நீ பேசும் மொழி தெரிந்தும்
உன்னிடம் மௌனியானேன் என்
உணர்வுகளை நீ புரிந்து கொள்ளாததால்
Jul 30, 2008
Views on Pharmaceutical
In this title I would like to share my views and updates in the pharma industry and also expecting your comments.
Upcoming blockbusters in Pharma-Industry
(Compound) --- (Sponsor) --- Indication
Liraglutide --- Novo Nordisk --- Type 2 Diabetes
Under development by Novo Nordisk, liraglutide is a member of a new class of antidiabetic medications called GLP-1 analogues. These mirror the effects of naturally produced glucagon-like peptide-1 (GLP-1), which includes glucose-dependent stimulation of insulin secretion, suppression of glucagon secretion, reduction of appetite and delay of food absorption
The current scenario is that Novo Nordisk announced Tuesday that it submitted once-daily GLP-1 analogue liraglutide for approval by Japanese regulators as a treatment for type 2 diabetes. The drugmaker noted that the Japanese Phase III programme for liraglutide involved 678 patients with type 2 diabetes. The product also leads to weight loss, according to Novo Nordisk, and the company is currently evaluating the drug for that indication.
Denosumab --- Amgen --- Osteoporosis
Phase III trial results for Amgen's denosumab met the primary endpoint of reducing new vertebral fractures in postmenopausal women with osteoporosis, compared with placebo, the drugmaker reported. In three year trial 7800 women, were received either subcutaneous injection of denosumab once in a six month or placebo. Roger Perlmutter, executive vice president of R&D at Amgen, noted that the findings "demonstrate that denosumab treatment both increased bone mass and reduced the risk of skeletal fractures in women with postmenopausal osteoporosis." Furthermore, the data showed that the incidence and type of adverse events in the trial were similar between those who received Amgen's drug and those who received placebo.
Drugs got RED signal
Bapinezumab --- Wyeth and Elan --- Alzheimer’s disease
Some analysts suggested that Wyeth's and Elan's investigational Alzheimer's disease drug bapineuzumab may not reach the market, after more detailed Phase II study results were presented on July 29. Results from the 234-patient trial showed that while bapineuzumab did not meet the study's primary endpoints, it might benefit patients who lack the ApoE4 gene. However, the results also demonstrated that 12 patients administered the compound developed vasogenic oedema (AE), compared with none who received placebo. The findings confirmed that the compound did not meet the trial's primary efficacy endpoints and raised concerns about potential adverse events.
Vimpat (lacosamide) --- UCB --- Diabetic neuropathic pain
FDA issued a not approval letter for UCB’s Vimpat (lacosamide) as treatment for Diabetic neuropathic pain. UCB did not specify why the regulator rejected the drug, but some industry analysts speculated that the decision was due to concerns about the product's efficacy, not its safety. US regulators are still reviewing the compound as an adjunctive treatment for partial onset seizures in patients with epilepsy aged 16 years and older, UCB noted. In June(2008), the EU's Committee for Medicinal Products for Human Use recommended Vimpat for approval as an adjunctive treatment for partial onset seizures in patients with epilepsy.
Vytorin (ezetimibe/simvastatin) --- Merck & Co. and Schering-Plough --- Aortic stenosis
In the trial, which involved 1873 patients with mild-to-moderate aortic stenosis without symptoms, patients were randomized to receive Vytorin or placebo. Patients who received Vytorin did have a statistically significant 22-percent reduction in atherosclerotic events alone, compared with placebo.Study data showed that Merck & Co.'s and Schering-Plough's cholesterol drug Vytorin (ezetimibe/simvastatin) failed to show an improvement in cardiovascular outcomes in patients with aortic stenosis, compared with placebo. "The study has given a clear-cut answer whether lipid lowering will influence the cause of aortic stenosis and we can conclude it does not," commented lead researcher Terje Pedersen of Ulleval University Hospital in Oslo. In addition, the data demonstrated that 39 patients who took the drug died of cancer, compared with 23 in the placebo group, which researchers indicated could be due to chance. No one type of cancer appeared to be more affected than another, and incidence rate didn't increase the longer patients took Vytorin, according to the findings.
