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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

« Verastem's Chances | Main | The Blackian Demon of Drug Discovery »

March 13, 2012

Nexavar Licensed by Force in India

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Posted by Derek

India has decided to invoke compulsory licensing, and is approving a local generic company's application to make and sell Bayer's Nexavar (sorafenib).

I'm assuming that there's a political dimension to this that I'm not quite following. There must be something else going on between Bayer and the Indian authorities. Nexavar is indeed expensive, but (meaning no offense to the people who discovered it, whom I know), it's not the most necessary part of the oncology drug world, either. Anyone have more details?

The most recent time this issue has come up here is 2007.

Comments (26) + TrackBacks (0) | Category: Drug Prices | Regulatory Affairs


COMMENTS

1. Anonymous on March 13, 2012 1:48 PM writes...

It's not just the matter of the overpricing. It's also an issue of politics, concerning local production/importing stuff, as well as caste politics. Bayer's been in India for over 100 years, and apparently some of the higher-ups have quietly supported some of the more hardline caste system supporters.

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2. PharmaHeretic on March 13, 2012 1:48 PM writes...

Not all countries are entirely run by corporate interests.

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3. CMCguy on March 13, 2012 2:02 PM writes...

I have no insight into the particulars behind this but surmise a couple things: Simply legitimizes what has been going on for years in India (and China as well) that have allowed companies to make and sell Patented products for "internal" consumption (if some exported to other "needy" countries well that's OK too). Also very likely a test case to act as precedent to apply to other expensive drugs to open mechanism for more CLs ( to be applied if Pharma's do not more willingly accede to demands).

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4. Nekekami on March 13, 2012 2:10 PM writes...

OK, I'm the Anon in post #1, forgot that I had cleared the cache.

To fill in with some more, according to some rumours on a mailing list centering around topics similar to Derek's blog, Bayer simply has no interest in an Indian market for Nexavar, one poster even going so far as stating that "Last year Bayer sold 493 boxes of 120 tabs of Sorafenib in India. That was enough for about 49 people, in a country with a population of 1,210,193,422.". The fact that the poster goes into very specific numbers does lead me to give at least some consideration that it might not be baseless.

Couple that with the fact that in a court case against another generic manufacturer, Cipla, Bayers argue that the Indian population does have access to Sorafenib, thanks to the same generic that they are trying to stomp out through the lawsuit...

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5. whiz on March 13, 2012 3:16 PM writes...

Its just irresponsible behavior and Price Gauging from Bayer that has led to this decision.

In general, US administration take on compulsory licensing is that it should be only used for communicable diseases under medical emergencies. I am not sure how important this drug is for cancer treatment ( some news sites saying it will increase the life span by an average of 3 months) but less than 2 percent of patients used the drug in India last year which says a lot.

Bayer had 3 years (compulsory licenses clauses are applied by India only after 3 years in case of non-emergencies) to grab a good market share with fair pricing. It costs $70K/year now and is used by 2%. If the drug was even $10K/year, it could have been used by a lot more people. Bayer would have still got good revenue and good profits.

I know Drug Discovery is a tough and there are many failed drugs for every successful one but pharma companies are not making any friends by evergreening and price gauging.

I applaud the decision of Controller of Patents, Mr Kurian. This decision should be an eye opener for Big Pharma. If they don't do fair play, they are set to lose.

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6. darwinsdog on March 13, 2012 4:10 PM writes...

History: Nexavar came out of ONYX Pharmaceuticlas which partnered it's bisaryl urea hits with Miles (Bayer) who co-selected one of these for development and it is sorafenib (Nexavar). Onyx still has some owenership of the drug which is the only reason they have a 2Bill market cap. today. It must make for interesting meetings to co-own a drug with a partner who is actively trying to develop a follow-on to compete with it.

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7. Student on March 13, 2012 5:15 PM writes...

I wonder if Pfizer scrapping their deal had anything to do with this move on India's part?

in.reuters.com/article/2012/03/13/pfizer-biocon-idINDEE82C01K20120313

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8. Derek Lowe on March 13, 2012 6:11 PM writes...

#6 Darwin: I'm not sure where the biaryl urea series came from originally, but I can tell you that sorafenib itself was made at Bayer, right down the hall from my old lab, not long before I arrived.

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9. HTSguy on March 13, 2012 6:50 PM writes...

It looks as though the program started at Onyx and then became a joint program:

http://dx.doi.org/10.1038/nrd2130

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10. Derek Lowe on March 13, 2012 7:28 PM writes...

It was a joint program, but (in an unusual reversal of the way these things usually work), the compound actually came from the larger company in this case. Sorafenib itself was synthesized in the lab of one of the coauthors of the paper referenced in #9 (Tim Lowinger), by his lab assistant Reina Natero. They're both on the patents mentioned Note that all the authors on these composition-of-matter patents are from Bayer.

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11. Entreprenuer on March 13, 2012 7:34 PM writes...

#6 Darwin: As Derek pointed out, Nexavar was discovered at Bayer after making tons of urea analogs. Original hit was commercially available urea compound. You are not alone who believes that it came out of Onyx, I guess, except bunch of Bayer chemists, almost everybody else thinks that way, I am not sure why!!

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12. Anonymous on March 14, 2012 12:32 AM writes...

"It was a joint program, but (in an unusual reversal of the way these things usually work), the compound actually came from the larger company in this case."

Do the chemists still work at Bayer???

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13. Anonymous on March 14, 2012 4:42 AM writes...

I read that as:

"Nexavar Licensed by Force India"

Which would have been an odd story, must be the impending F1 season getting into my head!

