25 Apr 2018 by AXXELIS
Shire Shares Gain After Deal With Takeda Nears Completion
Takeda Pharmaceutical Co. is nearing a preliminary agreement to acquire Shire Plc after the Japanese drugmaker sweetened its roughly $60 billion bid for the biotechnology company, according to people with knowledge of the matter.
Shire says Takeda has come up with a new buyout offer as reports spotlight a looming handshake deal
Shares of Shire are on the march back north this morning following a report from Bloomberg that Takeda is within reach of a preliminary buyout deal, which could come as early as today. And that piece was followed by a statement from Shire confirming that Takeda revised its offer for the company today — marking its 5th pitch.
“The Board announces that it has received a revised proposal from Takeda regarding a possible offer for the Company on 24 April 2018,” Shire stated. “The Board is considering its position. There can be no certainty that any firm offer for the Company will be made nor as to the terms on which any firm offer might be made.”
Biosimilar frontrunner Celltrion to lose first-to-market advantage for Truxima in the US
Celltrion, the South Korean biopharma company responsible for the launch of Truxima, the first-ever Rituxan biosimilar for oncology, faced a significant setback recently. Following Truxima’s approval by the European Medicines Agency (EMA) in February 2017, Celltrion also submitted for regulatory approval in the US, hoping to gain first-to-market advantage over rival Sandoz’s rituximab biosimilar Rixathon.
Rixathon was approved by the EMA in June 2017 and is currently under FDA review, with a Prescription Drug User Fee Act (PDUFA) date of July 12, 2018. On April 5, Celltrion received a complete response letter from the FDA rejecting the biologics license applications (BLAs) for Truxima, and also Celltrion’s Herceptin biosimilar, partially due to poor aseptic practices at Celltrion’s manufacturing plant in Incheon, South Korea. This negative decision is likely to push Truxima’s launch back to Q4 2018 at the earliest, from the original anticipated launch date of Q2 2018, creating an opportunity for Sandoz to take the lead with Rixathon in the US.