IBJNews

Lilly confident of FDA approval for Amyvid, Lechleiter says

Back to TopCommentsE-mailPrintBookmark and Share

Eli Lilly and Co. CEO John Lechleiter said he’s confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer’s disease.

Outside advisers to the Food and Drug Administration voted in January against immediate approval of the medicine, Amyvid, unless the Indianapolis-based drugmaker establishes a training program and a way to ensure that results of brain scans are read consistently. Lilly aims to resolve the FDA panel’s concerns in a few months, Lechleiter said in an interview in Tokyo on Wednesday.

“We are confident that we can work with the FDA and gain approval,” said Lechleiter, 57. “This is an imaging agent that we’ve used in our own clinical studies, so we are very familiar with it.”

Amyvid’s clearance by the FDA would vindicate Lilly’s $300 million purchase of the drug’s discoverer, closely held Avid Radiopharmaceuticals, in December. The acquisition hasn’t been viewed by investors as important to Lilly’s broader focus on replacing top products before they face competition from cheaper generic versions.

Lechleiter has struggled to get new drugs on the market before patents expire in the next three years on products responsible for 65 percent of revenue.

Sales growth this year will be “in the low single digit,” Lechleiter said Wednesday. In January, the company predicted total revenue growth in 2011 would be “be flat to slightly increasing.”

Lilly rose 32 cents, or 0.9 percent, to $34.98 at the 4 p.m. close in New York Stock Exchange composite trading Tuesday. The stock has fallen 0.2 percent in the past year.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. With Pence running the ship good luck with a new government building on the site. He does everything on the cheap except unnecessary roads line a new beltway( like we need that). Things like state of the art office buildings and light rail will never be seen as an asset to these types. They don't get that these are the things that help a city prosper.

  2. Does the $100,000,000,000 include salaries for members of Congress?

  3. "But that doesn't change how the piece plays to most of the people who will see it." If it stands out so little during the day as you seem to suggest maybe most of the people who actually see it will be those present when it is dark enough to experience its full effects.

  4. That's the mentality of most retail marketers. In this case Leo was asked to build the brand. HHG then had a bad sales quarter and rather than stay the course, now want to go back to the schlock that Zimmerman provides (at a considerable cut in price.) And while HHG salesmen are, by far, the pushiest salesmen I have ever experienced, I believe they are NOT paid on commission. But that doesn't mean they aren't trained to be aggressive.

  5. The reason HHG's sales team hits you from the moment you walk through the door is the same reason car salesmen do the same thing: Commission. HHG's folks are paid by commission they and need to hit sales targets or get cut, while BB does not. The sales figures are aggressive, so turnover rate is high. Electronics are the largest commission earners along with non-needed warranties, service plans etc, known in the industry as 'cheese'. The wholesale base price is listed on the cryptic price tag in the string of numbers near the bar code. Know how to decipher it and you get things at cost, with little to no commission to the sales persons. Whether or not this is fair, is more of a moral question than a financial one.

ADVERTISEMENT