Thursday, 3 April 2008
Number of cancer drugs in development at the end of 2007
In renal cancer, recently approved drugs are Sutent, Nexavar, Avastin (in EU) and Torisel. Everolimus had its phase 3 trial halted during an interim review a few weeks ago because the drug had already shown enough survival advantage to meet the trial's endpoint. According to Scrip Reports Outlook 2007 (a pharma industry magazine), there were 624 anticancer treatments in clinical trials in late 2006 (235 in Phase 1, 311 in Phase 2 and 78 in Phase 3). A high proportion of these were cancer vaccines.Many of these compounds will undoubtedly fail in trials, but others will work in lots of different cancer types like Avastin.I do have a very small holding in OXB, which I bought in at recent lows, but IMO I definitely wouldn't bet the house on it. Trovax's known advantages are its low side effects (which should allow it to be added on to other treatments) and Sanofi's big pharma clout+due diligence, but then cost as an add-on treatment and showing better survival become the big issues vs. the competition...
Tuesday, 1 April 2008
Roche's Good Cholesterol Drug Well Tolerated In Study
Swiss pharmaceutical company Roche Holding AG (RHHBY) said Tuesday that an experimental drug to raise the level of so-called good cholesterol was well tolerated in an intermediate study.
Roche, based in Basel, said its cholesterol ester transfer protein, or CETP, inhibitor R1658 has been shown to be well tolerated either alone or in combination with statins and has a similar safety profile to placebo in its effect on blood pressure.
CETP inhibitors work by increasing levels of HDL cholesterol, the so-called 'good cholesterol', thereby potentially reducing cardiovascular risk and formation of plaques in arteries. The most common adverse events reported in patients taking R1658 are gastrointestinal disorders and headache. R1658 is currently in late-stage development.
Many patients still remain at risk of heart disease despite being treated with low-density lipoprotein cholesterol, or LDL-C, lowering drugs, such as statins.
"These results are encouraging and show that to date, based on Phase II results, the compound doesn't appear to exhibit adverse cardiovascular effects or adverse effects on blood pressure when compared to placebo," said George Steiner, of the Department of Medicine, Toronto General Hospital, and lead author of the study.
"We will await future results with interest to see if R1658 has the potential to reduce morbidity and mortality in patients with cardiovascular disease, and at the same time is without significant safety concerns."
In addition, pre-clinical data also presented today at the ACC showed that R1658, in contrast to torcetrapib - an experimental drug whose development was stopped last year by its maker Pfizer Inc. (PFE) on safety concerns - had no impact in rats on blood pressure nor genes associated with the activation of a system that is involved in blood pressure control, known as renin angiotensin aldosterone system.
R1658 was licensed-in by Roche from Japan Tobacco Inc. (2914.TO) in late 2004 and the compound is now being jointly developed by Roche and the Japanese company.
Roche acquired full and exclusive commercial rights to R1658 in all territories except Japan, where Japan Tobacco has retained these rights.
Roche, based in Basel, said its cholesterol ester transfer protein, or CETP, inhibitor R1658 has been shown to be well tolerated either alone or in combination with statins and has a similar safety profile to placebo in its effect on blood pressure.
CETP inhibitors work by increasing levels of HDL cholesterol, the so-called 'good cholesterol', thereby potentially reducing cardiovascular risk and formation of plaques in arteries. The most common adverse events reported in patients taking R1658 are gastrointestinal disorders and headache. R1658 is currently in late-stage development.
Many patients still remain at risk of heart disease despite being treated with low-density lipoprotein cholesterol, or LDL-C, lowering drugs, such as statins.
"These results are encouraging and show that to date, based on Phase II results, the compound doesn't appear to exhibit adverse cardiovascular effects or adverse effects on blood pressure when compared to placebo," said George Steiner, of the Department of Medicine, Toronto General Hospital, and lead author of the study.
"We will await future results with interest to see if R1658 has the potential to reduce morbidity and mortality in patients with cardiovascular disease, and at the same time is without significant safety concerns."
In addition, pre-clinical data also presented today at the ACC showed that R1658, in contrast to torcetrapib - an experimental drug whose development was stopped last year by its maker Pfizer Inc. (PFE) on safety concerns - had no impact in rats on blood pressure nor genes associated with the activation of a system that is involved in blood pressure control, known as renin angiotensin aldosterone system.
R1658 was licensed-in by Roche from Japan Tobacco Inc. (2914.TO) in late 2004 and the compound is now being jointly developed by Roche and the Japanese company.
Roche acquired full and exclusive commercial rights to R1658 in all territories except Japan, where Japan Tobacco has retained these rights.
