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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

« Organizing Research | Main | The Other Shoe Drops at Ariad »

November 8, 2013

Exiting Two Therapeutic Areas

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Posted by Derek

So Bristol-Myers Squibb did indeed re-org itself yesterday, with the loss of about 75 jobs (and the shifting around of 300 more, which will probably result in some job losses as well, since not everyone is going to be able to do that). And they announced that they're getting out of two therapeutic areas, diabetes and neuroscience.

Those would be for very different reasons. Neuro is famously difficult and specialized. There are huge opportunities there, but they're opportunities because no one's been able to do much with them, for a lot of good reasons. Some of the biggest tar pits of drug discovery are to be found there (Alzheimer's, chronic pain), and even the diseases for which we have some treatments are near-total black boxes, mechanistically (schizophrenia, epilepsy and seizures). The animal models are mysterious and often misleading, and the clinical trials for the biggest diseases in this area are well-known to be expensive and tricky to run. You've got your work cut out for you over here.

Meanwhile, the field of diabetes and metabolic disorders is better served. For type I diabetes, the main thing you can do, short of finding ever more precise ways of dosing insulin, is to figure out how to restore islet function and cure it, and that's where all the effort seems to be going. For type II diabetes, which is unfortunately a large market and getting larger all the time, there are a number of therapeutic options. And while there's probably room for still more, the field is getting undeniably a bit crowded. Add that to the very stringent cardiovascular safety requirements, and you're looking at a therapeutic that's not as attractive for new drug development as it was ten or fifteen years ago.

So I can see why a company would get out of these two areas, although it's also easy to think that it's a shame for this to happen. Neuroscience is in a particularly tough spot. The combination of uncertainly and big opportunities would tend to draw a lot of risk-taking startups to the area, but the massive clinical trials needed make it nearly impossible for a small company to get serious traction. So what we've been seeing are startups that, even more than other areas, are focused on getting to the point that a larger company will step in to pay the bills. That's not an abnormal business model, but it has its hazards, chief among them the temptation to run what trials you can with a primary goal of getting shiny numbers (and shiny funding) rather than finding out whether the drug has a more solid chance of working. Semi-delusional Phase II trials are a problem throughout the industry, but more so here.

Comments (58) + TrackBacks (0) | Category: Business and Markets | Diabetes and Obesity | Drug Development | The Central Nervous System


COMMENTS

1. Janne on November 8, 2013 8:28 AM writes...

As a neuroscientist, I guess a major problem is that to a large degree we still don't actually know the precise mechanisms of many diseases. And without a clear understanding of what's happening you're effectively flying blind when trying to come up with therapies. With something like type I diabetes, at least it's clear exactly what the cause is.

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2. MTK on November 8, 2013 9:01 AM writes...

So I guess its oncology or bust for Big Pharma.

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3. Anonymous on November 8, 2013 9:13 AM writes...

@2: makes sense, because cancer rates go up exponentially with time in humans and so there is a better chance for the pharma company drug to receive full price for the drug from a Medicare reimbursement. Thats where the money is, after all.

So if Medicare could negotiate prices for drugs, that would trip up the pharm industry....

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4. petros on November 8, 2013 9:19 AM writes...

Who's left in neuroscience now amongst big pharma?

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5. emjeff on November 8, 2013 9:20 AM writes...

I guess it is ridiculous for me to think that perhaps Janet Woodcock would look at press releases like this and think "Maybe we should look at our ever-escalating requirements and see if we can entice companies back into areas like antibiotics, neurology, cardiovascular disease and diabetes". Probably too much to hope for...

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6. SteveM on November 8, 2013 9:27 AM writes...

#3 Anonymous "So if Medicare could negotiate prices for drugs, that would trip up the pharm industry...."

Good point. An obvious Pharma business strategy right now is creating genetically screened niche therapies for subsets of desperate patients. Even if the therapies have only marginal clinical value, $100,000 to $250,000 can be charged for the treatments.

