Fish Oil Doesnt Help Heart Attack Patients In Biggest Study
The report, presented today at the American College of Cardiology in Orlando, Florida, contradicts previous smaller studies that suggested a daily supplement may help ward off repeat heart attacks, strokes and death. After taking a gram of purified fatty-acid supplements each day for a year, patients in the latest research, the biggest of its kind, fared no better than those who were given olive oil.
The 3,827 patients studied also got the best recommended therapy for heart-attacks, the researchers said. Most of the earlier studies were performed when heart-attack treatments were less advanced, they said. New treatments for heart attacks are so effective, they may have overwhelmed benefits from the fatty acids, the scientists said.
“We saw no beneficial effect,” said Jochen Senges, professor of cardiology at Heart Center Ludwigshafen at the University of Heidelberg, Germany, in a statement. “In patients who are already taking optimal medical therapy, cardiac event rates become very low and omega-3 do not further improve them.”
In 2004, the U.S. Food and Drug Administration granted the supplements a “qualified health claim status” for preventing heart disease, allowing companies to advertise the benefits of the supplements based on evidence. An August study of fish oil to treat heart failure, a condition in which the heart cant pump enough blood to supply oxygen to other organs, found the pills reduced deaths by 9 percent.
Community Health Centers
The latest research was conducted in 104 community health centers in Germany. Researchers found that over the course of the average yearlong follow-up, 3.9 percent of patients had another nonfatal heart attack, 1.7 percent had a nonfatal stroke, and 4.1 percent died. There were no significant differences between the group that took omega-3 fatty acids and the one that took the dummy pills.
Recommended care for heart attack patients varies by patient and includes a combination of tests, procedures and medicines.
About 94 percent of patients in the study had an X-ray exam of the heart called an angiography and 78 percent had angioplasty procedures. About 94 percent were prescribed drugs known as beta-blockers, 94 percent received cholesterol drugs called statins, 95 percent received aspirin and 88 percent received Plavix, a blood thinner made by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.
Fda Says to Avoid Pistachios Amid Salmonella Scare
Still reeling from the national salmonella outbreak in peanuts, the Food and Drug Administration said central California-based Setton Pistachio of Terra Bella Inc., the nations second-largest pistachio processor, was voluntarily recalling a portion of the roasted nuts it has been shipping since last fall. A Setton spokeswoman said that amounts to more than 2 million pounds of nuts.
“Our advice to consumers is that they avoid eating pistachio products, and that they hold onto those products,” said Dr. David Acheson, assistant commissioner for food safety. “The number of products that are going to be recalled over the coming days will grow, simply because these pistachio nuts have then been repackaged into consumer-level containers.”
Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasnt been confirmed, Acheson said. Still, the plant decided to shut down late last week, officials said.
The recalled nuts represent a small fraction of the 55 million pounds of pistachios that the companys plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.
California alone is the second-largest producer of pistachios in the world.
According to the companys Web site, Setton Pistachio is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. The company sells nuts, dried fruit, edible seeds, chocolate and yogurt-coated candies.
The FDA learned about the problem last Tuesday, when Kraft Foods Inc. notified the agency that it had detected salmonella in roasted pistachios through routine product testing. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.
The FDA contacted Setton Pistachio and California health officials shortly afterward, in what Acheson called a “proactive move.”
By Friday, grocery operator Kroger Co. recalled one of its lines of bagged pistachios because of possible salmonella contamination, saying the California plant also supplied its nuts. Those nuts were sold in 31 states.
Fabia DArienzo, a spokeswoman for Tulare County-based Setton Pistachio, said the company was only recalling certain bulk roasted in-shell and roasted shelled pistachios that were shipped on or after September 1.
Because Setton Pistachio shipped tote bags of nuts weighing up to 2,000 pounds to 36 wholesalers across the country, it will take weeks to figure out how many products could be affected, said Jeff Farrar, chief of the Food and Drug Branch of the California Department of Public Health.
