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.
Thursday, September 13, 2007
Iressa Near To Sanofi's Taxotere In Lung Cancer
Lung-cancer patients who took AstraZeneca PLC's (AZN) Iressa drug lived about as long as those taking Sanofi-Aventis's (SNY) Taxotere chemotherapy, according to a new study.
AstraZeneca said Wednesday the late-stage study compared overall survival between Iressa and Taxotere in 1,466 patients with advanced, non-small cell lung cancer who had received previous treatment.
The study showed Iressa was "non-inferior" to Taxotere. AstraZeneca said it was the first time a drug in Iressa's category has proven non-inferiority for overall survival, relative to chemotherapy, in a head-to-head Phase 3 study in patients with previously treated non-small cell lung cancer.
The data were presented at the World Conference on Lung Cancer in Korea. AstraZeneca didn't provide specific survival figures in a press release.
AstraZeneca also said Iressa had a more favorable "tolerability profile" and "superior quality of life" for patients, versus Taxotere.
Iressa is a type of targeted therapy known as an epidermal growth factor receptor tyrosine kinase inhibitor. AstraZeneca initially had high hopes for the drug but they were dashed when a study in 2004 showed that Iressa failed to extend lives in lung cancer patients. The U.S. Food and Drug Administration subsequently restricted use of the drug to people who are benefiting or have benefited from it. Iressa has been shown, however, to be effective in treating Asians with lung cancer.
Iressa is available in 36 countries, but not in most major European countries. Global sales were $113 million for the first six months of 2007. Taxotere sales were EU402 million in the first half of the year.
AstraZeneca said it's sharing the latest data with regulatory agencies.
AstraZeneca said Wednesday the late-stage study compared overall survival between Iressa and Taxotere in 1,466 patients with advanced, non-small cell lung cancer who had received previous treatment.
The study showed Iressa was "non-inferior" to Taxotere. AstraZeneca said it was the first time a drug in Iressa's category has proven non-inferiority for overall survival, relative to chemotherapy, in a head-to-head Phase 3 study in patients with previously treated non-small cell lung cancer.
The data were presented at the World Conference on Lung Cancer in Korea. AstraZeneca didn't provide specific survival figures in a press release.
AstraZeneca also said Iressa had a more favorable "tolerability profile" and "superior quality of life" for patients, versus Taxotere.
Iressa is a type of targeted therapy known as an epidermal growth factor receptor tyrosine kinase inhibitor. AstraZeneca initially had high hopes for the drug but they were dashed when a study in 2004 showed that Iressa failed to extend lives in lung cancer patients. The U.S. Food and Drug Administration subsequently restricted use of the drug to people who are benefiting or have benefited from it. Iressa has been shown, however, to be effective in treating Asians with lung cancer.
Iressa is available in 36 countries, but not in most major European countries. Global sales were $113 million for the first six months of 2007. Taxotere sales were EU402 million in the first half of the year.
AstraZeneca said it's sharing the latest data with regulatory agencies.
J&J Ends Plan To Seek Wider Procrit Use
Johnson & Johnson called off plans to seek a broader list of approved uses for its drug Procrit, after the drug failed to show a reduction in the need for red-blood-cell transfusions among critically ill patients.
The finding, published today in the New England Journal of Medicine, is the latest blow to Procrit and other forms of erythropoietin, or EPO, a hormone that stimulates red-blood-cell production and is used widely in cancer, kidney and HIV patients.
In March, J&J added a prominent notice to Procrit's label, warning of an increased risk of death, heart attacks, and tumor growth in some situations, after studies indicated such risks. Next week, a Food and Drug Administration panel will hold a hearing on risks to kidney patients. Procrit sales have fallen 21% from two years ago.
The FDA has approved Procrit to treat anemic patients going into surgery or chemotherapy, and those who have kidney failure or HIV. J&J wanted to broaden that list to include anemic patients in an intensive-care unit, irrespective of a particular disease.
In the study, which J&J funded, doctors enrolled 1,460 ICU patients. Half received three injections of Procrit over a 15-day period, and the other half received a placebo.
A previous J&J study, published in 2002, suggested Procrit would reduce the need for red-blood-cell transfusions, but the latest study didn't show a reduction. As a result, J&J is calling off its attempt to broaden the drug's approved uses, a spokeswoman said.
Doctors are allowed to prescribe Procrit in the intensive-care unit anyway, but few do, said Aryeh Shander, the chief of the department of anesthesiology and critical-care medicine at the Englewood Hospital in Englewood, N.J. Today's study is likely to decrease such "off-label" use, said Dr. Shander, who has received grants and consulting fees from J&J.