While there are only a handful of such therapies on the market right now and Medicare surrenders to intense political pressure to pay for them, will it (and other payers) still pay when there are a couple of hundred on the market?

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7. Lyle Langley on November 8, 2013 9:36 AM writes...

@3, Anonymous...
"makes sense, because cancer rates go up exponentially with time in humans and so there is a better chance for the pharma company drug to receive full price for the drug from a Medicare reimbursement."

Couldn't the same be said for Alzheimer's (as far as rates of disease going up exponentially with time)? It's not as simple as Pharma getting a better chance of reimbursement - because if someone can get a drug to "cure" or at least "slow" AD/PD, the reimbursements will come. It's more of an understanding of the diseases, as #1 points out, and how difficult clinical trials can be in Neuroscience.

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8. alig on November 8, 2013 9:38 AM writes...

Fierce Pharma says they are also exiting HepC which, unlike the other two areas, is because of the amazing success Pharma has had treating that disease. There should be interferon-free cures available in the next couple years.

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9. Anonymous on November 8, 2013 9:53 AM writes...

Great, so now pharma will focus only on curing cancer so that everyone will live longer and develop Alzheimer's, which costs 10 times as much per patient. Let's see how that impacts overall healthcare costs!

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10. Calvin on November 8, 2013 9:56 AM writes...

#8 alig. Yeah and BMS has a superb virology group and people who have discovered some really cool compounds. That work. And will make money. They bring in one compound that crashes and burns very badly (Inhibitex) and they make the R&D group pay for it. Nice touch.

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11. alig on November 8, 2013 10:05 AM writes...

@10 someone has to pay for the failed $2.5 billion bet. Obviously it wont be the guy who made the bet, he is just too valuable.

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12. Anonymous on November 8, 2013 10:08 AM writes...

@11: There's nothing wrong with making such big bets as they should pay off on average, but the risk must be shared with more partners.

And no, I wasn't involved in any way.

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13. NMH on November 8, 2013 10:15 AM writes...

As I said before, if everybody went vegan, exercised, and if Medicare was allowed to negotiate drug prices the pharmaceutical companies would be brought to their collective knees in 20 years *cackles loudly, rubs hands together*

But not to worry. Americans are addicted to their bad habits like a pusher is to heroin. The pharm companies have deep pockets to buy off the appropriate legislators, like they did in 2003 with the "perscripition benefit program". The pharm companies have a bright future ahead, even if they are part of the reason why our gov't is going broke.

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14. luysii on November 8, 2013 10:15 AM writes...

Sad to see that they're exiting neuroscience, particularly since there is clear way to attack chronic pain without frying the brain. It has to do with figuring out a way to inhibit one sodium channel out of 9 (NaV1.7) leaving the rest alone. Tetrodotoxin inhibits 7 out of 9 of the sodium channels (including Nav1.7) the amino acid sequences of all 9 are known. It should be possible to accurately map the site in all 9 at which tetrodotoxin binds, and figure out a tetrodotoxin analog that inhibits just #7 leaving the rest alone.

It would be a blockbuster drug, enormously benefit humanity and bring frame and glory (not to mention money) to those accomplishing this. It won't be easy, but surely there must be a venture capitalist around with a long view, some ace synthetic chemists (just laid off), some computational chemists, and some cell biologists, X-ray crystallographers and microfluidic engineers -- to put all 9 channels into a series of wells, so compounds could be screened quickly.

For more details just go to my site. Unlike Alzheimer's we have a known target, and a compound (tetrodotoxin) which already does this -- unfortunately, because it clobbers the other sodium channels, making it more lethal than cyanide. Look at its structure, any organic chemist worth his/her salt can think of tons of ways to hang functional groups off the backbone -- which has to be rigid since it's essentially diamond writ small, to modify channel binding.

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15. alig on November 8, 2013 10:26 AM writes...

