Vertex Pharma Says Telaprevir-based Regimens Shows High SVR Rates In Treatment-failed HCV Patients
http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1108896%20&Category=Breaking%20News
Vertex Pharma recently released interim Phase III data that indicates their product, Telaprevir, is effective in achieving sustained viral response (a “cure”) in a greater number of patients than the standard of care. This trial, run in treatment-experienced HCV patients, is one of three that will eventually be used to support an NDA filing. Vertex hopes to make Telaprevir, co-administered with pegylated interferon alpha and ribavirin, the standard of care for HCV patients, across virus genotypes and resistance profiles.
This was the first hit that came up when I searched for “pharma news” on Google. After reading over, and consulting several other sites, it struck me as important for several reasons:
First of all, HCV has become a competitive market, with over 40 new treatments in clinical trials. Advancements in our understanding of viral biology have suggested numerous new targets and treatment strategies for this disease. Scientific advancement, coupled with a increase in infections and diagnoses, make HCV a hot target for many companies. It will be interesting to observe which products eventually make it through the clinic.
The current standard of treatment for HCV might seem to be adequate, it could be improved in several areas including ease of dosing (current treatment regimen includes continual injections), safety profile (pegylated interferonA naturally leads to flu-like symptoms), and efficacy (only about 1/2 the patients on medication are “cured”). This is a good opportunity to discuss the issues of “me too” drugs and the lack of research productivity. Some people might see the HCV landscape as a jumble of companies seeking to profit on incremental innovation. Other might conclude that the market is working to incentivize research and generate significant medical advances.
Over the years it will be interesting to see how much of a “first mover” advantage Vertex enjoys. Many of the later-stage HCV products are protease inhibitors, and it remains to be seen which product will have the most favorable safety/efficacy profile. How substitutable will these products be, and what will happen to Telaprevir sales if a superior product reaches the market several years later.
H1N1 Flu Vaccine Supply Issues
http://www.usnews.com/mobile/articles_mobile/production-problems-plague-delivery-of-swine-flu/index.html
http://www.npr.org/blogs/health/2009/10/blame_game_begins_for_swine_fl.html
http://www.npr.org/blogs/health/2009/10/swine_vaccine_shortage_sparks.html
http://www.npr.org/blogs/health/2009/10/cdc_frustrated_by_h1n1_vaccine.html
http://www.cdc.gov/H1N1flu/qa.htm
The CDC originally estimated that 40 million doses of H1N1 flu vaccine would be available by Oct. 15. Less than 17 million doses had become available by the last week of October. This has caused shortages throughout the country. Examples of its impact include that New York State temporarily suspending a requirement for health care workers to receive the vaccine because there’s not enough to go around. Health and Human services secretary Kathleen Sebelius says manufacturing shortcomings is the main cause of shortage. For example, Novartis reported that only about one-fifth of original cultures yielded vaccines.
President Obama declared the swine-flu outbreak as a national emergency. This allows for certain Medicare, Medicaid, and health privacy rules to be waived or modified. This allows for medical facilities to be set up more easily, for example in a school gym, in order to administer the vaccine. The death toll in the US is approximately 1000 since April. About 20,000 have been hospitalized.
Weight Gain Associated With Antipsychotic Drugs
http://www.nytimes.com/2009/10/29/health/research/29stem.html?ref=health
Young children and adolescents who take the newest generation of antipsychotic medications for schizophrenia or bipolar disorder, risk rapid weight gain and metabolic changes that could lead to diabetes and other illnesses according to a study published in the Journal of the American Medical Association. The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week. The four drugs in the study, the most popular antipsychotic medications, are industry blockbusters, with combined sales of $12.7 billion last year.
Thursday, October 29, 2009
Policy News (10/22-28)
House Leaders Compromise on Public Option
http://online.wsj.com/article/SB125676119579814007.html
http://news.yahoo.com/s/ap/20091026/ap_on_go_co/us_health_care_overhaul
http://www.nytimes.com/2009/10/28/health/policy/28health.html?ref=health
http://edition.cnn.com/2009/POLITICS/10/28/health.care/
The house overwhelmingly voted down what was considered the “strong” version of the public health insurance option. This was seen as a victory for health insurance companies and moderate Democrats.
The moderates objected to features of the bill that would expand federal subsidies of health insurance for the poor. Instead, the new legislation will likely expand Medicaid coverage to more low-income Americans. This was thought to be a cheaper way of extending coverage than additional subsidies.
Also at issue was language in the bill that indicated the public plan would negotiate reimbursement rates in tandem with Medicare. This was viewed by insurers as an unfair advantage because the joint entity (public plan + Medicare) would be able to negotiate with much more leverage than individual companies. Moving forward, the public plan will likely negotiate rates on its own.
Industry Years Behind on Testing Approved Drugs
http://www.nytimes.com/2009/10/27/health/policy/27fda.html?ref=health
Congressional investigators on Monday released yet another report pointing out that studies for approved drugs remain undone many years after being promised. Congress passed legislation in 2007 giving the Food and Drug Administration greater power to force drug makers to complete their promised studies. The Government Accountability Office said that from 1992 through Nov. 20, 2008, the FDA asked drug makers to complete 144 studies associated with 90 drug applications, and that drug makers had completed just two-thirds of the requested studies. The result is that doctors and patients are unable to confirm where medicines they are prescribing and taking are actually beneficial.
California Awards Grants for Nonembryonic Stem Cells Research
http://www.nytimes.com/2009/10/29/health/research/29stem.html?ref=health
California’s stem cell research program on Wednesday awarded $230M in grants intended to develop therapies using stem cells less controversial than embryonic stem cells. Grant recipients are supposed to have a therapy ready for initial human testing in four years. The grants represent a departure from the program’s original mission of getting around the restrictions on embryonic stem cell research imposed by the administration of President George W. Bush. This year, the Obama administration relaxed the previous administration’s restrictions.
Leaders of the California program say that what voters really care about are treatments for diseases, not what cell type is used. The grant awards are being hailed by those who believe using embryonic stem cells is immoral. They are stating that this grant bolsters one argument made by opponents of embryonic stem cell work: that such cells are not needed because treatments using adult cells are closer to fruition.
Projects funded using nonembryonic stem cells include:
- Repairing damage from a heart attack by retrieving cardiac stem cells from a patient’s heart, multiplying them in culture and placing them back in the heart.
- Treating a rare but debilitating skin disease (epidermolysis bullosa) using pluripotent stem cells made from a patient’s own skin cells.
- Suppress AIDS by taking a patient’s blood-forming stem cells, inactivating a gene to make them resistant to HIV, and putting them back into the body.
http://online.wsj.com/article/SB125676119579814007.html
http://news.yahoo.com/s/ap/20091026/ap_on_go_co/us_health_care_overhaul
http://www.nytimes.com/2009/10/28/health/policy/28health.html?ref=health
http://edition.cnn.com/2009/POLITICS/10/28/health.care/
The house overwhelmingly voted down what was considered the “strong” version of the public health insurance option. This was seen as a victory for health insurance companies and moderate Democrats.
The moderates objected to features of the bill that would expand federal subsidies of health insurance for the poor. Instead, the new legislation will likely expand Medicaid coverage to more low-income Americans. This was thought to be a cheaper way of extending coverage than additional subsidies.
Also at issue was language in the bill that indicated the public plan would negotiate reimbursement rates in tandem with Medicare. This was viewed by insurers as an unfair advantage because the joint entity (public plan + Medicare) would be able to negotiate with much more leverage than individual companies. Moving forward, the public plan will likely negotiate rates on its own.
Industry Years Behind on Testing Approved Drugs
http://www.nytimes.com/2009/10/27/health/policy/27fda.html?ref=health
Congressional investigators on Monday released yet another report pointing out that studies for approved drugs remain undone many years after being promised. Congress passed legislation in 2007 giving the Food and Drug Administration greater power to force drug makers to complete their promised studies. The Government Accountability Office said that from 1992 through Nov. 20, 2008, the FDA asked drug makers to complete 144 studies associated with 90 drug applications, and that drug makers had completed just two-thirds of the requested studies. The result is that doctors and patients are unable to confirm where medicines they are prescribing and taking are actually beneficial.
California Awards Grants for Nonembryonic Stem Cells Research
http://www.nytimes.com/2009/10/29/health/research/29stem.html?ref=health
California’s stem cell research program on Wednesday awarded $230M in grants intended to develop therapies using stem cells less controversial than embryonic stem cells. Grant recipients are supposed to have a therapy ready for initial human testing in four years. The grants represent a departure from the program’s original mission of getting around the restrictions on embryonic stem cell research imposed by the administration of President George W. Bush. This year, the Obama administration relaxed the previous administration’s restrictions.
Leaders of the California program say that what voters really care about are treatments for diseases, not what cell type is used. The grant awards are being hailed by those who believe using embryonic stem cells is immoral. They are stating that this grant bolsters one argument made by opponents of embryonic stem cell work: that such cells are not needed because treatments using adult cells are closer to fruition.
