Replies to post #75431 on Biotech Values

[DewDiligence]

Novo Nordisk knows how to write a press release. The first time I read through I had no idea what the hell it said. LOL

I’m not site you can blame NVO for the odd phrasing in the PR inasmuch as the PR is parroting the questions the FDA posed to the panel. The findings reported in NVO’s PR do seem somewhat contradictory, but that’s how the panel voted!

[DewDiligence]

The mixed voting of the Liraglutide panel screams out for a new survey!

Q: Will the FDA approve Liraglutide
on the first review cycle?

To vote, go to
http://investorshub.advfn.com/boards/board_surveymenu.asp?board_id=1418
and select survey #123.

[DewDiligence]

NVO – Here’s the WSJ’s unsuccessful attempt to make
sense of the odd voting at today’s Liraglutide panel.

http://online.wsj.com/article/SB123870773886884021.html

›Diabetes Drug Gets Mixed Review

APRIL 2, 2009, 6:11 P.M. ET
By JENNIFER CORBETT DOOREN

WASHINGTON – An advisory panel for the Food and Drug Administration split on whether the agency should approve liraglutide, a proposed diabetes drug from Novo Nordisk Inc.

The panel on Thursday voted 6-6 with one abstention on whether data on a certain type of thyroid tumor seen in rodent studies allow for marketing of the product.

The concern is that the type of tumor seen in rats and mice could cause a rare, but potentially more serious, type of thyroid cancer in humans. Both the panel and the FDA said, although it isn't clear whether the data are relevant to humans, they aren't enough to rule it out.

Liraglutide is Novo Nordisk's most important drug in development and now faces the possibility of approval delays if the FDA seeks additional clinical data. It belongs to the same class of drugs as Byetta, which is sold by Eli Lilly & Co. and Amylin Pharmaceuticals Inc.

However, the panel said a small number of a common type of thyroid tumor found in humans in clinical studies were likely found because study investigators were looking for thyroid problems, and 12 panel members said that alone shouldn't stop marketing of the drug. One person abstained from voting [i.e. the vote in favor of approval was 12-0 with one abstention, which would seem to contradict the 6-6- vote described above].

Mary Parks, the director of FDA's division of metabolism and endocrinology products, said the agency faced a "difficult task" in deciding whether to approve the product given the panel's divergent votes. [No kidding!]

Novo Nordisk officials weren't immediately available for a comment. The company said during the meeting it thought the "substantial" benefits of lowering blood-glucose levels in people with type 2 diabetes far outweighed potential cancer risks.

Earlier in the day, most panel members said the product wasn't linked to an excess in heart attacks and strokes, a key concern the FDA has with diabetes drugs that was sparked by a 2007 paper linking GlaxoSmithKline PLC's diabetes drug Avandia. Specifically, the panel voted 8-5 on a question that asked whether the liraglutide data was enough to rule out an "unacceptable excess cardiovascular risk relative to competitors."

During the panel meeting, the FDA said it saw a low cardiovascular event rate in clinical studies of liraglutide but raised concerns about a small number of patients who developed a type of thyroid cancer during clinical studies as well as tumors that were seen in animal studies. The agency said it didn't have data to "dismiss" the relevance of the rodent studies relative to humans.

Some panel members questioned whether the concerns about thyroid cancer might apply to Byetta. Ms. Parks told reporters after the meeting that the agency looked back at Byetta's clinical data and didn't see any thyroid-cancer risk. She also said the agency so far hasn't detected an increased risk when looking at post-marketing data but also said there are limited data to definitively rule out a possible increased risk.‹

[genisi]

While I was thinking cardiovascular and pancreatitis hurdles, none of these were the issue. Novo says these c-cells changes were seen only in rodents but not in monkeys or humans and that they are class effect of GLP-1s (I agree). Byetta preclinical data showed that rats on extremely high doses developed c-cell growths that weren't cancerous but I guess studies were up to 2 years. GLP-1 receptors appear on c-cells of the thyroid gland and c-cell cancer can take decades to develop. I think that the risk/benefit balance favors GLP-1 anlogs but Novo will have to come up with more data and monitoring plans. Perhaps checking patients for blood calcitonin levels is a good place to start.