Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech
Japan submission on horizon for AZ, Daiichi’s ADC
Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a key secondary endpoint in a pivotal Phase II study. Daiichi and partner AstraZeneca plc (LSE:AZN; NYSE:AZN) said Enhertu fam-trastuzumab deruxtecan-nxki led to an increased overall response rate and improved overall survival vs. chemotherapy for third-line or later treatment of HER2-positive metastatic gastric cancer. FDA approved the ADC in December as a third-line or later treatment for breast cancer, triggering a $125 million milestone payment to Daiichi as part of a March 2019 deal in which AZ paid Daiichi $1.35 billion up front to gain joint ex-Japan worldwide rights to the therapy (see “Antibody-Drug Conjugate Deal”).
Biocon, Mylan expect June FDA decision on insulin biosimilar
Following an August complete response letter for its biosimilar insulin glargine, Biocon Ltd. (NSE:BIOCON; BSE:532523) said on its earnings call late last week that its new PDUFA date is in June. FDA will inspect in February Biocon’s Malaysia insulin facility; the company had cited the facility as the reason for the CRL. Although the agency’s decision will come after March 23 -- the date when NDAs for insulin will be converted to BLA licenses -- Mylan N.V. (NASDAQ:MYL), who is partnered with Biocon, said the transition will not affect the candidate’s review or expected mid-2020 launch...