“It will be safe to assume based on the volume that this will be an ingredient in a lot of different products, and that may possibly include things like ice cream and cake mixes,” Farrar said. “The firm is already turning around trucks in transit to bring those back to the facility.”
For nuts, roasting is supposed to kill the bacteria. But problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.
Last winter, a national salmonella outbreak was blamed on a Georgia company under federal investigation for flouting safety procedures and knowingly shipping contaminated peanuts.
The outbreak is still ongoing. More than 690 people in 46 states have gotten sick. Nearly 3,900 products made with peanut ingredients from Peanut Corp of America have been recalled.
California public health authorities have taken hundreds of samples at Settons processing facility, but lab results have not yet determined whether salmonella was found at the plant, Farrar said. The food companies own tests of the contaminated products isolated four different types of salmonella, but none were the same strain as the one found in the peanuts, Acheson said.
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Once-a-day Heart Combo Pill Shows Guarantee In Study
The experimental combo pill was as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a persons risk of heart disease and stroke roughly in half, the study concludes.
The approach needs far more testing – as well as approval from the Food and Drug Administration, something that could take years – but it could make heart disease prevention much more common and more effective, doctors say.
“Widely applied, this could have profound implications,” said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke Universitys heart research institute. “President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that.”
The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.
“If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden” and respond by skipping doses, he said.
No price for the polypill has been disclosed, but its generic components cost only a total of $17 a month now and doctors expect the combo would sell for far less.
The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. Johns Medical College in Bangalore, India. The findings were presented Monday at the cardiology colleges conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the “water pill” thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).
Doctors have talked about such a possibility for years. As the patents on many heart medicines expired and the drugs became available as cheap generics, a few companies started trying to develop all-in-one pills.
Formulating a single pill of five drugs that work in five different ways is a complex task – more complex than simply mixing the medicines. Pills have coatings and other ingredients that control the rate at which the medicine is released into the bloodstream. The polypill must be designed so that the five drugs work as intended.
The Polycap is the furthest along, and this is the largest study of one so far.
The study involved about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease – high blood pressure, high cholesterol, obesity, diabetes or smoking.
Compared to groups given no blood pressure medicines, those who got the polypill lowered their systolic blood pressure (the top number) by more than 7 units and their diastolic (the bottom number) by about 6 – comparable to levels for people who were given the three drugs without aspirin and the cholesterol drug.
These drops were modest, probably because doses were low and most participants had only moderately high blood pressure to start with, Yusuf said.
LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.
Anti-clotting effects seemed the same with the polypill as with aspirin alone.
Side effect rates were the same for the polypill as for the five medicines individually.
Fish Oil Pills Dont Growth Benefit Of Heart Drugs
The study tested a 1-gram daily dose of a prescription version of highly purified omega-3 fatty acid – the “good fat” contained in certain oily fish that is thought to help the heart.
Researchers led by Dr. Jochen Senges of the University of Heidelberg gave fish oil or dummy capsules to more than 3,800 people who had suffered a heart attack in the previous two weeks. About 90 percent were already receiving all the medicines recommended to prevent a second attack, including aspirin, anti-clotting and cholesterol drugs.
After a year, it made no difference whether these patients took fish oil or dummy capsules. In both groups, fewer than 2 percent had suffered sudden cardiac death, 4 percent had another heart attack, and fewer than 2 percent had suffered a stroke.
If recent heart attack patients are already getting good care, “there is almost nothing you can do better on top of this” to further lower risk, Senges said. He presented the results Monday at an American College of Cardiology conference.
The research doesnt mean that fish oil is of no value, and the study didnt address whether it can help prevent heart disease in the first place, doctors said.
The prescription version used in the study, sold as Omacor and Lovaza in the United States and as Zodin in Europe, is a highly purified and standardized form, different from what many consumers buy off the shelf.
