Lonza to make Elan’s Alzheimer’s candidate
pharmafile | December 7, 2011 | News story | Manufacturing and Production |Â Â Abbott, Elan, LonzaÂ
Elan has awarded a manufacturing contract to Lonza to supply the active pharmaceutical ingredient (API) for its small-molecule candidate Alzheimer’s disease drug ELND005, which is currently in late-stage testing.
In a statement, Elan said the deal with Lonza “is fundamental to ensuring that a high quality supply of ELND005 will be available to support the advancement of the programme”. Lonza will take over manufacturing of the drug from Elan’s former production partner Abbott Laboratories.
The announcement reinforces Elan’s commitment to ELND005 (scyllo-inositol), which failed to meet its primary endpoints in a phase II study reported last year looking at cognitive and functional measures in Alzheimer’s patients. Two high-dose arms were also dropped on safety concerns after reports of nine deaths among patients receiving the drug.
At the time, Elan said it would press ahead with development “based on the preponderance of evidence, and input from the experts in this field”, but the disappointing results had consequences. Last December, Elan parted company with its former development partner for the product – Transition Therapeutics – which returned a 30% stake in the ELND005 programme.
The revised agreement meant that Elan paid Transition $9 million earlier this year and is due to pay an additional $11 million following the start of the next ELND005 study, but was no longer liable for a $25 million milestone on the start of Phase III trials.
Since then, Elan has presented additional data from the Phase II study which looked at the drug’s effects in earlier-stage disease, in line with “the general direction of the field for earlier intervention”.
ELND005 is designed to block the aggregation of beta amyloid in the brains of Alzheimer’s disease patients, disrupting the formation of the amyloid plaques which are a hallmark of the disease.
The Irish drugmaker also plans to evaluate ELND005 for other indications, such as bipolar disorder, and is planning a Phase II study in that indication.
Phil Taylor
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