@13 how do you explain that America spent less on drugs in 2012 than 2011? And it looks like we are on pace to spend less in 2013 than 2012. Maybe pharmaceutical companies are evil, but they seem to be losing their ability to fleece Americans.

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16. Anonymous on November 8, 2013 10:34 AM writes...

#13 - If everyone went vegan and exercised, cardiovascular disease and Type 2 diabetes rates would certainly plummet. There would be a minor but noticeable decrease in cancer rates. Wouldn't do diddly about infectious disease, Alzheimer's, schizophrenia, etc, etc.

Not sure how that adds up to bringing "pharmaceutical companies to their collective knees".

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17. NMH on November 8, 2013 10:40 AM writes...

Still waiting for a caustic devil's advocate comment from Lyle Langley 3...2...1....

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18. Anon on November 8, 2013 11:41 AM writes...

You forgot one of the "biggest tar pits of drug discovery" - stroke, which at least some organizations and approaches consider to be Neuro. It's produced a long string of failed clinical trials.

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19. Ted on November 8, 2013 11:59 AM writes...

@13:

Why would anyone want to work that hard to bring pharma to its knees?

Me? I bitch about things, do science, drink too much and work in exercise or even poetry when the mood strikes.

It seems to be bringing pharma to its knees quite nicely, and I don't even need to give up red meat... Abres los ojos.

-t

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20. ScientistSailor on November 8, 2013 12:04 PM writes...

@5 emjeff

The FDA has made large strides in smoothing the path for new antibiotic approval under the GAIN act. We no longer are required to do impossibly large non-inferiority trials.

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21. Anonymous on November 8, 2013 12:32 PM writes...

So what we've been seeing are startups that, even more than other areas, are focused on getting to the point that a larger company will step in to pay the bills. That's not an abnormal business model, but it has its hazards, chief among them the temptation to run what trials you can with a primary goal of getting shiny numbers (and shiny funding) rather than finding out whether the drug has a more solid chance of working. Semi-delusional Phase II trials are a problem throughout the industry, but more so here.

Delusional's probably not the right word, at least all the time. Scam artists and telemarketers know what they're doing - their business model is predicated on the ideas that 1) lots of other people don't know what the scammers are doing and 2) that other people are greedy enough to let the greed suppress the caution they should be using and make bets (whether they realize it or not) that they shouldn't be making. This sounds like much of the "pharma lite" business model in a nutshell (or at least the big pharma implementation of it). In general, people take more care with their own things than those of others (like drug candidates), and as long as there's a sucker, there'll be someone to sell them something worthless.

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22. Anonymous on November 8, 2013 12:40 PM writes...

I feel bad for the scientists losing their jobs in Pharma, because I want to see scientists have good jobs. I am a scientist myself (albeit a very poorly paid one in academia).

But I am absolutely disgusted that Medicare cannot negotiate drug prices with Pharma like everybody else can. I understand that in a capitalist society a company has a right to charge a price that the market can bear, but that only works if the consumer has free choice for purchasing the lowest price available. If Medicare is hamstrung by law to negotiate the lowest price possible, then there is not much holding Pharma from charging exorbinant prices. And they will.

This blog has taught me why Pharma is in so much trouble- biology is complicated. But its remarkable to me how Pharma is failing despite the fact that we have this huge support for it in our laws.

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23. Joe on November 8, 2013 12:58 PM writes...

re: 21 - Anonymous - you seem to be making a point but the language got in the way, or maybe this is real inside baseball stuff, as I could not understand Derek's comment either: "semi-delusional Phase II trials are a problem throughout the industry." How so? I thought all that Phase II was to get a proof of principle. Now if that is accomplished what is the problem here? I mean proof of principle for a topical drug probably is a lot more indicative than a proof of principle for a neurological one - that's not a very sophisticated leap. Where's the delusion?

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24. Anonymous on November 8, 2013 1:16 PM writes...