Omega-3 fatty acids also are found in wild oily fish such as salmon, tuna, mackerel, sardines and herring. Scientists think it raises HDL, or good cholesterol, lowers harmful fats called triglycerides and slows the growth of plaque that can clog arteries.
The American Heart Association recommends adults eat fish at least twice a week, said Alice Lichtenstein, a Tufts University nutrition professor and Heart Association spokeswoman. For people with heart disease, the association advises 1 gram of omega-3 a day.
“A modest, 3-ounce cooked salmon has a little more than a gram,” she said.
Fish oil capsules are not for children or women who are pregnant or nursing, because the pills pose a bleeding risk. Taking more than 3 grams a day from supplements should only be done under a doctors orders, the heart association warns. The capsules also should be stopped a week or so before surgery because of a risk of bleeding.
The German study shows that “we need to be a little more cautious about the prediction of individual benefit of any nutritional supplements,” said Lichtenstein, who had no role in the research.
“We see this pattern – people are so willing to embrace the simple answer,” as if its possible “to crack a capsule over a hot fudge sundae” and undo the harm of harmful diets and lack of exercise, she said.
On the Net:
Cardiology meeting: http://www.acc.org
Heart Association advice: http://tinyurl.com/25×6z
Fda Approves New Drug For Deadly Kidney Cancer
The Food and Drug Administration approved the pill on Monday to treat renal cell cancer, the most common form of kidney cancer.
The agency said patients tested with Novartis Afinitor lived more than twice as long without tumor growth as those who didnt receive the drug. The study by the Swiss drugmaker showed Afinitor delayed tumor growth nearly 5 months, compared with less than two months for patients not taking the drug.
Afinitor works by blocking a protein that helps cancer cells divide and grow. The drug was approved for patients who have already taken Pfizer Inc.s Sutent and Bayers Nexavar.
Kidney cancer is resistant to chemotherapy and radiation therapy, and the most effective remedy is usually to surgically remove the kidney. When the cancer is isolated to the kidney, a majority of patients will survive at least five years. If the cancer has spread to other parts of the body, the survival rate is much shorter.
About 13,000 patients died from the disease last year, according to the American Cancer Society.
Basel, Switzerland-based Novartis has submitted the drug for approval in the European Union, Japan and elsewhere.
Shares of Novartis fell 47 cents to close at $36.55 Monday.
Fda: Bristol-myers Diabetes Drug Appears Safe
Despite low rates of heart attacks and related problems in testing, the Food and Drug Administration will still ask an outside panel to scrutinize the companys safety data at a meeting Wednesday.
Bristol-Myers and partner AstraZeneca have asked the FDA to approve Onglyza to reduce blood sugar levels in patients with type 2 diabetes. The drug uses a chemical reaction similar to Mercks Januvia and would compete against the blockbuster medication, which had sales of $1.4 billion last year.
The drug is part of a new wave of medications taking aim at the U.S. diabetes market, which has grown to more than $5 billion as the disease becomes more prevalent.
Analyst estimates of Onglyzas market potential vary, given its similarity to a more established drug. Sales estimates range from $300 million per year to more than $1 billion.
Shares of New York-based Bristol-Myers climbed 36 cents, or 1.7 percent, to close at $21.02 Monday. U.S.-traded shares of London-based AstraZeneca rose $1.87, or 5.8 percent, to $34.25.
Regulators have begun demanding more rigorous safety testing of diabetes drugs since a 2007 analysis suggested GlaxoSmithKlines blockbuster pill Avandia could increase heart risks.
Under guidelines issued last year, FDA requires companies to test diabetes drugs on more high-risk patients, including the elderly, to detect potential heart problems. Detecting heart risks connected with diabetes drugs is challenging because patients with the disease are already at risk of heart problems.
Because Bristol-Myers and AstraZeneca conducted their studies before the guidelines were released, their testing “was not designed to prospectively measure cardiovascular risk,” agency reviewers noted. As a result the FDA said there is “insufficient information” to determine if some heart problems were related to the drug, according to briefing documents posted online.
