Last week I blogged about Eli Lilly's (LLY) "Coming Soon" banner ad I spotted in the online edition of The New England Journal of Medicine. It's designed to generate buzz about the company's crucial new bloodthinner that could win Food and Drug Administration approval this month.
Effient would compete with Bristol-Myers Squibb's (BMY) top-selling drug in that category, Plavix. Blog reader Dewey Steadman, an Equity Research Associate on the Specialty Pharmaceuticals team at RBC Capital Markets, emailed the picture of a bolder full-page Effient ad in the print edition of the Journal of the American Medical Association.
"Yes, we're old school, " Steadman writes, referring to the fact that they get the hard-copy of JAMA. "We were taken aback by it (the ad) as well, especially considering it was only July!" Steadman's photo is of the July 23rd issue of JAMA, two months before the expected FDA decision date of September 26th (take poll below).
On a much more positive note, Scott emailed me to say, "Keep up the great work!!! I've been in "Pharma" for the past 49 years. Actually started delivering Rxs when I was 13. I look to you for breaking news and credible reporting on a regular basis. You're very refreshing and indeed unique in today's world of hype over substance. Well done!!"
I stand corrected on my post earlier this week about Sciele (SCRX) where I referred to it as a "baby biotech." Rodman & Renshaw biotech analyst Mike King called me out on it yesterday at the BioCentury/Thomson Reuters conference his company co-sponsored. And so did blogreader Kenneth Wachsman in an email. He wrote, "Sciele should not be classified as biotech because it does little or no research. The entire product line they have in their portfolio was acquired from other companies." Wachsman said several years ago he worked at Sciele as a district manager when the company was named First Horizon Pharmaceuticals.
And I'm getting a lot of feedback and opinions about the ongoing safety scare for the diabetes drug Byetta from Amylin Pharmaceuticals (AMLN) and LLY. AMLN was down again Friday perhaps on the feared fallout for its once-a-week version of Byetta in the wake of a regulatory delay announced this morning by Novo Nordisk (NVO) on another new type of diabetes drug. NVO and LLY are at new lows.
Regarding my reporting Thursday on the AMLN presentation at the investment conference, Jim Rothschild with a financial firm bearing his name writes, "Please, please, it is time for the media to stop inflating news by making such statements as 'the elephant in the room' when a close analysis of the actual situation shows that the only elephant in the room is the distortion of the facts occurring in the media."
But Evan Tanalos points the finger at the FDA, not the media. "The FDA seems to be an agency out of control and their recent actions targeting drugs without proper documentation or proof is a detriment to the future of healthcare in this country," he wrote. The FDA disclosed two pancreatitis-related deaths that occurred among patients who'd been on Byetta. AMLN and LLY then came forward and revealed four additional deaths. The companies don't believe the fatalities are connected to Byetta, but in today's drug-safety and disclosure sensitive environment, officials felt compelled to go public with the information.