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December 22, 2011
More From Hua - A Change of Business Plans?
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)
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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 Comment2. 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 Comment3. 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 Comment4. 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 Comment5. Anonymous on December 22, 2011 5:09 PM writes...
Derek,
Permalink to CommentI 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.
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 Comment7. 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 Comment8. 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...
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