The delusion is in doing the wrong experiment, or ignoring the results when they are negative and doing Phase III regardless that there has been no meaningful proof of concept.

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25. Anonymous on November 8, 2013 1:43 PM writes...

I can't completely know what anyone else is thinking, but science is supposed to find pieces of truth, by testing observables as rigorously as possible to get answers. P2 trials for potential saleable candidates are sometimes run to avoid data that might jeopardize the candidate. The testing of a candidate for future sale (and sometimes for development) may be performed in the manner of preserving an illusion and not rigorously, for fear of finding unwanted answers. Companies may test in a small population, or among people who are less likely to present problems for the drug, for example. (I'm not sure how this works, never actually have it done it or analyzed it for a living).

If your ability to make money and survive depends on selling what you have to someone else, and if you have to tell potential buyers if you find a flaw in what you have, and you can't lie, you probably will check it for flaws as minimally as you can get away with.

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26. Joe on November 8, 2013 2:40 PM writes...

# 24 & 25 - Okay, roger that, I guess I find it hard to believe that a group would skew tests in an ongoing way to support what they know can't survive the scrutiny over the long haul - of course it means the people in these organizations are more interested in their own short term survival than the long term I suppose. What thats says about upper management is the next question - especially if a large company. A small outfit that is looking to get a payday and get out, well, that I understand could go on, but what a hustle and waste of time and energy, money and talent. I am beginning to think intellectual property is at the heart of this monster - and like software IP, needs to go away. Take away the lottery, take away the losers.

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27. Joe on November 8, 2013 2:40 PM writes...

# 24 & 25 - Okay, roger that, I guess I find it hard to believe that a group would skew tests in an ongoing way to support what they know can't survive the scrutiny over the long haul - of course it means the people in these organizations are more interested in their own short term survival than the long term I suppose. What thats says about upper management is the next question - especially if a large company. A small outfit that is looking to get a payday and get out, well, that I understand could go on, but what a hustle and waste of time and energy, money and talent. I am beginning to think intellectual property is at the heart of this monster - and like software IP, needs to go away. Take away the lottery, take away the losers.

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28. The Fat Layer on November 8, 2013 3:04 PM writes...

Make that THREE research areas: "hepatitis C, diabetes and neuroscience, but will increase spending on medicines that harness the immune system to fight cancer."

So cancer stays... for now.

See http://in.reuters.com/article/2013/11/07/bristolmyers-research-idINL2N0IS2QX20131107

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29. Anonymous on November 8, 2013 3:06 PM writes...

Patents help create this problem, but I don't think you'd get anything without patents, unless it were trade secreted, which I don't think really helps anyone. It costs too much to invest in a drug to get it to market, and since everyone will want to free-ride on the investment, I don't know why anyone would do so without the chance to make money from it.

Perhaps buying in earlier would help, as you'd have better control over candidate selection and bigger incentives to get better data earlier, but you'd have to buy more little companies, which means you have to spend lots on what might not even rise to the level of delusion. Better oversight and analysis of the data before purchase would probably help, and also people in management at bigger companies listening to their technical people and the answers they give (it was assumed not to have happened with the Sirtris purchase, for example). Scams depend on greed overcoming reason; people seeing too many dollar signs and with the power to run through red lights to get to them equals lots of badly spent money.

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30. cynical1 on November 8, 2013 3:14 PM writes...

It was my impression that the FDA, at least in the US, had to approve the clinical design correct? It's not like they're going to let you look for an irrelevant clinical endpoint. You may have to convince them that your clinical endpoint is relevant to the disease state and/or your drug's likely efficacy in a disease state for that phase II but it still has to pass the mustard with them before tiny pharmaceutical X can go sell their semi-delusional drug candidate to big pharma Y. I understand that the Phase II could be only looking at a surrogate marker but it still has to look for something of relevance. Or am I mistaken on that?

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31. NH_chem on November 8, 2013 3:14 PM writes...

