TuDiabetes - A Community for People Touched by Diabetes

Fri Jun 26, 2009 7:33am EDT
By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) - The history of past drug scares suggests concerns over the safety of Sanofi-Aventis's (SASY.PA) diabetes treatment Lantus will hit sales, whether or not a suggested link to cancer proves real.

Shares in the French drugmaker sank 7 percent on Friday, extending losses from the previous session, on growing concern that researchers are about to publish a damaging analysis of the company's modern, or analog, insulin drug.

"Our information is that indeed a study is likely to be published soon raising the possibility of a link between Lantus use and a certain cancer type," Sanford Bernstein analyst Tim Anderson said in a research note.

"We understand this will not come out in a small medical journal, but rather one of the major medical journals and it will be the first time that such a high-profile analysis has been published linking the drug to cancer in humans."

Although nothing is in the public domain yet, the widespread talk is likely to negatively influence both doctors' and patients' perceptions and uptake of Lantus.

"Even if Lantus were cleared of a potentially increased cancer risk, media focus will likely dramatically alter the growth profile," said Andrew Baum of Morgan Stanley.

Sanofi is relying on Lantus, which many analysts expect to be its second-biggest seller this year, to offset a fall in sales of other products, such as Plavix and Lovenox, that could soon face generic competition.

It cannot afford for Lantus sales to stall.

Sanofi has not commented on future studies about the safety of the drug, but a spokesman reiterated that past data from trials involving more than 70,000 patients, as well as data from post-marketing surveillance, showed a good safety profile.

AVANDIA AGAIN?

The fear is that Sanofi might suffer the same fate as GlaxoSmithKline (GSK.L) in 2007, when safety concerns over its diabetes drug Avandia saw prescriptions tumble almost 50 percent in the United States within six months.

JP Morgan analyst Alexandra Hauber estimates that a 50 percent reduction in global Lantus sales forecasts from 2010 onwards would cut 2010-13 earnings by between 7 and 13 percent.

Most industry analysts expect Lantus to generate sales of around $4 billion this year and consensus forecasts compiled by Evaluate Pharma suggest this will rise to $6.4 billion in 2014, making it the world's fifth biggest-selling medicine by then.

At the moment, analysts are holding fire on revising their forecasts, but that could change when any long-term safety data is published.

A link between Lantus and cancer does make some sense at a scientific level, according to analysts, and the issue could also affect other insulin analogues, such as Novo Nordisk's (NOVOb.CO) Levemir.

In fact, the theoretical possibility of Lantus being a mitogenic, cancer-causing compound has been around for nearly a decade, said Bernstein's Anderson, noting that U.S. Food and Drug Administration review documents dating back to 2000 mentioned findings of malignancies in rodents.

For Denmark's Novo Nordisk, whose shares fell nearly 4 percent on Friday, the issue is something of a two-edged sword, according to Sam Fazeli of Piper Jaffray.

Novo could potentially gain from problems at its rival, and it might also benefit from any shift in demand toward its short-acting insulins. But there is a risk that users will be wary of all modern insulins and there may be a more general switch to older, cheaper insulin products.


http://www.reuters.com/article/euPrivateEquityNews/idUSTRE55P2PM200...

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Oh, wow... you made my day Anna. My "hit by a bus" blog is surfacing again ... I love it! "Big blue marble" I am taking note on that saying and using it at the first chance I get.

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Danny - I've always had a thing for marbles - since I seem to be losing them from time to time with age - more so when I sway my head too fast - especially when driving my car and listening to good tunes - oh no - another marble just fell out my nose!!!!! I did have quite the collection of marbles tho' when I used to play with them as a child (wait - I'm still a child - insulin has preserved my brain as well ).

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haha aside from the fun marble talk your profile pic is absolutely hilarious Anna, you put a big smile on my face this morning :)

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hi my twin Anna! I used Lantus since 2004 and I liked it (I loved you Lantus) but now I'm afraid, I hate Lantus! Maybe it's a sordid story of dollars?Yes Insulin keeps me alive but I don't want a cancer. Yesterday I called Sanofi Aventis in Paris, it was a" panic in Paris"and the doctor at the phone did'nt give me a real information! He said "don't worry". Monday I have my rendez-vous with my Endo . I'm really down, I feel sad, so sad.

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me too dino me too :(

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So the journal article that Wall Street had been creeped out about Sanofi Aventis' Lantus (insulin glargine) was Diabetologia, published by The European Association for the Study of Diabetes. The link to the journal article is:

http://www.diabetologia-journal.org/cancer.html

The European Association for the Study of Diabetes also made an “urgent call for more research” studying Lantus and cancer. It said the concern was specific to artificial insulin like Lantus, but not biosynthetic human insulin, but as Collen noted, urged patients not to stop taking their insulin but to consult their doctor if concerned. As an FYI, organizations such as the U.K.'s Insulin Dependent Diabetes Trust (IDDT) have been raising this question for a number of years, now we have it published in a major diabetes medical journal. What this suggests is that long-acting analogues should not necessarily be the default treatment, and that there is some reason to be concerned about using it over a lifetime.

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So, pumps and rapid-acting for everyone?

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Thanks for the heads up marps.. but if I got scared when every new "study" comes out I would be a recluse not wanting to leave the house.. Who knows what else they find in my next 40 years.. Eating hotdawgs on the grill causes cancer.. So they say..GIMME A COUPLE!! With Chili!
75 units a day of lantus keeps my bs normal...

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ooo a sting of cancer... yet we keep on injecting. I'm with craig bring on the hotdawgs and chicken wings!

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I trusted my dr. with my high cholesterol.. he put me on Baycol... I told him that I was having BIG problems with burning leg muscles..I told hime I was not taking it any more.. Few weeks later they took it off the market.. I guess it filled the quota of killing enough people..

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right. well, they aren't taking Lantus off the market, so there's no comparison. There will always be isolated instances of drugs removed from the market. Be thankful there are so many alternatives. For example, I began having high AST and ALT results so I stopped taking my statin. My numbers dropped, so we tried a lower dosage. My numbers went up again--pretty conclusive it was the statin raising my AST and ALT above normal limits. My doc convinced me (i didn't want to take any more statins) to switch to another statin, and lo and behold my numbers have been excellent. If you find a med is causing difficulties, stop it and tell your doc, just like you did.

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Well if it starts giving people tumors that turn into cancer they will be taking it off the market,like the study suggests.. Baycol had been on the market for a while before they had enough findings that it was killing people.. So give it time and wait and see, there just might be a comparison.

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