In today's study, Procrit patients showed a drop in deaths, but the result wasn't statistically significant. Procrit did increase the risk of blood clots and other "thrombotic vascular" events, by roughly 40%, confirming the FDA's warnings and previous studies.
Procrit is made by Amgen Inc., which gets a 10% royalty from J&J. It sells the same drug to kidney patients undergoing dialysis as Epogen. J&J also sells a different synthetic erythropoietin, Eprex, internationally. J&J sold $758 million of Procrit and Eprex in the quarter ended in June.
The finding, published today in the New England Journal of Medicine, is the latest blow to Procrit and other forms of erythropoietin, or EPO, a hormone that stimulates red-blood-cell production and is used widely in cancer, kidney and HIV patients.
In March, J&J added a prominent notice to Procrit's label, warning of an increased risk of death, heart attacks, and tumor growth in some situations, after studies indicated such risks. Next week, a Food and Drug Administration panel will hold a hearing on risks to kidney patients. Procrit sales have fallen 21% from two years ago.
The FDA has approved Procrit to treat anemic patients going into surgery or chemotherapy, and those who have kidney failure or HIV. J&J wanted to broaden that list to include anemic patients in an intensive-care unit, irrespective of a particular disease.
In the study, which J&J funded, doctors enrolled 1,460 ICU patients. Half received three injections of Procrit over a 15-day period, and the other half received a placebo.
A previous J&J study, published in 2002, suggested Procrit would reduce the need for red-blood-cell transfusions, but the latest study didn't show a reduction. As a result, J&J is calling off its attempt to broaden the drug's approved uses, a spokeswoman said.
Doctors are allowed to prescribe Procrit in the intensive-care unit anyway, but few do, said Aryeh Shander, the chief of the department of anesthesiology and critical-care medicine at the Englewood Hospital in Englewood, N.J. Today's study is likely to decrease such "off-label" use, said Dr. Shander, who has received grants and consulting fees from J&J.
In today's study, Procrit patients showed a drop in deaths, but the result wasn't statistically significant. Procrit did increase the risk of blood clots and other "thrombotic vascular" events, by roughly 40%, confirming the FDA's warnings and previous studies.
Procrit is made by Amgen Inc., which gets a 10% royalty from J&J. It sells the same drug to kidney patients undergoing dialysis as Epogen. J&J also sells a different synthetic erythropoietin, Eprex, internationally. J&J sold $758 million of Procrit and Eprex in the quarter ended in June.
Mylan Laboratories Says FDA Approves Carvedilol Tablets
Mylan Laboratories Inc. (MYL) said Thursday its Mylan Pharmaceuticals Inc. unit received Food and Drug Administration approval for its Abbreviated New Drug Application for carvedilol tablets.
Carvedilol is the generic for GlaxoSmithKline PLC's (GSK) Coreg tablets.
Mylan, a Canonsburg, Pa. drug company, said about $1.65 billion of the tablets were sold in the U.S. in the year ending June 30.
Carvedilol is the generic for GlaxoSmithKline PLC's (GSK) Coreg tablets.
Mylan, a Canonsburg, Pa. drug company, said about $1.65 billion of the tablets were sold in the U.S. in the year ending June 30.
Teva Gets OK To Sell Generic Protonix, Though It May Wait
Though Teva Pharmaceutical Industries Ltd. (TEVA) won the right to sell a generic version of Wyeth's (WYE) Protonix, it remains unclear if it will actually move to launch the product immediately.
On Thursday, a federal court denied a preliminary motion to block Teva from launching a generic version of the treatment for erosive esophagitis associated with gastroesophageal reflux disease.
But complicating the matter is that the basis for the denial is unknown because the judge's opinion in the ruling, coming from the U.S. District Court for the District of New Jersey, was filed under seal pending review that it doesn't contain any confidential or proprietary information.
"Teva would obviously be much more willing to launch if the ruling was predicated on strong likelihood of success on the merits," writes Ken Cacciatore from Cowen & Co.
The full decision is expected to become available this coming Wednesday, according to a report from Bear Stearns.
"Teva intends to complete a thorough analysis of (Thursday's) decision before deciding upon its next course of action," the Israel company said in a statement.
Cacciatore said this is more cautionary language than usual from Teva following a preliminary injunction victory.
"Our best guess without seeing the ruling is that Teva and Wyeth may now reach a settlement and/or Teva will wait for a decision at trial," he said.
