Evenity finally wins EU approval; US-China biologics CDMO raises $60M
→ Amgen and partner UCB have managed to convince the EMA to finally approve their bone-building drug, Evenity, to treat osteoporosis. The drug, which was originally slapped with a negative recommendation by the EU regulator, was tested in three late-stage studies. Data showed the drug was effective, but serious CV adverse events were observed in one trial — triggering regulatory concern in the United States and Europe. The FDA granted Evenity approval in April, but the manufacturers view the EU as the least valuable region in terms of Evenity, Credit Suisse analysts wrote in a note in June, predicting modest EU sales and estimating the EU opportunity is worth $1-2 per share.
→ A little more than a year after bagging a $75 million round designed to boost its lead drug, Belgian biotech iTeos has inked an agreement with Merck to test the compound, EOS100850, in combination with Keytruda. The Phase I/II trial will focus on patients with solid tumors and enrollment will begin in early 2020.
→ Emory University’s drug development arm has sealed a licensing deal with its partners at NeuroTrauma Sciences, who are exercising their option after conducting preclinical research on Emory’s neuroprotectant compounds in the past year. The lead candidate is NTS-1104, but the deal also covers related small molecules engineered to penetrate the blood-brain barrier and potentially treat acquired brain injury — a category that spans ischemic stroke and traumatic brain injury, including concussion. NeuroTrauma plans to prioritize their work in stroke initially.
→ US-China biologics CDMO JOINN Bio, a subsidiary of JOINN Laboratories, has hauled in $60 million in Series A financing led by HG Capital, with participation from Nestbio Capital, Hong Kong LINKAGE Holdings, Xiangtang Capital and others. Proceeds from the funding will be used toward the construction of a 100,000-liter production base in Beijing and expansion of its biologics business in China and the US.
→ Matinas BioPharma, which is getting some renewed love from investors after Baker Bros took a stake in it, is boasting of a new agreement with Roche. The pharma giant will evaluate the feasibility of developing oral formulations of its drugs using Matinas’ lipid nano-crystal delivery tech.