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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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January 26, 2011

Those Me-Too Drugs

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Posted by Derek

So, me-too drugs, knock-offs, copycats: what say you? If you're a critic of the industry, you generally say quite a bit, and it's about lack of innovation, seeking easy profits and playing it safe, putting marketing over science, and so on. But what if that's not true?

We've talked about this here before, but now we can put some numbers on the topic, thanks to this article in Nature Reviews Drug Discovery. The authors have covered a lot of ground, looking at first-in-class drugs approved from the early 1960s up to 2003, with later entrants in the same areas accepted up to 2007. There are 94 of those different therapeutic classes over that period, with a total of 287 follow-on drugs coming after the pioneer compounds in each. So there you have it - case closed, eh?

Not so fast. Look at the timing. For one thing, over that nearly 50-year period, the time it takes for a second entry into a therapeutic area has declined steeply. Back in the 1970s, it took over nine years (on average) for another drug to come in and compete, but that's gone down to 1.7 years. (The same sort of speed-up has taken place for third and later entries as well). Here's what that implies:

Implicit in some of the criticism of the development of me-too drugs has been the assumption that their development occurs following the demonstration of clinical and commercial success by the first-in-class drug. However, given assessments of the length of time that is typically required for drug development — estimated at between 10 to 15 years — the data on the timing of entry of follow-on drugs in a particular class, in this study and in our previous study, suggest that much of the development of what turn out to be follow-on drugs must occur before the approval of the breakthrough drug.

That it does, and the overlap has been increasing. I've been in the drug industry since 1989, and for every drug class that's been introduced during my career, at least one of the eventual follow-on drugs has already been synthesized before the first one's been approved by the FDA. In fact, since the early 1990s, it's been the case 90% of the time that a second drug has already filed to go into clinical trials before the first one has been approved, and 64% of the time another compound has, in fact, already started Phase III testing. Patent filings tell the story even more graphically, as is often the case in this industry. For new drug classes approved since the 1970s, 90% have had at least one of the eventual follow-on drugs showing its first worldwide patent filing before the first-in-class compound was approved.

So the mental picture you'd get from some quarters, of drug companies sitting around and thinking "Hmmm. . .that's a big seller. Let's hang a methyl off it now that those guys have done the work and rake in the cash" is. . .inaccurate. As this paper shows (and as has been the case in my own experience), what happens is that a new therapeutic idea becomes possible or plausible, and everyone takes off at roughly the same time. At most, the later entrants jump in when they've heard that Company X is working in the same area, but that's a long time before Company X's drug (or anyone's) has shown that it's going to really work.

If you wait that long, you'd be better off waiting even longer to see what shortcomings the first drug has out in the real marketplace, and seeing if you can overcome them. Otherwise, you're too late to go in blind (like the first wave does). And blind it is - I can't count the number of times I've been working on a project where we know that some other company is in the same area, and wondering just how good their compound is versus ours. If you know what the structure is (and you don't always), then you'll make it yourself and check your lead structure out head-to-head in all the preclinical models you care about. But when it comes to the clinical trials, well, you just have to hold your breath and cross your fingers.

I'll let the authors sum things up:

Overall, these results indicate that new drug development is better characterized as a race to market among drugs in a new therapeutic class, rather than a lower risk imitation of a proven breakthrough. . .a race in which several firms pursue investigational drugs with similar chemical structures or with the same mechanism of action before any drug in the class obtains regulatory marketing approval. So, the distinctions that are often drawn between the relative innovative value of the development of the first-in-class and the me-too drugs in the same class may be misguided. . .

Over to you, Marcia Angell and the rest.

Comments (32) + TrackBacks (0) | Category: "Me Too" Drugs


COMMENTS

1. Reality Check on January 26, 2011 9:18 AM writes...

Thank you for posting this, as well as your commentary. I'll add one more tidbit to counter the musings of the Angell coven. If the first product in a class was the only product in a class as she seems to espouse, how many patients would never be adequately treated. Take for instance the statins, Would Mevacor alone have been enough to adequately treat high risk patients who need substantial LDL reduction? Suppose Baycol was the first product out and development of other products ceased. How many lives would that have cost?

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2. Old Pharma Guy on January 26, 2011 9:48 AM writes...

Reality Check got it right but I have a more extreme example of a class, the glitazone PPARgamma diabetes drugs.

Troglitazone, first out and withdrawn for liver tox not seen in the other 'me toos'

Rosiglitazone, second out and dead in Europe, dying in the US due to CV issues

Pioglitazone, last out and still standing with a vastly different CV profile than rosi and still on the treatment algorithm for type 2 diabetes.