Though obviously, if the ruling does contain strong language on the merits of Teva's rationale for challenging the patent, then it may move to launch immediately.
Such a move is known as an "at-risk" launch because the generic maker can later be compelled to pay substantial damages to the branded-drug companies if their patent is upheld in court.
In its own statement, Wyeth said the court emphasized that its findings were preliminary and that the generic companies "would need to meet a higher burden of proof, clear and convincing evidence."
The court determined that Teva had raised sufficient questions about the validity of the patent to preclude issuance of the "extraordinary remedy" of a preliminary injunction, the Madison, N.J., company said.
Wyeth and Altana Pharma AG, recently acquired by Nycomed, sued Teva and Sun Pharmaceutical Industries Ltd. (524715.BY) for alleged patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications seeking Food and Drug Administration approval to market generic Protonix before the patent expires July 19, 2010.
Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until Aug. 2, 2007, and Sun's ANDA until Saturday.
Teva received that approval, but agreed not to launch before a decision was issued on Wyeth's motion for a preliminary injunction to prevent the launch until the resolution of the lawsuit.
Teva will have a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing or a final court decision.
A trial date has not been set.
Protonix was Wyeth's third-best-selling product in 2006, with $1.8 billion in sales. Wyeth licenses the drug from Nycomed.
On Thursday, a federal court denied a preliminary motion to block Teva from launching a generic version of the treatment for erosive esophagitis associated with gastroesophageal reflux disease.
But complicating the matter is that the basis for the denial is unknown because the judge's opinion in the ruling, coming from the U.S. District Court for the District of New Jersey, was filed under seal pending review that it doesn't contain any confidential or proprietary information.
"Teva would obviously be much more willing to launch if the ruling was predicated on strong likelihood of success on the merits," writes Ken Cacciatore from Cowen & Co.
The full decision is expected to become available this coming Wednesday, according to a report from Bear Stearns.
"Teva intends to complete a thorough analysis of (Thursday's) decision before deciding upon its next course of action," the Israel company said in a statement.
Cacciatore said this is more cautionary language than usual from Teva following a preliminary injunction victory.
"Our best guess without seeing the ruling is that Teva and Wyeth may now reach a settlement and/or Teva will wait for a decision at trial," he said.
Though obviously, if the ruling does contain strong language on the merits of Teva's rationale for challenging the patent, then it may move to launch immediately.
Such a move is known as an "at-risk" launch because the generic maker can later be compelled to pay substantial damages to the branded-drug companies if their patent is upheld in court.
In its own statement, Wyeth said the court emphasized that its findings were preliminary and that the generic companies "would need to meet a higher burden of proof, clear and convincing evidence."
The court determined that Teva had raised sufficient questions about the validity of the patent to preclude issuance of the "extraordinary remedy" of a preliminary injunction, the Madison, N.J., company said.
Wyeth and Altana Pharma AG, recently acquired by Nycomed, sued Teva and Sun Pharmaceutical Industries Ltd. (524715.BY) for alleged patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications seeking Food and Drug Administration approval to market generic Protonix before the patent expires July 19, 2010.
Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until Aug. 2, 2007, and Sun's ANDA until Saturday.
Teva received that approval, but agreed not to launch before a decision was issued on Wyeth's motion for a preliminary injunction to prevent the launch until the resolution of the lawsuit.
Teva will have a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing or a final court decision.
A trial date has not been set.
Protonix was Wyeth's third-best-selling product in 2006, with $1.8 billion in sales. Wyeth licenses the drug from Nycomed.
Wednesday, September 12, 2007
Aspreva, Roche Won't Submit CellCept Reg Filings
Aspreva Pharmaceuticals Corp. (ASPV) and Roche Holdings AG will not submit regulatory filings for using the drug CellCept to treat lupus nephritis because its Phase III trial showed the drug was not "superior" to another treatment.
The Victoria, B.C., pharmaceutical company Aspreva said the trial compared CellCelpt, an immunosuppresant, with intravenous cyclophosphamide to treat the disease, which causes swelling of the kidneys.
The disease is caused by a malfunction of the immune system, which, if suppressed, can relieve symptoms.
The Victoria, B.C., pharmaceutical company Aspreva said the trial compared CellCelpt, an immunosuppresant, with intravenous cyclophosphamide to treat the disease, which causes swelling of the kidneys.
The disease is caused by a malfunction of the immune system, which, if suppressed, can relieve symptoms.
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