Takeda and CSL Behring are scaling up manufacturing of their coronavirus hyperimmune drug, but its reliance on blood donations could be a bottleneck. Eli Lilly has signed on Fujifilm to help make its COVID-19 antibody therapy as part of a Bill & Melinda Gates Foundation initiative to bring drugs for low- and middle-income countries. Roche blames pandemic-related hospital constraint and drug price cuts to its business slowdown in China this year. Astellas will buy bioelectronics developer Iota Biosciences in a deal worth up to $304 million. And more.
Takeda and CSL Behring, in their CoVIg Plasma Alliance, have started commercial manufacturing of their coronavirus-fighting, hyperimmune immunoglobulin drug as they kick of a phase 3 trial. Because making the therapy relies on blood donations, Takeda CEO Christophe Weber said he couldn’t tell how many doses of the treatment the partnership could make this year.
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Eli Lilly has tapped Fujifilm Diosynth Biotechnologies to help handle manufacturing of its COVID-19 antibody dug. For the job, the Japanese CDMO has reserved its Hillerød, Denmark, facility, which is getting $928 million to double its capacity. But just days after the announcement, the NIH paused phase 3 testing of Lilly and AbCellera’s antibody LY-CoV555 due to a potential safety concern, and the FDA cited Lilly’s Branchburg, New Jersey, site, where LY-CoV555 is being made, for inadequate “control of computer systems.” Lilly said the flaws weren’t related to the COVID drug.
3. Roche hit by 'high-end' biosimilar attack as Ocrevus, Tecentriq bounce back from COVID-19 slowdown
Roche’s China business has been underperforming compared with last year’s levels. “The main reason there was really capacity constraint in the hospitals,” Roche CEO Severin Schwan explained. In addition, the Swiss pharma cut the prices on Avastin, Rituxan and Herceptin in China by about 25% to requalify for national reimbursement, but volume growth wasn’t enough to compensate for the price loss.
Astellas has penned a deal worth up to $304 million to purchase partner bioelectronics developer Iota Biosciences. Astellas also pledged to spend $125 million to help grow the franchise over the next five years. The two started a research deal in 2019 to explore Iota’s “neural dust” platform—tiny wireless implants designed to monitor tissues or stimulate nerves—for delivering diagnostics and drugs.
Meanwhile, Astellas and partner Seagen have data showing that Padcev deserves a place in earlier bladder cancer use. In a phase 2 trial, the antibody-drug conjugate triggered a response in 52% of patients who had received previous immunotherapy but were ineligible for cisplatin chemo.
Fellow Japanese company Otsuka didn’t have the same luck with guadecitabine, a hypomethylating agent it acquired in its $886 million takeover of Astex Pharmaceuticals. The drug failed to prolong patients’ lives over physicians’ choice of alternative therapy in two phase 3 second-line blood cancer trials.
Takeda is launching a five-year digital transformation campaign, with help from Accenture and Amazon Web Services. The plan is to move 80% of its drug development applications to the cloud, and in CEO Christophe Weber’s words, “every Takeda employee will be empowered by an artificial intelligence assistant to help make better decisions.”
Chinese biotech EdiGene has raised $67 million in series B. The company’s two lead gene-editing therapies move closer to the clinic. ET-01, by editing autologous CD34+ cells to disrupt BLA11A, is meant for beta-thalassemia, and ET-02 is an off-the-shelf CAR-T candidate.
Chinese drug discovery biotech HitGen is buying Ligand Pharmaceuticals’ U.K.-based Vernalis research operations for $25 million in cash. HitGen sees synergies between its DNA-encoded chemical library with Vernalis’ fragment- and structure-based approaches to medicinal chemistry.
Two CROs are expanding their presence in China. Australia’s Novotech is merging with Shanghai-based PPC Group. While Novotech has a long history of helping international biotechs into the Asia-Pacific region, PPC’s clientele is mainly based in China. Meanwhile, newly re-IPOed PPD has chosen the Chinese city of Suzhou, near Shanghai, as the home for its new clinical research lab, which combines bioanalytical, biomarker and vaccine services.
COVID-19 has served as a wakeup call for countries to realize their dependence on medicines produced abroad. Mexico now aims to build its own drug supply. It has signed letters of intent with six Indian generics makers—Dr. Reddy's, Zydus Cadila, Glenmark, Torrent and Hetero—to set up a pharma hub in the state of Hidalgo.
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