Replies to post #43536 on Biotech Values

[jbog]

Abbott Dissolving Stent, Xience Product Show Promise (Update3)

By Avram Goldstein and Michelle Fay Cortez

March 24 (Bloomberg) -- Abbott Laboratories' experimental heart stents may threaten the market dominance of Boston Scientific Corp. and Johnson & Johnson based on positive results from two studies released today.

Abbott's Xience, a drug-coated stent marketed in Europe, was found superior to Boston Scientific's Taxus in keeping treated blood vessels open in a finding that may help propel the device to U.S. approval next year. Separately, a new stent made by Abbott that dissolves in arteries after about three years scored promising results in its first human trial.

The two studies, presented at a science meeting in New Orleans, position Xience at the front edge of new technology in the $5.4 billion-a-year drug-coated stent market, where devices seen as easier and safer to use are needed to help revive faltering sales. Patients getting Xience had fewer cardiac deaths, heart attacks and repeat procedures months later.

``The data really couldn't look any better,'' said Michael Weinstein, an analyst at J.P. Morgan Securities Inc., in an e- mail today. The fact they significantly reduce major cardiovascular complications, something never before seen in a major trial of drug-coated stents, ``is powerful,'' he said.

The study, presented at the annual meeting of the American College of Cardiology, found that Xience patients were much less likely than the Taxus stent, the top U.S. seller, to have blockages recur at eight months.

`Long-Term Outcomes'

``What that means for the patient is better long-term outcomes without recurrent heart problems,'' said lead researcher Gregg Stone, director of cardiovascular research at Columbia University Medical Center, in an interview.

The findings are likely to meet regulatory hurdles set by the U.S. Food and Drug Administration for approving the device, Stone said in a press conference today.

Investors and analysts were already expecting the Xience stent to capture 25 percent to 30 percent of the market, and Weinstein said those estimates may be adjusted up on Monday. U.S. approval for Xience is expected in the first half of 2008.

Stents are mesh tubes placed in arteries to keep them from re-closing after angioplasty, a procedure in which a balloon- tipped catheter is inflated to reopen a clogged blood vessel.

Drug-coated stents release medicine to prevent scar-tissue formation. Boston Scientific and J&J's devices are made of polymer-covered metal and remain permanently in the vessel after the drug is gone. Bioabsorbable stents dissolve in about three years, leaving behind nothing but a healed blood vessel.

Lactic Acid

The dissolving devices are made from lactic acid molecules linked to form the stent, said John Ormiston, an investigator on the Abbott study and a researcher at Auckland City Hospital in New Zealand. Lactic acid is a chemical naturally produced when a person exercises. Other devices, including absorbable screws and stitches, are also made using lactic acid.

Sales have fallen for coated forms of the devices since European researchers last September tied them to formation of potentially deadly blood clots years after they were implanted.

The market for the devices peaked at $5.4 billion in 2006, below Wall Street's earlier expectations. The shares of Boston Scientific, based in Natick, Massachusetts, have fallen 36 percent in the past month to $15.22 as of yesterday in New York Stock Exchange composite trading. New Brunswick, New Jersey- based J&J shares are down 5 percent in the period to $60.51.

In the most recent studies, patients with the dissolving stents were followed for six months, while the Xience patients were monitored for nine months.

Skepticism

Some doctors are skeptical about prospects for the dissolving stents.

``It's the devil you know versus the devil you don't,'' said William Maisel, a Harvard University heart specialist and chairman of a U.S. Food and Drug Administration advisory panel on heart devices, in a telephone interview. ``There's no replacing long-term follow-up.''

Some analysts said a Xience advantage in the study would hurt Boston Scientific. When that company bought Guidant Corp. and Xience last year, it sold the vascular products division to Abbott and kept rights to use the technology in its own products.

As part of the agreement, though, Boston Scientific will market the Xience stent under a different name, Promus. Sales of that device may erode those of Taxus, which generates higher margins for that company, Nalbone wrote.

Win-Win

Boston Scientific's chief executive office, Paul LaViolette, said he sees the study as a win-win. ``There are two stents in that study, and we have them both,'' LaViolette said in a telephone interview.