Sadly, life is not so simple as those in development world know. But nuance doesn't translate to soundbites and tweets.

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3. Lester Freamon on January 26, 2011 9:59 AM writes...

Thanks for adding some data to this (fairly silly) debate. But to take the side of the pharma-scolds,

1) The "me-too" company may have another compound in the same class "in development", but that's a bit of a naive description of how drug development works--so many compounds sit on the shelf and are delayed for years, and then when company B sees that company A has invested (risked) $100M in a phase III clinical trial that proved to be a success, then company B can be confident in taking that compound off the shelf and bringing it to market. But company A was the one who took the real risk. And we know the MBA masters of the pharma universe tell us that it's all about hedging our risks.

2) The argument in favor of me-too's being original but just getting beat to market by competitors is a bit hard to take given that the structures are usually so similar--I find it hard to believe that different chemistry operations would converge on the same structure every time. It's just copying and patent-busting off the class-leader, who again, was the first to show that this structure is the best.

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4. Cellbio on January 26, 2011 10:14 AM writes...

I agree with the first two posts, pharmacology does vary, and in meaningful ways.

The fine point I would add relates to the comment of Derek's about new therapeutic ideas becoming plausible. On the surface, that sounds OK, but I think the issue here still is a reluctance to take risk. Yes, the risk is not mitigated in the majority of cases by analyzing sales figures and then launching a chemistry effort, that would be too large a gap for a pure me-too strategy. However, the knowledge of others working on a target fuels concern for being left out of a hot field, while working on a target no body else is often seen as taking unproven, and unnecessary risk. Both these ideas are reasonable and have a place in portfolio decisions, but overplayed by risk averse managers this yields conservative pipelines that generate an industry with little variation in pipelines, extensive cumulative effort on a limited number of targets and too little exploration of novel targets.

This is especially a trend I see today with inadequate scientific leadership at the top of companies. WIth little ability to make their own judgement, the business leaders do what they do best, and rely on their 'social network' for validation of ideas and strategies. This herd mentality often serves to squash innovation and the careers of independent thinkers while rewarding those that follow well.

So how do we win the future? Innovation? Education? Yes, both required, but without reforming US business thinking, is it possible on a meaningful scale?

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5. Esteban on January 26, 2011 10:25 AM writes...

Another vote in support of me-too products. Even if two me-too's have the same *population* efficacy and tox profiles, there could be substantial differences in response among individuals, e.g., pharmacogenetics may be highly relevant. In the case of SSRIs for example, some people respond well to prozac but not zoloft, and vice versa.

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6. MTK on January 26, 2011 11:02 AM writes...

@Lester,

if you think Company B can let a compound sit then plan, recruit, start, execute, and conclude a Phase III study in a mere 1.7 years after Company A demonstrates success, then pass the pipe, pal. Except in the case of something like an antibiotic, that's not happening.

As for managing risk, you're forgetting the other part of the equation, namely the risk of opportunity loss. Are you actually contending that companies intentionally slow down a potential first-in-class drug so that they can see what the competition does first in Phase III? Oh yeah, that makes a lot of sense. Let's let a multi-billion opportunity go while the patent clock clicks away so we can be second or third in class.

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7. barry on January 26, 2011 11:08 AM writes...

The first once-a-day NSAID was yanked from the market within months after a spate of deaths. The second one (shall we call it a me-too?) was piroxicam. It has been relieving inflammation for twenty years now. It may be that no one would have pursued the concept again if they only weighted the decision after benoxiprofen crashed.
But the best argument for me-toos remains the statins. It was long after they hit the market that anyone figured out that it is tissue-distribution that distinguishes the most efficacious statins from the most toxic. We only learned that because so many of them got out into the market.

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8. petros on January 26, 2011 12:23 PM writes...

Historically the first in class agent wasn;t the best with respect to factors such as potency or dosing regimen, so me toos could often be better. Now when 1st in class is usually qd it becomes harder for later products to be differentiated initially.


Look at the sartan market to see how many me toos can be tolerated for some indications. While other companies, eg the WDF, also aggressively pursued the same approach but without getting a drug through

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9. pete on January 26, 2011 12:35 PM writes...

Another vote of support for so-called me-too's.

I credit those companies willing to intelligently put their money down on the notion that a target in question is a key disease driver, even if arriving late to the game. At its best, creative molecular engineering, or even a combination-drug approach, might just win you that fabled best-in-class PD/PK/tox profile. And it can sometimes beat the hell out of being stuck in Discover-Another-Target mode (aka, DAT -- as in, "DAT one, over dere").