At the agencys request, the companies went back after the fact and tried to analyze reports of heart problems with the drug. Based on that assessment, the level of heart attacks, deaths and other cardiovascular problems appeared well within the new safety limits imposed by the FDA.
The agency will ask its panel of experts on Wednesday whether the companys results are strong enough to make a follow-up safety study unnecessary.
A decision on whether to approve the drug is expected by the end of April. The FDA is not required to follow its panels advice, though it usually does.
Bristol-Myers and British firm AstraZeneca are just two of the drugmakers looking to capitalize on the U.S. epidemic of Type 2 diabetes, which affects some 23 million adults and teenagers.
Onglyza, known generically as saxagliptin, belongs to the DPP-4 inhibitor family of the diabetes medications, which also includes Mercks drug Januvia.
The drugs work by blocking the DPP-4 enzyme, which spurs release of insulin-boosting proteins that help control blood sugar levels.
On Thursday FDAs panel will review another proposed diabetes treatment from Novo Nordisk. The Danish drugmakerss liraglutide boosts insulin while restricting the hormone GLP-1 hormone, which drives up blood sugar.
If approved, the once-daily injection would compete with Eli Lilly and Amylin Pharmaceuticals Byetta, a twice-daily injectable drug in the same family of medications. The makers of Byetta are working on their own extended-release version of the drug that would only require one injection per week.
Boston Scientific Stents Less Effective Than Others In Studies
Taxus Liberte, Boston Scientifics newest stent, required more repeat procedures than products from Medtronic and J&J in a South Korean study reported yesterday at the American College of Cardiology meeting in Orlando, Florida. In a separate trial, two Taxus models were linked with an 88 percent higher risk of heart-related deaths than Abbotts market-leading Xience stent.
Stent makers are competing for a $4 billion market. In January, seven months after its U.S. debut, Xience had grabbed 28 percent of the market, Boston Scientific said in a call with investors. Taxus, with 24 percent, was third behind the 25 percent recorded for a Xience copy, called Promus, that is licensed from Abbott and sold by Boston Scientific.
Market leadership is “just a credit to Bostons sales and marketing prowess,” said Tim Fischell, the director of cardiovascular research at Borgess Research Institute in Kalamazoo, in an e-mail. Given the stents showing in past trials, “its amazing that Taxus is used over J&Js Cypher,” which has just 14 percent of the market.
Boston Scientific, based in Natick, Massachusetts, last year introduced both Taxus Liberte, an updated version of the companys existing drug-coated stent, and Promus, the Xience copy it licenses from Abbott Park, Illinois-based Abbott. Stents are tiny mesh devices that keep arteries from closing down after theyve been cleared with angioplasty.
Unlikely to Change
The results for Xience and Cypher, made by New Brunswick, New Jersey-based J&J, are unlikely to change market share, said Sidney Smith, a University of North Carolina cardiologist, in a telephone interview. Xience, introduced in July, is already the top-selling stent. Also, some doctors were skeptical about Cyphers surprisingly low rate of triggering blood clots in the South Korean trial, called Zest, Smith said.
With all four companys stents performing relatively equally in past studies, the battle may come down to price, said Smith, director of the schools Center for Cardiovascular Science and Medicine.
Drug-coated stents sell for $2,000 apiece, and the manufacturers so far havent shown any willingness to compete on cost, he said.
“The results were seeing in Zest and the other trials dont really argue for choosing one stent over another,” Smith said. “In that setting, price is going to become a bigger factor to consider.”
Cypher More Effective
The Zest researchers found Cypher more effective at keeping arteries open, and at least as safe, as Medtronics Endeavor and Taxus Liberte. The study, partly funded by Medtronic, found Endeavor equally as effective as Taxus Liberte and safer.
“Theres a significant difference in disfavor of Endeavor” and for Cypher, said Stephan Windecker, a cardiologist at the University of Bern in Switzerland.
