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 nel peach on -
I blame my genes on the cancer..was about to spell : jeans ...diagnosed with type 1 at 42 1/2 , diagnosed with breast cancer at 44 plus...( mastectomy and recently an increase dose of lymphedema ... I call it my fat arm ; actually suddenly fatter than when this started in 1999 ) ; have been to the Doc ...never a lantus user
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Permalink Reply by Yvonne C. on -
Yes, I heard about this.
Here is the article I read today. This is scary.
http://diabetes.webmd.com/news/20090702/lantus-insulin-cancer-link-...
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Permalink Reply by Amanda on -
strange...i wonder why in only type two diabetics. this article only proves one thing to me...everything causes cancer in one way or another. they have proven years and years ago that the sun may cause cancer but nobody stopped using it. i think it's just the cards your dealt. from what i read from this article any insulin can cause EXISTING cancer cells to grow faster, it's just that it is more true in long lasting than fast acting. it also does not state that the insulin causes the cancer cells but that it may make existing cells grow faster. existing cells that have been caused by something else.
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Permalink Reply by Gerri on -
Study focused on Type 2s probably because there are 10x more Type 2s than Type 1s.
Some researchers believe that we all have some cancer cells & that it depends on other factors if they profilerate, or are safely destroyed. Who knows?
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Permalink Reply by Sareln Pupkies on -
I just read the article on WebMD. The first sentence stated that Lantus "might slightly increase cancer risk in Type 2" diabetics.
The German study stated that "patients taking Lantus did not have more cancers than people taking other forms of insulin." The Swedish ahd Scottish studies showed "no increased cancer risks in patients who took Lantus along with other forms of insulin." "Findings do not prove a link between Lantus and cancer." The UK study showed no link.
Each one of us must make our own decision. I have been taking Lantus for years and I will continue to take it until more studies have been done and show that there is a direct link between Lantus, T1s, and cancer. Because the word "cancer" appeared in a study, people are jumping ship and changing to Levemir. My intention is not to freak people out anymore than they already are and I must admit I know nothing about Levemir but are we really certain that it would pass our scrutiny if the same kind of studies were conducted on it at some point in the future? Think before you act, base your decisions on evidence not fear.
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Permalink Reply by Amanda on
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they need to get all the info together and release it all at once so we don't get all bent out of shape again. do they realize how scary this was?? guess not. as for now i'm sticking with my lantus until i can afford a pump.
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Permalink Reply by Yvonne C. on
-
My pharmacist did not even hear about this.
Here is a link from the FDA regarding Lantus.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformation...
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Permalink Reply by Hayaa on -
Reuters
Novo Nordisk Insulin Analogs Have Proven Safety Profiles
Sun Jun 28, 2009 3:18pm EDT
http://www.reuters.com/article/pressRelease/idUS58585+28-Jun-2009+P...
PRINCETON, N.J., June 28 /PRNewswire/ -- On Friday June 26, Diabetologia, the
journal of the European Association for the Study of Diabetes (EASD) published
online data from four studies relating to a possible link between a
long-acting insulin analog, insulin glargine, and cancer(1). As a basis for
such a possible link, an accompanying editorial explains that certain insulin
analogs have a structure making them more likely to bind to the IGF-1 receptor
which is known to be involved in promoting tumor growth(2).
Novo Nordisk markets three insulin analogs, Levemir(R) (insulin detemir), a
long-acting basal insulin analog, NovoRapid(R)/NovoLog(R) (insulin aspart), a
short-acting insulin analog, and NovoMix(R)/NovoLog(R) Mix 70/30 (biphasic
insulin aspart). To avoid unnecessary speculation about whether Novo Nordisk
insulin analogs may be associated with an increased risk of cancer, the
company wishes to highlight the following:
-- For the past 20 years, all Novo Nordisk insulin analogs have been
tested
for IGF-1 receptor binding in the early research phase and only
insulins
with a binding ratio between the insulin and IGF-1 receptors similar
to,
or better than, that of human insulin have been accepted for further
development(3).
-- Studies on receptor binding and cell growth together show that insulin
aspart, the insulin analog present in NovoRapid(R)/NovoLog(R) and
NovoMix(R)/NovoLog(R) Mix 70/30 has an in vitro safety profile that is
identical to that of human insulin(3,4).
