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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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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

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April 29, 2014

Concert's First Drug: Not So Great

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Posted by Derek

Concert Pharmaceuticals, famous among medicinal chemists as the apparent leaders in the "deuterated drug" strategy, has reported clinical trial results for their lead compound, CTP-499. Unfortunately, it missed its primary endpoint of improving albumin/creatinine ratios in patients. There are some signs that it might be doing some good, and some room to argue that this endpoint is not as good a choice as it seemed to be at the time, but overall, these are not good numbers.

And as this article in Xconomy shows, the initial read on these numbers actually hit last summer, while Concert was readying an IPO. They pulled it, realizing the effect that the results would have on their fund-raising abilities, and took the compound into a second 24-week round of testing, the results of which we're seeing now. Fortunately for Concert, another compound (CTP-354) showed enough promise in the interim to be the peg for their public offering, which went off in February (pretty much just in time, given what's happened in the biotech market since then).

It's a bit alarming to realize how much of a small company's fortunes depend on, well, fortune. Maybe that should be a capital-F Fortune, the blindfolded goddess depicted in allegorical paintings holding a large wheel on which people's standing rose and fell. You'd like to be able to control things, and you try to as much as possible, but a lot is riding on things that are outside of anyone's control whatsoever: what the results are, and what the scientific and financial weather is when they appear.

Comments (15) + TrackBacks (0) | Category: Business and Markets | Clinical Trials


COMMENTS

1. NJBiologist on April 29, 2014 9:00 AM writes...

In Fortunae solio
sederam elatus,
prosperitatis vario
flore coronatus;
quicquid enim florui
felix et beatus
nunc a summo corrui
gloria privatus.

(Translation from a random web site: "On the throne of Fortune I had sat elated, crowned with the gay flower of prosperity; however much I flourished, happy and blessed, now I have fallen from the pinnacle, deprived of my glory.")

Permalink to Comment

2. annon on April 29, 2014 10:59 AM writes...

The integrity of many biotechs is appalling.

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3. Erebus on April 29, 2014 11:25 AM writes...

@2 -
That's true... but it's true of many other business types, as well. And, in this case, one could argue that the FDA's heavy-handedness, particularly with respect to the amount of money it costs to bring drugs to market, has a lot to do with it.

Permalink to Comment

4. pgwu on April 29, 2014 11:25 AM writes...

#2-where did they learn and whom did they learn from?

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5. Hap on April 29, 2014 11:45 AM writes...

The problem is that big pharmas probably started the problem, by trying to oversell things to markets where the reward-risk ratio was not high enough to justify their use. When the inevitable side effects ooccurred, and the FDA got flayed for letting the drugs through, well, it seems obvious what was going to happen next. If you sell your soul, then you get to reap the rewards, such as they are; when you sell your trust, people aren't going to take your word to have any more value than you give it.

The FDA's caution has made it tough for smaller companies to get drugs to market alone, but the market for partnering with or buying smaller companies is responsive to the needs and wishes of the bigger ones. When you buy hype and smoke, and ignore everything else, guess what you're going to get more of? (You're also going to drive out anyone unwilling to furnish said smoke, providing lots of openings for ambitious and conscienceless marketeers). Again the "reap and ye shall sow" thing.

Between this behavior and "merge yourself to greatness", pharma seems to be doing a great job at destroying itself and salting its fields.

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6. annon on April 29, 2014 3:07 PM writes...

to 3 and 4: State a truth, and folks attack. Pathetic.

I don't defend any other's actions if they are inappropriate. It's just that many biotechs very clearly manipulate information and advertising about their compounds just before being acquired or an IPO. The transparency is as clear as a closed room at midnight with out a full moon.

The SEC should take a role in having more oversight in these actions to help protect investors, or punish those who misrepresent themselves as in the case of Concert.

Permalink to Comment

7. Anonymous on April 29, 2014 4:17 PM writes...

#2/#6 where do you see the wrongdoing from concert. reading their S1 discloses the issues with the CTP-499 trial. If you buy into an IPO and haven't read the S1, that is your fault.

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8. annon on April 29, 2014 5:10 PM writes...

#7: I did not buy Concert and would not buy stock in any company that had been associated with Westphall. Hie track record in actually making drugs is zero, and that is what I care about, not hype, pump, and dump.

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9. Proteus on April 29, 2014 9:01 PM writes...

@annon:I agree with the spirit here but the SEC has plenty to worry about without having to master the subtleties of med chem and clinical development.

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10. Insilicoconsulting on April 29, 2014 10:33 PM writes...

This is exactly the reason why the current clinical methodologies are outdated, slow. The idea should be to test a class of compounds for a particular effect and companies should be able to rapidly change course from 1st to 2nd compound when desirable effects are not seen. Provided intial population sample sizes are large and trials are double blinded.

1 drug, 1 clinical trial makes no sense in the modern world. That's what kills small biotech companies, not the science.

Permalink to Comment

11. Morten G on April 30, 2014 4:29 AM writes...

Really? So their clinical end-point was a diagnostic marker for renal issues in diabetes and a quite bad one. Two minutes spent on Wikipedia would have told you that. In addition to
"For the diagnosis of microalbuminuria, care must be taken when collecting sample for the urine ACR. An early morning sample is preferred. The patient should refrain from heavy exercises 24 hours before the test. A repeat test should be done 3 to 6 months after the first positive test for microalbuminuria. Lastly, the test is inaccurate in a person with too much or too little muscle mass."
creatine and therefore creatinine levels are highly dependent on intake of meat and seafood and workout supplements.

Now that I've actually read the piece, Tung seems a sensible chap and while UACR end-point may have been a mistake he seems like he's not above admitting that and fixing it.

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12. newnickname on April 30, 2014 3:01 PM writes...

The linked Xconomy article says: "The company was started up in 2006 by Tung, one of the scientists who left Merck in 1989 with Joshua Boger to start up Vertex Pharmaceuticals." Boger recently joined Alkeus Pharm (Boston) that is using the deuterium KIE approach to slow down Stargardt Disease and Macular Degeneration. It's based on the work of Ilyas Washington at Columbia Presbyterian Ophthalmology Dept.

Permalink to Comment

13. newnickname on April 30, 2014 3:41 PM writes...

I've been having trouble accessing Pipeline at different times on different computers. Sometimes I get NO comments, partial page loads, zero page loads (blank screen), no "Post A Comment" capability, etc.. Are others having such problems? Can you (Derek? Someone?) ask the web guys (Corante?) to investigate and fix? THANK YOU.

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14. petros on May 1, 2014 6:55 AM writes...

#13
You are not alone

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15. annon on May 1, 2014 7:05 AM writes...

13: Me too.

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