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10. CMCguy on January 26, 2011 12:36 PM writes...

I have long attributed the overlapping development phenomenon to common linkages to the basic info from attending the same meetings and reading same papers. It is not surprising to me at all that two or more different companies can be "inspired" by same trigger to work in same therapeutic areas (and have seen it happen in practice). Even the fact that come up with similar compounds before patents published often is not unbelievable (per #3), both because likelihood of same starting "lead" (paper or presentation)and fact chemical training or fads converge so ideas not dissimilar. I am not sure "secrets" are as secure as they once existed in Pharma (i.e. layoffs spread knowledge) however think the lack of "originality" is more commonality of circumstance and not from nefarious sources. Along the lines of what #4 Cellbio states there is great aversion to risk and even though discovery may wish to promote different programs they believe are viable nothing increases the managements priority of a project like knowing a competitor is working in the same area (and may be more advanced)

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12. Lester Freamon on January 26, 2011 1:28 PM writes...

@MTK: Point taken. Certainly a company wouldn't wait on a 1st in class, amazing, sure-to work compound. But there are few of those. A huge proportion of preclinical work is in the "hmm, company X is interested in target Y, let's see what we can get in that area" and then closely following along. And I probably mean following at phase II more than phase III.

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13. Cialisize Me on January 26, 2011 1:49 PM writes...

Good points all. No one has mentioned the real problem, which is the CYA mentality (as in Cover Your A##) that gives rise to the perceived lack of originality and abundance of me-too drugs. It is fine to have multiple companies racing for the same target in order to get the best in class drug. But come on, you end up with *every* company working on the *same* targets. Why? Well if company X, Y, and Pfizer work on it, we should do it as well. If it fails, well, all the other smart companies were working on it, so we don't look so bad. It gives the appearance of reducing risk, but the only risk being reduced is your risk of a hella good spanking from your boss in the end. After all, all the *smart* people were doing it. So you are still perceived as smart, and you can always buy a program from some biotech.

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14. Tom on January 26, 2011 1:53 PM writes...

An interesting read, but I'm not sure this is quite as exculpatory as you make it out to be. So, okay, yes, it seems that me-toos are not responses to one another, but rather simultaneous and independent development efforts. But:

* Doesn't this undercut the argument (often advanced here) that "basic" research (aka publicly funded research) is a portion of the drug development process of minor importance relative to the attention it's given by Angell et al? At the very least this paper seems to be an argument in favor of shifting how we perceive the distribution of value (not to say cost) across the drug development process.

* The points made in comments about the value of me-toos seem convincing. But are you maintaining that these opportunities to improve or fine-tune a drug class are as important as the creation of that class? This seems like a stretch to me, though perhaps I'm wrong to think so. Yet our present system seems to provide incentives for fine-tuning at the same (or in aggregate, a greater) level than the initial discovery. To some extent this is an intractable chicken-and-egg problem. But it does seem as though a world with perfect information sharing (impossible without the removal of competitive pressure) would allow for more efficient resource allocation. That kind of perfectly utopian scenario is clearly not achievable, but surely there are ways to improve the set of incentives we have now (shorter periods of patent protection for later entries in a class, as determined by their emergence from Phase X?).

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15. johnnyboy on January 26, 2011 2:15 PM writes...

to #11: I don't think pharmas lose 100% market share when their drug goes generic. Many docs keep prescribing the original drug despite availability of generic, because many docs prefer sticking with what they know - unless they are forced to switch because of insurance/reimbursement issues.

to #14: I don't really see the link you're making between those two arguments. As to your second point, the first-in-class drug does get something of a preferential treatment; FDA will always be more lenient in approval for a FIC (especially one targeting a poorly-met need) than it is for the me-toos that come later. For one, the me-toos will have to prove not only that they are efficaceous, but also that they are similar or better than the FIC in some respect. The other incentive of course is that being FIC allows a lot more freedom for pricing, whereas me-toos have to more or less follow the FIC's price.

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16. qetzal on January 26, 2011 2:25 PM writes...

Tom,

Based on some of the examples above, it sounds to me that the fine tuning may well be just as valuable as creating the class. It seems to be pretty common that the first in class is actually not such a great drug, often due to unexpected tox. A new drug class doesn't have much value if the first and only class member turns out to be fairly crappy.

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17. RickW on January 26, 2011 3:17 PM writes...

I haven't seen biosimilars mentioned here, yet. These will be more like me-too drugs than generics in terms of money and time, and at this point they are starting from scratch, competing with already established biologics. Some of these will turn out to be better drugs, but with so many big biopharmas committing to biosimilar development I have to think that will take resources away from new targets and disease areas. Probably a good move for the companies, though.

