Legend Biotech's Johnson & Johnson-partnered CAR-T therapy Carvykti won an FDA go-ahead to challenge Bristol Myers Squibb's Abecma in multiple myeloma. Biocon Biologics is offering to buy partner Viatris out of its biosimilars business for up to $3.3 billion. Sanofi is incorporating Adagene's "safe" antibody technology in four candidates in a deal potentially worth $2.5 billion. And more.
1. Johnson & Johnson, Legend's CAR-T Carvykti enters myeloma ring with FDA nod
Legend Biotech and Johnson & Johnson’s BCMA-targeted CAR-T therapy Carvykti, also known as cilta-cel, has won FDA approval to treat multiple myeloma after four previous therapies. Having watched Bristol Myers Squibb struggle with supply of first-to-market rival drug Abecma, the two companies plan a phased launch of Carvykti, which they hope could hit over $5 billion in peak sales.
2. Viatris unloads biosimilar business to partner Biocon for $3.3B
Biocon Biologics is paying up to $3.335 billion for Viatris’ biosimilars franchise in a cash-and-stock deal. The two are already partnered on several biosimilar projects including the first FDA-approved interchangeable biosimilar Semglee, which references Sanofi’s insulin med Lantus. As Biocon has been responsible for R&D and manufacturing, the Indian company is really buying Viatris’ global biosimilar commercial capabilities.
3. Sanofi picks a 'safe' bet for Adagene's antibody tech in $2.5B biobucks tie up
In a heavily backloaded deal worth up to $2.5 billion, Sanofi has tapped Adagene’s SAFEbody technology for four candidates. The platform is designed to avoid toxicity in healthy tissues by only allowing antibodies to become activated in a tumor environment. Adagene has also partnered with Bristol Myers Squibb and the National Institutes of Health and has a pipeline of its own.
4. Huadong buys into Heidelberg, signs nearly $1B deal to gain access to four cancer assets
Huadong Medicine will invest about $118 million for a 35% stake in Heidelberg Pharma. The Chinese company will also shell out up to $930 million for rights to four of the German company’s oncology programs in certain Asian territories.
5. FDA pushes back GC Pharma's blood derivative approval due to inspection delay
GC Pharma has received an FDA complete response letter for Alyglo, an immunoglobulin product meant for primary immunodeficiency diseases. The rejection was caused by the FDA’s failure to conduct an inspection of a plant in Ochang, South Korea, the company said.
Shionogi has filed its oral COVID-19 drug, S-217622, for a domestic approval in Japan. The antiviral showed it could reduce viral load, but, in a phase 2b clinical trial, Shionogi saw no significant difference between the drug and placebo in the time-weighted average change in the total score of 12 COVID-19 symptoms. The drug did confer some benefits in some respiratory symptoms.