Welcome to this week's FiercePharmaAsia report, which includes stories about JLABS' first program outside of North America, a series of repercussions in the Philippines over Sanofi's Dengvaxia safety issue, Astellas' acquisition of mitochondrial company Mitobridge, and more.
Johnson & Johnson has picked Shanghai to station its first center outside of North America. The 4,400-square-meter facility will be located in Zhangjiang Hi-Tech Park, where lots of biopharma companies large or small are based. The new site is slated to open in the second quarter of 2019 and have capacity to host up to 50 life science and healthcare startups.
Sanofi soon found itself in a quagmire after it released an analysis about Dengvaxia’s potential harm to dengue-naïve people. The WHO amended its recommendation, and the Philippines—the first country to have rolled out a mass immunization program—has pulled the vaccine off the market, initiated a Justice Department-led investigation into health officials’ original decision and sworn to take legal action against Sanofi.
Astellas partnered with Mitobridge (then Mitokyne) in 2013 for rights to a few candidates that target mitochondrial function. Now, the Japanese pharma has exercised its option to buy the company in full, a deal that could be valued at $450 million. The lead project, MA-2011, currently in phase 1, is a PPAR-delta modulator intended for Duchenne muscular dystrophy.
Having cleared a Biocon plant of manufacturing issues, the FDA has approved its Mylan-partnered Herceptin biosimilar, Ogivri. After approving the pair’s plan to fix issues at the plant, the EMA had also accepted their resubmitted application for the same drug, as well as for their copy of Amgen’s Neulasta.
WuXi Biologics’ $150 million, 30,000-liter-capacity biologics facility is now in full operations. Two 1,000-liter bioreactors for perfusion processes were completed last year, and now 14 additional 2,000-liter bioreactors for fed-batch cell culture have started. The company pointed to the China Marketing Authorization Holder pilot program for potential contract manufacturing businesses pouring in.
CDMO PharmaForce, which belongs to a U.S. subsidiary of Daiichi Sankyo that makes sterile injectable drugs, will invest about $145 million to add 140,000 square feet to its New Albany, Ohio, site, and another 1,800 square feet to a production facility in Hilliard, Ohio. The new round of expansion will create 80 new jobs, the company said.