Lantus verdict (May Cause Cancer)
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...
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...
Replies to This Discussion
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Permalink Reply by Manny Hernandez on -
Wanted to share this very good post by Kelly Close @ Close Concerns about this whole issue:
http://closeconcerns.typepad.com/close_concerns_weblog/2009/07/sano...
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Permalink Reply by Dave _ on -
For all of you freaking out over this nonsense, here's what the FDA says: (click link below)
FDA Tells Patients to Stick With Diabetes Drug Linked to Cancer
http://www.ajc.com/health/content/shared-auto/healthnews/-gen/62866...
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Permalink Reply by Anna Kiff (FatCatAnna) on -
Well Dave, some people are pretty freaked out - everyone is different with how they are handling the current news on Lantus - one of my diabetic friends has gone over to Levemir rather then using Lantus (at least they are still taking insulin)!
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Permalink Reply by Brigitte on -
Yes, next sunday I will start Levemir and say bye bye to Lantus. One year ago my endo told me to switch on Levemir, so ... I have the right to be afraid after reading the studies. Yes they are not perfect studies about Lantus, yes Sanofi Aventis called me last monday to say that they will make a study, they don't say it's nothing just a rumour( rumeur). 24 millions of people used Lantus? lots of money . When do they start the right study? A Five years study? I 'm sure I don't want to wait. And of course I'm still taking insulin! You know Anna, I'm not a stupid person with a stupid fear, Of course I'm afraid about cancer. And switch to another analog insulin is just a change, and sometimes changes are good.
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Permalink Reply by Brigitte on
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Sanofi Aventis called me Monday morning because I called them Friday when I heard the news on a radio. They have my phone and name because last year I have a problem with a cartridge, I was thinking that this cartridge didn't work well. So after two months, I sent them back the cartridge ( who was on my desk, at the sun, in summer and they wrote me a letter that the cartridge was perfect!!!! So i wrote them a letter to congrate them about this wonderfull Lantus which can stay under sun such a long time. That problem made me suspicious ( I hope it's the right word); Last monday the woman on the phone called to me to say that they were going to do a study. I was a type 1 with bad A1C and now I have 7,1% but since a few months and with the help of TuDiabetes' members I used low carbs diet and I 'm counting carbs. So I can change for a new Episode in my diabetic's life and try Levemir. If the next studies show me that Lantus is safe maybe I come back with Sanofi Aventis, but ... It's enough difficult to live with type 1 and my bad heart.
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Permalink Reply by Marps on -
I will definitely say that I've had much better control on Levemir than on Lantus. I trust Levemir and have had no issues whatsoever. They also just came out (or atleast I've just discovered) the Levemir kwikpens, which I think are so cool!
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Permalink Reply by Anna Kiff (FatCatAnna) on
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Brigitte - mon dieu - I think you misunderstood what I wrote above that it was you I was writing about. Sorry - did not imply that you were "stupid" - never ever mon amis!!! I am the stupid one for not having looked over carefully of what I wrote. Having been thru' cancer myself - I would feel the same way as you do with continuing on with Lantus - and plan on changing over to Levemir (if it's available here in Canada that is) - next time I see my endo in the Fall. I presently keep Lantus on hand - incase of pump failure - which hasn't occured yet - but when / if I decide to take a pump vacation - I want to be on an insulin that perhaps will be better.
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Permalink Reply by nel peach on -
Yes, Anna , Levimir is available in Canada and I read at the CDA website, that Ontario Government is making Levimir available ...probably by special authorization as is Lantus .
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Permalink Reply by Anna Kiff (FatCatAnna) on
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Great ! Thanks Nel.
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Permalink Reply by MeadowLark on
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Awesome! My mother had Lupus and Cancer in her bladder area. sigh.... My father? Diabetic,33 heartattacks that I know of, ulcers and other problems.
I knew I was gonna die some day. Nice to know how I will go. Huh? Sigh... Chemicals to stay alive... chemicals to die by. I'm moody today. I'll be better tomorrow.
Cheer Up Tomorrow will be better.
Huggles
MeadowLark
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Permalink Reply by Amanda on -
what's a five year study going to do for anyone?? there are soo many people that have been on it for way longer than five years and so far everything is great, no cancer. they are going to have to study lifelong effects and then who's to say the cancer didn't come from something else.
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