The exit from Hep C tells all that Gilead is the clear cut winner. Of course, the Inhibitex debacle probably is the main reason why BMS gave up on HCV.

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32. The Fat Layer on November 8, 2013 3:18 PM writes...

@1: We can only do with what we know, or THINK we know, on a disease based on current knowledge.

Every day there are publications on new proteins, how they interact with other proteins, what role they MAY play in the disease, etc.

We don't know everything that goes on in a cell, and every cell type has a different genetic structure which complicates things further.

It's a tough problem, but if companies give up on it, who will work on it then?

I sure don't know what the answer is, but I do know that giving up is not to lead to a solution.

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33. The Fat Layer on November 8, 2013 3:30 PM writes...

@2: "So I guess its oncology or bust for Big Pharma."

Like I posted regarding @1, cancer is also on the same boat: nobody knows exactly what goes on in every cancer cell type... AND cancer stem cells.. and on...

It is not even clear what approaches are going to be efficacious: margeting a single oncoprotein? multiple targets? which ones? in which order? where in the cell (receptor, in the cytoplasm, in the nucleus)? gene and protein mutations? small molecule, antibody, conjugates?

Investors have been running away from companies working on cancer because of the high risk.

So, there can be arguments for not going into cancer, but as I said before, if companies give up, when who will come up with anything against cancer?

Tough, tough, tough...

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34. Twinkle Toes on November 8, 2013 4:40 PM writes...

You know what we need to solve this problem? More STEM graduates.....

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35. Dont_H1B_Me_Bro! on November 8, 2013 5:24 PM writes...

@34

And an increase in the number of H1B's/year in immigration law.

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36. Anonymous on November 8, 2013 6:09 PM writes...

@#31 It is not exactly like that I think. They are stopping the discovery efforts but not the development and clinical. They recently reported filing in Japan of an oral combo. I think everyone expects that the earnings in the Hep C market will accumulate in the first few years from launch since treatments will cure the disease in a high percentage of the cases an that is the reason given to stop discovery work.

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37. Anonymous Big Pharma Researcher on November 9, 2013 6:26 AM writes...

The comment from "36. Anonymous" on November 8, 2013 at 6:09 PM has it correct: BMS will indeed continue with DEVELOPMENT of its impressive HCV pipeline, but will not continue DISCOVERY of new HCV compounds.

However, unlike the decision to leave neuroscience and diabetes, which did come as a major surprise to many people inside and outside BMS, the decision to cease HCV discovery efforts has already been known both inside and outside the company for some time.

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38. Ananalogous on November 9, 2013 9:30 AM writes...

@34 and 35 -

Wow, that just about sums it up!

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39. Anonymous on November 9, 2013 11:46 AM writes...

Indeed, when the problem is lack of demand, just increase the supply until the price drops through the floor.

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40. Anonymous on November 9, 2013 12:21 PM writes...

A while ago there was a study from a consulting company. Their conclusion was that big pharma would adapt to focus on development, clinical and commercialization but not really in the discovery of new molecular entities. Discovery would become a cluster of small companies highly specialized by disease area and big pharma would buy compounds to then feed them into their development organization.
Things are starting to shape up in that model.

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41. Anonymous on November 9, 2013 2:27 PM writes...

@40: Unfortunately those consultancies don't understand that value is only added by doing difficult things, otherwise you end up paying full price for others to do the difficult things and adding no value yourself.

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42. Moneyshot on November 10, 2013 9:36 AM writes...

Does anyone know if wallingford in CT was hit?

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43. A on November 10, 2013 11:19 AM writes...

@ #10 - HCV compounds in development are still full steam ahead, they're just stopping discovery. And Hep A and HIV are still active within discovery, so their virology is shifting focus but not going away entirely

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44. Pennpenn on November 10, 2013 7:23 PM writes...

@13- Perhaps it's my bias showing, but I can't help but feel that such a simplistic veiw would cause more problems that it would ever solve.