Projects funded using nonembryonic stem cells include:
- Repairing damage from a heart attack by retrieving cardiac stem cells from a patient’s heart, multiplying them in culture and placing them back in the heart.
- Treating a rare but debilitating skin disease (epidermolysis bullosa) using pluripotent stem cells made from a patient’s own skin cells.
- Suppress AIDS by taking a patient’s blood-forming stem cells, inactivating a gene to make them resistant to HIV, and putting them back into the body.
Company News (10/22-28)
Biogen Shares Drop as Tysabri PML Cases Climb to 23
http://www.marketwatch.com/story/biogen-elan-fall-dr-reddys-rallies-2009-10-23
Biogen shares dropped ~5% last week as further data was released regarding the safety profile of Tysabri, one of their flagship drugs. Reported cases of PML, a rare, often fatal, brain infection, in patients taking Tysabri have now climbed to 23. Tysabri was originally released to the market in 2004, but was voluntarily recalled in 2005 due to several occurrences of this infection. Tysabri was re-introduced in 2006. Biogen’s estimate is that patients taking Tysabri have a 1/1000 chance of contracting this infection.
PML, or progressive multifocal leukoencephalopathy, is a viral brain infection most common in patients with AIDS. It is suspected that patients taking Tysabri along with other immunosuppressive drugs are at increased risk of PML due to a weakened immune system. Tysabri specifically inhibits immune cells from passing through the blood brain barrier. The therapeutic mechanism of action is therefore likely linked to the incidence of this deadly side effect.
This is a striking example of the risk/benefit analysis required when deciding whether to allow a drug on the market. Even though the drug has been shown to increase the risk of a fatal brain disorder, the FDA has made no indication that patients should be denied access to it. This is ostensibly because the benefits of Tysabri (significantly decreased rate of deterioration and decreased incidence of MS recurrence versus the standard of care) outweigh the harm. For indications for which more good treatments are available, or for less serious illnesses, Tysabri’s safety profile would be unacceptable.
Aerie Reports Positive Results In Phase 2a Study
http://clinicaltrials.pharmaceutical-business-review.com/news/aerie_reports_positive_results_in_phase_2a_study_for_ar12286_091022/
Aerie Pharmaceuticals reported positive results from a phase 2a study of its Rho-kinase (ROCK) inhibitor, AR-12286. The study evaluated the safety, tolerability and efficacy of three different doses of AR-12286 in 88 patients with primary open angle glaucoma or ocular hypertension. The study results suggested that AR-12286 was safe and well-tolerated. In addition, the phase 2a study achieved statistical significance in demonstrating lowered intraocular pressure (IOP) with both once-daily and twice-daily treatment. AR-12286 has achieved a maximum change of mean IOP of 28% from baseline, which is comparable to, or exceeds, pressure lowering attained by the most commonly used glaucoma drugs, as reported in other studies.
EMEA Issues Positive Opinion For Micardis (manufactured by Boehringer Ingelheim)
http://regulatoryaffairs.pharmaceutical-business-review.com/news/emea_issues_positive_opinion_for_micardis_091023/
The EMEA issued a positive opinion for the approval of Micardis (telmisartan) for reducing the risk of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus. The opinion follows a review of clinical trial results including The ONTARGET Trial involving 25,620 patients. It confirmed Micardis as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk. The study results also demonstrated that Micardis is better tolerated than the previous gold standard ramipril and associated with higher treatment adherence.
The FDA has approved Micardis for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older, at high risk of developing major CV events who are unable to take ACE inhibitors.
http://www.marketwatch.com/story/biogen-elan-fall-dr-reddys-rallies-2009-10-23
Biogen shares dropped ~5% last week as further data was released regarding the safety profile of Tysabri, one of their flagship drugs. Reported cases of PML, a rare, often fatal, brain infection, in patients taking Tysabri have now climbed to 23. Tysabri was originally released to the market in 2004, but was voluntarily recalled in 2005 due to several occurrences of this infection. Tysabri was re-introduced in 2006. Biogen’s estimate is that patients taking Tysabri have a 1/1000 chance of contracting this infection.
PML, or progressive multifocal leukoencephalopathy, is a viral brain infection most common in patients with AIDS. It is suspected that patients taking Tysabri along with other immunosuppressive drugs are at increased risk of PML due to a weakened immune system. Tysabri specifically inhibits immune cells from passing through the blood brain barrier. The therapeutic mechanism of action is therefore likely linked to the incidence of this deadly side effect.
This is a striking example of the risk/benefit analysis required when deciding whether to allow a drug on the market. Even though the drug has been shown to increase the risk of a fatal brain disorder, the FDA has made no indication that patients should be denied access to it. This is ostensibly because the benefits of Tysabri (significantly decreased rate of deterioration and decreased incidence of MS recurrence versus the standard of care) outweigh the harm. For indications for which more good treatments are available, or for less serious illnesses, Tysabri’s safety profile would be unacceptable.
Aerie Reports Positive Results In Phase 2a Study
http://clinicaltrials.pharmaceutical-business-review.com/news/aerie_reports_positive_results_in_phase_2a_study_for_ar12286_091022/
Aerie Pharmaceuticals reported positive results from a phase 2a study of its Rho-kinase (ROCK) inhibitor, AR-12286. The study evaluated the safety, tolerability and efficacy of three different doses of AR-12286 in 88 patients with primary open angle glaucoma or ocular hypertension. The study results suggested that AR-12286 was safe and well-tolerated. In addition, the phase 2a study achieved statistical significance in demonstrating lowered intraocular pressure (IOP) with both once-daily and twice-daily treatment. AR-12286 has achieved a maximum change of mean IOP of 28% from baseline, which is comparable to, or exceeds, pressure lowering attained by the most commonly used glaucoma drugs, as reported in other studies.
EMEA Issues Positive Opinion For Micardis (manufactured by Boehringer Ingelheim)
http://regulatoryaffairs.pharmaceutical-business-review.com/news/emea_issues_positive_opinion_for_micardis_091023/
The EMEA issued a positive opinion for the approval of Micardis (telmisartan) for reducing the risk of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus. The opinion follows a review of clinical trial results including The ONTARGET Trial involving 25,620 patients. It confirmed Micardis as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk. The study results also demonstrated that Micardis is better tolerated than the previous gold standard ramipril and associated with higher treatment adherence.
The FDA has approved Micardis for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older, at high risk of developing major CV events who are unable to take ACE inhibitors.
Thursday, October 22, 2009
Company news (10/15-21)
Pfizer closes acquisition of Wyeth
http://www.nytimes.com/2009/01/26/business/26drug.html
Pfizer announced that they closed acquisition deal of Wyeth, after nine months they agreed to acquire Wyeth for $68 billion at January this year. Even though they reported third-quarter profit 2009 increased 26 percent to $2.9 billion versus the comparable period in 2008, their sales revenue went down 3% than the same period, 2008.
Now, nearly 20,000 job cuts are expected; thousands of workers are already gone.
Wyeth’s several blockbuster drugs including biotech drug Enbrel for rheumatoid arthritis, menopause treatments Premarin and Prempro, Centrum vitamins, Advil pain reliever and the top-selling vaccine in history, Prevnar for children's pneumococcal diseases, will make Pfizer’s product portfolio stronger with Pfizer's impotence pill Viagra, Alzheimer's drug Aricept and pain treatments Celebrex and Lyrica.
Pfizer will have to sell about half of Wyeth's animal health business.The combined company will have about $57 billion in revenue and, once job cuts are finished, roughly 110,000 workers.
GE plans healthcare venture capital fund and will expand cancer research partnership with Eli Lilly, GE buys ONI Medical Systems
http://www.ft.com/cms/s/0/51d207b2-be88-11de-b4ab-00144feab49a.html
General Electric announced that it is starting a $250m fund to invest in startup healthcare technology, focusing on companies that specialise in healthcare IT, life sciences and diagnostic technology to promote preventitive medicine.
With venture fund’s investment drastically going down, this GE fund is expected bio medical entrepreneurs to encourage and to have a good opportunity to directly work with global leader.
The company said also it was formalising its partnership with Eli Lilly to work on new ways of mapping proteins to determine how people respond to cancer treatments. Meanwhile, GE, which has seeking potential breakthrough technologies, announced that it had acquired ONI Medical Systems, a private company which makes magnetic resonance imaging systems that allow patients to have specific joints scanned rather than their entire bodies.
http://www.nytimes.com/2009/01/26/business/26drug.html
Pfizer announced that they closed acquisition deal of Wyeth, after nine months they agreed to acquire Wyeth for $68 billion at January this year. Even though they reported third-quarter profit 2009 increased 26 percent to $2.9 billion versus the comparable period in 2008, their sales revenue went down 3% than the same period, 2008.
Now, nearly 20,000 job cuts are expected; thousands of workers are already gone.
Wyeth’s several blockbuster drugs including biotech drug Enbrel for rheumatoid arthritis, menopause treatments Premarin and Prempro, Centrum vitamins, Advil pain reliever and the top-selling vaccine in history, Prevnar for children's pneumococcal diseases, will make Pfizer’s product portfolio stronger with Pfizer's impotence pill Viagra, Alzheimer's drug Aricept and pain treatments Celebrex and Lyrica.