Shionogi Shares Jump On Crestor's Surprise Study Results
Shares of Shionogi & Co. (4507.TO) climbed 9.2% Tuesday on hopes for increased sales of cholesterol-lowering drug Crestor after a recent clinical study found the drug may lower a patient's chances of dying from a heart attack or other cardiovascular problem.
The 15,000-patient clinical study, which is called Jupiter, was the first to provide evidence of Crestor's ability to reduce cardiovascular-related mortality.
In trading on the Tokyo Stock Exchange Tuesday, investors showed a healthy appetite for Shionogi's shares, judging that the surprising outcome of the study conducted by AstraZeneca PLC was a favorable development for the Japanese drug maker, whose income from the drug accounted for over 70% of its group operating profit last fiscal year.
After rising as high as Y1,920, Shionogi's shares finished at Y1,858. The sharp gains outpaced a 1% rise in the Nikkei 225 Stock Average.
Analysts also took a positive view to possible impact of the drug on Shionogi's earnings.
KBC Securities Japan analyst Philip Hall raised the drug maker's rating two notches to "buy" from "sell" on a three-tier scale and lifted the target price to Y2,000 from Y1,600.
"It is difficult to quantify the impact on Crestor given that the specific Jupiter results remain unpublished, but as a large numbers of patients fall into the eligible-for-treatment category, we tentatively see upside to our current earnings forecasts in the 20% range," Hall said in a note to clients.
While investors were quick to pick up shares in the Japanese drug maker, the results of the study, which was halted prematurely, have yet to be published. Citing ethical reasons, AstraZeneca said Monday it stopped the study early after Crestor showed clear benefits over a placebo.
A Shionogi spokesman said that it hasn't set a date for when it will announce details of the study and that it is too early to say what kind of impact it will have on the company's sales or market share.
In a typical practice by pharmaceutical companies in unveiling clinical trial data, AstraZeneca is likely to release the Jupiter results at an upcoming medical industry meeting.
Meetings planned by organization in the field of cardiovascular medicine later this year include the European Society of Cardiology in August and the American Heart Association in November.
The 15,000-patient clinical study, which is called Jupiter, was the first to provide evidence of Crestor's ability to reduce cardiovascular-related mortality.
In trading on the Tokyo Stock Exchange Tuesday, investors showed a healthy appetite for Shionogi's shares, judging that the surprising outcome of the study conducted by AstraZeneca PLC was a favorable development for the Japanese drug maker, whose income from the drug accounted for over 70% of its group operating profit last fiscal year.
After rising as high as Y1,920, Shionogi's shares finished at Y1,858. The sharp gains outpaced a 1% rise in the Nikkei 225 Stock Average.
Analysts also took a positive view to possible impact of the drug on Shionogi's earnings.
KBC Securities Japan analyst Philip Hall raised the drug maker's rating two notches to "buy" from "sell" on a three-tier scale and lifted the target price to Y2,000 from Y1,600.
"It is difficult to quantify the impact on Crestor given that the specific Jupiter results remain unpublished, but as a large numbers of patients fall into the eligible-for-treatment category, we tentatively see upside to our current earnings forecasts in the 20% range," Hall said in a note to clients.
While investors were quick to pick up shares in the Japanese drug maker, the results of the study, which was halted prematurely, have yet to be published. Citing ethical reasons, AstraZeneca said Monday it stopped the study early after Crestor showed clear benefits over a placebo.
A Shionogi spokesman said that it hasn't set a date for when it will announce details of the study and that it is too early to say what kind of impact it will have on the company's sales or market share.
In a typical practice by pharmaceutical companies in unveiling clinical trial data, AstraZeneca is likely to release the Jupiter results at an upcoming medical industry meeting.
Meetings planned by organization in the field of cardiovascular medicine later this year include the European Society of Cardiology in August and the American Heart Association in November.
Monday, 31 March 2008
QuantRx Announces Commencement of Phase I Clinical Trial by FluoroPharma for BFPET™, A Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission
QuantRx Biomedical Corporation announced that FluoroPharma is commencing Phase I clinical trials for BFPET following institutional review board (IRB) approval of the proposed studies. The Phase I trial is a single center, open label study, designed to evaluate safety, distribution, and dosimetry of BFPET as a PET tracer for myocardial perfusion imaging in healthy subjects. The study will be led by Dr. Alan Fischman, Professor of Radiology at Harvard Medical School and former Director of the Nuclear Medicine Division at Massachusetts General Hospital. BFPET is FluoroPharma's second cardiovascular PET agent to enter clinical trials.
