Switching patients from Pfizer Inc.'s (PFE) cholesterol drug Lipitor to a generic version of Merck & Co Inc.'s (MRK) Zocor has been linked to a 30% increase in the risk of major heart complications, according to a Pfizer-sponsored study.
The study was presented Wednesday at the European Society of Cardiology meeting in Vienna, Austria, and is due to be published in the British Journal of Cardiology.
The study was based on an analysis of a database of more than 11,000 U.K. patients which included records from October 1997 to June 2005.
The analysis compared 2,522 patients who had taken Lipitor for six months or more and were switched to Zocor, which is generically known as simvastatin, with 9,009 patients who remained on Lipitor therapy.
According to the study, patients who switched cholesterol treatment had 30% higher risk of death, heart attack, stroke and heart surgery than those who continued taking Lipitor.
Zocor and Lipitor belong to a class of drugs called statins, used to lower cholesterol levels in people with, or at risk of, cardiovascular disease.
"It's not beneficial to have a universal switch to cheaper statins," said study author Peter Lansberg, of the Academic Medical Centre, University of Amsterdam, The Netherlands.
"We need to make a distinction between patients who benefit from generic statins and high-risk patients who need a more aggressive therapy."
The launch of generic copies of Zocor, which lost patent protection in June last year, has hurt Lipitor sales as health insurers have been encouraging patients to switch to the cheaper cholesterol-lowering drug.
In 2006, Lipitor sales reached $12.9 billion, making it the top-selling drug of all time and a key product for New York-based Pfizer in the last decade.
However, in the second quarter of 2007, the company's profit fell 48% on the back of slowing Lipitor prescriptions, whose global sales fell 13% compared with the same period in 2006.
The decline was steeper in the U.S., where sales slid 25% to $2.7 billion in the second quarter.
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Business,Demographic Trends Favor Generic Drug Makers-Analyst
Profits for generic drug makers should scale new heights in coming years, although the threat of an innovation drought and increased competition loom, a top industry analyst said Thursday.
Sales in the global generic drug market are increasing at a 14% annual rate, far better than the single-digit annual growth rate at brand-name drug makers.
"The wind is behind the backs of the generic pharmaceutical industry," Doug Long, vice president at drug research firm IMS Health Inc. told an audience of several hundred industry professionals at the Generic Pharmaceutical Association's policy conference.
However, Long cautioned executives from companies, including Teva Pharmaceutical Industries (TEVA), Watson Pharmaceuticals Inc. (WPI), and Barr Pharmaceuticals Inc. (BRL), that an innovation slowdown could bring the generic drug makers up short.
Even though generic drugs accounted for 63% of all drug prescriptions in the U.S. last year, growth depends on having new drugs to replicate, Long cautioned.
In the meantime, generic drug companies are sitting pretty as medicines worth $12 billion lose patent protection this year and $20 billion worth will be up for grabs next year, including Merck & Co.'s (MRK) osteoporosis drug Fosamax and Johnson & Johnson's (JNJ) schizophrenia treatment Risperdal.
It doesn't hurt that the Medicare prescription drug benefit, which launched in 2006, has boosted federal spending on pharmaceuticals. The program accounts for 20% of prescriptions filled in the U.S., according to Long, and 66% of those prescriptions are for generic drugs.
As more retiring baby boomers become eligible for the program over the next five to 10 years, Long estimates the government will handle more than half of U.S. spending on pharmaceuticals.
Despite these positive trends, Long said the industry, which is concentrated among a few key players, likely will face headwinds in the form of price competition from companies in developing countries, such as India and China.
At the same time, the lack of new drug products that has stifled growth at pharmaceutical giants, such as Pfizer Inc. (PFE) and Wyeth (WYE) could negatively affect the companies that copy their blockbuster drugs.
"What will have to be reckoned with eventually is the innovation drought for the brand manufacturers, which will mean a drought for the generic marketplace," Long said.
One avenue of growth currently closed to generic drug companies is the market for biotech drugs, where revenues are expanding at 18% a year, compared with growth of 2% for patented, traditional drugs.
Lobbyists for the generic drug companies are pushing lawmakers to include an amendment, allowing generic companies to replicate biotech drugs in a bill almost certain to be approved by Congress this year because it reauthorizes user fees that drug companies pay to help fund the Food and Drug Administration's approval process.
However, allowing the generic replication of biotech drugs, which are much more complicated than traditional, chemical-based drugs, doesn't seem to have the support of key House legislators.
Even Rep. Henry Waxman, a Democrat from California who has been an industry ally on the Hill, says he isn't optimistic generic biotech legislation will pass this year.
"The prospects are extremely slim, but it is still in play," Waxman told attendees at Thursday's conference. Waxman co-authored the bill that became law, allowing the first approved generic drugs in the early 1980s.
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