Actos

Docs: Use cheap diabetes meds first

Tracy Staton — Tue, 28 Oct 2008 12:00:59 -0400

A new study could spell lower sales for newer, more costly diabetes meds. Americans with diabetes nearly doubled their prescription drug spending over the past six years, with the 2007 total reaching a whopping $12.5 billion. Though there are more people in treatment for the potentially deadly disease, the increase has been driven mostly by new, more expensive drugs.

The study comes just a week after experts issued updated treatment advice for Type 2 diabetes, saying doctors should try older, cheaper medications first. And another study adds heft to an older, cheaper drug metformin, a generic in use for decades; researchers found that it may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit. (And as you know, there's been a variety of safety questions about GlaxoSmithKline's Avandia over the past 18 months or so.)

"If you can achieve the same glucose control at lower cost and lower side effects," Dr. David Nathan, diabetes chief at Massachusetts General Hospital told the Associated Press, "that's what you want to do."

If doctors take this advice to heart, GSK and Avandia wouldn't be the only ones to suffer. Other newer, more costly meds include Takeda's Actos, Eli Lilly's Byetta, and Merck's Januvia.

- read the AP story

Takeda offers $8.8B for Millennium

Thu, 10 Apr 2008 06:59:58 -0400

Takeda Pharmaceutical is placing an $8.8 billion bet on cancer meds. The Japanese drugmaker has offered $25 per share for Millennium Pharmaceuticals, which not only makes the lucrative blood-cancer med Velcade, but boasts a pipeline of up-and-coming cancer therapies, too.

Analysts see the deal as "a positive move." Takeda has had a $10 billion war chest ready for dealmaking, and it's been needing some way to offset the looming loss of exclusivity on its blockbuster diabetes med Actos, whose U.S. patent expires in 2011. The offering price for Millennium amounts to a 53 percent premium over market.

- see the press release from Takeda
- read the story from the Financial Times

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JAMA: Actos, Avandia risky for 65-plus

Wed, 12 Dec 2007 06:59:58 -0500

And the studies keep coming. An independent study of 159,000 older people with diabetes found that patients treated with GlaxoSmithKline's Avandia and Takeda Pharmaceuticals' Actos had a higher risk of heart attack and death. Published in the Journal of the American Medical Association, the study concluded that these patients had a 60 percent increase in the risk of heart failure, 40 percent increase in heart attack risk, and a 30 percent increase in the risk of death.

"At least in this high-risk population, the harms may outweigh the benefits," the study's lead author said. For every 100 people treated with Actos or Avandia over a four-year-period, she said, there would be five additional deaths, four additional heart attacks and three additional episodes of heart failure.

The FDA in November added a heart-attack warning to Avandia's label, but said the evidence linking the diabetes drug to heart attacks was inconclusive. Actos' label is free of the heart-attack language. The new study won't change the agency's recommendations, the FDA said in a statement.

GlaxoSmithKline, Avandia's manufacturer, said the new data is flawed because the patients using the drug typically were those who'd failed other treatments, and so they were sicker to start with.

- check out GSK's release
- read the Chicago Tribune report
- see this report The New York Times
- read the JAMA study abstract

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5. Actos - Top 10 Warnings and Recalls

Tracy Staton — Thu, 29 Nov 2007 09:41:35 -0500

Drug: Actos

2006 sales: $3.05 billion

Manufacturer: Takeda

Safety concern: “black box;” heart failure

Related Articles:
> Takeda touts Actos as heart attack-free. Report
> Actos on a good-news roll. Report
> Actos study points to reduction in heart attacks, strokes. Report
> Diabetes drug helps reduce rate of strokes. Report
> Avandia, Actos don't boost death risk. Report

Diabetes groups warn against Avandia

Wed, 28 Nov 2007 06:59:58 -0500

American and European diabetes associations are jumping on the anti-Avandia bandwagon. In their new consensus statement on treatment protocols, the American Diabetes Association and the European Association for the Study of Diabetes are urging docs to use caution when prescribing drugs for type 2 diabetes. The statement cites "additional hazards" from using the thiazolidedione class of meds, which includes Actos and Avandia, and cites the risk of heart attack from "rosiglitazone (Avandia) in particular."