Maisel's FDA advisory panel said in December that drug- coated stents, which have been on the market since 2003, could cause blood clots and fatal heart attacks years in one of every 200 patients after implantation. As a result, patients are being told by many physicians to take a blood thinner, such as Bristol-Myers Squibb Co.'s Plavix, for a year or more after they have a device implanted.

Stents that dissolve after they've done their job have long been discussed as an option to the current use of permanent metal devices. The study announced today on Abbott's product is one of the earliest to show results.

In that study, Ormiston and Patrick Serruys of Erasmus Medical Center in Rotterdam followed 30 patients for six months and saw no blood clots. One patient needed a repeat procedure to reopen a vessel, and there were no deaths or heart attacks.

`Natural State'

``The potential is to allow the patient's vessel to return to a more natural state without the permanent implantation of a mechanical structure,'' said James Capek, senior vice president of Abbott's vascular division, in a telephone interview.

Johnson & Johnson is working on a metal stent with a fully coating that will dissolve after the suppression drug has been delivered, leaving a bare-metal stent behind, company spokesman Chris Allman said.

Other competitors aren't convinced bioabsorbable stents will be safe.

``Some chord is struck with physicians who have the notion that the metallic implant seems unnatural and that it seems potentially desirable to have them go away,'' said Boston Scientific's LaViolette. ``It's an idea that has been interesting but always debated and always disappointing. The materials just never seem to be ideal.''

Just the same, all stent manufacturers, including Boston Scientific, are pursuing bioabsorbable products, Maisel said.

``If it plays out that this is the way to go, they don't want to get caught with their pants down,'' he said. ``But they're not going to abandon developing metal stents.''

To contact the reporter on this story: Avram Goldstein in Washington at [e-mail] .

Last Updated: March 24, 2007 16:44 EDT

[DewDiligence]

The much anticipated drugs-vs-stents data is
finally out: it’s a draw with respect to survival
and prevention of heart attacks.

So many articles were written in the past few
days predicting this outcome that the press
surely knew the outcome. I.e., the press
was abiding by the ACC news embargo while
still telling readers what the outcome would be.
They did this by writing in embargo-ese,
which contains a heavy use of the subjunctive
where one would ordinarily see the indicative.

One major drawback of this study is that only 3%
of the stents used were the drug-eluting variety.
(Drug eluting stents did not reach the U.S. market
until 2003, after the study was well underway.)
Nonetheless, the study is apt to add yet another
round of negative fallout for the stent makers,
especially BSX.

http://www.nytimes.com/2007/03/27/health/27stent.html

>>
In Trial, Drugs Equal Benefits of Artery Stents

March 27, 2007
By BARNABY J. FEDER

NEW ORLEANS, March 26 — Many heart patients routinely implanted with stents to open arteries gain no lasting benefit compared with those treated just with drugs, researchers reported Monday.

The researchers said patients with stents to prop open coronary blood vessels in addition to being treated with statins and other heart drugs in a five-year trial had better blood flow to the heart than patients treated only with drugs. But they did not live longer or suffer fewer heart attacks, a finding that confirmed the results of smaller studies.

The researchers also found that the stents were highly successful at improving blood flow and relieving symptoms, including chest pain and shortness of breath, but that the advantage disappeared over time.

“When I saw the results, I was incredulous,” said Dr. William E. Boden, a cardiologist at the University at Buffalo School of Medicine and Biomedical Sciences, lead author of a report on the study published online on Monday by The New England Journal of Medicine.

The use of stents, which has boomed in the United States in the last 10 years, has come under question. One study showed that stents could save lives when implanted during or shortly after a heart attack but that 50,000 Americans a year had the procedure too long afterward to benefit.

The new study was the first large trial to look at a far larger group who had symptoms of clogged arteries and were in no immediate danger. The nearly 2,300 patients in the trial all had a relatively stable form of coronary artery disease that generally progresses slowly.

A majority of Americans who receive stents are in this category, Dr. Boden said. They suffer pain or breathlessness when they try to exercise or are under stress because their heart is not receiving enough oxygen, although that condition sometimes shows up just in clinical stress tests.

But they are not believed to be in immediate danger of heart attacks or hospitalization, even though accumulating plaque has narrowed coronary arteries 70 percent or more.

