Corante

About this Author
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

Chemistry and Drug Data: Drugbank
Emolecules
ChemSpider
Chempedia Lab
Synthetic Pages
Organic Chemistry Portal
PubChem
Not Voodoo
DailyMed
Druglib
Clinicaltrials.gov

Chemistry and Pharma Blogs:
Org Prep Daily
The Haystack
Kilomentor
A New Merck, Reviewed
Liberal Arts Chemistry
Electron Pusher
All Things Metathesis
C&E News Blogs
Chemiotics II
Chemical Space
Noel O'Blog
In Vivo Blog
Terra Sigilatta
BBSRC/Douglas Kell
ChemBark
Realizations in Biostatistics
Chemjobber
Pharmalot
ChemSpider Blog
Pharmagossip
Med-Chemist
Organic Chem - Education & Industry
Pharma Strategy Blog
No Name No Slogan
Practical Fragments
SimBioSys
The Curious Wavefunction
Natural Product Man
Fragment Literature
Chemistry World Blog
Synthetic Nature
Chemistry Blog
Synthesizing Ideas
Business|Bytes|Genes|Molecules
Eye on FDA
Chemical Forums
Depth-First
Symyx Blog
Sceptical Chymist
Lamentations on Chemistry
Computational Organic Chemistry
Mining Drugs
Henry Rzepa


Science Blogs and News:
Bad Science
The Loom
Uncertain Principles
Fierce Biotech
Blogs for Industry
Omics! Omics!
Young Female Scientist
Notional Slurry
Nobel Intent
SciTech Daily
Science Blog
FuturePundit
Aetiology
Gene Expression (I)
Gene Expression (II)
Sciencebase
Pharyngula
Adventures in Ethics and Science
Transterrestrial Musings
Slashdot Science
Cosmic Variance
Biology News Net


Medical Blogs
DB's Medical Rants
Science-Based Medicine
GruntDoc
Respectful Insolence
Diabetes Mine


Economics and Business
Marginal Revolution
The Volokh Conspiracy
Knowledge Problem


Politics / Current Events
Virginia Postrel
Instapundit
Belmont Club
Mickey Kaus


Belles Lettres
Uncouth Reflections
Arts and Letters Daily
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

« Merry Christmas, Fred | Main | Holiday Break »

December 22, 2011

More From Hua - A Change of Business Plans?

Email This Entry

Posted by Derek

You may remember the mention of Hua Pharmaceuticals here back in August, and the follow-up with details from the company. They're trying to in-license drugs from other companies and get them approved as quickly as possible in China. The original C&E News article made them sound wildly ambitious, while the company's own information just made them sound very ambitious.

Now we have some more information: Roche has licensed their glucokinase activator program (for diabetes) to Hua (that's a development effort I wrote about here). And that's an interesting development, because the Hua folks told me that:

"Hua Medicine intends to in-license patented drugs from the US and EU, and get them on the market and commercialized in the 4 year timeframe in China. This is about the average time it takes imported drugs (drugs that are approved and marketed in the US or EU but are coming newly into the Chinese market) to get approved by the SFDA in China."

And that's fine, but Roche's glucokinase activators haven't been approved or marketed anywhere yet. In fact, I'm not at all sure of the lead compound ever even made it to Phase III, so there's a lot of expensive work to be done yet, and on a groundbreaking mechanism, too. The only thing I can say is that approval in the US for diabetes drugs has gotten a lot harder over the years - the market is pretty well-served, for one thing, and the safety requirements (particularly cardiovascular) have gotten much more stringent. Perhaps these concerns are not so pressing in China, leading to an easier development path?

Easier or not, these compounds have a lot of time and money left to be put into them, which is not the sort of program that Hua seemed to be targeting before. One wonders if there just weren't any safer bets available. At any rate, good luck to them, and to their financial backers. Some will be needed; it always is.

Comments (8) + TrackBacks (0) | Category: Business and Markets | Diabetes and Obesity | Drug Development


COMMENTS

1. pilsner on December 22, 2011 11:26 AM writes...

You have to wonder if the strategy of in-licensing what would seem to be cast offs from large pharma will ultimately play out favorably. It seems to be a trend that is growing in popularity, but I have my doubts.

Permalink to Comment

2. exmbb on December 22, 2011 11:46 AM writes...

You have to understand the context here. The Chinese government wants to have a domestic branded Blockbuster drug. The SFDA will potentially look the other way

Permalink to Comment

3. MTK on December 22, 2011 12:33 PM writes...

@1,

There's lots of examples of compounds that were rescued from the trash heap and ended up being successful drugs, so the model can, in theory, work.

Given the low success rate of compounds chosen to go into the clinic or given priority over others, it's easy to imagine that the risk in trying to develop those that were deprioritized is not that much greater.

Permalink to Comment

4. Dylan on December 22, 2011 12:48 PM writes...

Derek, the first comment in your follow-up piece on Hua said that they are looking to license in earlier stage compounds as well as already commercial stage. I didn't get the impression that they were still going to try to get these earlier stage drugs to market in China in 4 years.

Permalink to Comment

5. Anonymous on December 22, 2011 5:09 PM writes...

Derek,
I believe you are correct about the CV requirements and how that effected the decision making at Roche. But also, don't forget that the GK activators were discovered in NJ while the met. dieases headquarters (mother ship) was based in Basel. So, my understanding was that there were some serious Swiss/US politics that also came into play.

Permalink to Comment

6. Anonymous on December 23, 2011 9:24 AM writes...

Hua needs to show investors that they have something in their pipeline and that they can afford in-licensing compounds, thus they will be able to get more financial backing. I don't think any GKA can be successful

Permalink to Comment

7. Anonymous on December 25, 2011 8:03 PM writes...

Roche dropped the entire small molecule programms in diabetes area two years ago.

Roche GKa has been in phase II for a long time....

Permalink to Comment

8. Anonymous on January 1, 2012 6:00 PM writes...

Roche needs new chemistry management in Nutley, NJ. Passing around rubber chickens isn't going to lead to productivity or motivation. The immaturity is destroying the place...

Permalink to Comment

POST A COMMENT




Remember Me?



EMAIL THIS ENTRY TO A FRIEND

Email this entry to:

Your email address:

Message (optional):




RELATED ENTRIES
XKCD on Protein Folding
The 2014 Chemistry Nobel: Beating the Diffraction Limit
German Pharma, Or What's Left of It
Sunesis Fails with Vosaroxin
A New Way to Estimate a Compound's Chances?
Meinwald Honored
Molecular Biology Turns Into Chemistry
Speaking at Northeastern