Pfizer will have to sell about half of Wyeth's animal health business.The combined company will have about $57 billion in revenue and, once job cuts are finished, roughly 110,000 workers.
GE plans healthcare venture capital fund and will expand cancer research partnership with Eli Lilly, GE buys ONI Medical Systems
http://www.ft.com/cms/s/0/51d207b2-be88-11de-b4ab-00144feab49a.html
General Electric announced that it is starting a $250m fund to invest in startup healthcare technology, focusing on companies that specialise in healthcare IT, life sciences and diagnostic technology to promote preventitive medicine.
With venture fund’s investment drastically going down, this GE fund is expected bio medical entrepreneurs to encourage and to have a good opportunity to directly work with global leader.
The company said also it was formalising its partnership with Eli Lilly to work on new ways of mapping proteins to determine how people respond to cancer treatments. Meanwhile, GE, which has seeking potential breakthrough technologies, announced that it had acquired ONI Medical Systems, a private company which makes magnetic resonance imaging systems that allow patients to have specific joints scanned rather than their entire bodies.
Health policy (10/15-21)
Democrats push to reverse Medicare payment cuts to doctors
http://www.foxnews.com/politics/2009/10/15/moderate-democrats-concerned-plan-spend-billion-medicare-doctors/
After months of struggling to put together a major health bill, Senate leaders opted for a new strategy last week. Now their goal is to pass two major health bills: one to expand health insurance coverage and the other to avoid cuts in the payments doctors receive from Medicare.
Under current law, the rates that Medicare pays physicians are scheduled to decline by more than 20% at the end of the year. No one, least of all the doctors, wants this to happen. So Congress has been looking for a way to fix the problem. Until last week, the Medicare doctor fix had been included in the larger health bills winding their way through Congress. The House bill had a permanent fix, at a cost of $245 billion over ten years, while the Baucus bill had a one-year fix, at a cost of $11 billion. Senate leaders are trying a new strategy in which the main health insurance bill would still be budget neutral, while the doctor fix would get passed separately.
The two-bill strategy adopted by the Senate can be attributed to the “budget politics”. If Congress isn’t willing to pay for a permanent fix right away, then it should enact a one-year fix, and pay for it. That’s the approach taken in recent years and in the Baucus health bill. This approach is not perfect, but it would allow the merits of a long-run doctor fix to be addressed next year when our leaders will reportedly be more concerned about our harrowing fiscal situation. However, one of the reasons Senate democrats want to hustle this bill through the House now amidst all the insurance coverage debate, is to possibly garner support of the doctors for their bill. This is especially important since the American people look at the doctors as the “voice of reason” in this long winding road to healthcare reform.
CDC: Production of H1N1 flu vaccine lagging
http://www.cnn.com/2009/HEALTH/10/16/h1n1.vaccine.delay/index.html
H1N1 flu is running rampant throughout the U.S., and the country will have received only 25 percent of the vaccine that was expected by the end of October. As of last week, there were more than 5,000 cases of flu reported, compared to 7 cases in October of last year
CDC officials say there should be widespread availability of the vaccine by mid-November. The vaccine shortage was blamed on lower than predicted yields from vaccine manufacturers and on some manufacturing "glitches" that have occurred since May. The yields are now more in line with original predictions and that any glitches have been corrected. CDC said that most people will require just one vaccination rather than the two originally predicted; two vaccinations are recommended for children under the age of 10.
A study released Tuesday from Purdue University said it may be too late for the H1N1 vaccine to be of any benefit to Americans, as they may contract the virus before the vaccine takes effect. The study said most people would be infected during the month of October at a time when the vaccine is not available to most Americans.
FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm
Merck & Co.’s Gardasil, a vaccine used to prevent cervical cancer in women, won U.S. regulatory approval for preventing genital warts in boys, and penile and throat-and-neck cancers. The U.S. Food and Drug Administration cleared the vaccine for use in males ages 9 to 26, Merck said today in a statement. Expanding the shot’s use could revive sales, which declined 5 percent last year, analysts have said.
Expanding the indication of the vaccine to both genders has enlarge the market size. It is expected that approval in boys could add as much as $200-300 million to annual sales, as compared to the $1.4 billion revenue that Gardasil generated last year. This is just in time to counter the anticipated drop in sales that Gardasil would have with the introduction of GSK’s Cervarix.
FDA Approves New Vaccine for Prevention of Cervical Cancer
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm
www.ft.com
As of last Friday, the FDA has approved a second vaccine intended for the prevention of cervical cancer. Cervarix, manufactured by GlaxoSmithKline, was approved Friday for prevention of cervical cancer and pre-cancerous lesions caused by human papillomavirus (HPV) types 16 and 18 in girls and women ages 10 through 25. According to GSK, the vaccine is 70 percent effective against precancerous lesions, regardless of HPV type. While already approved in 99 other markets, including across the European Union, GSK’s sales of Cervarix had been hampered by US reluctance to approve AS03, the adjuvant used in its vaccine.
GlaxoSmithKline plans to undercut its rival Merck in a battle for sales following US regulatory approval for its cervical cancer vaccine Cervarix. The UK-based pharmaceutical group said it would charge less than Gardasil, Merck’s vaccine, in a fight that will stress Cervarix’s exclusive concentration on those most at risk. GSK, which undercut Merck to win contracts for Cervarix in countries including the UK, revealed a wholesale acquisition cost – ahead of discounts – in the US on Monday of $386 a three-course dose, compared with $399 for Gardasil.
http://www.foxnews.com/politics/2009/10/15/moderate-democrats-concerned-plan-spend-billion-medicare-doctors/
After months of struggling to put together a major health bill, Senate leaders opted for a new strategy last week. Now their goal is to pass two major health bills: one to expand health insurance coverage and the other to avoid cuts in the payments doctors receive from Medicare.
Under current law, the rates that Medicare pays physicians are scheduled to decline by more than 20% at the end of the year. No one, least of all the doctors, wants this to happen. So Congress has been looking for a way to fix the problem. Until last week, the Medicare doctor fix had been included in the larger health bills winding their way through Congress. The House bill had a permanent fix, at a cost of $245 billion over ten years, while the Baucus bill had a one-year fix, at a cost of $11 billion. Senate leaders are trying a new strategy in which the main health insurance bill would still be budget neutral, while the doctor fix would get passed separately.
The two-bill strategy adopted by the Senate can be attributed to the “budget politics”. If Congress isn’t willing to pay for a permanent fix right away, then it should enact a one-year fix, and pay for it. That’s the approach taken in recent years and in the Baucus health bill. This approach is not perfect, but it would allow the merits of a long-run doctor fix to be addressed next year when our leaders will reportedly be more concerned about our harrowing fiscal situation. However, one of the reasons Senate democrats want to hustle this bill through the House now amidst all the insurance coverage debate, is to possibly garner support of the doctors for their bill. This is especially important since the American people look at the doctors as the “voice of reason” in this long winding road to healthcare reform.
CDC: Production of H1N1 flu vaccine lagging
http://www.cnn.com/2009/HEALTH/10/16/h1n1.vaccine.delay/index.html
H1N1 flu is running rampant throughout the U.S., and the country will have received only 25 percent of the vaccine that was expected by the end of October. As of last week, there were more than 5,000 cases of flu reported, compared to 7 cases in October of last year
CDC officials say there should be widespread availability of the vaccine by mid-November. The vaccine shortage was blamed on lower than predicted yields from vaccine manufacturers and on some manufacturing "glitches" that have occurred since May. The yields are now more in line with original predictions and that any glitches have been corrected. CDC said that most people will require just one vaccination rather than the two originally predicted; two vaccinations are recommended for children under the age of 10.
A study released Tuesday from Purdue University said it may be too late for the H1N1 vaccine to be of any benefit to Americans, as they may contract the virus before the vaccine takes effect. The study said most people would be infected during the month of October at a time when the vaccine is not available to most Americans.
FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm
Merck & Co.’s Gardasil, a vaccine used to prevent cervical cancer in women, won U.S. regulatory approval for preventing genital warts in boys, and penile and throat-and-neck cancers. The U.S. Food and Drug Administration cleared the vaccine for use in males ages 9 to 26, Merck said today in a statement. Expanding the shot’s use could revive sales, which declined 5 percent last year, analysts have said.
Expanding the indication of the vaccine to both genders has enlarge the market size. It is expected that approval in boys could add as much as $200-300 million to annual sales, as compared to the $1.4 billion revenue that Gardasil generated last year. This is just in time to counter the anticipated drop in sales that Gardasil would have with the introduction of GSK’s Cervarix.