BFPET is a PET blood flow imaging agent for use in classic "rest-stress" cardiac testing. Each year more than 9 million Americans undergo myocardial perfusion imaging, the standard test to assess coronary artery disease (CAD). As a PET imaging tracer, BFPET may have a significant advantage due to its potential to improve the sensitivity and specificity of CAD diagnosis and to provide information on myocardial mitochondrial damage.
BFPET is a PET blood flow imaging agent for use in classic "rest-stress" cardiac testing. Each year more than 9 million Americans undergo myocardial perfusion imaging, the standard test to assess coronary artery disease (CAD). As a PET imaging tracer, BFPET may have a significant advantage due to its potential to improve the sensitivity and specificity of CAD diagnosis and to provide information on myocardial mitochondrial damage.
Cephalon's Treanda Gets FDA OK To Treat Type Of Leukemia
Cephalon Inc. (CEPH) said Thursday the Food and Drug Administration approved Treanda for injection to treat of patients with chronic lymphocytic leukemia, a slowly progressing blood and bone marrow disease.
The Frazer, Pa., biopharmaceutical company said it anticipates Treanda, or bendamustine hydrochloride, will be available to doctors and patients in the U.S. in April.
In a study, patients who received Treanda had better clinical outcomes and a longer progression-free survival period than those treated with another FDA-pproved treatment, according to Cephalon.
The company said the drug's application as a treatment for chronic lymphocytic leukemia received priority review from the FDA and was approved within six months.
Treanda has been granted orphan drug status by the FDA, providing marketing exclusivity through March 2015.
Cephalon said the American Cancer Society estimates more than 15,000 new cases of chronic lymphocytic leukemia will be diagnosed in the U.S. this year.
The Frazer, Pa., biopharmaceutical company said it anticipates Treanda, or bendamustine hydrochloride, will be available to doctors and patients in the U.S. in April.
In a study, patients who received Treanda had better clinical outcomes and a longer progression-free survival period than those treated with another FDA-pproved treatment, according to Cephalon.
The company said the drug's application as a treatment for chronic lymphocytic leukemia received priority review from the FDA and was approved within six months.
Treanda has been granted orphan drug status by the FDA, providing marketing exclusivity through March 2015.
Cephalon said the American Cancer Society estimates more than 15,000 new cases of chronic lymphocytic leukemia will be diagnosed in the U.S. this year.
Genetics May Bring New Life To Failed Drugs
As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.
The idea is "to take some of these compounds, capitalize on past investments sitting idle, and now selectively accelerate them in the development process," says Terry Hisey, a pharmaceutical-industry strategist at the consultancy Deloitte LLP.
The ultimate goal is to develop medicines tailored to patients with a particular genetic makeup or who have diseases with a particular gene variation that are more responsive to a specific treatment. While few have been fully realized so far, there are a small but growing number, such as cancer drug Gleevec from Novartis AG and NitroMed's BiDil, a heart-disease medicine.
"There's a big buzz about it," says Edward Abrahams, executive director of the Personalized Medicine Coalition, a nonprofit education and advocacy group comprising industry, academia and government organizations.
While the markets for these therapies are smaller than for those that treat the general population, pharmaceutical companies are realizing there are hefty profits to be made because patients are more likely to use, and stick with, a tailored medicine that works better than a one-size-fits-all drug. For instance, biotechnology giant Genentech Inc.'s Herceptin, which is taken by women with breast cancer who have a particular variant of the HER-2 gene, reaped $1.3 billion in sales last year.
The broader shift toward so-called personalized medicine dovetails with pharmaceutical makers' recognition of how hard it is to maintain a business model that relies on producing a few drugs that bring in billions of dollars a year.
"The old sort of pharmaceutical model is under pressure right now," says Wayne Rosenkrans, chairman and president of the Personalized Medicine Coalition. "Personalized health care is one of those potential solutions."
Drug development typically can take 10 years or more. Failures cost companies both time and money, from $15 million per compound at the first stage of human testing to $86 million in late-stage trials, according to a 2003 study on the cost of drug innovation published in the Journal of Health Economics. Historically, these cost have increased over time above the rate of inflation, but there aren't more recent data available for pharmaceuticals, says Joseph DiMasi, a study author who is director of economic analysis at the Tufts Center for the Study of Drug Development.
Many drug makers say they routinely evaluate why a formulation didn't work, and genetic information offers another way of sleuthing.
"Does genomic information help us understand the cause of failure and give us any information about whether we can resurrect the project?" says Liam Ratcliffe, head of clinical quantitative and innovative medicine at Pfizer Inc. "We do this routinely." Mr. Ratcliffe says this approach hasn't yet helped salvage any Pfizer products, though, an assessment echoed by some other big pharmaceutical companies.