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15. RB Woodweird on March 14, 2012 7:03 AM writes...

There's quite a hot conversation about this going on over at Reddit right now:

http://www.reddit.com/r/worldnews/comments/qu4lc/indian_govt_uses_special_powers_to_slash_cancer/

The derp there seems to be going like this:
1. Most drug research is done in academia
2. Pharma rips off those drugs and bribes the government to give out monopolies
3. The cost to bring a drug to market is only about $50 million or so
4. etc. etc.

Example post below, as it relates to this venue:

(first poster, defending numbers obtained from In The Pipeline posts) I don't know Derek, but I do know that he knows more about the industry than anyone posting here.

(second poster replies) That's your problem. You see, I know who Derek Lowe is. He's a shill for the pharmaceutical industry, having taken large sums of money from them before.

I don't know what he knows about the industry, but I do know is that I wouldn't take his word for it. He's a paid mouthpiece for them, why should anyone believe him? Why don't the pharmaceutical companies just do away with all this argument that has been going back and forth about drug costs for 2 decades now? All they have to do is release a breakdown of R&D costs so people can do their own calculations. But they have consistently refused to do this, while hiring paid mouthpieces like Lowe and DeMasi before him to push ridiculous numbers with absolutely no basis in any public records.

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16. RB Woodweird on March 14, 2012 7:38 AM writes...

And this is being argued over on Slashdot as well:

http://science.slashdot.org/story/12/03/13/1716206/indian-govt-uses-special-powers-to-slash-cancer-drug-price-by-97

with this beaut of a sample comment:

1. Most drug company expenditure is on marketing;
2. Most drug research is academic;
3. They can settle for less profit;
4. If they won't settle for less profit, someone else will be prepared to take their position in the market.

Problems solved.

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17. johnnyboy on March 14, 2012 9:27 AM writes...

@RB (#15, 16): sadly, this is essentially the essence of pretty much every lefty layman discussion about pharma. The only point missing would be
5. Most of the pharma research is on made-up diseases like ED and PMS

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18. Anonymous on March 14, 2012 10:37 AM writes...

Woodweird--thanks for pointing out the takeaway that the public is getting from this. Geez that's depressing.

Reminds me of all the nationalizations in "Atlas Shrugged" that everyone laughs at. "We'll just make them cure our diseases for us!"

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19. Sigivald on March 14, 2012 1:15 PM writes...

Its just irresponsible behavior and Price Gauging from Bayer that has led to this decision.

Price gouging, ah. The old standby of someone who thinks they know The Real Price Of A Good better than the people who actually have to make a living selling it.

Sorry, but I hear "price gouging" and all that comes through is "I want it cheaper" - because in real examples of the term being used, that is all it's ever meant every time I've seen it.

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20. CMCguy on March 14, 2012 2:14 PM writes...

"I know who Derek Lowe is. He's a shill for the pharmaceutical industry, having taken large sums of money from them before" Gosh Derek you most really like the lab/Boston because if you made salary and bonuses of either lobbyist or Pharma CEOs (true shills) would have expected you to be posting your blog from a tropical island or other such venue.

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21. darwinsdog on March 14, 2012 4:03 PM writes...

Those filings are much more recent (2000's). The original patent issuings had Onyx scientists and Miles - remember this pharmacophore was discovered in the early 90's chemists at Onyx and Miles subsequently made a minor modification to the Onyx lead bis aryl urea to improve PK - it's all been published.

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22. researchfella on March 14, 2012 4:32 PM writes...

@darwinsdog: You'd better read those publications again. If you think the initial urea screening hit that Onyx contributed to this project (i.e, commercially available compound, IC50 = 17 uM against Raf, nanomolar against p38) was the major part of this drug discovery effort, then you understand very little about drug discovery. The major breakthroughs to achieve sub-micromolar potency against Raf and the optimization work to achieve decent PK and ultimately a drug candidate were all by Bayer research employees at Bayer, West Haven, CT. None of that medchem work was carried out at Onyx, contrary to popular misconception. Yes, the first patent, but only the first patent, includes both Onyx and Bayer researchers, and it describes analogs of the screening hit that were quite weak as Raf inhibitors - sorry. The breakthrough and significantly optimized compounds are described in multiple Bayer-only patents that followed.

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23. researchfella on March 14, 2012 4:36 PM writes...

@Anonymous re: "Do the chemists still work at Bayer???"
Well, considering that the entire Bayer campus in West Haven, CT was shut down in 2007, I think you can answer that question.

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24. Thomas on March 15, 2012 2:33 PM writes...

I heard that the USA applied compulsory licensing to Cipro around 2001, the anti-anthrax antibiotic by Bayer. Googling it now tells me that this has not been the case, but some people thought it should.

Which leads me to believe that reporting about this is often biased.

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25. metaphysician on March 15, 2012 4:23 PM writes...

IMO, "price gouging" in itself shouldn't ever be a crime. If you charge what the market can be, then that is that. However, "price gouging" in the sense of charging much more than would logically seem to be the fair market price, can be an indicator that some *other* unfair market practice might be at work.

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26. anon on March 17, 2012 12:37 PM writes...

#23: Nexavar was discovered shortly before I started working at Bayer. I overlapped with Reina briefly before she left to study pharmacy.

Most of the chemists left West Haven in Jan-Feb 2007, but a few higher level people were retained to go to Germany. Several of my former chemistry colleagues also chose to pursue careers in fields such as clinical and regulatory, and some stayed with Bayer in those pursuits (moved to NJ or Asia).

Three former chemistry colleagues from Bayer are now at my current employer, as well as an HR person (and probably more that I am not aware of).

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