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
If you want to see the effects of (a) patent expirations on big-selling small molecules and (b) the lack of patent expiration effects on biologics (for now), take a look at the likely list of best-selling drugs of 2012. There are three small molecule therapies in the top ten: Advair, Crestor, and Lipitor, all of which are getting rather elderly. More show up below that point, but it's going to be hard to dislodge those antibodies from the upper reaches of the list. . .
I don't know...I am cautiously optimistic about antibodies, although as an article I blogged about a while back described, biologics have problems of them own: http://tinyurl.com/8o73ea7
That's what happens when Pharma pretty much throws in the towel on drug discovery. They used to tell us "The Patient is Waiting". The patient's next of kin will take little comfort from that assurance.
5. NoDrugsNoJobs on November 20, 2012 10:26 AM writes...
Interestingly, Hatch-Waxman has incentivized the rapid cannibalization of small molecule drugs with the goal of bringing affordable meds to patients and in the process has driven drug makers out of small molecules and more into much more expensive biologicals (law of unintended consequences?)Instead of trying to rectify the problem by recognizing the serious trouble the small molecule pharma industry will/is finding itself in and making the necessary changes to Hatch Waxman to encourage further research, our government is seeking to make it easier to destroy the biological industry as well. Instead of win-win we will ultimately find ourself at lose-lose. The terms of patents and data exclsuivity periods are not set in stone and the relative incentive for all different technology should not be the same but yet it is. Why do we give almost the same patent life to a shaving razor with an extra blade that took 1 year and 5 million to develop as we do to a drug that took 15 years and >1 billion to develop? Does this make sense? I am afraid by the time people eventually figure all this out, what was once our noble industry will lie in smoking ruins and the government that once worked so hard to bring it to its knees will be actively subsidizing it, reminding me of a thing I once heard:
If it moves, tax it; if it still moves; regulate it; when it stops moving; subsidize it.
6. Leedschemist on November 20, 2012 11:16 AM writes...
Surprised to see herceptin up there, it doesn't work all that well! It struggled to get approval in the UK for use on the NHS.
Antibody treatments are very exciting in general the Seatle genetics ADC stuff (room for chemists on that type of project as well BTW) is really cool, although getting homogeneous ADCs is tough they tend to be administored with average drug loadings.
Antibodies are the fashion at the mo but fashions change(hopefully quite quickly).
7. Helical_Investor on November 20, 2012 11:40 AM writes...
Well yeah. We can in part thank Hatch-Waxman for driving companies to invest more in biotherapeutics, where the products can command higher prices and the risk of patent expiration / market collapse is only modest. Why create a small molecule for only on average ~10 years of market exclusivity (and only 5 for sure), when you can create a biopharmaceutical that should maintain significant share even post expiration.
One scary upside (if you want to call it that) is that the market acceptance of high price biotherapeutics seems to be allowing pharmas to price small molecule drugs much higher (for now). Do you think that even Pfizer would have the gall to consider pricing small molecule Xeljanz/tofacitinib where it is if not for the price tag on Humira.
The next 'arena' for me too drugs is small molecules attempting to compete with biologics where they think they can.
1. Curious Wavefunction on November 19, 2012 11:23 AM writes...
I don't know...I am cautiously optimistic about antibodies, although as an article I blogged about a while back described, biologics have problems of them own: http://tinyurl.com/8o73ea7
Permalink to Comment2. TBW on November 19, 2012 11:58 AM writes...
Does anyone else work at a company that blocks Twitter?
Permalink to Comment3. Fred on November 19, 2012 12:21 PM writes...
That's what happens when Pharma pretty much throws in the towel on drug discovery. They used to tell us "The Patient is Waiting". The patient's next of kin will take little comfort from that assurance.
Permalink to Comment4. Morten G on November 20, 2012 6:52 AM writes...
TBW, it's a list from the ugliest website in the world: http://www.fiercepharma.com/special-reports/15-best-selling-drugs-2012
And it's not best-selling drugs, it's highest grossing! Big, humongous difference.
Permalink to Comment5. NoDrugsNoJobs on November 20, 2012 10:26 AM writes...
Interestingly, Hatch-Waxman has incentivized the rapid cannibalization of small molecule drugs with the goal of bringing affordable meds to patients and in the process has driven drug makers out of small molecules and more into much more expensive biologicals (law of unintended consequences?)Instead of trying to rectify the problem by recognizing the serious trouble the small molecule pharma industry will/is finding itself in and making the necessary changes to Hatch Waxman to encourage further research, our government is seeking to make it easier to destroy the biological industry as well. Instead of win-win we will ultimately find ourself at lose-lose. The terms of patents and data exclsuivity periods are not set in stone and the relative incentive for all different technology should not be the same but yet it is. Why do we give almost the same patent life to a shaving razor with an extra blade that took 1 year and 5 million to develop as we do to a drug that took 15 years and >1 billion to develop? Does this make sense? I am afraid by the time people eventually figure all this out, what was once our noble industry will lie in smoking ruins and the government that once worked so hard to bring it to its knees will be actively subsidizing it, reminding me of a thing I once heard:
If it moves, tax it; if it still moves; regulate it; when it stops moving; subsidize it.
Permalink to Comment6. Leedschemist on November 20, 2012 11:16 AM writes...
Surprised to see herceptin up there, it doesn't work all that well! It struggled to get approval in the UK for use on the NHS.
Antibody treatments are very exciting in general the Seatle genetics ADC stuff (room for chemists on that type of project as well BTW) is really cool, although getting homogeneous ADCs is tough they tend to be administored with average drug loadings.
Antibodies are the fashion at the mo but fashions change(hopefully quite quickly).
Permalink to Comment7. Helical_Investor on November 20, 2012 11:40 AM writes...
Well yeah. We can in part thank Hatch-Waxman for driving companies to invest more in biotherapeutics, where the products can command higher prices and the risk of patent expiration / market collapse is only modest. Why create a small molecule for only on average ~10 years of market exclusivity (and only 5 for sure), when you can create a biopharmaceutical that should maintain significant share even post expiration.
One scary upside (if you want to call it that) is that the market acceptance of high price biotherapeutics seems to be allowing pharmas to price small molecule drugs much higher (for now). Do you think that even Pfizer would have the gall to consider pricing small molecule Xeljanz/tofacitinib where it is if not for the price tag on Humira.
The next 'arena' for me too drugs is small molecules attempting to compete with biologics where they think they can.
Ralph
Permalink to CommentHelical Investor