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18. Petros on January 26, 2011 3:20 PM writes...

Companies certainly don't lose 100% of revenues when generics bite, especially in Europe.

In 2009 Adalat (invented ca 1963) still produced nearly $1 billion in revenues for Bayer while Aspirin generated $438 million!

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19. milkshake on January 26, 2011 3:25 PM writes...

If you don't have a good lead from HTS you are likely to start looking into structures that came out in someone else patents, and chances are that you will find a good way to bust these patents. That's why the 2-3 years delay for me-too series.

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20. ex-Pfizerite on January 26, 2011 3:33 PM writes...

to #11 the fifth largest generic "company" is Greenstone the generic division of Pfizer and Sandoz, the generic division of Novartis is the 2nd or 3rd largest generic in the US. Foe both companies you will see them sell both a branded and generic of the same drug with different pricing. For off-patent Pfizer drugs your best choice is to go with Greenstone.

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21. William B Swift on January 26, 2011 5:15 PM writes...

#15 and 20: Thanks. That is more or less what I thought, but I don't know enough myself and didn't have a better idea where to find more information.

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22. drug_hunter on January 26, 2011 11:28 PM writes...

The biggest issue here is the difficulty of target validation. We all end up working on the same targets, at about the same time, because we're all depending on the same public information to decide what to work on. In 20 years, I can only recall a couple of times where my company has been way ahead of the pack -- despite a strong emphasis on pursuing novel targets. The usual pattern goes like this: (1) Pick an interesting target that is pretty new, based on academic literature and/or our own in-house biology. (2) Look around and find no pharma publications or patents. (3) Jump in, and assume we are in the lead. (4) 18-24 months later, start reading lots of papers and patents from all over the industry and realize that 5 other companies all started working on the target at more or less the same time we did.

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23. CMCguy on January 26, 2011 11:45 PM writes...

#11 WBS I have some different responses to the statements. Although true some Pharma's have own generics divisions to "compete" with themselves more often than not the "Branded" product remains high priced. I also found it somewhat crazy partly because you would expect certain inherent advantages and when I have asked some one in Marketing they said "we can't do that as it will give the wrong impression" which I find ludicrous considering how cutting prices once off patent would probably generate a better public view.

Conversely traditional Pharma Manufacturing & Plants can carry both high overhead burden, big margin mandates and older technology that make them unable to reduce costs as much as many generics/outsourcing facilities so not that much competitive advantage. Likewise unlike majority of chemical industry Pharma returns has not forced efficient process development so old drugs can be made with 15-20 year dated technology without introduction of much continued improvements. Once set there is so much resistance to any changes that drug manufacture is "locked" and without ability to demonstrate strong ROI the incentive may be stay less than ideal routes/facilities. Generic companies may not be innovative in discovery and often model is outsource to lowest cost counties (who can have 5-10 year old technology lag) however there are some focused on process and engineering that will introduce beneficial advances to making older drugs. It really is a strange situation.

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24. me-too on January 27, 2011 3:25 AM writes...

First there is no clear definition of a me-too drug, only that it is a) structural similar (whatever that means) and/or b) have the same mode of action than the first in class drug. I think one of the reasons why "me-too" drugs are seen as "bad" or non-innovative, is the focus on structural similarity, as expressed in this comment:" these opportunities to improve or fine-tune a drug class are as important as the creation of that class?" The problem with this is that activity and further PK/PD/Tox properties or profiles are often far from obvious. A perceived simple structural change (fine tune) can turn a compound from not acceptable to a drug. The whole drug design process is focused on finding these changes in an efficient way. In general this easy task (believing the critics of me-toos) takes about 4 years and the design and synthesis of hundreds to a couple of thousand compounds made for this structural class. The reason why this is such a complex task was already shown by a german chemist in 1840 Friedrich Wöhler who published under the pseudonym of S. C. H. Windler an article where he argues against the substitutions theory. Sadly this seems still hard to accept and to understand not only in the public, but also in the chemistry community. Drug design is an art as it is a science.

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25. BCP on January 27, 2011 10:20 AM writes...

Another point here is that it can often be a crapshoot with a competing group of compounds all within a year or two in development, as to who will make it across the line first? Or will anyone? A couple of examples pop into my head, the first was the glliptins - Januvia made it first, while Galvus ran into a buzz saw at FDA post NDA filing. The other example that is currently playing out is the CETP inhibitor race: Pfizer looked to have that sewn up until torcetrapib imploded. Now anacetrapib is left in sole possession of the lead in that area. Of course, Merck has now got an increased perception risk on it's hands as a reward; if they're successful their decision to follow Pfizer will be brave and visionary, if they fail it'll obviously be because of their "me too" approach.

