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June 23, 2010
Lilly's Statin - Yes, It Is 2010
Posted by Derek
Aficionados will remember that Warner-Lambert nearly killed Lipitor along the way because they felt that the statin market was too crowded. Well, now Lipitor's patent is going to finally expire next year, which will make it even harder for anyone to turn a buck on anything higher-priced.
So Eli Lilly is, yes, bringing a statin of their own to market. Livalo (pitavastastin) will try to make headway based on a slightly lower price than Crestor (the big dog, after next year, among the patent-protected statins) and a different metabolic profile that might decrease drug-drug interactions.
Lilly brought this one in from Kowa of Japan, and it's hard to see how they'll get too many people excited about it. And while I certainly understand to need to make some money, one way or another, making it this way doesn't add mmuch to the case for Big Pharma innovation, does it? Maybe there are enough people out there who will benefit from another alternative - but no one can say that the world was waiting for another statin, that's for sure.
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1. Mark on June 23, 2010 12:32 PM writes...
When I saw this news I thought "How big of a market could drug-drug interactions be with statins?"
1% of the current market? Maybe? And even then you could probably switch to another generic statin.
Mark
Permalink to Comment2. emjeff on June 23, 2010 1:36 PM writes...
I certainly agree with this post. The risk of bringing another statin to market, given the large outcome trials that need to be done for registration seems not to be worth the effort.
Permalink to Comment3. David on June 23, 2010 2:10 PM writes...
@emjeff
Permalink to CommentI certainly don't understand why Lilly would want to go to the effort to market a relatively undifferentiated statin w/o any outcomes studies to back it up in a largely generic market where the other branded statins have shiny bright halos from years of sales and outcomes studies (especially the recent data on Crestor). That said, the drug has already been approved, and (for now at least) it is still possible to register on LDL lowering alone with no need for outcomes. Of course successful registration and getting reimbursement are two completely different things.
4. Skeptic on June 23, 2010 11:57 PM writes...
You can never have enough statins for the simple reason that the fantasies of them being useful in treating AD never ends.
Permalink to Comment5. Kent G. Budge on June 24, 2010 3:32 PM writes...
I find the statistics on improved outcomes for diabetic patients taking statins to be persuasive enough that I'd hate to give mine up.
But I'm taking pravastatin, being a tightwad and all.
Permalink to Comment6. NHR_GUY on June 24, 2010 9:33 PM writes...
What is not being appreciated is that while this statin is way late to the game, this statin is indeed differentiated from others because it is not metabolized by CYP3A4. Most of my career has been in the CV arena and with every drug we pushed forward we had to be very cognizant and careful about CYP3A4 inhibition. The reason being that most of the patients who would be taking our drugs would also likely be taking a statin. The obvious affect being an unwanted DDI and hence higher levels of statin in the system and thus more unwanted side effects. I think if doctors had a statin in their arsenal, that could get their patients to target and also could be co-administered with other CV drugs they would prescribe it. BTW, I bet the inventors of Lipitor, if given a chance to go back and do it again, would make a drug that would not be metabolized by 3A4 (but they would try and keep in the serendipitous enterohepatic recirculation of the Lipitor metabolite which gives Lipitor an efficacy boost).
Permalink to Comment7. Anonymous on July 28, 2010 10:02 PM writes...
OK, so now i guess anyone a new and improved statin can go ahead and drink grapefruit juice and not worry about drug/drug interactions and driving their cholesterol levels to new lows. Remember, cholesterol is critical for life. Have a look at Smith-Lemli-Opitz Syndrome...a where there's a defect in the cholesterol synthesis pathway.
http://en.wikipedia.org/wiki/Smith-Lemli-Opitz_syndrome
Cholesterol is probably not the culprit...it's the circulating band aid that depot's on lesions in an attempt to protect them. Cholesterol levels is just a read-out or biomarker. It's validity as a biomarker is still questionable. I think what you will see in the future is new biomarkers emerging that read/target inflammation. I could be wrong but let's wait and see...
Permalink to Comment8. Cheri on August 1, 2010 9:20 PM writes...
Obviously those of you who don't see the need to bring a new statin on the market that would eliminate drug interaction have never experienced it!!!!! I have taken numerous varities of statins to lower my cholesterol, only to have severe muscle reactions that make it necessary to quit them all. Thank you Lily for persisting in this endeavor!!!
Permalink to Comment9. Anonymous on August 4, 2010 9:32 PM writes...
#8 Your observed side effect is not new and not due to drug/drug interactions. it is a common side effect of statins. Some statins are worse than others in this regard. The worse case scenario is Rhabdomyolosis. That's why Bayer's statin (Baycol) was pulled from the market. it was so potent at shutting down the HMG-coA reductase pathway that the concommitent side effects were apparently amplified.
http://en.wikipedia.org/wiki/Rhabdomyolysis
I would also be concerned about chronic lowering of cholesterol levels. It has the potential to open one up to infections as well as a host of other phenomena. Remember, cholesterol is vital for life.
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