Iloperidone --- Vanda Pharmaceuticals --- Schizophrenia
The FDA issued a not approvable letter for Vanda Pharmaceuticals' schizophrenia compound iloperidone, due in part to concerns about the drug's efficacy compared with Johnson & Johnson's Risperdal (risperidone) in prior studies. The agency requested an additional efficacy trial and asked for further safety data for the atypical antipsychotic. To further demonstrate the drug's efficacy, the FDA requested an additional study comparing iloperidone with placebo, and including a comparator such as Risperdal or Eli Lilly’s Zyprexa (olanzapine), in patients with schizophrenia. Vanda noted that the agency also asked for more safety data for the compound dosed at a range of 20 milligrams to 24 milligrams per day. As a result, the drugmaker said it has put on hold all development of iloperidone, pending further review.
Drugs info:
Malaria drug may increase antibiotic resistance
Data published in the journal PLoS ONE suggest that exposure to antimalarial drug chloroquine could boost Escherichia coli resistance to antibiotic ciprofloxacin, which Bayer markets as Cipro. The findings may have implications for other antibiotics, as well as for newer antimalarials, according to researcher Michael Silverman.
The investigators studied the inhabitants of remote villages in Guyana where there had been extensive use of chloroquine over the previous two years, but no exposure to fluoroquinolones, such as ciprofloxacin. The results demonstrated that 4.8 percent of villagers carried strains of E. coli that were resistant to ciprofloxacin. Silverman commented that "chloroquine use for malaria may make the fluoroquinolones less effective for many common tropical diseases...in the developing world."
The researcher indicated that the resistance to ciprofloxacin could extend to other fluoroquinolones such as Johnson & Johnson's Levaquin and Bayer's Avelox. Silverman also noted that the results could have implications for newer artemisinin-based combination therapies for malaria, which are recommended by the World Health Organization because of growing resistance to older drugs. Future efforts should focus on the prevention of malaria, including the development of new vaccines, he said.
Gene mutation linked to myopathy in patients taking statins
Findings published in the New England Journal of Medicine suggest that a genetic mutation may be linked to an increased risk of myopathy in patients taking statins. Testing for this mutation could help "achieve the benefits of statin therapy more safely and effectively," according to the researchers.
Researchers conducted genetic analyses on 85 patients with definite or incipient myopathy and 90 controls who were all taking high daily doses of simvastatin, which Merck & Co. sells as Zocor, as part of a 12 000-patient trial. The findings showed that patients carrying variants of the SLCO1B1 gene were 4.5 to 16.9 times more likely to develop myopathy, compared with those who did not carry the genetic mutation. The researchers said that they confirmed the results using data from a second study involving patients who were administered a lower dose of the statin.
Hypertension drugs may reduce risk of Alzheimer's
Study data presented at the 2008 International Conference on Alzheimer's disease showed that patients taking angiotensin receptor blockers (ARBs) had a lower risk of developing Alzheimer's disease or dementia, compared with those who were taking other treatments. The findings also suggest that the class of hypertension drugs may slow the progression of the disease.
Researchers examined records from the US Department of Health Systems Veterans Affairs for about six million patients treated for hypertension between 2001 and 2006. The data demonstrated that those administered ARBs had about a 35 percent to 40 percent lower risk of developing Alzheimer's disease or dementia, compared with those who received other drugs. Furthermore, in patients who were already suffering from Alzheimer's or dementia, those who received ARBs had up to a 45 percent lower risk of developing delirium, being admitted to nursing homes or dying.
"When we took account of the effects of age and cardiovascular disease, strokes and diabetes, or anything else that could influence a patient's outcome, these medications still looked very impressive. Potentially, this will have a large public health impact," commented study researcher Benjamin Wolozin. "For those who already have dementia, use of ARBs might delay deterioration of brain function and help keep patients out of nursing homes," he added.
Pfizer's Viagra improves sexual function in women taking antidepressants
The trial involved 98 pre-menopausal women taking either selective or nonselective serotonin reuptake inhibitors, who had no problems with sexual dysfunction before taking antidepressants. Patients were randomly assigned to take placebo or Viagra prior to sexual activity for a period of eight weeks. The findings showed that 27 percent of patients who took placebo reported improvement in sexual function, compared with 72 percent of patients who received Viagra.Women with antidepressant-related sexual dysfunction who took Pfizer's Viagra (sildenafil) reported an improvement in their condition, compared with those who took placebo.
