Lonza to supply Elan with API for trials of candidate Alzheimer’s disease drug
In a press statement Elan said: “This agreement is fundamental to ensuring that a high quality supply of ELND005 will be available to support the advancement of the program.”
This was confirmed by an Elan spokeswoman who told Outsourcing-pharma.com the deal is a manufacturing and technology transfer agreement that will see Lonza make the active pharmaceutical ingredient (API) – scyllo-inositol - at a facility in the Czech Republic.
She went on to explain that the Switzerland-headquartered contract manufacturer was selected as the supplier after the expiry of Elan’s previous agreement with Massachusetts, US-based healthcare major Abbott Laboratories.
The news follows just weeks after Abbott announced its intention to split into a diversified products company – which will most likely include its contract manufacturing business - and an R&D focused biopharmaceutical firm, although Abbott's decision is not thought to have been a factor in the expiry of the contract with Elan.
Trial progress
Dublin headquartered Elan – which recently sold its drug delivery business to Alkermes - has been working on ELND005 since 2006 when it partnered with Canada-based biopharmaceuticals firm Transition Therapeutics.
In December last year the agreement was renegotiated, after which Transition exercised its opt-out right and ceased funding further development of ELND005 and handed back its 30 per cent ownership in the drug to Elan.
Nevertheless, securing a new API supplier was important for Elan as, under the reworked deal, it “has until December 2012 to advance the asset in clinical trials or must terminate the collaboration agreement, unless Elan plays Transition $11m by January 31, 2013.”
Data announced at the recent Conference on Clinical Trials on Alzhimer’s Disease suggest ELND005 shows some promise with analysis from a Phase II study – AD201 - indicating that it could play a role in preventing Alzheimer’s neuropsychiatric symptoms.
