Fujifilm to make Thrombogenics' newly US approved eye drug in UK
The commercial supply contract – which builds on a 2010 deal that saw Fujifilm producing the Jetrea active, ocriplasmin, for clinical trials – is the second product that will be produced at the UK site, which it acquired from Merck & Co in 2011.
Fujifilm spokeswoman Bridget Hall told Outsourcing-pharma.com that: “No extra staff or equipment have been brought in to service this specific contract."
She added that “We are a multi-product contract manufacturing organisation (CMO) and as such are set up to manufacture multiple development and commercial products.”
Hall declined to say if Fujifilm will be ThromboGenics’ sole supplier, or how much ocriplasmin the firm would produce for commercial reasons, but did confirm that: “We produce the bulk substance only and this is sent elsewhere for fill/finish.”
The US Food and Drug Administration (FDA) approved Jetrea for Symptomatic Vitreomacular Adhesion (VMA) last month after a successful Phase III development programme for which Fujifilm supplied the active pharmaceutical ingredient (API).
Speaking last month Thrombogenics CEO Patrik De Haes said the plan is to launch Jetrea in the US in January next year and reiterated that it is expected to sell for around $3000 per treatment. According to Reuters, US insurance claims suggest that around 250,000 people suffer from VMA.
In Europe the drug is currently being assessed by the European Medicines Agency (EMA) and a CHMP opinion is expected early next year.
If approved in Europe, Jetrea will be marketed by Thrombogenics' marketing partner Novartis, through its Alcon, unit which holds rights to the drug outside the US.
It has not been announced whether Fujifilm or another third-party manufacturer will supply Alcon with ocriplasmin if the drug is cleared by the EMA.
