Shortly after signing a COVID-19 vaccine supply deal with Pfizer and BioNTech, Japan has agreed to buy from AstraZeneca as well. And the country will have more available from Takeda, as the Japanese pharma takes local responsibility for Novavax's shot. Samsung Biologics aims to set up a $2 billion "Super Plant" by 2022. Eisai will move its U.S. headquarters to the ON3 bio-ecosystem in Nutley, New Jersey. And more.
Japan has agreed to buy 120 million doses of AstraZeneca and the University of Oxford’s COVID-19 vaccine, following a similar pact with Pfizer and BioNTech on their mRNA candidate. Several local firms, including JCR Pharmaceuticals, Daiichi Sankyo, KM Biologics and Meiji Seika Pharma will help bolster Japanese supplies of the AZ shot.
Separately, Takeda has signed on to develop, manufacture and sell Novavax’s adjuvanted nanoparticle COVID-19 vaccine, NVX-CoV2373, in Japan. The country's health authorities will help fund technology transfer, new infrastructure and manufacturing scale-up. The goal is to build up capacity to produce 250 million doses of the shot annually.
Samsung Biologics is known for its aggressive expansions in recent years. Now, the South Korea CDMO giant is plotting a $2 billion “Super Plant” at its Incheon hub, expecting to go online in 2022. Encompassing 256 million square feet of floor space, the new place will boast a footprint as large as its other three facilities combined. It will add 256,000 liters of capacity to its existing 365,000 liters.
Eisai will relocate its U.S. headquarters from Woodcliff Lake, New Jersey, to a 15-story complex at the ON3 bio-ecosystem in Nutley, New Jersey, by the end of 2021. Eisai will be the first biopharma tenant at the 116-acre site, formerly Roche's U.S. headquarters, but other residents hail from the healthcare, R&D and diagnostics fields.
Eli Lilly and its Chinese partner Innovent Biologics unveiled detailed results for PD-1 inhibitor Tyvyt in previously untreated nonsquamous non-small cell lung cancer. In the phase 3 Orient-11 trial, the drug, used in tandem with Lilly’s Alimta and platinum chemo, produced tumor progression data very similar to what Merck’s Keytruda had demonstrated in its Keynote-189 study. But Tyvyt only reported a “nominally significant” improvement in patients' lifespan.
NS Pharma, a subsidiary of Japan’s Nippon Shinyaku, has won accelerated FDA approval for Viltepso for Duchenne muscular dystrophy patients with a mutation amenable to exon 53 skipping—the exact same population as Sarepta’s Vyondys 53. The nod is based on the surrogate marker of dystrophin production, which previously got Sarepta and the FDA in hot water.
Lupin will pull a lot of 11,000 bottles of 10 mg lisinopril tablets in the U.S. because 20 mg tablets were found mixed up in at least one bottle. Meanwhile, Sun Pharma is recalling one lot of 3,516 bottles of clonazepam tablets on potential cross-contamination with clozapine.
WuXi Biologics is planning to place the headquarters of its new vaccines joint venture with Hile Bio-Technology at a facility in Dundalk, Ireland. Now, the Chinese CDMO has picked Jian Dong, the former head of the company overseeing site operations, as the unit’s CEO.