FDA Approves New Vaccine for Prevention of Cervical Cancer
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm
www.ft.com
As of last Friday, the FDA has approved a second vaccine intended for the prevention of cervical cancer. Cervarix, manufactured by GlaxoSmithKline, was approved Friday for prevention of cervical cancer and pre-cancerous lesions caused by human papillomavirus (HPV) types 16 and 18 in girls and women ages 10 through 25. According to GSK, the vaccine is 70 percent effective against precancerous lesions, regardless of HPV type. While already approved in 99 other markets, including across the European Union, GSK’s sales of Cervarix had been hampered by US reluctance to approve AS03, the adjuvant used in its vaccine.
GlaxoSmithKline plans to undercut its rival Merck in a battle for sales following US regulatory approval for its cervical cancer vaccine Cervarix. The UK-based pharmaceutical group said it would charge less than Gardasil, Merck’s vaccine, in a fight that will stress Cervarix’s exclusive concentration on those most at risk. GSK, which undercut Merck to win contracts for Cervarix in countries including the UK, revealed a wholesale acquisition cost – ahead of discounts – in the US on Monday of $386 a three-course dose, compared with $399 for Gardasil.
Business Ethics (10/15-21)
“Merck pays $3m in speaker fees to US doctors” (FT, October 20th)
In an effort to promote greater transparency in the pharmaceutical industry, Merck has announced that it paid close to $3million in speaker fees to US doctors during the second quarter of this year. The company has provided less information, however, than Eli Lilly, which in recent months became the first big US pharma to release a detailed list of payments made to doctors, with names and addresses, in exchange for consultancy services. However, this announcement marks the lack of consistency in the sector, as the other pharma giants, GlaxoSmithKline and Pfizer, have yet to follow suit.
In contrast to Eli Lilly which listed $22m in total payments during the first quarter to more than 3,300 doctors on its “faculty registry”, the Merck data does not show consultancy fees or other broader payments to doctors. They also do not distinguish between the fees and expenses involved in attending the meetings.
While this is an important first step, much remains to be done regarding doctor consultancy fees and overall transparency within this sector. Furthermore, while PHRMA, the US trade body, launched a toughened code of practice at the start of this year, clamping down on payments and gifts to doctors, it has yet to fully enforce its policies.
On the opposite side of the Business Ethics spectrum…
“French generic drug raids point to wider probe” (Oct 8-20)
On October 7th, the European Commision raided the French offices of Sanofi-Aventis, Ratiopharm, Teva, Ranbaxy, Mylan and Novartis, in a wide-spanning antitrust probe. Speculation is that the raids are part of generic deal in which “anticompetitive business practices and/or abuse of a dominant position” have been conducted. Recent speculation indicates that the probe may be even wider reaching and may span across the European Union.
Concentrating on antitrust behavior among generic companies would be an embarrassment for the sector and also a severe blow to the industry, which has tried to focus attention on aggressive practices by pharmaceutical companies to block generic competition. Greg Perry, head of the European Generics Association, the trade body, said his lobbying with the Commission over the pharmaceutical sector inquiry it recently finalized had not focused on antitrust issues but regulatory matters such as legal tactics to defend and extend patents. It will be interesting to follow this story and see how far the probe reaches, and which companies are implicated.
In an effort to promote greater transparency in the pharmaceutical industry, Merck has announced that it paid close to $3million in speaker fees to US doctors during the second quarter of this year. The company has provided less information, however, than Eli Lilly, which in recent months became the first big US pharma to release a detailed list of payments made to doctors, with names and addresses, in exchange for consultancy services. However, this announcement marks the lack of consistency in the sector, as the other pharma giants, GlaxoSmithKline and Pfizer, have yet to follow suit.
In contrast to Eli Lilly which listed $22m in total payments during the first quarter to more than 3,300 doctors on its “faculty registry”, the Merck data does not show consultancy fees or other broader payments to doctors. They also do not distinguish between the fees and expenses involved in attending the meetings.
While this is an important first step, much remains to be done regarding doctor consultancy fees and overall transparency within this sector. Furthermore, while PHRMA, the US trade body, launched a toughened code of practice at the start of this year, clamping down on payments and gifts to doctors, it has yet to fully enforce its policies.
On the opposite side of the Business Ethics spectrum…
“French generic drug raids point to wider probe” (Oct 8-20)
On October 7th, the European Commision raided the French offices of Sanofi-Aventis, Ratiopharm, Teva, Ranbaxy, Mylan and Novartis, in a wide-spanning antitrust probe. Speculation is that the raids are part of generic deal in which “anticompetitive business practices and/or abuse of a dominant position” have been conducted. Recent speculation indicates that the probe may be even wider reaching and may span across the European Union.
Concentrating on antitrust behavior among generic companies would be an embarrassment for the sector and also a severe blow to the industry, which has tried to focus attention on aggressive practices by pharmaceutical companies to block generic competition. Greg Perry, head of the European Generics Association, the trade body, said his lobbying with the Commission over the pharmaceutical sector inquiry it recently finalized had not focused on antitrust issues but regulatory matters such as legal tactics to defend and extend patents. It will be interesting to follow this story and see how far the probe reaches, and which companies are implicated.
Product News (10/15-21)
Novartis’ potential Gleevec replacement, Tasigna, more effective in Phase III trial
http://www.novartis.com/newsroom/media-releases/en/2009/1348449.shtml
As Gleevec’s patent expiration date draws nearer, Novartis is looking for Tasigna to help replace the lost revenue. While Tasigna has been approved since 2007, it has been used as a second-line treatment for patients no longer responding to Gleevec. In this study, Tasigna as a first-line treatment has had better outcomes than Gleevec for patients with chronic myeloid leukaemia (CML).
An interesting approach that Novartis could be hoping to take is that, by showing Tasigna to be superior to Gleevec, Novartis could hope to extend their control of the CML market past Gleevec’s patent protection. Gleevec’s protection ends in 2015, providing Novartis with plenty of time to continue comparing their products. As part of a lifecycle management strategy to replace Gleevec following the introduction of generic competitors, Novartis will have to convince medical practitioners that the added cost of Tasigna over the Gleevec-based generic competition is worth paying.
Cytos Biotechnology’s nicotine vaccine misses a primary endpoint
http://www.cytos.com/userfiles/file/Cytos_Press_E_091015.pdf
Cytos Biotech was working on a vaccine designed to lead to production of antibodies specific to nicotine in the brain. The proposed mechanism of action was that the bound nicotine would be incapable of crossing the blood-brain barrier, thereby preventing uptake & the associated reward stimulus. The primary endpoint not met was the high antibody titers necessary for effective treatment of addiction. Since the drug still appears safe and well-tolerated, Novartis has decided to continue the study to the end of its scheduled 12-month lifespan.
AstraZeneca’s Symbicort (asthma) approved in Japan; Crestor approved in US for pediatrics
http://www.forbes.com/feeds/afx/2009/10/16/afx7009001.html
http://www.astrazeneca.com/media/latest-press-releases/crestor-peads-us-approval?itemId=7206113
Symbicort is a long-term maintenance treatment for handling asthma in adult patients. In the first half of 2009, the drug had more than $1 billion in sales. The introduction of the product into the Japanese market via an agreement between Astra-Zeneca and Astellas (who will actually handle Japanese sales) should boost sales significantly.
Crestor, meanwhile, was approved by the FDA for treating children with heterozygous familial hypercholesteraemia. However, Astra-Zeneca have stated they won’t act on this additional approval.
Amgen’s Prolia sees approval delayed
http://wwwext.amgen.com/media/media_pr_detail.jsp?year=2009&releaseID=1343288
http://www.bloomberg.com/apps/news?pid=20601103&sid=aeQkVbhT4VyY
The FDA took issue with several aspects of Amgen’s filing for Prolia, a treatment for postmenopausal osteoporosis. Citing a number of aspects that needed to be improved, including the post-marketing surveillance program and the need for a Risk Evaluation and Mitigation Strategy, the FDA will not approve the drug until these requests are met. Some analysts predict that the turnaround time for a response to the FDA could be as short as a few weeks, leaving open the possibility of approval in mid-2010. The drug is predicted to reach sales of up to $5 billion by 2015.
Simponi shown effective for rheumatoid arthritis
http://www.easybourse.com/bourse/actualite-financiere/j-j-schering-arthritis-drug-shows-success-in-stopping-US5893311077-746711
http://www.investor.jnj.com/releaseDetail.cfm?ReleaseID=416376
The new rheumatoid arthritis treatment Simponi, a product of Johnson & Johnson and Schering-Plough Corp., has shown better results than the current standard of care in two phase-three trials. Significantly, the results could have implications for the purchase of Schering-Plough by Merck. Should Schering-Plough formally change control, Johnson and Johnson will gain the rights to Simponi in spite of Schering-Plough’s current ownership of most marketing rights, affecting the merger’s appeal for Merck. A similar situation exists for the Schering-Plough arthritis treatment Remicade.
