Acomplia Goes Away -- It's a Good Thing :: Michael Shulman's Biotech Blitz

Acomplia Goes Away -- It's a Good Thing

Sanofi-Aventis (SNY) pulled the New Drug Application for its obesity drug Acomplia, called Zimulti in the U.S., and said it would resubmit to U.S. regulatory authorities at a later date.

It's good for the FDA panel that rejected the drug. This is the wrong kind of treatment for the nationwide epidemic of obesity. I don't want to get into too many details but Acomplia is an example of a new kind of drug that sort of treats a wide variety of maladies -- none in a compelling way -- and has lots of side effects that scared off the FDA. If this segment interests you, keep an eye on the clinical trials for pramlintide from Amylin (AMLN) -- it is much closer to getting it right.

What we need is a twofold approach to obesity: how to prevent it and how to cure it. They are very different needs.

Preventing obesity is about the kind of food we eat, how much we eat (or feed our children), and how much exercise we get. Once someone is 10% or more overweight for a year or so, then that person is bordering on having a medical illness. If a person is more than 10% overweight for more than a year, he/she has a real medical problem that could be a permanent problem. Not an addiction, not a psychological problem, not a lack of discipline -- a disease.

Unfortunately, most big pharma (and a lot of little pharma) research has focused on the wrong solution: how to suppress appetites, control behavior, etc. Acomplia/Zimuilti fit this mode.

Well, an appetite manager isn't going to cut it! One-million years of human evolution has trained the species to resist starvation -- and when you go on a diet you are starving yourself -- so 40,000 generations of natural selection kick in and the typical diet fails because the body is biologically trained to the effort to slim down and resist starvation.

A whole new approach is needed - and Acomplia was not it. I'm actually complimenting the FDA on something it did. Wow!

More on that later. Now I need to go eat my 260 calorie, healthy breakfast -- not a Nutrisystem -- just pita, fat-free Greek yogurt and strong black coffee. I was in a Middle Eastern mood this morning, family from Israel are staying with us.

Of course, they wanted Chinese food last night. What's an analyst to do?!

Comments

Sanofi-Aventis (SNY) pulled the New Drug Application for its obesity drug Acomplia, called Zimulti in the U.S., and said it would resubmit to U.S. regulatory authorities at a later date. It's good for the FDA panel that rejected the drug. This is the wrong kind of treatment for the nationwide epidemic of obesity. I don't want to get into too many details but Acomplia is an example of a new kind of drug that sort of treats a wide variety of maladies -- none in a compelling way -- and has lots of side effects that scared off the FDA. If this segment interests you, keep an eye on the clinical trials for pramlintide from Amylin (AMLN) -- it is much closer to getting it right. What we need is a twofold approach to obesity: how to prevent it and how to cure it. They are very different needs. Preventing obesity is about the kind of food we eat, how much we eat (or feed our children), and how much exercise we get. Once someone is 10% or more overweight for a year or so, then that person is bordering on having a medical illness. If a person is more than 10% overweight for more than a year, he/she has a real medical problem that could be a permanent problem. Not an addiction, not a psychological problem, not a lack of discipline -- a disease. Unfortunately, most big pharma (and a lot of little pharma) research has focused on the wrong solution: how to suppress appetites, control behavior, etc. Acomplia/Zimuilti fit this mode. Well, an appetite manager isn't going to cut it! One-million years of human evolution has trained the species to resist starvation -- and when you go on a diet you are starving yourself -- so 40,000 generations of natural selection kick in and the typical diet fails because the body is biologically trained to the effort to slim down and resist starvation. A whole new approach is needed - and Acomplia was not it. I'm actually complimenting the FDA on something it did. Wow! More on that later. Now I need to go eat my 260 calorie, healthy breakfast -- not a Nutrisystem -- just pita, fat-free Greek yogurt and strong black coffee. I was in a Middle Eastern mood this morning, family from Israel are staying with us. Of course, they wanted Chinese food last night. What's an analyst to do?!