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26. Vader on January 27, 2011 1:16 PM writes...

Old Pharma Guy is right, and I'd add metformin to the lists of drugs that superficially look like a "me too" but prove safer or more effective than the original. What I don't understand is why this is surprising anyone. Why can't improvements be incremental?

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27. ba on January 27, 2011 1:32 PM writes...

I think the term "patent bust" has some unfairly negative connotations which are closely related to those of the "me-too" type. Most of the time, a close reading of a patent will give substantial clues as to which compound/s therein are the leads. Often one "skilled in the art" will be able to pick out exactly which compound is THE lead. Furthermore, once in the clinic, the structure of the lead compound is given. When a company puts together a patent, usually every compound that has been synthesized (and shows any measurable activity) will be included in that patent as a table example. Therefore, if you can find a small structural change that results in a series of compounds that compare favorably to the known lead, I'd argue that is a good thing. While this is considered a "patent bust", if the parent company could not or did not think to synthesize your new variant, why should the collective med-chem community not explore this space? If it leads to a drug, that result is good for everyone, except perhaps the parent company who missed something. That is life in a competitive marketplace.

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28. Trottelreiner on January 28, 2011 2:15 AM writes...

At little bit nitpicking, but at least in the case of the SSRIs, one can argue which one is the first drug in class; before fluocetine, there was fluvoxamine, and even before that, zimelidine, though that one was later withdrawn. Of course, fluvoxaimne was approved in the US later than fluvoxamine, but one can argue that the introduction in Europe was something of a proof of concept. More important might be that using worldwide data, e.g. drugs in Europe and the US might change some of the earlier dates.

In the case of the selective estrogene receptor modulators, initial use was as an contraceptive, where they failed, it was later they were used in breast cancer. Controlling for serendipity in the use of a drug class might change the picture, too.

A general problem is that most of the drugs were approved in the late 70s and after, which skews the data towards smaller time frames in the present.

Also of interest would be to look at the chemical similarity and the time frame, e.g. timolol and propanolol are quite similar in chemical terms, but there are 10 years between them; fluoxetine and sertraline are quite unrelated, but it only was 4 years between them.

Other than that, even before this paper, looking at the epic fail that were the CB1 antagonists should have put a damper on any industry bashing, though thiongs like escitalopram and like get my blood pressure rising...

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29. Janoa FISCHER on January 28, 2011 2:23 AM writes...

Dear Colleague,

I agree with your analysis. I recommend all the experts to read the books "Analogue-based Drug Discovery I and II (2006 and 2010 at Wiley-VCH) to get rid of this misleading term "me-too".

28 January 2011 Janos Fischer

Permalink to Comment

30. Karoly Tihanyi on January 28, 2011 8:19 AM writes...

Let's think patient-wise and try to forget big-pharma attitude for a moment.

As a patient I am happy to have a wide selection of statins (exemply gratia)and make my choice on therapeutic ground : I can select the least brain penetrant, or the more efficient or the least prone to DDI etc. drug. I could also cite the SSRIs with slightly differing profile, all having special therapeutic value.
To me therapeutic value listed in the first line even though marketing value usually takes over the number one aspect.
On the ground of "new therapeutic value"-wise thinking the development of "me too " drugs is more than justified.

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31. Terry McCormick on January 28, 2011 10:57 AM writes...

Glad to see this issue highlighted and appreciate the data & insights. Back in the 1980's we saw this first hand while developing the first ACE inhibitors and looking "over our shoulder". Twenty years later in 2002, I presented a smaller analysis showing the evidence of such "fast follower strategies". See the link below for another overview with those graphics. This showed how first-to-market advantages started slipping in the 1990's. The gold overlaid line in the third graphic is an average of all major drug sales patterns. True NME's lost growth to "me-too" peers just 2.5 years post launch. On my blog: http://www.randdreturns.com/a-history-of-time-to-market-thinking-in-pharma/

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32. simpl on January 31, 2011 10:57 AM writes...

I agree with BCP in #25 that current approval appear to make 2nd past the post tougher, with the FDA seeming to change goalposts after clinical trials start, based on their knowledge of competing molecules. My examples would be MS drugs, where cladribine got discarded on uncertainty in a largely unclear theraputic area. On fall-away by selection in the market, consider COX II inhibitors, where none of the entrants escaped unblemished, though they differ in side-effects. The selection process didn't seem that rational, however.

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