GSK & Human Genome Sciences release Benlysta results
http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10115.htm
http://www.bloomberg.com/apps/news?pid=20601124&sid=aRSLnsWoL5bU
http://www.marketwatch.com/story/human-genome-glaxo-progress-with-lupus-treatment-2009-10-20
http://washington.bizjournals.com/washington/stories/2009/10/19/daily36.html?ana=from_rss#
http://www.firstwordplus.com/Fws.do?articleid=B1F758F37DDC4651BE2B88FCB25D1182
GSK & Human Genome Sciences have released results from one of their clinical trials for the drug Benlysta, potentially the first drug to be approved for treatment of lupus in 50 years. Given the approximately 320,000 lupus patients in the United States alone (2/3rds of whom are potential patients), Human Genome’s chief commercial officer is hoping for sales of over $1 billion once the drug is approved. The companies are awaiting results from the second clinical trial of the drug before submitting it for regulatory approval; the positive results seen only 16 weeks into this trial are extremely promising.
These results actually appear to come as a surprise to many analysts. Lupus has historically been a very challenging condition to treat (as evidenced by half a century without the emergence of new drugs) and some of the early clinical trials showed little promise.
http://www.novartis.com/newsroom/media-releases/en/2009/1348449.shtml
As Gleevec’s patent expiration date draws nearer, Novartis is looking for Tasigna to help replace the lost revenue. While Tasigna has been approved since 2007, it has been used as a second-line treatment for patients no longer responding to Gleevec. In this study, Tasigna as a first-line treatment has had better outcomes than Gleevec for patients with chronic myeloid leukaemia (CML).
An interesting approach that Novartis could be hoping to take is that, by showing Tasigna to be superior to Gleevec, Novartis could hope to extend their control of the CML market past Gleevec’s patent protection. Gleevec’s protection ends in 2015, providing Novartis with plenty of time to continue comparing their products. As part of a lifecycle management strategy to replace Gleevec following the introduction of generic competitors, Novartis will have to convince medical practitioners that the added cost of Tasigna over the Gleevec-based generic competition is worth paying.
Cytos Biotechnology’s nicotine vaccine misses a primary endpoint
http://www.cytos.com/userfiles/file/Cytos_Press_E_091015.pdf
Cytos Biotech was working on a vaccine designed to lead to production of antibodies specific to nicotine in the brain. The proposed mechanism of action was that the bound nicotine would be incapable of crossing the blood-brain barrier, thereby preventing uptake & the associated reward stimulus. The primary endpoint not met was the high antibody titers necessary for effective treatment of addiction. Since the drug still appears safe and well-tolerated, Novartis has decided to continue the study to the end of its scheduled 12-month lifespan.
AstraZeneca’s Symbicort (asthma) approved in Japan; Crestor approved in US for pediatrics
http://www.forbes.com/feeds/afx/2009/10/16/afx7009001.html
http://www.astrazeneca.com/media/latest-press-releases/crestor-peads-us-approval?itemId=7206113
Symbicort is a long-term maintenance treatment for handling asthma in adult patients. In the first half of 2009, the drug had more than $1 billion in sales. The introduction of the product into the Japanese market via an agreement between Astra-Zeneca and Astellas (who will actually handle Japanese sales) should boost sales significantly.
Crestor, meanwhile, was approved by the FDA for treating children with heterozygous familial hypercholesteraemia. However, Astra-Zeneca have stated they won’t act on this additional approval.
Amgen’s Prolia sees approval delayed
http://wwwext.amgen.com/media/media_pr_detail.jsp?year=2009&releaseID=1343288
http://www.bloomberg.com/apps/news?pid=20601103&sid=aeQkVbhT4VyY
The FDA took issue with several aspects of Amgen’s filing for Prolia, a treatment for postmenopausal osteoporosis. Citing a number of aspects that needed to be improved, including the post-marketing surveillance program and the need for a Risk Evaluation and Mitigation Strategy, the FDA will not approve the drug until these requests are met. Some analysts predict that the turnaround time for a response to the FDA could be as short as a few weeks, leaving open the possibility of approval in mid-2010. The drug is predicted to reach sales of up to $5 billion by 2015.
Simponi shown effective for rheumatoid arthritis
http://www.easybourse.com/bourse/actualite-financiere/j-j-schering-arthritis-drug-shows-success-in-stopping-US5893311077-746711
http://www.investor.jnj.com/releaseDetail.cfm?ReleaseID=416376
The new rheumatoid arthritis treatment Simponi, a product of Johnson & Johnson and Schering-Plough Corp., has shown better results than the current standard of care in two phase-three trials. Significantly, the results could have implications for the purchase of Schering-Plough by Merck. Should Schering-Plough formally change control, Johnson and Johnson will gain the rights to Simponi in spite of Schering-Plough’s current ownership of most marketing rights, affecting the merger’s appeal for Merck. A similar situation exists for the Schering-Plough arthritis treatment Remicade.
GSK & Human Genome Sciences release Benlysta results
http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10115.htm
http://www.bloomberg.com/apps/news?pid=20601124&sid=aRSLnsWoL5bU
http://www.marketwatch.com/story/human-genome-glaxo-progress-with-lupus-treatment-2009-10-20
http://washington.bizjournals.com/washington/stories/2009/10/19/daily36.html?ana=from_rss#
http://www.firstwordplus.com/Fws.do?articleid=B1F758F37DDC4651BE2B88FCB25D1182
GSK & Human Genome Sciences have released results from one of their clinical trials for the drug Benlysta, potentially the first drug to be approved for treatment of lupus in 50 years. Given the approximately 320,000 lupus patients in the United States alone (2/3rds of whom are potential patients), Human Genome’s chief commercial officer is hoping for sales of over $1 billion once the drug is approved. The companies are awaiting results from the second clinical trial of the drug before submitting it for regulatory approval; the positive results seen only 16 weeks into this trial are extremely promising.
These results actually appear to come as a surprise to many analysts. Lupus has historically been a very challenging condition to treat (as evidenced by half a century without the emergence of new drugs) and some of the early clinical trials showed little promise.
Thursday, October 15, 2009
Product news (10/8-14)
(1) AIDS Vaccine Results Questioned
http://latimesblogs.latimes.com/booster_shots/2009/10/aids-vaccine-results-questioned.html
Last month, U.S. Army and Thai researchers announced that a combination vaccine tested on 16,000 participants in Thailand showed a statistically significant 31 percent reduction in new HIV infections. A secondary analysis of the data suggests that the true reduction was only 24 percent and not statistically significant. The first analysis included all 16,000 participants, while the second analysis excluded those patients who did not follow the experimental regimen. The data last month was released pre-publication, eliciting criticism from the scientific community; however, the researchers wished to release the data to avoid being scooped. The full data is expected to be made public on Oct. 20, and the researchers hope to submit a manuscript to the New England Journal of Medicine.
(2) FDA comments on new multiple sclerosis drug
http://blogs.wsj.com/health/2009/10/09/fda-talks-wall-street-listens-and-ms-drug-makers-stock-plunges/
http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docKey=600-200910140725BIZWIRE_USPR_____BW5609-7QBSTA39OJEG6GT60I2UCB2U3I&provider=Businesswire&docDate=October%2014%2C%202009&press_symbol=4121848
A small New York drug company whose name is Acorda Therapeutics is developing a drug whose name is Fampridine-SR which aimed to restore the functioning of damaged nerves. The drug has entered Phase 3 and has produced two favorable trials. However, the FDA has recently remarked that the improvement of patients is “numerically quite small”. This raised questions on whether the drug’s benefit is clinically meaningful. After the comment, the stock price of the company fell by 20%. The FDA expert panel will hold a review on the drug’s evidence.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meets today to review and discuss Acorda's New Drug Application (NDA) for Fampridine-SR for improvement of walking ability in people with multiple sclerosis (MS). Acorda’s stock trading was halted.
(3) 1918 flu pandemic: deaths caused by aspirin?
www.nytimes.com/2009/10/13/health/13aspirin.html?_r=1&scp=1&sq=1918%20flue&st=cse
A new article investigates the connection between aspirin use and the 1918 flu pandemic. High doses of aspirin, amounts considered unsafe today, were commonly used to treat the illness, and the symptoms of aspirin overdose may have been difficult to distinguish from those of the flu, especially among those who died soon after they became ill. Because Bayer lost the patent for aspirin in 1918, copyright infringement was rampant and aspirin packaging often contained no warnings or instructions. With the current H1N1 flu epidemic, the theory may provide insight into the way we understand flu related deaths.
(4) New Type 2 Diabetes Tablet Offers Powerful Blood Glucose Control Without Weight Gain
http://www.pharmalive.com/News/Index.cfm?articleid=658052
Merck Frosst Canada Ltd. announced the approval of its new type 2 diabetes drug, Janumet, in Canada. Janumet is the first drug to combine a DPP-4 inhibitor with metformin in a single therapy. Both metformin and sitagliptin (the DPP-4 inhibitor) have been separately approved for type 2 diabetes treatment by the FDA. A metformin plus sitagliptin treatment is equivalent to a metformin-only treatment in terms of glycemic efficiency. However, patients taking metformin plus sitagliptin regimen lose weight on average (-1.5 kg), whereas patients taking a metformin-only regimen gain weight on average (+1.1 kg). In addition, patients taking metformin plus sitagliptin have fewer episodes of hypoglycemia than those on a metformin-only regiment. Therefore, taking metformin and sitagliptin is a preferable treatment approach.