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45. Anonymous on November 10, 2013 8:34 PM writes...

Bristol needs to funnel major resources into their immuno-oncology clinical trials to keep a lead over Merck, Roche and GSK. Other than Sprycel, internal discovery has been a bust, mostly me-toos. The hope for Eliquis generating quick sales is fading while Sustiva, Baraclude and Abilify are losing patent protection in 2014-15. They are hitting the wall in continuous prices increases especially in Europe. They made a great move in acquiring the Mederex pipeline on the cheap otherwise they would be gone. There is a lot more cost cutting coming if they are to make their numbers.

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46. Anonymous on November 10, 2013 10:16 PM writes...

Bristol is carrying too many Northeast R&D sites, Wallingford, Devens, Hopewell and Princeton; expect one to be shuttered soon.

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47. MTK on November 11, 2013 8:16 AM writes...

@41,

Your discovery bias is showing.

Development, clinical, and yes, commercialization is not easy. It's not only expensive, but requires a great deal of coordination, expertise, and creativity to do it all efficiently as the patent clock ticks away.

There's a tremendous amount of value added and its not easy in the least.

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48. Anonymous on November 11, 2013 8:34 AM writes...

@47: Development, clinical, and commercialization are only difficult if you have crap compounds (with only marginal or questionable benefit) in the first place.

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49. Anonymous on November 11, 2013 8:43 AM writes...

In other words, you get what you pay for.

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50. MTK on November 11, 2013 9:05 AM writes...

@48

Not even remotely true.

Let me put it another way. Is the average NAV for a compound higher pre-clinical or post-approval?

If it's higher post-approval where did that value come from?

I'll hang up and listen.

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51. Anonymous on November 11, 2013 9:10 AM writes...

@50: It comes from de-risking all the crap that comes out of discovery at present, but that costs a lot of money, so you need to look at ROI not NAV.

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52. Anonymous on November 11, 2013 9:20 AM writes...

And by the way, you can't just look at NAV post-approval vs pre-clinical because it excludes the cost of all the failures, so your question is screwed up.

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53. Calvin on November 11, 2013 9:30 AM writes...

@43 A. Thanks. That's good to hear.

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54. MTK on November 11, 2013 9:42 AM writes...

@51,

OK. I'll play along.

It's been reported that pre-clinical research constitutes just under 30% of all R&D budgets. Clinical activities are just over 50%. (The rest is in Phase IV and regulatory activities.) So let's say Development costs twice that of research.

The ROI for each which would be a NAV pre-clinical/R costs vs. NAV at FDA filing/D costs. I don't know the exact #'s, but I'm going to guess that the ROI on D is substantially higher.

That's one of the arguments for companies to in-license. Spend your money on those activities that give you higher ROI.

I'm not saying I necessarily agree with it, because the comparison should not be R ROI vs D ROI, but rather internal R ROI vs. external R ROI, because someone has to do the R.

But the argument that D adds marginal value doesn't pass any reasonable test, IMO.

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55. Anonymous on November 11, 2013 9:51 AM writes...

@54: In fact Development ROI has been declining more rapidly than Research ROI as failure rates in Phase 3 (and beyond on the market) have been increasing much more rapidly than failure rates in Phase 1 and 2.

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56. Anonymous on November 11, 2013 9:58 AM writes...

...which indicates that pharma will just be buying in more rubbish at greater cost, unless they get a grip on quality upstream.

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57. Me on November 11, 2013 1:49 PM writes...

@35 I can't say that I appreciate your attitude. Why should able and capable chemists not be welcomed. Just as americans are welcomed outside the US.

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58. Anonymous on November 12, 2013 10:22 PM writes...

One thing that is clear from the layoffs last week and last year, Bristol is aggressively targeting older med chemists. They are not even bothering to disguise it anymore by picking a few younger employees. You have to wonder where they find the managers to carry out all the dirty work.

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