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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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February 5, 2013

Not Working Out So Well at Merck?

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Posted by Derek

Here's a rather grim analysis from the AP of Merck's current status. The company's stock was recently downgraded by two analysts after last Friday's earnings call didn't go very well (links added by me below):

Future sales of Vytorin, a controversial combination drug on sale since 2004 that includes Zocor, and prospects for a crucial experimental osteoporosis drug called odanacatib were thrown into question Friday as Merck announced its fourth-quarter results. Company executives made some cryptic comments, suggesting significant problems with both drugs. . .

Merck said Friday that it won't apply for approval of odanacatib, a new type of osteoporosis drug, until 2014 instead of by this June. Management said it was reviewing safety and efficacy data from one study and now won't apply for approval until they have longer-term data from an extension study.

Executives also said a committee monitoring its 18,000-patient study of Vytorin, called IMPROVE-IT, had requested a new interim analysis of patient data in March. The study is meant to determine whether Vytorin reduces risk of heart attack, stroke and death in heart disease patients — the ultimate purpose of cholesterol drugs — but Merck executives, grilled by analysts on a conference call, wouldn't say that they're confident the study will show that benefit.

I wouldn't, either, if I were in their shoes. The Vytorin story has been long and complex, and that complexity comes from two sources: the drug's unique mechanism of action (at least the ezetimibe part), and the uncertainties of human lipid handling and its relationship to cardiovascular outcomes. Honestly, these things could go any way at all, and the same goes for Merck's high-profile push in CETP. A lot of the company is riding on some very uncertain science.

But I wonder, as I was speculating on in that last link, if that isn't where the whole industry is these days. By now, we've attacked all the things that we believe we really know something solid about. What's left is often big, important, potentially very profitable. . .and risky enough to make you leave fingernail marks in the armrests of your chair. The higher up you sit, and the nicer the material that chair is made of, the more damage is being done to it.

Comments (14) + TrackBacks (0) | Category: Business and Markets | Clinical Trials


COMMENTS

1. Lane Simonian on February 5, 2013 12:01 PM writes...

Merck's last osteoporosis drug--Fosamax--did not turn out so well. It has been linked in several studies to atrial fibrilation, severe esophagitis, esophageal cancer, jaw necrosis, and irregular femur breaks. And the FDA has quietly collected data on a possible connection between Fosamax and dementia.

Either Merck is being careful with odanacatib based on suspicions that it pushed through drugs such as Fosamax and Vioxx through the FDA approval process while hiding very serious side effects or this new osteoporosis drug has major safety questions surrounding it. I have little hope for its BACE1 inhibitor drug either for Alzheimer's disease, unless it is working on a curcumin-like analog that works upstream from BACE1 by inhibiting phospholipase C gamma. Some of Merck's drugs have done much more damage than good so I shed no tears if the company is falling on hard times.

Permalink to Comment

2. simpl on February 5, 2013 1:16 PM writes...

#1 There is a mix of two arguments here. I respect Merck for going for breakthrough drugs, and am also happy for them to persue less-risky ones to fund these high-risk high-benefit targets.
The dry eyes arise for allowing "we need the money" to cloud the evaluation of adverse findings. Harder times might exascerbate that trend, in any company, as would betting the house on one Hail Mary project.

Permalink to Comment

3. John Wayne on February 5, 2013 1:32 PM writes...

Seems like most companies are betting their futures on a handful of products in late stage development; I don't think anybody has a choice. Let's hope that the decisions that were made back when these projects were pushing into the clinic lead to compounds that both help people and fund research for the generation of drugs.

Permalink to Comment

4. TX Raven on February 5, 2013 2:23 PM writes...

"By now, we've attacked all the things that we believe we really know something solid about"

Exactly. And I bet the way to discover drugs acting at novel targets will be quite different to what we do today.

Exciting times... those with flexibility and smarts to acknowledge these differences will learn a lot.

Permalink to Comment

5. Brian on February 5, 2013 3:30 PM writes...

When talking about Merck, it would be more clear to those to mention which Merck you're talking about. Is it Merck & Co, or Merck KGaA (Merck-Millipore in the USA)? This makes for an easier read for those of us who are unfamiliar with this specific case?

Permalink to Comment

6. Anonymous on February 5, 2013 3:47 PM writes...

Isn't this the way that pharma has always been. We have always being playing out high risk Phase 3 studies with a few molecules. All the low hanging fruit weren't that low hanging when they were developed and all the blockbusters of the past (at least the first in class) were big gambles on untried and largely unknown biology. Most of the knowledge we have gained has been as a result of drugs being on the market to allow full mechanistic studies - and even then new discoveries still come along.

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7. exGlaxoid on February 5, 2013 4:23 PM writes...

#5. Merck & Co in the US is the owner of Vytorin, Zocor, and the CETP drug, so that would be the correct Merck. Merck KGaA is not well known in the US for its pharmaceuticals. It is amazing the length of the lingering aftereffects of WWI.

Permalink to Comment

8. marklar on February 5, 2013 4:47 PM writes...

I'd like to see a compilation of all these ridiculous sounding clinical trial acronyms throughout pharma. IMPROVE-IT?
This should be a topic of its own on another post.

Looks like there already is such a compilation:
http://www.wikidoc.org/index.php/Acronyms_of_Clinical_Trial_Names

Maybe they use an acronym generator like: http://trialacronym.net/Default.aspx

Permalink to Comment

9. PharmaHeretic on February 5, 2013 6:22 PM writes...

Who says MBAs can't make noises out of both holes at once?

----

http://www.pharmalot.com/2013/02/where-oh-where-has-all-the-pharma-talent-gone/

"File this under ‘sad irony.’ Now that the pharmaceutical industry has tossed thousands of people overboard during the last decade – an estimated 150,000 or so just since 2009 – a slight majority of drugmakers complain that it has become increasingly difficult to find the right talent and most worry they will not have access to the people they need to hire, according to a report from PricewaterhouseCoopers.

Specifically, 51 percent of life science execs – which is the highest of 19 sectors examined – say that hiring is getting tough and only 28 percent are confident about finding the right candidates. This comes as roughly 60 percent of pharma execs plan to invest more heavily over the next three years to create a more skilled workforce and 72 percent intend to boost their R&D capacity over the next 12 months, PwC reports."

Permalink to Comment

10. Anonymous BMS Researcher on February 5, 2013 9:42 PM writes...

@marklar: I share a printer with some folks who run clinical trials. I have seen them take printouts from some acronym-generator site (dunno if it's the same one) from that printer.

Permalink to Comment

11. Anonymous on February 6, 2013 8:48 AM writes...

@9: a slight majority of drugmakers complain that it has become increasingly difficult to find the right talent and most worry they will not have access to the people they need to hire

Translation: it has become increasingly difficult to find the right talent who is no older than 35 with no more than 5 years experience in (insert esoteric and extremely specific job function which typically requires 10 years or more of experience for mastery here) who will accept a "globally competitive" salary and not saddle us with healthcare, pension or other profit-eroding longterm costs. The 150,000 we laid off need not apply. They were all low performers. We only lay off poor performers. We are looking for highly motivated team players

Permalink to Comment

13. Anonymous on February 8, 2013 12:09 AM writes...

Nothing works well at Merck. Espcially right now.

Permalink to Comment

14. Anonymous on February 8, 2013 4:01 PM writes...

Watch....they'll initiate another round of layoffs...

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