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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My doctor switched me off of Lantus today. Given that I am currently dealing with colon cancer, he thought it would be a good idea stop using Lantus in case the continuing studies prove that there is in fact a link to cancer.

"there are multiple studies which will possibly be published in two medical journals. He doesn't know when. Kliff said his source claims the reports will show evidence of a link between Lantus and colon cancer..." "Our sources have indicated that the data is compelling,"
http://seekingalpha.com/article/145727-how-bad-is-sanofi-s-safety-s...
I have being trying to avoid this cause I'm on Lantus. Now I'm gonna phone the team tomorrow and find out what they think. Hopefully they will not dismiss me, hopefully I will be put on Levemir. Anyone know if it's available in Ireland ? Will google now.
Hey, Brian. Sorry to hear about your colon cancer. I used to think having diabetes meant there was just no way something else could strike ....
I really do not want to switch to NPH. I asked my doc about levemir and he said it is similar to Lantus being an analog insulin. He said it would not make any sense to switch to it.
until told otherwise i'm going to keep taking lantus, what other choice do most of us have. It does help my sugars and the only bad side effect is low blood sugar... I think we need more information before anything drastic is done.
What she said! The PWD type 2 study participants had a lot going on that may be more causal to cancer than the Lantus, such as obesity and inflammation.
hi brian, congrads on your 5k you have been very informative and inspirational i . am off lantus since lapband surgery 10/07.(desperate move) ive lost 20lbs and my blood sugar is controlled with oral meds severe stroke 10/01 my appetite wen beserk out of control my weekend warrior exploits tennis and golf club champs blessed me with an wxtremely resilient circulatory system . lantus/ cancer link interests me any links for more info would be appreciated thank g-dand bless youwith improved health, stan
as they say pick your poison
If you had cancer right now with no family history, how do you think you would feel when you heard reports that suggest a link between Lantus and cancer. Do you think you was be as quick to dismiss them?
Brian,

Agree!

Soon as I heard about this I thought of you & what you've been through. Read your other post also. Sorry your doctor is being obstinate about changing to Levemir. Aside from this latest info, I did much better on Levemir than Lantus. Rather foolish, I think, to say they're similar when people clearly react differently to different brands of basal & rapid acting. For all we know, Levemir may end up having cancer links as well, but am sorry that your doctor wasn't sensitive to your concerns.
honestly with no insurance or regular doc and the fact i get my medicine free through sanofi aventis...
nothing my hands are tied
I've been reading anything I can get my hands on, about what I'm injecting into my body.(Lantus/24U) Allie's Voice had an article about "What's in your insulin" I Googled Lantus vs. Levimer. Lantus is produced in a vat of e-coli. Levimer is produced in a vat of yeast. Then they're purified,etc.,etc. There are carcinogenic agents in the insulin,too.(maybe as preservatives and stabilizers) I was just in a discussion tonight about which is worse... ingesting chemicals or injecting chemicals. Pick your poison! Since 2005, I have been working feverishly to get off insulin. I understand from many different sources, that it IS possible. I fear that the longer I'm on it, the less my body will do on it's own, to heal itself and get stronger and/or that I'm causing permanent damage with these chemicals. I'm in search of a new endo. who will hopefully help me achieve my goal. I' managing my own diabetes and he's there to guide me through the science part.
Allie's voice is a great source for insulin information. She's keen on getting someone to start producing safe, natural animal insulin.(again) Read all you can, get a good endo. and manage the heck out of your diabetes. Then we'll all have success stories we can take to the authorities,who reign over the industry part of it! There's my 2 cents worth!

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