Protalix files BLA to compete with Sanofi Genzyme; Rallybio collects another Alexion alum
→ Protalix BioTherapeutics has filed a BLA for their Fabry Disease treatment, pegunigalsidase alfa. The drug is a recombinant enzyme grown in plant cell cultures and designed to supplement the lysosomal enzyme that is deficient in patients with the genetic disorder. Chiesi Global Rare Diseases has signed up to commercialize the drug, in a deal that’s worth up to $760 million. A phase III study showed the Israeli biotech’s drug led to much higher concentration of enzyme than Fabrazyme, the longtime standard-of-care from Sanofi Genzyme.
→ Just days after lining up $145 million to pay for their first foray into the clinic, the Rallybio team is going back to Alexion for their latest hire. They’ve recruited Róisín Armstrong, who will head the development of RLYB211, a plasma-derived hyperimmune globulin in development for the prevention of fetal and neonatal alloimmune thrombocytopenia. Armstrong served as VP and Global Medicine Team leader at Alexion.
→.MacroGenics $MGNX was buoyed by the news that the FDA isn’t planning on holding an expert committee meeting to review its application for margetuximab. That removes one potential barrier as they close in on a PDUFA date of December 18.
→ Versant Ventures, the Basel-based discovery engine, announced its latest company: Monte Rosa Therapeutics. Backed with $32.5 million in Series A funds, the company will work on developing small molecules that degrade disease-causing proteins, a rapidly growing field.