The associations are just the latest in a queue of groups casting a jaded eye on GlaxoSmithKline's Avandia. A few weeks ago, Health Canada set out a series of restrictions on Avandia use. Last month, the U.S. Department of Veterans Affairs dropped the drug from its formulary; before that, the VA had accounted for 8 percent of Avandia's U.S. sales. Overall, sales of the drug have dropped 48 percent since news of its link to heart problems began to emerge.

And then there's Glaxo's black eye. A Congressional committee last week concluded that company executives--including CEO Jean-Pierre Garnier and former research helmsman Tachi Yamada--tried to intimidate a diabetes expert into keeping quiet about Avandia's safety problems.

- check out this report for more

Related Articles:
New Avandia warning 'a muddle'. Report
Avandia warning, comeback imminent? Report
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Avandia, Actos don't boost death risk. Report
FDA adds to drumbeat of bad news for Avandia. Report
Expert committee says Avandia should stay. Report

Takeda touts Actos as heart attack-free

Fri, 16 Nov 2007 06:59:57 -0500

When is the best time to hit your opponents? When they're down, of course. And you hit them where they're most vulnerable. It's a strategy that explains Takeda's new marketing press. The company is launching new ads touting its star diabetes drug today, saying, "If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke."

Sound like it's aimed at GlaxoSmithKline's Avandia? Bingo. The FDA essentially gave Takeda this edge when it required GSK to add new warnings of cardiovascular risks to Avandia's label. Though the wording was literally inconclusive, the warning is a vulnerability Takeda can now exploit.

The Japanese drug maker, though, says the ads are aimed at lifting the cloud of uncertainty that's lingered over diabetes pills since news of Avandia's risks started breaking in May. But that seems a bit disingenuous; after all, Actos' sales skyrocketed during the summer and fall as Avandia's went into free-fall. Before May, the drugs were, as the Wall Street Journal puts it, neck-and-neck.

- read this Pharmalot item
- see the AP report

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FDA adds to drumbeat of bad news for Avandia. Report

New Avandia warning 'a muddle'

Thu, 15 Nov 2007 06:59:58 -0500

The FDA has spoken--and GlaxoSmithKline is breathing a sigh of relief. The agency did stiffen warnings on the embattled diabetes med Avandia, but it shied away from linking the drug to heart attacks more directly than its competitors. "There isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments," the FDA stated. As part of its deal with the agency, GSK has agreed to stage a head-to-head clinical trial pitting Avandia against Takeda's Actos. The trial would gauge both meds' risk of cardio problems.

The FDA also is requiring Avandia rivals to note on their labels that no oral diabetes med has been shown conclusively to cut diabetes patients' risk of heart problems. The upshot of the new wording? A muddle, The New York Times says. As one blogger noted, the FDA's decision falls close to European regulators' position on the warning spectrum. The European Medicines Enforcement Agency kept Avandia on the market without adding warnings at all. In contrast, Health Canada last week set out some strict limitations for Avandia use, warning heart failure patients to stay away from the drug completely.

Will the less-stringent-than-feared warning help revive Avandia sales, though? Analyst opinions are mixed. Meanwhile, consumer groups are still warning patients against the drug. Rest assured that lots of eyes will be watching those sales trends.

- read the warning from the FDA
- check out GSK's release
- read this report from The New York Times
- see the Financial Times report
- read analysts' opinions

Related Articles:
Avandia warning, comeback imminent? Report
Avandia cleared FDA by one vote. Report
Avandia, Actos don't boost death risk. Report
FDA adds to drumbeat of bad news for Avandia. Report
Expert committee says Avandia should stay. Report

Avandia warning, comeback imminent?

Wed, 14 Nov 2007 06:59:54 -0500

The black-box wait is almost over. Within days, Avandia's label will get its new heart-attack warning, the FDA says, ending months of suspense.

What will it say? That's not yet clear, but during negotiations with the FDA, GlaxoSmithKline CEO Jean-Pierre Garnier (photo) said it wasn't the black box itself that concerned him, but the warning's actual wording. According to news reports, Garnier told the Reuters Health Summit in New York that he actually expects Avandia sales to rebound once the FDA's decision is handed down.

You'll recall that Canadian regulators warned doctors just this week that heart failure patients shouldn't take Avandia at all, and they restricted use of the drug in other patients.

