Eisai and Biogen's lecanemab has got a largely expected FDA approval for Alzheimer's disease. Astellas inked two new deals in rare disease and antibody research to kick off 2023. Samsung Biologics is wrapping up work at its plant to start making antibody-drug conjugates in early 2024, its CEO said. And more.
1. With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch
Eisai and partner Biogen have won a much-anticipated FDA accelerated approval for Alzheimer’s disease drug lecanemab, now to be sold as Leqembi. The drug’s name carries an element of the Japanese language. Leqembi comes with a list price of $26,500, slightly lower than its predecessor Aduhelm’s about $28,000 after Biogen cut that first med’s sticker in half amid criticism. Eisai now hopes to change Medicare’s coverage policy and is taking a “phased approach” to Leqembi’s launch, the company’s U.S. chief Ivan Cheung said.
2. Astellas continues intergalactic licensing quest, signing onto 2 new pacts
Astellas has signed two more deals. For $10 million upfront and up to $340 million in milestones, Astellas got Selecta Biosciences' immunoglobulin protease to pair with its Pompe disease gene therapy candidate. The Japanese pharma has also signed another antibody research collaboration with Twist Bioscience after an initial collab in May 2022.
3. JPM23: Samsung plans to kick off antibody-drug conjugate manufacturing in early 2024
Samsung Biologics plans to start making antibody-drug conjugates (ADCs) at its Plant 4 in Incheon starting early 2024, CEO John Rim said at the J.P. Morgan Healthcare Conference. Rim called ADC “probably the quickest area growth” for the Korean CDMO. The company also expects to start construction soon at its first plant at its Bio Campus 2.
4. FDA rejects Biocon insulin biosimilar over data, manufacturing concerns
Biocon is the maker of the first FDA-approved interchangeable biosimilar to Sanofi’s Lantus, but the company’s application for a copycat of Novo Nordisk’s NovoLog was hit with a complete response letter. During a preapproval inspection of Biocon’s facilities in Bengaluru, India, the FDA noted the need for more data and corrective measures.
5. JPM23: Takeda taps contract manufacturer for dengue vaccine launch as it works to grow capacity
Takeda is expanding its manufacturing capacity for dengue vaccine Qdenga in anticipation of strong demand, CEO Christophe Weber said during JPM. Such efforts include using a contract manufacturer. Weber is a bit unsure of how the vaccine will perform in a public market. “When the public market will kick off and how it will happen, we have to see that,” he said.
A Takeda rare disease partnership just hit a setback. In a phase 2 trial, Takeda and Arrowhead Pharmaceuticals’ fazirsiran triggered a dose-dependent reduction in serum mutant alpha-1 antitrypsin (AAT) protein in the rare genetic disorder AAT deficiency. But the drug didn’t outperform placebo on a liver fibrosis marker.
Other News of Note
8. Zai Lab targets 2025 wide-scale profitability thanks to Novocure’s cancer tech (news blurb)