The trial results demonstrate “not all drug-eluting stents are the same,” said Christopher Allman, a J&J spokesman, in an e-mail. “Only Cypher has shown sustained patient outcomes now out to six years, which is another point of differentiation among drug eluting stents.”
The study showed Endeavor to be “non-inferior” to Cypher in terms of safety, while it had 29 percent fewer deaths, heart attacks and repeat procedures than the better-selling Liberte, said Joseph McGrath, a Medtronic spokesman, in an e-mail.
Fewer Clots
The trial found a much lower rate of clotting for Cypher and higher rates of repeat procedures for Liberte than past studies, so conclusions should be tempered by those past results, said Donald Baim, Boston Scientifics chief medical officer.
“This data doesnt jibe with what we know with all the other trials,” Baim said in an interview.
Boston Scientific has kept its grip on the market partly due to its two offerings, Taxus Liberte and Promus, Baim said. Each has a different drug coating and underlying architecture that serve different types of patients, he said.
Heart Scans Costing $2,000 Each Unneeded In One Of Five Cases
Almost one-quarter of the unneeded tests were ordered by doctors who werent heart specialists, according to research reported today at the American College of Cardiology meeting in Orlando, Florida. Some heart doctors may give the test to assure “worried well” patients, even if they dont have sufficient symptoms to warrant a scan, said Michael Crawford, chief of cardiology at the University of California at San Francisco.
“The consumer asks a cardiologist, Am I going to drop dead?” said Crawford, who was not involved in the study, in a telephone interview. “You think: Probably not. But gee, if the person drops dead, is the family going to sue me?”
The research, supported by both insurer and cardiologist groups, reviewed 3,035 so-called nuclear heart scans involving 6,351 patients. It found that 66 percent were appropriate. Another 18 percent werent needed and 16 percent were ambiguous. The tests, which measures blood flow at rest and during exercise to identify possible blockages, are the second largest expense for Unitedhealth Group Inc. after office visits, said Chad Peel, vice president of cardiology services at the insurers United Healthcare unit, in a telephone interview.
Reining in runaway imaging tests could save $260 million to help fund health-care reform, U.S. President Barack Obama said in his budget proposal to Congress.
Nearly Double
Use of all types of diagnostic imaging tests rose 44 percent in 2007 from 2002, nearly double the 23 percent growth in overall physician services per patient, the Medicare Payment Advisory Commission, or MedPAC, said in a March 2009 report to Congress.
The study measured use of nuclear heart scans, called SPECT MPI, or single-photon emission computed tomography myocardial perfusion imaging. Researchers used a computer program that weighed symptoms such as chest pain and factors such as age, high blood pressure, diabetes and history of smoking to identify unjustified tests. It flagged doctors when they didnt justify the test in some patients, the authors said.
“We need to be better stewards of our health-care dollar,” Ralph Brindis, a co-author of the report and senior adviser for cardiovascular disease at Northern California Kaiser Permanente, said in an interview. “To get the best kick for the buck, we want to do the right test for the right person at the right time.”
Use of the nuclear screens, developed 20 years ago, has been debated. MedPAC and other critics have focused on “self- dealing” specialist doctors who earn income from using their own diagnostic equipment.
Incentive to Use Them
“Once providers purchase machines, they have an incentive to use them as frequently as possible,” said MedPAC chairman Glenn M. Hackbarth in March 17 testimony to the subcommittee on health of the House Ways and Means Committee.
GE Healthcare, a unit of General Electric Co. in Fairfield, Connecticut; Philips Healthcare, a unit of Royal Philips Electronics in the Netherlands, and Siemens Healthcare, a unit of Siemens AG in Munich, Germany, are among companies that make the machines.
Study Funders
The study was funded by the American College of Cardiology Foundation and United Healthcare, a unit of UnitedHealth Group Inc. of Minnetonka, Minnesota, the largest U.S. supplier of medical benefits. The American Society of Nuclear Cardiology was also a partner in the study.
