EU Approval for Lilly's Amyvid

Eli Lilly and Company ( LLY - Analyst Report ) recently announced the approval of its radioactive diagnostic agent, Amyvid (florbetapir F 18 Injection), by the European Commission (EC). Amyvid has been designed to help detect the density of beta-amyloid neuritic plaques in patients (with cognitive impairment) who are being evaluated for Alzheimer's disease and other causes of cognitive decline.

While a negative scan would mean little to no neuritic plaques are present, a positive scan would point towards the presence of moderate to frequent neuritic plaques. It is to be noted that while moderate to frequent amyloid neuritic 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 Dec 2009 acquisition of privately-held company, Avid Radiopharmaceuticals, Inc.

Amyvid is already available in the US where it was approved in Apr 2012. Eli Lilly intends to launch Amyvid in select areas within the EU starting from the second quarter of 2013.

Our Take

Amyvid’s launch in the EU should provide Eli Lilly with a near-term revenue source. We note that Amyvid is a good fit 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.

We currently have a Neutral recommendation on Eli Lilly, which carries a Zacks Rank #2 (Buy). Other large-cap pharma companies like Johnson & Johnson ( JNJ - Analyst Report ) also carry a Zacks Rank #2.