Over the past few months, Lilly ceo John Lechleiter has made speeches in which he criticized various government policies for hindering research and development efforts (see this). And central to his theme has been the importance of innovation. "Innovation is not a panacea for the challenges facing our health care systems, but it is hard to see any way out of the current crisis – and I don't think that's too strong a word – without innovation," he told the American Chamber of Commerce in Germany which, earlier this year, was preparing to cut brand-name drug prices ( look here).
Today, however, the drugmaker has begun marketing yet another statin for controlling cholesterol, which it calls Livalo. This is a big market, of course, with statins ringing up some $13 billion in sales last year. But do patients really need another one? Lilly, which actually licensed the pill from Kowa Pharmaceuticals, hopes Livalo will be distinguished from the pack because it's metabolized differently than most statins, which could reduce unwanted interactions with other drugs.
"While there are some very good medicines in this category today, based on the number of patients who are untreated and who fail to stay on therapy tells us there is a good opportunity here," Lechleiter tells The Indianapolis Star in an advance interview.
Maybe so, but as Miller Tabak analyst Les Funtleyder tells the paper: "I think it's going to take a lot of work to interest physicians in a new statin. It's going to have to work much better, or be much cheaper, or have fewer side effects than anything else on the market." Adds Hilliard Lyons analyst Steve O'Neill: "The space for cholesterol drugs is extremely crowded. That's just a simple fact." Lilly hopes pricing will help - at $3.30 a tablet wholesale, Livalo will be 15 percent cheaper than Crestor.
Like its rivals, Lilly faces a huge dropoff in revenue as big sellers lose patent protection, but its situation is more precarious than others. Matters are not helped by the poor performance of its new Effiant bloodthinner. So Lilly, which recently overhauled its R&D operation, can hardly be blamed for pursuing a tactic that may help weather the storm. In fact, while Lilly has never been known for cardiovascular drugs, Lechleiter says more cholesterol-fighting research may be pursued as a way out of its mess. Whatever works, as they say. It is ironic, though, that a drugmaker that regularly describes itself as an "innovation-driven company" and whose ceo harps on that theme is forced to rely on a variation of the 'me-too' approach to try to get by.
9 Comments
Can anyone comment on the different metabolic pathway for this drug?
I believe that Lechleiter is referring to innovation across the board and not just physically at Lilly Research Laboratories (LRL.) Lilly is aggressively networking with discovery resources, including academics and biotech firms. They are also participants in venture investing around the world, including in Asia and even(shocking to some!)in partnership with Merck and Pfizer. The guy is largely on target. We are in a risk averse climate that is discouraging investment. We need to move taxes away from beating up corporate innovation and keep them focused on individual incomes. As with energy, it is clear that tax incentives tempt capital flows whether for windmills or biomedical R/D.
In a couple of years more statins will cost a lot less per month than most professionals spend on coffee each day. Encourage innovation in neurodegenerative diseases and cancer. Meanwhile eat your broccoli.
I can't really tell without a lot more information that is probably not published.
As I recall rhabdomyolysis (rapid muscle breakdown and secondary renal failure) with statins is due to certain metabolites that are formed by the CYP3A4 isozymes and is increased with larger molar doses and drug interactions that not only induce CYP3A4 but also typically block transporters that pump the drugs back out into the gut. thus there is also an increase in rhabdo with certain drug (antivirals), food interactions (grapfruit juice) and ethnic groups (african americans that result in induction of CYP3A4/5 as well effect the transporter.
From the labeling of this drug it appears that it is also metabolized by CYP3A4/5 and is a substrate for the same transporter. Plus it has all the labeling for rhadbo. So the relative risk of rhabdo with this drug is dependent upon a variety of factors including the relative toxicity of the metabolites, the relative molar doses, the relative propensity for drug interactions, etc..
In essence I can't tell if this is fluff or has a true theoretical basis based on a quick look. Even so it would take large comparative clinical demonstrate such a claim which isn't likely to occur. So it's likely this is fluff and even if it isn't it's still a form of off-label marketing.
Salmon
Innovation? Statins have been around for 20-25 years and at least a few are generic. This "new" drug has actually been around for about 10 years in Japan. As to more effective, much cheaper and fewere side effects, at least the price is 50 cents less. Let the spinning begin!!!!
Day late and a dollar short. The Framingham study evidence underlying the “lipid hypothesis” was never strong to start with. Since then a massive lipid lowering campaign has shown no effect on heart disease rates. While an elegant and seemingly intuitive hypothesis, more and more openly people are rightly questioning the wisdom of the cholesterol lowering campaign.
Cholesterol is an essential component of every cell membrane and important for myriad physiologic functions. When Dr. Uffe Ravnskov, MD PhD looked at the medical literature he found something quite surprising had been documented there. On average people with higher cholesterol live longer. You can read on this here http://healthjournalclub.blogspot.com/2009/10/do-people-with-high-cholesterol-live.html and http://healthjournalclub.blogspot.com/search/label/Cholesterol if interested. Cholesterol lowering is a racket.
The point to be borne in mind is the use of long term drug therapy to lower cholesterol levels, where it is unclear what the full effects might be over a 30 year period. In spite of this, the Food and Drug Administration (FDA) gives approval for this class of drugs on the basis of less than 10 years’ clinical trials.
Me tooism at it's best. The real drug to drug interaction potential for patients is very small with statins.
Innovation won't help us out of the debt crisis or the health care financing crisis.
Thanks to medical advances, people are living longer than they can possibly support themselves financially. That's why we have - need - Medicare and well-financed insurance around the world.
The health care industry is going to have to face facts. Doctors, hospitals, drug and devise makers, nursing homes, etc are all going to have to charge less - make less money. Otherwise they risk leaving millions of Americans without access.
The health care industry is looting the country because they provide a product people will pay anything to obtain. People will spend themselves into personal bankruptcy and we act like that's OK. It's not OK; it's irresponsible.
The only innovative thing going on here is the way the executives pay themselves despite this company's pipeline, and layoffs.