Upcoming blockbusters in Pharma-Industry
(Compound) --- (Sponsor) --- Indication
Liraglutide --- Novo Nordisk --- Type 2 Diabetes
Under development by Novo Nordisk, liraglutide is a member of a new class of antidiabetic medications called GLP-1 analogues. These mirror the effects of naturally produced glucagon-like peptide-1 (GLP-1), which includes glucose-dependent stimulation of insulin secretion, suppression of glucagon secretion, reduction of appetite and delay of food absorption
The current scenario is that Novo Nordisk announced Tuesday that it submitted once-daily GLP-1 analogue liraglutide for approval by Japanese regulators as a treatment for type 2 diabetes. The drugmaker noted that the Japanese Phase III programme for liraglutide involved 678 patients with type 2 diabetes. The product also leads to weight loss, according to Novo Nordisk, and the company is currently evaluating the drug for that indication.
Denosumab --- Amgen --- Osteoporosis
Phase III trial results for Amgen's denosumab met the primary endpoint of reducing new vertebral fractures in postmenopausal women with osteoporosis, compared with placebo, the drugmaker reported. In three year trial 7800 women, were received either subcutaneous injection of denosumab once in a six month or placebo. Roger Perlmutter, executive vice president of R&D at Amgen, noted that the findings "demonstrate that denosumab treatment both increased bone mass and reduced the risk of skeletal fractures in women with postmenopausal osteoporosis." Furthermore, the data showed that the incidence and type of adverse events in the trial were similar between those who received Amgen's drug and those who received placebo.
Drugs got RED signal
Bapinezumab --- Wyeth and Elan --- Alzheimer’s disease
Some analysts suggested that Wyeth's and Elan's investigational Alzheimer's disease drug bapineuzumab may not reach the market, after more detailed Phase II study results were presented on July 29. Results from the 234-patient trial showed that while bapineuzumab did not meet the study's primary endpoints, it might benefit patients who lack the ApoE4 gene. However, the results also demonstrated that 12 patients administered the compound developed vasogenic oedema (AE), compared with none who received placebo. The findings confirmed that the compound did not meet the trial's primary efficacy endpoints and raised concerns about potential adverse events.
Vimpat (lacosamide) --- UCB --- Diabetic neuropathic pain
FDA issued a not approval letter for UCB’s Vimpat (lacosamide) as treatment for Diabetic neuropathic pain. UCB did not specify why the regulator rejected the drug, but some industry analysts speculated that the decision was due to concerns about the product's efficacy, not its safety. US regulators are still reviewing the compound as an adjunctive treatment for partial onset seizures in patients with epilepsy aged 16 years and older, UCB noted. In June(2008), the EU's Committee for Medicinal Products for Human Use recommended Vimpat for approval as an adjunctive treatment for partial onset seizures in patients with epilepsy.
Vytorin (ezetimibe/simvastatin) --- Merck & Co. and Schering-Plough --- Aortic stenosis
In the trial, which involved 1873 patients with mild-to-moderate aortic stenosis without symptoms, patients were randomized to receive Vytorin or placebo. Patients who received Vytorin did have a statistically significant 22-percent reduction in atherosclerotic events alone, compared with placebo.Study data showed that Merck & Co.'s and Schering-Plough's cholesterol drug Vytorin (ezetimibe/simvastatin) failed to show an improvement in cardiovascular outcomes in patients with aortic stenosis, compared with placebo. "The study has given a clear-cut answer whether lipid lowering will influence the cause of aortic stenosis and we can conclude it does not," commented lead researcher Terje Pedersen of Ulleval University Hospital in Oslo. In addition, the data demonstrated that 39 patients who took the drug died of cancer, compared with 23 in the placebo group, which researchers indicated could be due to chance. No one type of cancer appeared to be more affected than another, and incidence rate didn't increase the longer patients took Vytorin, according to the findings.
