Healthy Skepticism Library item: 5489

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Publication type: news

Haber G.
AstraZeneca could gain as generic arrives : Market for cholesterol drugs is headed for shake-up
The News Journal 2006 Jul 14
http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20060714/BUSINESS/607140338/1003

Full text:

AstraZeneca could gain as generic arrives
Market for cholesterol drugs is headed for shake-up

By GARY HABER
The News Journal
07/14/2006

The introduction of a generic version of the blockbuster cholesterol drug Zocor this summer is not expected to take patients from AstraZeneca’s own cholesterol reducer, Crestor.

In fact, one analyst believes Crestor’s sales will double in coming years.

That’s important news for AstraZeneca, which employs 5,000 at its U.S. headquarters in Fairfax. AstraZeneca’s fifth-best selling drug, Crestor is crucial to the company’s prospects. Its sales rose 38 percent last year, accounting for $1.27 billion of the company’s nearly $24 billion in global sales.
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Crestor is still one of the smaller players in the $16.2 billion U.S. market for statins — a class of drugs that lower LDL, or so-called “bad” cholesterol, by blocking the enzyme that produces it.

But because it’s a smaller player, with an estimated 6.3 percent of the market, Crestor could avoid much of the fallout from generic Zocor’s introduction, experts say. That’s because the health insurers, employers and pharmacy benefit managers prodding patients to switch to the less-expensive generic version of Zocor will first target patients taking Lipitor, the most popular branded statin, with a commanding 51.6 percent of the market.

Lipitor’s size puts it “in the cross hairs” said Mason Tenaglia, president of the Amundsen Group, a pharmaceutical consulting firm in Lexington, Mass.

“I think Crestor’s going to have much fewer issues,” Tenaglia said.

Merck & Co.‘s patents on Zocor, which has the second-largest piece of the U.S. statin market at 28.9 percent, expired last month. At least three companies will sell generic Zocor — the chemical name for which is simvastatin — at prices expected to eventually be up to 80 percent less than the branded version.

That could translate to substantial savings for patients and their employers.

Express Scripts, a large pharmacy benefit manager that has an interest in lowering drug costs, says 85 percent of statin prescriptions could be switched to generics and be equally effective in lowering cholesterol. That would save patients and their employers $10.3 billion a year, the company says.

In Delaware, just 5 percent of anti-cholesterol prescriptions are for generics.

Express Scripts says the savings here could top $27 million.

Experts expect a significant number of patients will switch from branded statins to generic Zocor because the co-pay will be less. The amount of the co-pay varies depending on the insurer and plan, but savings could be about $15 to $20 a month.

“I think it’s going to have a significant impact on the prescribing patterns of physicians,” said Edward Goldenberg, a cardiologist at Christiana Care Health System, who prescribes a variety of different statins, including Zocor, for his patients.

Jostling of the market

The switch will be particularly hard on Lipitor, experts believe.

In a recently released survey by Prudential Equity Group of managed-care pharmacy executives, who run the drug plans millions of Americans rely on, 64.1 percent said they expect Lipitor use to drop either “significantly” or “moderately” in the face of generic competition.

In a note to clients issued Tuesday, Gbola Amusa, a pharmaceutical industry analyst with Sanford C. Bernstein & Co., cut his projection for 2010 U.S. sales of Lipitor to $5.5 billion, down from $8.1 billion.

At the same time, Amusa raised his forecast for 2010 U.S. sales of Crestor to $2.5 billion, up from $1.2 billion.

And the Prudential survey found that only 22.3 percent of pharmacy executives predicted decreased use of Crestor.

Experts say patients will stick with Crestor because it is more effective in lowering cholesterol than other statins and is the only one that also may help unclog arteries.

The drug maker has positioned Crestor as a drug that lowers cholesterol for patients at risk of cardiovascular disease even when less powerful treatments like Zocor don’t work. The timing for AstraZeneca is good because doctors are setting more aggressive cholesterol targets. Recent studies suggest that at-risk patients may need to lower LDL levels below 70, compared with 100 for other patients.

That could benefit more powerful cholesterol-reducers like Crestor and Vytorin, a single pill that combines Merck’s Zocor with Schering-Plough Corp.‘s Zetia, a drug that reduces the intestines’ ability to absorb cholesterol.

“Vytorin and Crestor still come out as winners in our analysis,” David Moskowitz, a Friedman, Billings, Ramsey & Co. analyst wrote in a recent note to clients. “The superior lipid-lowering efficacy of these two products, combined with current trends in clinical practice moving toward more aggressive treatment goals,” suggests both drugs “will continue to see strong growth,” Moskowitz wrote.

AstraZeneca’s planning plays a role

Appealing to high-risk patients, who have the greatest need for lowering their LDL cholesterol level, is part of AstraZeneca’s strategy.

“Crestor is well-positioned to co-exist with generic statins very well,” said Mike Tilton, vice president, cardiovascular at AstraZeneca.

In a recent note to clients, Amusa said he foresees a system in which doctors try patients first on a less powerful statin, and if that doesn’t work, step them up to a more powerful one, like Crestor.

“Our logic is that the market moves to step therapy, putting newly diagnosed patients on simvastin, moving them to brands only when and if they fail to reach goal.”

Industry watchers say a number of recently released studies also set Crestor apart from its competitors and leave it well positioned to handle generic Zocor’s introduction.

A study presented last month at the International Symposium on Atherosclerosis showed patients who took the highest dose of the drug in combination with Zetia lowered LDL levels by as much as 70 percent.

This article contains information from Bloomberg News. Contact Gary Haber at (302) 324-2878 or ghaber@delawareonline.com.