The research began in 2007. Doctors at six practices across the U.S. used computers to enter data on patients referred for nuclear heart scans that check for signs of heart disease.
The computers were equipped with a program containing guidelines on who should get the tests. The guidelines, previously drawn up by the cardiology college, incorporated almost 100 medical criteria and recommended the tests for people who had symptoms, such as pain while resting or that worsened during exercise, or heart rhythm disturbances, which suggested they had a high risk of coronary artery disease and imminent heart attack.
“Doctors are competitive souls; we dont want to be the ones with highest inappropriate numbers,” said study leader Robert Hendel, a cardiologist with Midwest Heart Specialists in Winfield, Illinois, and one of the authors of the study. Grading and feedback helped one medical practice group trim many unneeded tests to 13 percent from 22 percent, he said.
Alternative Test
Lower Is Better For Cholesterol In Crestors Jupiter Study
Patients with normal cholesterol levels who took AstraZeneca Plcs Crestor were able to cut their chances of heart attack, stroke or death 79 percent by reducing cholesterol and CRP, an indication of inflammation in the body, to the lowest levels found among 15,548 people studied. The research was presented today at the American College of Cardiology in Orlando and published by the British journal, the Lancet.
More than half of heart attacks occur in people who dont have high cholesterol. Todays report is a new analysis of data from a November study, known as Jupiter, which found that giving cholesterol-lowering drugs to people with normal levels of cholesterol over five years may prevent 250,000 heart complications in the U.S. The benefit may grow if doctors focus on dropping CRP and cholesterol levels as low as possible for their paitents, todays report suggested.
“How low? The lower the better,” said Aaron Kugelmass, chief of cardiology at the Baystate Medical Center in Springfield, Massachusetts and program director at the heart meeting, in an interview yesterday. “As a doctor I dont know that this is enough evidence to change a patients drug dose. But what this study clearly shows is that the lower you drive down the CRP and the lower you drop LDL cholesterol, the more you decrease risk.”
Vein Clots
Using Crestor in people with high levels of CRP, or C- reactive protein, the compound linked to inflammation, decreased the risks of serious heart problems by 47 percent, according to the study. Patients who lowered their LDL cholesterol to less than 1.8 millimoles per liter, and CRP to less than 2 milligrams per liter, had a 65 percent reduction.
Those whose CRP levels went even lower, to 1 milligram per liter or less, had heart events drop by 79 percent.
In a separate analysis of data from Jupiter, also released today and published in the New England Journal of Medicine, researchers found that Crestor may reduce blood clots that can form in the deep veins of the body, including the pelvis or leg. The clots, known as venous thromboembolisms, result from surgery and can be fatal if they block blood from the heart or lungs.
Patients taking Crestor were 43 percent less likely to have a vein clot than those taking a placebo. There were no significant differences between the treatment groups in rates of excessive bleeding, a potential side effect.
Not Definitive
The study was the first to show that cholesterol-lowering drugs, known as statins, may prevent the vein clots, which kill more than 100,000 people in the U.S. each year. Since only 94 venous-clot cases were found in 17,802 people in the study, the report isnt enough to show definitively that Crestor should be given to surgery patients at risk of clots, Kugelmass said.
“The findings are provocative and beg further investigation,” Kugelmass said. The study should be used as the basis in a trial that focuses on patients at risk of the developing the condition, he said.
Treating CRP
AstraZeneca said it plans to submit Jupiter findings to U.S. and European regulators in the first half of 2009, seeking approval to expand use of the drug to people with high levels of CRP. Other statins include Pfizer Inc.s top-selling Lipitor and cheap generic copies of Merck & Co.s Zocor.
“People who even have low cholesterol levels, it turns out, may have high risk of cardiovascular events,” said Alex Gold, executive director of clinical development at AstraZeneca, in an interview yesterday. “In this trial, Crestor lowered these patients risk significantly.”
