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CHMP backs Piramal's Alzheimer's imaging agent

Neuraceq recommended for approval in Europe

EMAPiramal is close to winning EU approval for its Alzheimer's disease (AD) diagnostic Neuraceq after a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP).

Neuraceq (florbetaben F18) is a radiopharmaceutical used alongside positron emission tomography (PET) to visualise and measure beta amyloid plaques in the brains of AD patients, one of the hallmarks of the disease.

The CHMP recommends that it should be approved for use - as an add-on to current clinical evaluations - in patients with signs of cognitive impairment who are being evaluated for AD. For example, if there are no or few amyloid plaques in the central nervous system then it is likely the cognitive decline is being caused by some other factor.

If the European Commission follows the CHMP's advice to approve Neuraceq, which it generally does within three months of a CHMP positive opinion, it will join Lilly's Amyvid (florbetapir 18F) and GE Healthcare's Vizamyl (flutemetamol F18) on the market.

Lilly's diagnostic was first launched in the US last year and was approved in Europe in January 2013, but has seen its sales growth pegged back by a decision by the Centers for Medicare & Medicaid Services (CMS) in the US not to reimburse Amyvid - which costs around $3,000 per procedure - unless patients are in clinical trials.

Lilly has not published data on sales volumes for the product, but said during its third-quarter results statement that the CMS' decision was a "significant setback for patients and for the AD community". It is hard to envision a situation in which other AD imaging agents with very similar mechanisms of action will be viewed differently by the CMS.

Analysts have suggested that without broader reimbursement cover sales of Amyvid are expected to be low - under $100m a year - although with cover they could increase to $500m a year. Ahead of the CMS verdict Lilly had been talking about potential sales of $750m a year.

Piramal acquired rights to Neuraceq from Bayer in 2012, saying at the time it expected the global market for PET imaging agents for AD to reach $1.5bn at peak.

Article by
Phil Taylor

24th December 2013

From: Research, Regulatory

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