There’s a lot to say here. Let’s get to it…

The Research

After Thursday’s advisory panel meeting for Novo’s liraglutide (lira), it seems like Amylin’s (AMLN) Exenatide LAR (LAR) will almost certainly face an uphill battle. The agency has made it very clear that long-acting GLP-1’s have a thyroid risk (specifically, thyroid C-cell carcinoma risk) and it’s possible that AMLN is betting that the vast patient history and safety database of Byetta will go to bat for LAR. This may ultimately prove futile. However, in a note to investors on Friday, Morgan Stanley reported that AMLN just started monitoring for thyroid cancer biomarkers in its ongoing LAR studies.

Additionally, experts at Novo’s panel mentioned that the thyroid signal was found in two species (rats and mice), in both sexes and at clinically relevant doses. AMLN’s LAR has 2 year rat toxicology (no mice) and C- cell carcinomas have been detected. The difference is that LAR’s thyroid signal was only in females and at doses that were significantly higher than anticipated human doses.

We think most likely the recent Novo debacle will seriously affect AMLN’s chances with LAR. AMLN must now prove that GLP-1 thyroid effects are not class specific and they must do this by providing clean toxicology in a second species with supplemental strong biomarker data (or lack thereof) in their LAR trials. Their data must also be convincing enough to demonstrate human dose equivalents will not pose thyroid risks.

As for Novo, the agency will vote in a few weeks and we believe that the final decision will be an approvable letter requesting further data. At best, a black box. Here’s the Journal’s take.

Pesky Thyroids

Now we get into it. After some googling, we can’t help but wonder if Novo just got the crappy end of the stick. The panel’s chairman Kenneth Burman, M.D. is an international thyroid expert. Burman is THE THYROID GUY. Look, we’re not on anyone’s side here, but Novo faced a panel headed by someone who has devoted his life to thyroid research. Burman has served on numerous clinical trials and has over 250 publications. His specific research interests include Graves’ disease, Hashimoto’s thyroiditis, and thyroid cancer.

Looks like Novo got screwed. OK, OK we kid. Good for FDA, we can’t have this out there.

What’s also scary is that Google gives us too much info. If you google Kenneth Burman, M.D., the first search result is the guy’s phone number and home address (301-949-0367, 9811 Hillridge Dr, Kensington, MD 20895). FYI, you can also see where this guy lives via Google Maps. Just for fun yeah, but Google is scary!!!

That Damn Novo Spring Break

We wonder if a possible lira delay was discussed at the recent Novo Spring Break. Word has it that Novo spent upwards of $10M to fly 3000 of its sales reps out to the 5-day Caribbean cruise this past March for a good ol’ “training.” We have a rep who claims that the cruise was mainly “partying and sex (most of it extramarital)” with “intermittent training” and preparation for the lira launch. Novo had also been in the process of hiring an entire lira team, but it appears layoffs or employment start dates will be pushed back, or perhaps axed altogether.

Lira might get approved, but there will definitely be a significant delay — it might not get launched until well into late 2010. The lack of sales from lira will seriously hurt Novo’s bottom line for 2010 — wonder if there’ll be a Spring Break next year? Talking about sinking “10-mil.”

And we’re done…

Image from caep

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