-- Studies on receptor binding have shown that Levemir(R) in comparison
to
human insulin has a relative affinity to the IGF-1 receptor which is
equal to or slightly lower than to the insulin receptor(4,5).
Levemir(R)
distinguishes itself from insulin glargine, which has been shown to
have
increased affinity for the IGF-1 receptor compared to human
insulin(4,5,6).
-- All Novo Nordisk insulin analogs on the market have been studied in
many
randomized, controlled trials, in observational studies and are
furthermore monitored for any safety signals through rigorous
post-marketing safety surveillance. Novo Nordisk has not identified
any
cancer signals for any of the three insulin analogs.
-- Novo Nordisk has over the last 20 years discovered and developed
insulin
analogs to improve the treatment success rate for people with
diabetes.
Extensive clinical testing has provided evidence that Levemir(R),
NovoRapid(R)/NovoLog(R) and NovoMix(R)/NovoLog(R) Mix 70/30 possess
clinical advantages for many patients with diabetes compared to human
insulin.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of
Novo Nordisk, says: "Our science-driven approach to the discovery and
development of safe, improved insulin analogs, together with the existence of
comprehensive insulin safety databases, convinces us that our insulin analogs
improve treatment outcomes in diabetes patients relative to human insulin."
Conference call
On June 29 at 8 a.m. CET, corresponding to 2 a.m. EDT, a conference call for
investors will be held. Investors will be able to listen in via a link on the
investor section of novonordisk.com. Presentation material for the conference
call will be made available approximately one hour before on the same page.
About insulin and IGF-1 receptors
Insulin can bind to two different receptors: insulin and IGF-1 (insulin-like
growth factor-1) receptors. The former mainly causes glucose lowering whereas
the latter mainly induces cell proliferation. Insulin binds much stronger
(more than 500-fold) to the insulin receptor than to the IGF-1 receptor and it
is if this binding profile is unfavorably changed due to alterations in the
insulin molecule that an insulin analog can increase the risk of cell
proliferation via the IGF-1 receptor.
Prescribing Information for Levemir(R), NovoLog(R) and NovoLog(R) Mix 70/30 is
available by contacting Novo Nordisk or visiting novonordiskcare.com.
About Levemir(R), NovoLog(R) and NovoLog(R) Mix 70/30
Indications and Usage:
Levemir(R) (insulin detemir [rDNA origin] injection) is indicated for once- or
twice-daily subcutaneous administration for the treatment of adult and
pediatric patient with type 1 diabetes mellitus or adult patients with type 2
diabetes mellitus who require basal (long-acting) insulin for the control of
hyperglycemia. NovoLog(R) (insulin aspart [rDNA origin] injection) is an
insulin analog indicated to improve glycemic control in adults and children
with diabetes mellitus. NovoLog(R) Mix 70/30 (70% insulin aspart protamine
suspension and 30% insulin aspart injection, [rDNA origin]) is indicated for
the treatment of patients with diabetes mellitus for the control of
hyperglycemia.
Important Safety Information:
Hypoglycemia is the most common adverse effect of insulin therapy, including
Levemir(R), NovoLog(R), and NovoLog(R) Mix 70/30. As with all insulins, the
timing of hypoglycemia may differ among various insulin formulations. Glucose
monitoring is recommended for all patients with diabetes. Any change of
insulin dose should be made cautiously and only under medical supervision.
Changes in insulin strength, manufacturer, type, species, or method of
manufacture may result in the need for a change in dosage.
Levemir(R), NovoLog(R) and NovoLog(R) Mix 70/30 are contraindicated during
episodes of hypoglycemia and in patients hypersensitive to any of their
excipients.
Potential side effects associated with the use of all insulins include
hypoglycemia, hypokalemia, lipodystrophy, and allergic reactions. Less common
but more serious area severe cases of generalized allergy, including
anaphylactic reaction, which may be life threatening. Other adverse events
commonly associated with insulin therapy may include injection site reactions
such as lipodystrophy, redness, pain, itching, hives, swelling and
inflammation. Insulin may cause sodium retention and edema, particularly if
previously poor metabolic control is improved by intensified insulin therapy.