The single formulation Janumet was shown to be equivalent to a sitagliptin plus metformin treatment. Enabling a single formulation is cost-effective, easier for patients to handle, and a source of new revenue for Merck Frosst Canada.
http://latimesblogs.latimes.com/booster_shots/2009/10/aids-vaccine-results-questioned.html
Last month, U.S. Army and Thai researchers announced that a combination vaccine tested on 16,000 participants in Thailand showed a statistically significant 31 percent reduction in new HIV infections. A secondary analysis of the data suggests that the true reduction was only 24 percent and not statistically significant. The first analysis included all 16,000 participants, while the second analysis excluded those patients who did not follow the experimental regimen. The data last month was released pre-publication, eliciting criticism from the scientific community; however, the researchers wished to release the data to avoid being scooped. The full data is expected to be made public on Oct. 20, and the researchers hope to submit a manuscript to the New England Journal of Medicine.
(2) FDA comments on new multiple sclerosis drug
http://blogs.wsj.com/health/2009/10/09/fda-talks-wall-street-listens-and-ms-drug-makers-stock-plunges/
http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docKey=600-200910140725BIZWIRE_USPR_____BW5609-7QBSTA39OJEG6GT60I2UCB2U3I&provider=Businesswire&docDate=October%2014%2C%202009&press_symbol=4121848
A small New York drug company whose name is Acorda Therapeutics is developing a drug whose name is Fampridine-SR which aimed to restore the functioning of damaged nerves. The drug has entered Phase 3 and has produced two favorable trials. However, the FDA has recently remarked that the improvement of patients is “numerically quite small”. This raised questions on whether the drug’s benefit is clinically meaningful. After the comment, the stock price of the company fell by 20%. The FDA expert panel will hold a review on the drug’s evidence.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meets today to review and discuss Acorda's New Drug Application (NDA) for Fampridine-SR for improvement of walking ability in people with multiple sclerosis (MS). Acorda’s stock trading was halted.
(3) 1918 flu pandemic: deaths caused by aspirin?
www.nytimes.com/2009/10/13/health/13aspirin.html?_r=1&scp=1&sq=1918%20flue&st=cse
A new article investigates the connection between aspirin use and the 1918 flu pandemic. High doses of aspirin, amounts considered unsafe today, were commonly used to treat the illness, and the symptoms of aspirin overdose may have been difficult to distinguish from those of the flu, especially among those who died soon after they became ill. Because Bayer lost the patent for aspirin in 1918, copyright infringement was rampant and aspirin packaging often contained no warnings or instructions. With the current H1N1 flu epidemic, the theory may provide insight into the way we understand flu related deaths.
(4) New Type 2 Diabetes Tablet Offers Powerful Blood Glucose Control Without Weight Gain
http://www.pharmalive.com/News/Index.cfm?articleid=658052
Merck Frosst Canada Ltd. announced the approval of its new type 2 diabetes drug, Janumet, in Canada. Janumet is the first drug to combine a DPP-4 inhibitor with metformin in a single therapy. Both metformin and sitagliptin (the DPP-4 inhibitor) have been separately approved for type 2 diabetes treatment by the FDA. A metformin plus sitagliptin treatment is equivalent to a metformin-only treatment in terms of glycemic efficiency. However, patients taking metformin plus sitagliptin regimen lose weight on average (-1.5 kg), whereas patients taking a metformin-only regimen gain weight on average (+1.1 kg). In addition, patients taking metformin plus sitagliptin have fewer episodes of hypoglycemia than those on a metformin-only regiment. Therefore, taking metformin and sitagliptin is a preferable treatment approach.
The single formulation Janumet was shown to be equivalent to a sitagliptin plus metformin treatment. Enabling a single formulation is cost-effective, easier for patients to handle, and a source of new revenue for Merck Frosst Canada.
Comapny news (10/8-14)
(1) Vaccinating girls, not boys, against HPV is best bet
http://latimesblogs.latimes.com/booster_shots/2009/10/vaccinating-girls-not-boys-against-hpv-is-best-bet.html
The Food and Drug Administration (FDA) is considering a proposal from Merck, the makers of the HPV vaccine Gardasil, to approve the vaccine for boys between the ages of nine and 15. Harvard University researchers have found that public health campaigns for Gardasil targeted at boys costs seven times more than a campaign targeted towards girls. Sales of Gardasil in recent months have been slumping; as a result, Merck is eager to try to expand the vaccine’s market. With the FDA’s approval, Merck would be free to advertise Gardasil to boys, similar to their “One Less” ad campaign for girls and young women.
(2) Onyx to acquire Proteolix in deal worth as much as $851 million
http://www.bloomberg.com/apps/news?pid=20601103&sid=amw6jcSX0gsw
http://www.firstwordplus.com/Fws.do?articleid=468CCCCB609343269CE017212B90489E
Onyx recently announced that it will acquire Proteolix, for a total sum of up to $851 million. Onyx is a biopharmaceutical company with a focus on cancer therapeutics. It currently has one oral cancer drug, sorafenib, approved in more than 80 countries for liver and advanced kidney cancer. Sorafenib belongs to the class of protein tyrosine kinase inhibitor. In acquiring Proteolix, Onyx hopes to expand its pipeline by gaining Proteolix’s phase 2b drug, carfilzomib. Carfilzomib is a structurally and mechanistically novel proteasome inhibitor, which holds potential in the treatment of multiple myeloma. Proteolix also has two other proteasome inhibitors in preclinical development, one of them being immunoselective. Onyx will pay $276 million up-front to Proteolix and an additional $575 million if a developmental milestone is reached and carfilzomib gains regulatory approval in the US and Europe. Annual sales for carfilzomib are estimated to reach $100 billion. Onyx aims to submit the drug for regulatory approval by the end of 2010.
(3) Pfizer suspends enrollment in late-stage lung cancer drug trial (deaths)
http://www.firstwordplus.com/Fws.do?articleid=D6B4BFECE4C347619C766B232E7916F0
http://www.bloomberg.com/apps/news?pid=20601202&sid=aBisSQQvAy3w
Pfizer has suspended enrollment in a lung cancer phase III trial of the drug figitumumab due to reports of elevated fatalities. Patients receiving the drug in combination with carboplatin and paclitaxel, common chemotherapeutics, experienced an increased number of serious adverse effects, including fatalities, over those receiving carboplatin and paclitaxel alone. Patients currently enrolled in the trial may continue their treatment regimen if they so desire. Figitumumab is a IGF1-R inhibitor, which Pfizer intends as a treatment for non-adenocarcinoma, non-small-cell lung cancer. Pfizer is working with the data safety monitoring board to conduct a thorough analysis of these reports.
(4) J&J records 14.1 percent drop in 3Q pharma sales
http://www.firstwordplus.com/Fws.do?articleid=40BA3F6C0A1848CD8170841AFE042F17
Johnson & Johnson reported a record third-quarter revenue drop of 14.1 percent in the pharmaceuticals unit. Analysts cite generic competition and negative impact of currency exchange as reasons. Most striking were revenue drops for Risperdal and Topamax, which fell 40 and 76 percent, respectively, due to generic competition. Analysts indicate the need for Johnson & Johnson to buy products at an even earlier stage to ensure maximum revenue.
Product:
http://latimesblogs.latimes.com/booster_shots/2009/10/vaccinating-girls-not-boys-against-hpv-is-best-bet.html
The Food and Drug Administration (FDA) is considering a proposal from Merck, the makers of the HPV vaccine Gardasil, to approve the vaccine for boys between the ages of nine and 15. Harvard University researchers have found that public health campaigns for Gardasil targeted at boys costs seven times more than a campaign targeted towards girls. Sales of Gardasil in recent months have been slumping; as a result, Merck is eager to try to expand the vaccine’s market. With the FDA’s approval, Merck would be free to advertise Gardasil to boys, similar to their “One Less” ad campaign for girls and young women.
(2) Onyx to acquire Proteolix in deal worth as much as $851 million
http://www.bloomberg.com/apps/news?pid=20601103&sid=amw6jcSX0gsw
http://www.firstwordplus.com/Fws.do?articleid=468CCCCB609343269CE017212B90489E
Onyx recently announced that it will acquire Proteolix, for a total sum of up to $851 million. Onyx is a biopharmaceutical company with a focus on cancer therapeutics. It currently has one oral cancer drug, sorafenib, approved in more than 80 countries for liver and advanced kidney cancer. Sorafenib belongs to the class of protein tyrosine kinase inhibitor. In acquiring Proteolix, Onyx hopes to expand its pipeline by gaining Proteolix’s phase 2b drug, carfilzomib. Carfilzomib is a structurally and mechanistically novel proteasome inhibitor, which holds potential in the treatment of multiple myeloma. Proteolix also has two other proteasome inhibitors in preclinical development, one of them being immunoselective. Onyx will pay $276 million up-front to Proteolix and an additional $575 million if a developmental milestone is reached and carfilzomib gains regulatory approval in the US and Europe. Annual sales for carfilzomib are estimated to reach $100 billion. Onyx aims to submit the drug for regulatory approval by the end of 2010.