- see this report
- read about GSK's stock reacted to Garnier's comments in the Houston Chronicle

Related Articles:
Avandia cleared FDA by one vote. Report
Avandia, Actos don't boost death risk. Report
FDA adds to drumbeat of bad news for Avandia. Report
Expert committee says Avandia should stay. Report

Canadians warn patients against Avandia

Mon, 12 Nov 2007 06:59:56 -0500

More limits on Avandia use, this time from Canadian regulators. While the FDA continues to debate adding various warnings to GlaxoSmithKline's embattled diabetes drug, HealthCanada has induced GSK to release new, restrictive guidelines.

According to GSK's Dear Doctor letter, the drug should never be used in a patient with heart failure, not even in the early stages. The drug can be added to metformin treatment, but only if metformin alone doesn't work. And Avandia should only be used on its own or with sulfa drugs if the patient can't tolerate metformin or has tried metformin without success. And it shouldn't be taken with insulin.

- see the "Dear Health Care Professional" letter at HealthCanada
- check out this item at Pharmalot
- read the report from The Record

Related Articles:
Avandia cleared FDA by one vote. Report
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FDA adds to drumbeat of bad news for Avandia. Report
Expert committee says Avandia should stay. Report

ALSO NOTED: Merck vaccine prevents cervical cancer in older women; Diabetes sales drive 37 percent increase in Takeda profits;

Mon, 05 Nov 2007 06:59:50 -0500

> Gardasil protects against cervical cancer in women as old as 45, a new study shows; previously, the vaccine was only proven to work in women ages 9 to 26. Report

> Strong sales of its Actos diabetes drug boosted Takeda Pharmaceuticals to a 37 percent hike in half-year profits. Report

> Cardinal Health posted an 11 percent increase in profits to $301.8 million, but trouble in its pharmaceutical supply-chain services unit prompted a change in management. Report

> Prague's Zentiva Pharmaceuticals saw profits fall 31 percent in the first nine months, but it expects full-year sales to come in with 20 percent growth. Report

> The FDA warned consumers against two unapproved products sold as ED treatments; they contain potentially harmful ingredients that can cause low blood pressure, the agency said. Report

And Finally... Besides its obvious effects, the ED remedy sildenafil citrate may also be a love potion. Report

Diabetes drugs linked to fracture risk

Thu, 04 Oct 2007 06:59:56 -0400

One more strike against diabetes drugs. Australia's regulators are warning that the class of drugs including Avandia and Actos may boost the risk of bone fractures in older women.

A four-year study of 4,360 patients showed that post-menopausal women taking one of the thiazolidinediones were more likely to break a bone. The Therapeutic Goods Administration won't withdraw the drugs, but manufacturers are warning doctors about the newly identified risks.

- read the report from the Sydney Morning Herald

Related Articles:
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Avandia, Actos don't boost death risk

Fri, 28 Sep 2007 06:59:55 -0400

Teva's timing may, in fact, be pretty good: A new study in this week's Lancet shows that while Avandia and its counterpart/rival Actos do boost the risk of heart failure, they don't increase the risk of death from cardiac problems. Study researchers say they wanted to clarify the risks so that doctors could choose which patients should get one of these drugs and which should opt out.

This study follows the now infamous Nissen study, published in June in the New England Journal of Medicine, which indicated that Avandia increased the likelihood of heart attack and death. The Lancet researchers said they analyzed data from trials that had all been peer-reviewed and published, whereas Nissen relied in part on unpublished work.

But also in today's Lancet is an editorial pushing an idea newly in vogue, but quite commonsensical--that diabetes drugs shouldn't be judged just on their effects on blood sugar, but on their ability to combat the effects of the disease.

- see the study abstract from The Lancet
- read the article from the Boston Globe

Related Articles:
Actos on a good-news roll. Report
Actos study points to reduction in heart attacks, strokes. Report
Diabetes drug helps reduce rate of strokes. Report
Avandia risks back in the headlines. Report

Actos on a good-news roll

Fri, 21 Sep 2007 06:59:56 -0400

The EU's drug committee also gave the go-ahead for a new combo pill that melds the diabetes remedy Actos with old blood-sugar standby metformin. This thumbs-up follows a spate of good news for Actos, including a new study unveiled Wednesday that showed it controlled blood sugar and lipid levels better than Avandia did. Another study, presented at the same meeting of the European Association for the Study of Diabetes, showed that Actos cut heart attack risk by 38 percent.

- check out this EMEA release on the Actos combo drug
- and this release on the Actos studies

Related Articles:
Actos study points to reduction in heart attacks, strokes. Report
Diabetes drug helps reduce rate of strokes. Report
Avandia risks back in the headlines. Report