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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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September 25, 2006

A Spray-Painted Crystal Ball

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Posted by Derek

Looking through my files, I found a chart which I clipped out of Genetic Engineering News back in late 2004 or so. It's a table of expected drug launches and sales potentials, based on data from Mehta Partners (a well-known and often-quoted pharmaceutical-sector investment and consulting firm).

Now that we're in the last quarter of 2006, this little document has gone from looking hopeful to looking downright creepy. The Y axis is sales potential, divided into eight tiers, and the X axis is a timeline, quarter-by-quarter. Let's take it from the upper left corner and look at the expected big winners from 2005 and 2006:

Macugen: Expected launch 1Q 05, sales potential 1.25 to 1.5 billion. The reality: the launch went off pretty much as expected, but the sales, well. . .they're running at about 10% of that peak estimate. OSI bought the drug's developer, Eyetech, and people wondered at the time what they were thinking. Maybe they're wondering now, too. . .

Indiplon: Expected launch 4Q 05, sales potential 1.25 to 1.5 billion. The reality: oh, dear. Neurocrine is trying to go it alone until they find a new partner, and they're still in there pitching, but this has been a real development disaster.

Let's pause a moment to note that both of these were printed in green type, which the chart helpfully informs us were considered "low risk" at the time. After meditating on the implications of that statement, we move on to:

Edifoligide: Expected launch 4Q 05, sales potential 1.25 to 1.5 billion. The reality: Aaargh. The drug, an oligonucleotide "decoy" designed to tie up a particular set of transcription factors involved in vein graft failure, completely missed its clinical endpoints in a major trial. Bristol-Meyers Squibb dropped it; its developer (Corgentech) went through a near-death experience and emerged with a changed name and an (appropriate) focus on pain management.

Accomplia: Expected launch 1st half 06, sales potential 1.5 to 2.75 billion. The reality: the drug is slowly, slowly creeping into the market in Europe. But no one has any idea of when it might be approved in the US (where most of that money is going to be made, if it ever is), and Sanofi-Aventis has been extraordinarily uncommunicative on the issue. It won't be 2006, that's for sure. Next year? That's what they thought last year. . .

Plavix (for Japanese market): Expected launch 1st half 06, sales potential 1.25 to 1.5 billion. The reality: they made it in May of this year, but the cost has been heavy. And, of course, Plavix and its profits have been making the news for other reasons entirely.

Asoprisnil: Expected launch 2nd half 06, sales potential 1.25 to 1.5 billion. The reality: who knows? Takeda/Abbott and Schering, after some clinical difficulties, have written off 2006 and refuse to say when the uterine bleeding drug might be submitted for approval. Judging from the lack of recent statements, the outlook isn't good.

Not a pretty picture. Just think of how many investment decisions were made based on forecasts like this - it's enough to give you the shivers. But I'm not really blaming Mehta Partners for this - after all, they did what they could with the information they had from the companies involved. And the companies aren't completely to blame, either - many of them really believed that these things were going to work, or at least do better than they have, and they put a lot of their own money on those opinions. No, it's hard to find someone to take the entire fall. Research and development ishard.

Comments (4) + TrackBacks (0) | Category: Clinical Trials | Drug Development


COMMENTS

1. Insider on September 26, 2006 1:18 AM writes...

I'm wondering how they could have missed Pargluva! LOL

What's on Mehta Partners "current" radar chart, I also wonder?

Cheers!

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2. Morten on September 26, 2006 1:28 AM writes...

Umm... what do the little buggers do? Or rather what were they supposed to do?

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3. tom bartlett on September 26, 2006 8:20 AM writes...

Well, I always ASSUME 10% of what analysts expect.

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4. Thurston Howell V on September 27, 2006 1:10 AM writes...

I wonder if you have any comment about these two subjects:
One is the company AtheroGenics, and their anti-inflammatory drugs.
Two is the veterinary anti- arthritis drug, Cartrophen. We had our elderly Kelpie on it in Australia, it took years off her age. Brought her to New York where it is unavailable, she deteriorated alarmingly, to the point where we bought a cart to tow her around in- though it didn't get to that stage, mainly because this summer we took her to a vet in Canada, got a supply of Cartrophen, and she now walks 3.2 miles (GPS measured) daily. It is very effective.
Is Cartrophen being assessed for human use? Will it be OK'ed for US veterinary use?
Many thanks.

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