In the new trial, a surprising finding was that after five years more than 7 of 10 patients in both groups were free of angina pains, the common symptom of restricted blood flow to the heart muscle, said the researchers, who reported their results at a meeting here of the American College of Cardiology.

Previously, doctors had assumed that stents performed much better than drugs at relieving symptoms over the long run. “It’s very intuitive that fixing the narrowing with a stent will yield important long-term benefits, but it didn’t,” said Dr. Steven E. Nissen, president of the cardiology group.

Dr. Nissen, who termed the new study a blockbuster, said it sent a clear message that doctors and patients should feel secure about relying on modern drugs as a “very safe, reasonable and cost-effective strategy” for treating coronary artery disease. The findings raised new questions about the role of angioplasty and stenting, which has been used in six million patients around the world since the mid-’90s and is especially popular in the United States.

Close to one million Americans a year receive stent implants after angioplasty to create pathways through severe blockages in coronary arteries by inflating tiny balloons in them.

Angioplasty quickly became popular in the ’80s as a less invasive approach for coronary blockages than open heart surgery to construct bypasses around them. Stents improved the procedure by combating the tendency of many vessels to reclose quickly after angioplasty.

Studies have shown that angioplasty and stenting can save lives when used in heart attacks. The procedure is also recommended for many patients whose symptoms of poor blood flow to the heart are not relieved by rest or drugs.

For such patients, the debate is not whether to use stents in addition to drugs but whether stents are used in too many seriously ill patients who might live longer with bypass surgery.

Angioplasty with stenting generally costs $25,000 and up. The latest drug-coated stents cost $2,200 apiece and are especially effective at preserving the channel created by angioplasty.

Stents generate nearly $3 billion a year in sales in the United States for Boston Scientific and Johnson & Johnson, the two companies that dominate the market.

In a statement issued after the results became public, Dr. David E. Kandzari, chief medical officer of the Cordis Cardiology business at Johnson & Johnson, said that modern drugs slowed the progression of coronary artery disease, but that stenting was superior at relieving symptoms, so both should be available. His counterpart at Boston Scientific, Dr. Donald S. Baim, said what was apparently the loss of the symptom relief advantage of stents over time in the study might have occurred because the trial ended in 2004, just as the drug-coated stents were introduced. Just 3 percent of the patients received them.

Dr. Baim also said it was important to note that nearly one-third of the group that started on drug treatment ended up receiving stents or having bypass surgery because their symptoms worsened. He said most of them would have been free of angina symptoms after five years because of stents but would have still been counted in the drug group.

Shares in the two companies’ stock began falling even before the official announcement. Boston Scientific, which is far more reliant on the stent business than Johnson & Johnson, fell to $14.22, down from $15.22, to its lowest point in the last year. It drifted lower in after-hours trading.

Sales of the drug-coated stents have been falling in the United States since last spring because of studies that showed that potentially deadly clots formed in a small percentage of patients long after the stents had been implanted. The clots were thought to occur in a handful of every 1,000 patients, but no one knows how long the risk continues.

Recipients of drug-coated stents are now told by most doctors to take anticlotting drugs indefinitely. Doctors are switching some patients to older bare metal stents that do not seems to have the same late-clotting risk. The disadvantage of that stent is that the arteries reclog twice as often, exposing patients to repeat procedures.

The new clinical study adds questions about the effectiveness of stenting to the safety debate, at least in the patients studied in the trial, named Courage, for Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation. Guidelines from the American Heart Association and the American College of Cardiology have since 2002 called for using angioplasty and stenting or bypass surgery only after extensive efforts to treat such patients’ symptoms with drugs.

But cardiologists say patients and doctors increasingly ignore the guidelines, choosing the quicker and initially reliable relief of stenting.

“There will be a lot of analysis and dissection of the study,” said Dr. Boden of the University at Buffalo. “But that doesn’t necessarily mean we will do far fewer angioplasties.”

Examples of how the results might be questioned emerged even before the data. Dr. Kandzari of Cordis noted that the nearly 2,300 patients in the trial were largely from veterans’ hospitals in the United States and Canada. Those patients receive many medicines free and are more likely to take them as prescribed.

The trial was supported financially by eight major drug companies in addition to the United States and Canadian governments.
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