Alexion on track with FcRn antibody after manufacturing hitch

After inheriting an impurity in the drug product of early-phase antibody ALXN1830, Alexion Pharmaceuticals says new batches will be available by the end of the year.

In November 2018, Alexion Pharmaceuticals acquired Syntimmune in a deal worth up to $1.2 billion, adding ALXN1830, a clinical-stage humanized monoclonal antibody that inhibits the interaction of neonatal Fc receptor (FcRn) in trials for warm autoimmune hemolytic anemia (WAIHA) and generalized myasthenia gravis (gMG).

But earlier this year, the firm discovered an issue in Syntimmune’s manufacturing process resulting in an impurity in the drug product.

Image: iStock/jurgenfr

“We’ve identified the cause and the source, and we’ve corrected those manufacturing issues with new drug substance runs that will allow for clinical supply by the end of this year when we can sort of reinitiate the clinical program,” John Orloff, Alexion’s head of Research and Development said during an investor call in March.

And speaking this week during Alexion’s Q2 financial presentation, Orloff confirmed: “We have run new drug substance runs that will deliver new drug product by the end of the year. So drug product will be delivered by December, which allows us to restart the program in January,” reflecting a slight delay in the start of pivotal programs.

For the second quarter 2019, sales grew 15% year-on-year to $1.2 billion. This was  driven in part by a 9% increase in sales of monoclonal antibody Soliris (eculizumab), which clocked in $981 million in the quarter.

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