Some industry experts say it is too time-consuming for big pharmaceutical makers to try to salvage drugs; they say it might be more promising to form a partnership with or sell development rights to smaller biotech or specialty pharma companies. Such alliances have grown sharply in recent years; about $19 billion was spent on securing such partnerships in both 2006 and 2007, compared with less than $10 billion annually from 1999-2005, although the increase can't be attributed solely to targeted treatments, according to the Ernst & Young Global Biotechnology Center.
When the antidepressant vilazodone failed to show a significant benefit in a mid-stage trial its originator, Merck KGaA, decided to take its portfolio in a different direction.
The German company -- which isn't affiliated with New Jersey-based Merck & Co. -- sold the rights to Genaissance Pharmaceuticals, a company since acquired by Clinical Data Inc. of Newton, Mass. The drug had shown promise in some patients and had a good safety profile, and Clinical Data wanted to identify the patient population for whom it works best, according to Carol Reed, the company's chief medical officer.
It was a matter of figuring why certain patients responded and others didn't, Dr. Reed says. In September, Clinical Data said it found potential genetic markers that enhance the drug's efficacy in some patients, and last week announced it would begin clinical trials for the second of its two critical late-stage studies. The company is "confident" it will be able to develop the biomarker test to identify the population segment most likely to respond, Chief Executive Drew Fromkin says.
Another drug close to being resurrected is bucindolol, which had been sidelined by other pharmaceutical companies when research on similar cardiovascular medicines appeared to show more promise. Rather than let the drug die, a company research scientist, Michael Bristow, bought the rights and formed a new company to develop it.
Dr. Bristow and his colleague Stephen Liggett have since identified one gene variant that improves patients' response to bucindolol and another that is linked with heightened risk of side effects, according to Dr. Bristow, chief science and medical officer. The company, ARCA Discovery in Denver, will file for Food and Drug Administration approval within the next month or two and hopes to bring the drug to market in the summer of 2009.
Success stories remain rare, however, and coming up with personalized treatments is challenging, genomic scientists say. Researchers not only must identify genetic variations that are related to how a disease works, but figure out how they interact with a medication as well.
Even when genomic knowledge can't save a drug, it can shed light on the reasons for failure and spur a new way of thinking about how a medication works, according to Scott Reines, a vice president in the pharmaceutical research-and-development unit of Johnson & Johnson. Companies could also develop and market tests that identify patients with a particular genetic variant.
"I think the bigger value isn't in going back and rescuing a particular drug, but you may be able to go back and rescue a particular line of thinking around a particular pathway," says Dr. Rosenkrans of the Personalized Medicine Coalition.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.
The idea is "to take some of these compounds, capitalize on past investments sitting idle, and now selectively accelerate them in the development process," says Terry Hisey, a pharmaceutical-industry strategist at the consultancy Deloitte LLP.
The ultimate goal is to develop medicines tailored to patients with a particular genetic makeup or who have diseases with a particular gene variation that are more responsive to a specific treatment. While few have been fully realized so far, there are a small but growing number, such as cancer drug Gleevec from Novartis AG and NitroMed's BiDil, a heart-disease medicine.
"There's a big buzz about it," says Edward Abrahams, executive director of the Personalized Medicine Coalition, a nonprofit education and advocacy group comprising industry, academia and government organizations.
While the markets for these therapies are smaller than for those that treat the general population, pharmaceutical companies are realizing there are hefty profits to be made because patients are more likely to use, and stick with, a tailored medicine that works better than a one-size-fits-all drug. For instance, biotechnology giant Genentech Inc.'s Herceptin, which is taken by women with breast cancer who have a particular variant of the HER-2 gene, reaped $1.3 billion in sales last year.
The broader shift toward so-called personalized medicine dovetails with pharmaceutical makers' recognition of how hard it is to maintain a business model that relies on producing a few drugs that bring in billions of dollars a year.
"The old sort of pharmaceutical model is under pressure right now," says Wayne Rosenkrans, chairman and president of the Personalized Medicine Coalition. "Personalized health care is one of those potential solutions."
Drug development typically can take 10 years or more. Failures cost companies both time and money, from $15 million per compound at the first stage of human testing to $86 million in late-stage trials, according to a 2003 study on the cost of drug innovation published in the Journal of Health Economics. Historically, these cost have increased over time above the rate of inflation, but there aren't more recent data available for pharmaceuticals, says Joseph DiMasi, a study author who is director of economic analysis at the Tufts Center for the Study of Drug Development.
