Vizamyl: The FDA OKs an imaging product without a market

Project name: flutemetamol F18 injection
Disease: Beta amyloid (Alzheimer's) imaging agent
Peak sales estimate: Less than $100 million
Approved: Oct. 25
Company: GE Healthcare

The Scoop:
For now, Vizamyl is a product without much of a market.

This was the second imaging agent to be approved for lighting up clusters of beta amyloid in the brain. Eli Lilly ($LLY) scored the first approval with Amyvid. And like Lilly, GE ($GE) will have to wait and see whether its new imaging agent can ever gain much traction in diagnosing the disease.

The big problem here is that while everyone can agree that beta amyloid looks like a promising suspect as a primary cause of Alzheimer's, there's no certainty that that is the case. As a result, Medicare has refused to cover the use of Amyvid to diagnose the disease, and the FDA has refused to provide an approval for either imaging agent as a tool to flag the memory-wasting illness. Doctors can ­use these agents to rule out Alzheimer's in the absence of the toxic protein; they just can't use them to rule it in.

Vizamyl, though, will rival Amyvid for use in clinical studies of new drugs that propose to fight the memory-wasting disease by eliminating beta amyloid. Merck ($MRK), for example, partnered with GE to use its product in late-stage studies of MK-8931, a BACE inhibitor that recently cleared a Phase II safety hurdle. That's not much of a sales opportunity, but it's better than nothing. And one day, after Alzheimer's is better understood, a market could open up.

The absence of a market hasn't deterred others in this field, either. India's Piramal Healthcare--which grabbed Bayer's molecular imaging pipeline in 2012--appears close to snagging European approval for Neuraceq (florbetaben F18) after gaining a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). Navidea Biopharmaceuticals ($NAVB) has a fourth beta amyloid imaging agent in development. Like Amyvid, Vizamyl and Neuraceq, NAV4694 (AZD4694) binds to beta amyloid and lights up in a PET scan. All four look to compete for a slice of a very small market, probably less than $100 million. -- John Carroll (email | Twitter)

For more:
FDA approves another Alzheimer's imaging agent with no market in sight
FDA signs off on GE Healthcare's Alzheimer's imaging agent
Eisai to deploy GE's Alzheimer's imaging agent for clinical trial screening
Eli Lilly rolls the dice on combo approach against Alzheimer's disease

Vizamyl: The FDA OKs an imaging product without a market

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