Alexion, the makers of the monoclonal antibody Soliris (eculizimab), has had several issues with in-house manufacturing in the past, with a US FDA Warning Letter being issued to its Rhode Island production plant in 2013, and a string of recalls since.
But the firm said during a conference call to discuss third quarter results last week it intends to invest in its own manufacturing network, with one of its objectives being to bring capabilities in-house.
“We really have an expanding global manufacturing network where our objective is redundancy in the system from both drug through fill and finish, and right out to labelling and packaging,” said CEO David Hallal (transcript here).
The firm has already recently invested $500m into a biologics facility in Ireland and Hallal said Alexion would continue to focus “on the best talent in the industry, industry leading quality systems and [investment] in our facilities.”
All this could come as bad news to Swiss Contract Manufacturing Organisation (CMO) Lonza, which not only produces Soliris from two of its manufacturing sites but in July set up a dedicated suite for Alexion’s products at its facility in Portsmouth, New Hampshire.
However, Lonza has been making Soliris – which at over $500,000 per patient per year is the world’s most expensive drug – for almost a decade and in July told this publication the suite would enable “Alexion to add dedicated [undisclosed] product supply for 10 years.”
For the quarter, Alexion reported a 20% year-on-year increase in net Soliris sales to $665m and also updated stakeholders on the progress of its enzyme replacement therapy Kanuma (sebelipase alfa).
In September, the US FDA pushed back action on the breakthrough therapy by three months, asking Alexion for additional chemistry, manufacturing and controls (CMC) data.
“Kanuma continues to be reviewed under the breakthrough therapy designation and priority review with the PDUFA date of December 8,” Hallal said last week.
“We submitted additional chemistry manufacturing and controls or CMC data last month in response to the FDA's request.”