(3) Pfizer suspends enrollment in late-stage lung cancer drug trial (deaths)
http://www.firstwordplus.com/Fws.do?articleid=D6B4BFECE4C347619C766B232E7916F0
http://www.bloomberg.com/apps/news?pid=20601202&sid=aBisSQQvAy3w
Pfizer has suspended enrollment in a lung cancer phase III trial of the drug figitumumab due to reports of elevated fatalities. Patients receiving the drug in combination with carboplatin and paclitaxel, common chemotherapeutics, experienced an increased number of serious adverse effects, including fatalities, over those receiving carboplatin and paclitaxel alone. Patients currently enrolled in the trial may continue their treatment regimen if they so desire. Figitumumab is a IGF1-R inhibitor, which Pfizer intends as a treatment for non-adenocarcinoma, non-small-cell lung cancer. Pfizer is working with the data safety monitoring board to conduct a thorough analysis of these reports.
(4) J&J records 14.1 percent drop in 3Q pharma sales
http://www.firstwordplus.com/Fws.do?articleid=40BA3F6C0A1848CD8170841AFE042F17
Johnson & Johnson reported a record third-quarter revenue drop of 14.1 percent in the pharmaceuticals unit. Analysts cite generic competition and negative impact of currency exchange as reasons. Most striking were revenue drops for Risperdal and Topamax, which fell 40 and 76 percent, respectively, due to generic competition. Analysts indicate the need for Johnson & Johnson to buy products at an even earlier stage to ensure maximum revenue.
Product:
Industry news (10/8-14)
(1) Patent system reform
Article on the USPTO decision to withdraw proposed rules:
http://online.wsj.com/article/SB125513250890977347.html?mod=WSJ_hpp_sections_business
Article on GlaxoSmithKline’s dismissal of lawsuit:
http://www.firstwordplus.com/Fws.do?articleid=BED140BA251C47E199928DFA0AF05AC6
On Thursday (last week), the new patent office director David Kappos announced his term’s priority: coping with the massive patent application backlog. Now the patent office has a backlog of around 700000 patent applications. This affects the drug industry because the backlog lengthens the time scale of patent review (or pending status) and thus creating more uncertainties in the drug developing process.
Second, he scrapped the rules limiting the number of claims a patent application can have and the amount of information on each claim, proposed during Bush administration. These rules could have limited the quality of patents that innovative firms can get. A U.K. drug firm whose name is GlaxoSmithKline has fought against those rules in federal court since 2007. After the USPTO decided to withdraw the rules, the company and the USPTO reached an agreement to dismiss the litigation. GlaxoSmithKline’s vice-president Sherry Knowles said that "we applaud the PTO ... for deciding to withdraw these rules, which we believe would have harmed innovation across all industries."
(2) Poorer nations get swine flu jabs
http://news.bbc.co.uk/2/hi/health/8302416.stm
The World Health Organization (WHO) said this week that about 100 developing nations will be receiving donations of the H1N1 vaccine, starting sometime in November. These vaccine doses were donated by pharmaceutical companies Sanofi-Aventis and GlaxoSmithKline (150 million doses) as well as Medimmune. A group of rich nations, including the United States, have also pledged to donate 10 percent of their total vaccine purchases to developing nations.
(3) Rapid Rise in Pediatric Deaths From Swine Flu, Officials Say
http://www.washingtonpost.com/wp-dyn/content/article/2009/10/09/AR2009100903216.html
As the H1N1 virus continues to spread in the United States, a rapidly increasing amount of children, teenagers, young adults and pregnant women are dying after contracting the virus. Last week, another 19 pediatric deaths were reported in Maryland, pushing the total number of deaths under age 18 to 76. Although most children who eventually died from H1N1 did have other existing health conditions, most of the deaths occurred in otherwise healthy children. As a result, government officials are advocating H1N1 vaccination for parents and children. The government has spent $2 billion to buy at least 250 million doses of the vaccine and has pledged to purchase more if there is sufficient demand.
(4) World pharma market to grow up to 6 percent in 2010: IMS forecast (NEED ENTRY)
http://www.firstwordplus.com/Fws.do?articleid=81C3EF2F1DC34EC08D86E40C88C17758
http://www.bloomberg.com/apps/news?pid=20601202&sid=a2Qi4a8CN.8E
IMS Health has forecast the global pharmaceutical market to grow between 4 and 6 percent in 2010. In the US, the pharmaceutical market is ecpected to increase between 3 and 5 percent in 2010. IMS attributes this increase to sustained price increases of drugs, increased use of discounts and rebates, and changing inventory stocking patterns in pharmacies. Health care reforms were also taken into consideration, primarily the impact of previously uninsured patients gaining access to treatment. Near-coming patent expiration on several major drugs and resulting generic competition is a huge concern, however, and pharmaceutical revenues may drop by 2013. Top emerging markets, such as China, Brazil, Russia, Mexico, India, Turkey and South Korea are expected to strongly contribute to global pharmaceutical sales growth through the next five years.
(5) CDC downplays risk of swine flu vaccine
http://www.boston.com/news/health/articles/2009/10/12/cdc_official_downplays_risk_of_swine_flu_vaccine/
The CDC came out last week in support of flu vaccines. They aimed to reassure the public that the risks of actually getting the flu outweighed any side effects associated with the flu vaccine. Because of the vast amounts of confusion surrounding the H1N1 vaccine as well as the seasonal flu vaccine, the authorities wanted to emphasize the recommendation of getting both in order to be fully protected.
Article on the USPTO decision to withdraw proposed rules:
http://online.wsj.com/article/SB125513250890977347.html?mod=WSJ_hpp_sections_business
Article on GlaxoSmithKline’s dismissal of lawsuit:
http://www.firstwordplus.com/Fws.do?articleid=BED140BA251C47E199928DFA0AF05AC6
On Thursday (last week), the new patent office director David Kappos announced his term’s priority: coping with the massive patent application backlog. Now the patent office has a backlog of around 700000 patent applications. This affects the drug industry because the backlog lengthens the time scale of patent review (or pending status) and thus creating more uncertainties in the drug developing process.
Second, he scrapped the rules limiting the number of claims a patent application can have and the amount of information on each claim, proposed during Bush administration. These rules could have limited the quality of patents that innovative firms can get. A U.K. drug firm whose name is GlaxoSmithKline has fought against those rules in federal court since 2007. After the USPTO decided to withdraw the rules, the company and the USPTO reached an agreement to dismiss the litigation. GlaxoSmithKline’s vice-president Sherry Knowles said that "we applaud the PTO ... for deciding to withdraw these rules, which we believe would have harmed innovation across all industries."
(2) Poorer nations get swine flu jabs
http://news.bbc.co.uk/2/hi/health/8302416.stm
The World Health Organization (WHO) said this week that about 100 developing nations will be receiving donations of the H1N1 vaccine, starting sometime in November. These vaccine doses were donated by pharmaceutical companies Sanofi-Aventis and GlaxoSmithKline (150 million doses) as well as Medimmune. A group of rich nations, including the United States, have also pledged to donate 10 percent of their total vaccine purchases to developing nations.
(3) Rapid Rise in Pediatric Deaths From Swine Flu, Officials Say
http://www.washingtonpost.com/wp-dyn/content/article/2009/10/09/AR2009100903216.html
As the H1N1 virus continues to spread in the United States, a rapidly increasing amount of children, teenagers, young adults and pregnant women are dying after contracting the virus. Last week, another 19 pediatric deaths were reported in Maryland, pushing the total number of deaths under age 18 to 76. Although most children who eventually died from H1N1 did have other existing health conditions, most of the deaths occurred in otherwise healthy children. As a result, government officials are advocating H1N1 vaccination for parents and children. The government has spent $2 billion to buy at least 250 million doses of the vaccine and has pledged to purchase more if there is sufficient demand.
(4) World pharma market to grow up to 6 percent in 2010: IMS forecast (NEED ENTRY)
http://www.firstwordplus.com/Fws.do?articleid=81C3EF2F1DC34EC08D86E40C88C17758
http://www.bloomberg.com/apps/news?pid=20601202&sid=a2Qi4a8CN.8E
IMS Health has forecast the global pharmaceutical market to grow between 4 and 6 percent in 2010. In the US, the pharmaceutical market is ecpected to increase between 3 and 5 percent in 2010. IMS attributes this increase to sustained price increases of drugs, increased use of discounts and rebates, and changing inventory stocking patterns in pharmacies. Health care reforms were also taken into consideration, primarily the impact of previously uninsured patients gaining access to treatment. Near-coming patent expiration on several major drugs and resulting generic competition is a huge concern, however, and pharmaceutical revenues may drop by 2013. Top emerging markets, such as China, Brazil, Russia, Mexico, India, Turkey and South Korea are expected to strongly contribute to global pharmaceutical sales growth through the next five years.
