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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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June 16, 2008

Alli: "Underwhelming"

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Posted by Derek

About a year ago, I wrote about GSK's attempt to sell the lipase inhibitor orlistat over the counter as Alli:

"So my forecast for Alli is strong sales - for a while. Then it takes a dive, never to scale those heights again, as the word gets out. And the demand continues to grow for a weight-loss drug that works. . ."

Thanks to Pharmalot, this week we find this AP story which seems to confirm that suspicion. Sales for Alli aren't up to GSK's hopes, and the company is declining to say how much repeat business there is after people have tried it out, which says all that needs to be said. And this after one of their biggest marketing campaigns ever.

What still throws me is that an analyst quoted in the piece still talks about it as a drug that should, in theory, be a big seller. As that post from last summer makes clear, I've never once understood that, since Roche never could make it a huge seller as Xenical. You'll never be able to get around the unpleasant side effects of a pancreatic lipase inhibitor, as far as I can see, and you'll never be able to advertise one without mentioning them.

I think that the new, slimmed-down GSK organization is wasting money on this whole idea. But hey, Marketing thinks it's a great opportunity. . .

Comments (12) + TrackBacks (0) | Category: Business and Markets | Diabetes and Obesity


COMMENTS

1. Henri on June 16, 2008 7:11 AM writes...

The current development of DGAT inhibitors might possibly also have similar side effects as Ali. Yes- GSK- God help these guys. They seem to be done as a company. They should seriously consider merging to at least save their brand name, forget about doing research.

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2. Retread on June 16, 2008 9:09 AM writes...

When it first came out, I mentioned the drug and its side effects (flatulence etc. etc.) to my 90 year old uncle. His comment -- "I don't need a drug to do that".

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3. petros on June 16, 2008 9:31 AM writes...

The worst side effect, "rectal leakage" is surely sufficient to discourage repeat usage and the OTC doses are lower than the modestly efefctive doses marketed as Xenical.

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4. Rev. Howard Furst on June 16, 2008 10:17 AM writes...

Henri, DGAT inhibitors acting in the liver have the additional side effect of exacerbating progression of fibrosis due to accumulation of fatty acids. Yamaguchi et al. (2007) Hepatology 45:1366-74. Inhibition of lipid synthesis seems like a good idea in principal, but almost invariably leads to problems somewhere due to precursor accumulation.

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5. asd on June 16, 2008 1:18 PM writes...

Petros, yes, that side effect is quite real, and thoroughly convinced me never to take Alli again last summer. I imagine that others have similar experiences, which is probably why the success of the drug has tapered off.

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6. henri on June 16, 2008 5:32 PM writes...

The fibrosis in liver is not unexpected, TLR's pathway is probably quite activated resulting in stellate cells changes leading to excessive collagen secretion

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7. The Pharmacoepidemiologist on June 16, 2008 11:25 PM writes...

I'll bet some hot-shot rising MBA at GSK has a PowerPoint slide deck showing an overwhelmingly positive Net Present Value for Alli as an OTC. I'll bet even more there's a slide in that deck suggesting that if "only" GSK management hikes DTC ads, sales will double if not triple. At least a month's salary! Any takers?

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8. Morten on June 17, 2008 1:55 AM writes...

Hey, do DPP-4 inhibitors make people lose weight? They should. In theory...

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9. Jonadab on June 17, 2008 6:59 AM writes...

I'm going to go out on a limb here and say that there will never EVER be a weight-loss drug that really meets the expectations and hopes people have for what a weight-loss drug ought to be. All weight-loss drugs are going to disappoint in some fashion.

People want to eat whatever they want and have absolutely no consequences. Well, yeah, and I'd like a perpetual motion machine, but it ain't gonna happen. The food you eat has to go somewhere. By definition, if it's not going into the bloodstream, it's got to pass through the digestive tract without getting fully digested. That's bound to be unpleasant in some way.

People don't like appetite suppressants, either, because they -- by definition -- make you feel like you don't want to eat. There are, to my knowledge, only two feelings that make you not want to eat: nausea, or fullness. Both are uncomfortable. My dad's on Byetta (exenatide) and hates it. He's taken to starting his meal *before* he takes the drug. (What was that you said the other day about patient compliance?)

Fundamentally, weight-loss drugs are always going to disappoint. They're never going to work in the fashion people imagine they should. I'm not saying they can never be useful at all, or that they can never be a sales success, but they're never going to live up to what people imagine they should do -- either in terms of actual weight-loss effect, or sales.

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10. SelenesMom on June 27, 2008 10:39 AM writes...

Weight-loss drugs don't address behavioral causes of overeating and/or underactivity. Usually they address appetite, except of course for orlistat, which addresses your desire not to soil yourself, I guess.

But a lot of overeating comes from things like stress, procrastination, or not paying attention (seriously -- the chips and salsa phenomenon). We all know how sedentary lifestyles have become, and that plays a role too. All this needs some sort of behavioral fix, perhaps with the support of drugs in some cases.

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11. JD Sullivan on June 27, 2008 10:41 AM writes...

Positive Net Value of Alli as an OTC? It may not be equivalent to your one month's salary. Check the patent expiration date for the Orlistat patent--June 9, 2009, less than a year from now. Roche spent 6 years and millions of dollars looking for a remedy for the adverse events as Xenical revenues suffered. They looked at 200+ possibilities but finally to their credit they fixed THEIR problem by selling Orlistat to GSK for a $200 million dollars. To date GSK's investment in alli approaches a half billon.

The irony, a remedy for the TE was discovered in 2006, 5 patents applied for and then it was offered to GSK. No thnaks, said Steve Burton, we are going to 'market around the problem'. Two weeks ago he was allowed to fall on his sword. The remedy combined with a generic orlistat will be in the market in late 2009 but not under a GSK label. You gotta wonder what the MBA's and Marketing Gods are thinking.....go to www.chelatexx.com to see a preview of coming attractions coming to the OTC counters next year!!

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12. anon on June 29, 2008 9:16 AM writes...

Market around the problem?!? Don't these marketing guys read the comments on amazon or drugstore.com to see what the consumers think about their products? There are tons of comments about Alli on both, and they are usually either really positive or really negative (mostly due to treatment effects issues).

Alli could have had a shot at being great if GSK would have accepted the offer to purchase the chelatexx, if it is all that it is advertised to be. I personally wouldn't take Alli (fear of treatment effect at work and colleagues never forgetting this!), but would take the combination if it is safe and effective. GSK already has a huge amount of money invested in Alli, and probably could have recovered the additional cost of the chelatexx deal in increased sales. A marketing problem that they have now is the association of Alli with needing to wear depends.

I didn't realize that the patent expiration is coming up in less than a year.

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