset. The FDA has put a partial hold on a phase 3 alopecia trial of JAK inhibitor deuruxolitinib. The halt came after a patient who received the 12-mg, twice-daily dose of the drug developed a pulmonary embolism.
4. Pfizer, Astellas build case for Xtandi in early-stage hormone-sensitive prostate cancer
Astellas and Pfizer shared detailed data on Xtandi in non-metastatic hormone-sensitive prostate cancer. Compared with the hormone therapy leuprolide, a combo of Xtandi and leuprolide lowered the risk of metastasis or death by 58%. Xtandi alone cut the risk by 37%. The companies plan to file for FDA approval in this use between June and August, Astellas CEO Naoki Okamura said during an investor call last week.
5. Astellas dials up Xtandi peak sales projection, preps for 2 new launches (Investor presentation, PDF)
Based on the positive readout, Astellas has dialed up its annual peak sales estimate for Xtandi to above 700 billion Japanese yen ($5.2 billion), with about 40 billion yen to 50 billion yen expected to come from the potential new indication. For the fiscal year ended in March, Xtandi turned up 661 billion yen in sales, up 8.5% year over year, although generics to J&J’s rival drug Zytiga are taking a toll in the U.S. Meanwhile, Astellas is also focused on the potential launches of menopause therapy fezolinetant and cancer drug zolbetuximab.
6. Otsuka, Lundbeck gain FDA nod for longer-acting version of schizophrenia drug Abilify
Otsuka and Lundbeck won FDA approval for Abilify Asimtufii, a long-acting version of the antipsychotic drug that can be administered every two months. In a trial of schizophrenia and bipolar patients, the new drug achieved plasma concentrations comparable to those seen in the monthly Abilify Maintena, plus comparable safety and efficacy.
Other News of Note
7. Merck KGaA, on an expansion spree, plots raw materials production plant in Korea
8. Daewoong plots new $74.6M factory in South Korea to pump out Botox rival
9. BeiGene, fresh from hiring diversity czar, aims for global gender parity at VP level and up by 2030