Eli Lilly and Company
) recently announced the availability of its radioactive diagnostic
agent, Amyvid (florbetapir F 18 Injection), in certain markets in
the US. The company said that Amyvid is available in imaging
centers at markets in the vicinity of 16 manufacturing sites. Eli
Lilly has also launched an online training program.
The US Food and Drug Administration (FDA) had approved Amyvid in
April 2012. Amyvid has been designed to help detect the density of
beta-amyloid plaques in patients (with cognitive impairment) who
are being evaluated for Alzheimer's disease and other causes of
While a negative scan would mean little to no amyloid plaques
are present, a positive scan would point towards the presence of
moderate to frequent plaques. It is to be noted that while moderate
to frequent plaques are usually found in patients with Alzheimer's,
the same may also be in the case of patients with other neurologic
conditions or in elderly people with normal cognition.
Amyvid became a part of Eli Lilly's portfolio with its December
2009 acquisition of privately-held company, Avid
Radiopharmaceuticals, Inc. In March 2011, Amyvid had received a
complete response letter (CRL) from the FDA. Prior to the CRL, the
FDA's Peripheral and Central Nervous System Drugs Advisory
Committee had voted against granting approval to Amyvid based on
the submitted data.
In its CRL, the FDA had said that Eli Lilly needs to implement a
reader training program which will help ensure accurate and
consistent interpretation of existing Amyvid scans.
Amyvid's launch should provide Eli Lilly with a near-term
revenue source. Moreover, it should fit well in Eli Lilly's product
portfolio as the company itself has been pursuing the development
of treatments for Alzheimer's disease. Meanwhile, Amyvid's approval
provides physicians an additional tool that can be used with other
diagnostic options to evaluate a patient.
The worldwide Alzheimer's disease market represents huge
commercial potential with companies like
Johnson & Johnson
) working on developing treatments for the disease. Eli Lilly
currently has a phase III Alzheimer's disease candidate,
solanezumab, in its pipeline.
We currently have a Neutral recommendation on Eli Lilly, which
carries a Zacks #3 Rank (short-term Hold rating).
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