Many drug makers say they routinely evaluate why a formulation didn't work, and genetic information offers another way of sleuthing.
"Does genomic information help us understand the cause of failure and give us any information about whether we can resurrect the project?" says Liam Ratcliffe, head of clinical quantitative and innovative medicine at Pfizer Inc. "We do this routinely." Mr. Ratcliffe says this approach hasn't yet helped salvage any Pfizer products, though, an assessment echoed by some other big pharmaceutical companies.
Some industry experts say it is too time-consuming for big pharmaceutical makers to try to salvage drugs; they say it might be more promising to form a partnership with or sell development rights to smaller biotech or specialty pharma companies. Such alliances have grown sharply in recent years; about $19 billion was spent on securing such partnerships in both 2006 and 2007, compared with less than $10 billion annually from 1999-2005, although the increase can't be attributed solely to targeted treatments, according to the Ernst & Young Global Biotechnology Center.
When the antidepressant vilazodone failed to show a significant benefit in a mid-stage trial its originator, Merck KGaA, decided to take its portfolio in a different direction.
The German company -- which isn't affiliated with New Jersey-based Merck & Co. -- sold the rights to Genaissance Pharmaceuticals, a company since acquired by Clinical Data Inc. of Newton, Mass. The drug had shown promise in some patients and had a good safety profile, and Clinical Data wanted to identify the patient population for whom it works best, according to Carol Reed, the company's chief medical officer.
It was a matter of figuring why certain patients responded and others didn't, Dr. Reed says. In September, Clinical Data said it found potential genetic markers that enhance the drug's efficacy in some patients, and last week announced it would begin clinical trials for the second of its two critical late-stage studies. The company is "confident" it will be able to develop the biomarker test to identify the population segment most likely to respond, Chief Executive Drew Fromkin says.
Another drug close to being resurrected is bucindolol, which had been sidelined by other pharmaceutical companies when research on similar cardiovascular medicines appeared to show more promise. Rather than let the drug die, a company research scientist, Michael Bristow, bought the rights and formed a new company to develop it.
Dr. Bristow and his colleague Stephen Liggett have since identified one gene variant that improves patients' response to bucindolol and another that is linked with heightened risk of side effects, according to Dr. Bristow, chief science and medical officer. The company, ARCA Discovery in Denver, will file for Food and Drug Administration approval within the next month or two and hopes to bring the drug to market in the summer of 2009.
Success stories remain rare, however, and coming up with personalized treatments is challenging, genomic scientists say. Researchers not only must identify genetic variations that are related to how a disease works, but figure out how they interact with a medication as well.
Even when genomic knowledge can't save a drug, it can shed light on the reasons for failure and spur a new way of thinking about how a medication works, according to Scott Reines, a vice president in the pharmaceutical research-and-development unit of Johnson & Johnson. Companies could also develop and market tests that identify patients with a particular genetic variant.
"I think the bigger value isn't in going back and rescuing a particular drug, but you may be able to go back and rescue a particular line of thinking around a particular pathway," says Dr. Rosenkrans of the Personalized Medicine Coalition.
FDA Alert On J&J's HIV Drug, Possible Link To Liver Damage
Health regulators have warned doctors about a possible link between a Johnson & Johnson (JNJ) HIV drug and potentially fatal liver damage.
The Food and Drug Administration said Friday it has received reports of drug-induced hepatitis in patients taking J&J's Prezista, which is used in combination with another HIV drug ritonavir.
The agency highlighted the risks in a message to doctors posted on its Web site.
J&J and FDA added new warnings to Prezista's label earlier this month.
The new labeling indicates that 0.5% of patients in the original trials of the drug showed hepatitis. Since the drug was approved, FDA has received additional reports of the liver illness, some of which were fatal.
Most of the reported problems were in patients with advanced HIV who were taking multiple medications, according to the label.
FDA cleared Prezista in 2006 for use in patients who don't respond to treatment with other antiretroviral drugs.
The Food and Drug Administration said Friday it has received reports of drug-induced hepatitis in patients taking J&J's Prezista, which is used in combination with another HIV drug ritonavir.
The agency highlighted the risks in a message to doctors posted on its Web site.
J&J and FDA added new warnings to Prezista's label earlier this month.
The new labeling indicates that 0.5% of patients in the original trials of the drug showed hepatitis. Since the drug was approved, FDA has received additional reports of the liver illness, some of which were fatal.
Most of the reported problems were in patients with advanced HIV who were taking multiple medications, according to the label.
FDA cleared Prezista in 2006 for use in patients who don't respond to treatment with other antiretroviral drugs.
Subscribe to:
Posts (Atom)