Iloperidone --- Vanda Pharmaceuticals --- Schizophrenia
The FDA issued a not approvable letter for Vanda Pharmaceuticals' schizophrenia compound iloperidone, due in part to concerns about the drug's efficacy compared with Johnson & Johnson's Risperdal (risperidone) in prior studies. The agency requested an additional efficacy trial and asked for further safety data for the atypical antipsychotic. To further demonstrate the drug's efficacy, the FDA requested an additional study comparing iloperidone with placebo, and including a comparator such as Risperdal or Eli Lilly’s Zyprexa (olanzapine), in patients with schizophrenia. Vanda noted that the agency also asked for more safety data for the compound dosed at a range of 20 milligrams to 24 milligrams per day. As a result, the drugmaker said it has put on hold all development of iloperidone, pending further review.
Drugs info:
Malaria drug may increase antibiotic resistance
Data published in the journal PLoS ONE suggest that exposure to antimalarial drug chloroquine could boost Escherichia coli resistance to antibiotic ciprofloxacin, which Bayer markets as Cipro. The findings may have implications for other antibiotics, as well as for newer antimalarials, according to researcher Michael Silverman.
The investigators studied the inhabitants of remote villages in Guyana where there had been extensive use of chloroquine over the previous two years, but no exposure to fluoroquinolones, such as ciprofloxacin. The results demonstrated that 4.8 percent of villagers carried strains of E. coli that were resistant to ciprofloxacin. Silverman commented that "chloroquine use for malaria may make the fluoroquinolones less effective for many common tropical diseases...in the developing world."
The researcher indicated that the resistance to ciprofloxacin could extend to other fluoroquinolones such as Johnson & Johnson's Levaquin and Bayer's Avelox. Silverman also noted that the results could have implications for newer artemisinin-based combination therapies for malaria, which are recommended by the World Health Organization because of growing resistance to older drugs. Future efforts should focus on the prevention of malaria, including the development of new vaccines, he said.
Gene mutation linked to myopathy in patients taking statins
Findings published in the New England Journal of Medicine suggest that a genetic mutation may be linked to an increased risk of myopathy in patients taking statins. Testing for this mutation could help "achieve the benefits of statin therapy more safely and effectively," according to the researchers.
Researchers conducted genetic analyses on 85 patients with definite or incipient myopathy and 90 controls who were all taking high daily doses of simvastatin, which Merck & Co. sells as Zocor, as part of a 12 000-patient trial. The findings showed that patients carrying variants of the SLCO1B1 gene were 4.5 to 16.9 times more likely to develop myopathy, compared with those who did not carry the genetic mutation. The researchers said that they confirmed the results using data from a second study involving patients who were administered a lower dose of the statin.
Hypertension drugs may reduce risk of Alzheimer's
Study data presented at the 2008 International Conference on Alzheimer's disease showed that patients taking angiotensin receptor blockers (ARBs) had a lower risk of developing Alzheimer's disease or dementia, compared with those who were taking other treatments. The findings also suggest that the class of hypertension drugs may slow the progression of the disease.
Researchers examined records from the US Department of Health Systems Veterans Affairs for about six million patients treated for hypertension between 2001 and 2006. The data demonstrated that those administered ARBs had about a 35 percent to 40 percent lower risk of developing Alzheimer's disease or dementia, compared with those who received other drugs. Furthermore, in patients who were already suffering from Alzheimer's or dementia, those who received ARBs had up to a 45 percent lower risk of developing delirium, being admitted to nursing homes or dying.
"When we took account of the effects of age and cardiovascular disease, strokes and diabetes, or anything else that could influence a patient's outcome, these medications still looked very impressive. Potentially, this will have a large public health impact," commented study researcher Benjamin Wolozin. "For those who already have dementia, use of ARBs might delay deterioration of brain function and help keep patients out of nursing homes," he added.
Pfizer's Viagra improves sexual function in women taking antidepressants
The trial involved 98 pre-menopausal women taking either selective or nonselective serotonin reuptake inhibitors, who had no problems with sexual dysfunction before taking antidepressants. Patients were randomly assigned to take placebo or Viagra prior to sexual activity for a period of eight weeks. The findings showed that 27 percent of patients who took placebo reported improvement in sexual function, compared with 72 percent of patients who received Viagra.Women with antidepressant-related sexual dysfunction who took Pfizer's Viagra (sildenafil) reported an improvement in their condition, compared with those who took placebo.
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