The dose of any insulin may need to be adjusted in patients with renal or
hepatic impairment.
Levemir(R) should not be diluted or mixed with any other insulin preparations.
Concomitant oral antidiabetes treatment may require adjustment. Levemir(R)
is not to be used in insulin infusion pumps. Inadequate dosing or
discontinuation of treatment may lead to hyperglycemia and, in patients with
type 1 diabetes, diabetic ketoacidosis. Dose and timing of administration may
need to be adjusted to reduce the risk of hypoglycemia in patients being
switched to Levemir from other intermediate or long-acting insulin
preparations.
NovoLog(R) has a more rapid onset and shorter duration of action than regular
human insulin. An injection of NovoLog(R) should be immediately followed by a
meal within 5 to 10 minutes. Because of the short duration of action of
NovoLog(R), a longer-acting insulin should also be used in patients with type
1 diabetes and may be needed in patients with type 2 diabetes. When used in
an external subcutaneous insulin infusion pump, NovoLog(R) should not be mixed
with any other insulin or diluent. Glucose monitoring is recommended for all
patients with diabetes and is particularly important for patients using
external pump infusion therapy. As with all insulin preparations, the time
course of action of NovoLog(R) may vary in different individuals or at
different times in the same individual and is dependent on many conditions,
including injection site, local blood supply, temperature, and level of
physical activity. Insulin, particularly when given intravenously or in
settings of poor glycemic control, may cause hypokalemia.
Because NovoLog(R) Mix 70/30 has peak pharmacodynamic activity 1 hour after
injection, it should be administered with meals. Because of differences in
the action of NovoLog(R) Mix 70/30 and other insulins, care should be taken in
patients in whom these conditions may be clinically relevant (e.g., patients
who are fasting, have autonomic neuropathy, are using potassium-lowering
drugs, or are taking drugs sensitive to serum potassium level). Do not mix
NovoLog(R) Mix 70/30 with any other insulin product. Changes in
cross-reactive antibodies were more common after NovoLog(R) Mix 70/30 than
with human premixed 70/30, but the clinical significance of these antibodies
has not been established.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 86-year history of innovation and
achievement in diabetes care. The company has the broadest diabetes product
portfolio in the industry, including the most advanced products within the
area of insulin delivery systems. In addition to diabetes care, Novo Nordisk
has a leading position within areas such as hemostasis management, growth
hormone therapy, and hormone therapy for women. Novo Nordisk's business is
driven by the Triple Bottom Line: a commitment to social responsibility to
employees and customers, environmental soundness and economic success. With
headquarters in Denmark, Novo Nordisk employs more than 27,900 employees in 81
countries, and markets its products in 179 countries. Novo Nordisk's B shares
are listed on the stock exchanges in Copenhagen and London. Its ADRs are
listed on the New York Stock Exchange under the symbol 'NVO'. For global
information, visit novonordisk.com; for United States information, visit
novonordisk-us.com.
References:
(1) www.diabetologia-journal.org/
(2) Baserga R, Peruzzi F, Reiss K (2003): The IGF-1 receptor in cancer
biology. Int J Cancer 107: 873-877
(3) Gammeltoft S, Hansen BF, Dideriksen L, Lindholm A, Schaffer L, Trub T,
Dayan A, Kurtzhals P (1999): Insulin aspart, a novel rapid-acting human
insulin analogue. Exp Opin Invest Drugs 8 (9): 1431-1442
(4) Kurtzhals P, Schaffer L, Sorensen A, Kristensen C, Jonassen I, Schmid C,
Trub T (2000): Correlations of receptor binding and metabolic and mitogenic
potenticies of insulin analogs designed for clinical use. Diabetes 49:
999-1005
(5) Center for Drug Evaluation and Research, FDA. Application number 21-536:
Pharmacology review of insulin detemir
(6) Shukla A, Grisouard J, Ehemann V, Hermani A, Ensmann H, Mayer D (2009)
Analysis of signalling pathways related to cell proliferation stimulated by
insulin analogs in human mammary epithelial cell lines. Endocrine-Related
Cancer 16: 429-441
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