The first way patients should reduce their risk is through exercise, diet and quitting smoking, said Paul Ridker, the lead author of the study and director of the Center for Cardiovascular Disease Prevention at Brigham and Womens Hospital in Boston, in a presentation today.
Ridker has been researching CRP as an indicator of heart risk for a decade, and his research led to the first U.S. guidelines for CRP as a new method to detect cardiovascular disease, issued in 2003.
Glaxo Cancer Vaccine Loses Blockbuster Chance After U.s. Delays
Glaxos Cervarix, once touted as more potent than Merck & Co.s rival vaccine Gardasil, has faced regulatory delays in the U.S. Meanwhile, Gardasil sales are waning because the pool of girls who havent been vaccinated is shrinking, an indication that Glaxos chances for a blockbuster product are disappearing.
“Glaxo is too late for the party,” said Ira Loss, an analyst with Washington Analysis in D.C., who has followed the U.S. Food and Drug Administration for more than 30 years.
Cervarix, which protects women against the sexually transmitted human papillomavirus, had the potential to generate annual revenue of as much as $4 billion, according to Jeffrey Holford, an analyst at Jefferies International. He has cut the estimate to $1.2 billion and says even that may be ambitious.
Mercks marketing campaigns for Gardasil, backed with television and print advertisements, have tapped many of the teenage girls who were vaccination candidates, according to company executives. The drugmakers sales of Gardasil plunged 16 percent last quarter to $286 million.
“Glaxo is three to four years late into the market,” Holford said. “They have lost the bulk of the opportunity in the U.S.”
Unlike traditional medicines that get rising revenues for years after regulatory approval as doctors become more comfortable with them, the biggest market for a new vaccine exists soon after its introduced.
Different Vaccines
Glaxo of London first asked the FDA to approve Cervarix in March 2007. The U.S. agency turned down Glaxos request for an accelerated review and said it couldnt clear the product without longer-term data on safety and effectiveness. Neither Glaxo nor the FDA gave details about what regulators asked for.
The product contains a chemical, or adjuvant, designed to boost the patients immune response and make the vaccine more effective. Unlike Merck, which uses a more traditional adjuvant, Glaxo said it used a proprietary one known as AS04, which may have spurred the FDA to ask for longer studies to check its safety, analysts said.
Glaxo last June said it would submit the results of an advanced clinical study, known as HPV-008, to the FDA in the first half of 2009. The company will also refile its FDA application in the first half, Sarah Alspach, a spokeswoman, said in a telephone interview.
Glaxos Troubles
Glaxo needs Cervarix to offset an onslaught of cheaper generic copies that eroded U.S. sales of at least four medicines last year. Profit fell last quarter. Safety concerns dragged down demand for the diabetes drug Avandia, whose sales slid 40 percent last year. The companys stock has dropped 14 percent in the past three months, the fourth-worst performance in a Bloomberg index of 18 European drugmakers.
Vaccine sales are growing by 15 percent to 20 percent a year now at Glaxo, and that will increase “significantly” in the next five years, said Jean Stephenne, president of the companys biologicals division, in a telephone interview. Cervarix is one of about half a dozen new immunizations that will drive the growth, he said.
Gains in Europe
Not all regulators share the FDAs concern about Cervarix. The vaccine is approved in more than 60 countries, including all of Europe, Australia and Singapore. National health programs in the U.K. and the Netherlands have selected the product instead of Gardasil.
“The Dutch and the British tenders were winner takes all, so everybody who gets vaccinated in those countries only get Cervarix,” Chief Executive Officer Andrew Witty told investors at Cowen & Co.s Annual Health Care Conference on March 17. “That demonstrates our willingness to win those tenders and also the strength of the vaccine.”
The products sales grew to 125 million pounds ($181.3 million) in 2008. Gardasil, by contrast, is sold in 109 countries and generated $1.4 billion for Merck last year.
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