(5) CDC downplays risk of swine flu vaccine
http://www.boston.com/news/health/articles/2009/10/12/cdc_official_downplays_risk_of_swine_flu_vaccine/
The CDC came out last week in support of flu vaccines. They aimed to reassure the public that the risks of actually getting the flu outweighed any side effects associated with the flu vaccine. Because of the vast amounts of confusion surrounding the H1N1 vaccine as well as the seasonal flu vaccine, the authorities wanted to emphasize the recommendation of getting both in order to be fully protected.
Health policy (10/8-14)
(1) Republican’s Vote Lifts a Health Bill, but Hurdles Remain
www.nytimes.com/2009/10/14/health/policy/14health.html?_r=1&hp
U.S. Senator Olympia Snowe (R-ME) voted with the Democrats as the Senate Finance Committee approved the $829 billion Max Baucus health care bill, 14-9. The bill now goes to the Senate and House floors for further debate. Snowe, who opposes a government backed public option, was the only Republican to side with the Democrats. She opined, “Is this bill all that I would want? Far from it. Is it all that it can be? No. But when history calls, history calls. And I happen to think that the consequences of inaction dictate the urgency of Congress to take every opportunity to demonstrate its capacity to solve the monumental issues of our time.”
(2) Obama’s weekly radio talk addressed the progress of the healthcare reform
online.wsj.com/article/SB125512846770976969.html?mod=googlenews_wsj
Obama said that the healthcare reform was gaining momentum. On Tuesday, the Senate Finance Committee will be voting on a bill central to the reform. The bill will form the backbone of the healthcare reform legislation. It requires a mandate of insurance for healthcare for each American. To keep prices of insurances low enough that poor people can afford, the bill requires other healthy Americans also pay at least a minimum of about 8% of their income for healthy insurance or they’ll be fined. Only people whose annual income is lower than twenty-nine thousands can be exempt.
Interesting arguments: The republican argued that this is anti-constitution and the democrats responded by citing mandatory car insurances and the republican in turn said that the owning a car is optional.
In Obama’s address, he noted some of the pre-eminent republicans who supported the legislation: Arnold Schwarzenegger, NYC Mayor Michael Bloomberg, and so on.
http://online.wsj.com/article/SB125517110855978033.html
On Tuesday, the Senate finance committee voted in favor of the bill. Obama commented that we were closer to passing the healthcare reform but not yet there.
http://online.wsj.com/article/SB125543637111982309.html
(3) State plan may place limits on patients’ hospital options
http://www.boston.com/news/health/articles/2009/10/11/massachusetts_plan_could_limit_patients_hospital_choices/
In an effort to contain rising costs of the Massachusetts healthcare plans, authorities are exploring limitation on patients’ hospital options. Officials are considering a switch to a system where providers are paid a per-patient annual fee instead of the traditional fee-for-service scheme. Because Massachusetts residents often get their care from academic medical centers, where costs are higher, the state may consider limiting the use of these hospitals. Another way to reduce costs would be to set prices at teaching hospitals equal to an average price charged by community hospitals. Both proposals are much more ambitious than any other under consideration at the federal level.
(4) Insurance lobby says rates would rise
http://www.cnn.com/2009/POLITICS/10/12/health.care/index.html
On the eve of the Senate Finance Committee vote for a health care overhaul, the insurance lobby issued a report claiming that insurance premiums would rise for all existing insurance plans. The validity of the report is immediately criticized by politicians and industry observers. Congressmen are suspicious of the report that is timed so precisely to the vote on legislation that would severely impact the profits of insurance companies.
(5) Regular immunizations are overlooked among flu hype
http://online.wsj.com/article/SB10001424052748703790404574469182618819504.html
As the push gets under way to immunize Americans against swine flu and the seasonal flu, experts warn that many adults haven't received vaccinations for at least half a dozen other preventable diseases. This behavior may put people who get influenza at even greater risk for complications and death. In all, more than 50,000 U.S. adults die from vaccine-preventable diseases annually—more than from breast cancer, AIDS, or traffic accidents.
www.nytimes.com/2009/10/14/health/policy/14health.html?_r=1&hp
U.S. Senator Olympia Snowe (R-ME) voted with the Democrats as the Senate Finance Committee approved the $829 billion Max Baucus health care bill, 14-9. The bill now goes to the Senate and House floors for further debate. Snowe, who opposes a government backed public option, was the only Republican to side with the Democrats. She opined, “Is this bill all that I would want? Far from it. Is it all that it can be? No. But when history calls, history calls. And I happen to think that the consequences of inaction dictate the urgency of Congress to take every opportunity to demonstrate its capacity to solve the monumental issues of our time.”
(2) Obama’s weekly radio talk addressed the progress of the healthcare reform
online.wsj.com/article/SB125512846770976969.html?mod=googlenews_wsj
Obama said that the healthcare reform was gaining momentum. On Tuesday, the Senate Finance Committee will be voting on a bill central to the reform. The bill will form the backbone of the healthcare reform legislation. It requires a mandate of insurance for healthcare for each American. To keep prices of insurances low enough that poor people can afford, the bill requires other healthy Americans also pay at least a minimum of about 8% of their income for healthy insurance or they’ll be fined. Only people whose annual income is lower than twenty-nine thousands can be exempt.
Interesting arguments: The republican argued that this is anti-constitution and the democrats responded by citing mandatory car insurances and the republican in turn said that the owning a car is optional.
In Obama’s address, he noted some of the pre-eminent republicans who supported the legislation: Arnold Schwarzenegger, NYC Mayor Michael Bloomberg, and so on.
http://online.wsj.com/article/SB125517110855978033.html
On Tuesday, the Senate finance committee voted in favor of the bill. Obama commented that we were closer to passing the healthcare reform but not yet there.
http://online.wsj.com/article/SB125543637111982309.html
(3) State plan may place limits on patients’ hospital options
http://www.boston.com/news/health/articles/2009/10/11/massachusetts_plan_could_limit_patients_hospital_choices/
In an effort to contain rising costs of the Massachusetts healthcare plans, authorities are exploring limitation on patients’ hospital options. Officials are considering a switch to a system where providers are paid a per-patient annual fee instead of the traditional fee-for-service scheme. Because Massachusetts residents often get their care from academic medical centers, where costs are higher, the state may consider limiting the use of these hospitals. Another way to reduce costs would be to set prices at teaching hospitals equal to an average price charged by community hospitals. Both proposals are much more ambitious than any other under consideration at the federal level.
(4) Insurance lobby says rates would rise
http://www.cnn.com/2009/POLITICS/10/12/health.care/index.html
On the eve of the Senate Finance Committee vote for a health care overhaul, the insurance lobby issued a report claiming that insurance premiums would rise for all existing insurance plans. The validity of the report is immediately criticized by politicians and industry observers. Congressmen are suspicious of the report that is timed so precisely to the vote on legislation that would severely impact the profits of insurance companies.
(5) Regular immunizations are overlooked among flu hype
http://online.wsj.com/article/SB10001424052748703790404574469182618819504.html
As the push gets under way to immunize Americans against swine flu and the seasonal flu, experts warn that many adults haven't received vaccinations for at least half a dozen other preventable diseases. This behavior may put people who get influenza at even greater risk for complications and death. In all, more than 50,000 U.S. adults die from vaccine-preventable diseases annually—more than from breast cancer, AIDS, or traffic accidents.
Thursday, October 8, 2009
Policy news (Week 2)
Pfizer Wins, CVS Loses as Senate Weighs Health Plan: Pfizer and others win out in the newest version of the healthcare plan by maintaining deals that limit the threat to profits of pharmaceutical companies. They have managed to hold on to a deal that will limit their contribution to the overhaul to $80 billion, out of an estimated $4 trillion total for the next ten years. While $80 billion might seem like a lot to pay, its actually a good deal compared to what could be paid. Relevant because it is directly tied to the profits and funds of large pharmaceutical companies. Also, according to this same article, Biotech companies have so far done a good job of fighting off profit-reducing policies.
http://bloomberg.com/apps/news?pid=20601202&sid=a1WUMHwwB6UY
Study Shows Patients Can Ward-Off Heart Attacks and Reduce Medical Expenses with a Simple Generic Drug Regimen: By some estimates, only 25% of medicine provided has been proven to be truly effective—this is billions of dollars wasted in health care spending. In a Kaiser Permanente study, patients with diabetes or heart disease were given a low-cost regimen of aspirin, a generic cholesterol-lowering drug, and a blood-pressure drug. Compared with similar patients not taking the combination, these patients had 60%-80% fewer heart attacks and strokes in a two-year period. The approach saved hundreds of dollars per patient. The study was started when Kaiser began wondering if it was treating the wrong population with an expensive cholesterol drug from Merck. This is relevant because it shows that simple, low-cost generic drug regimens could produce increased health benefits and cost savings compared to using expensive brand-name drugs.
http://www.businessweek.com/bwdaily/dnflash/content/oct2009/db2009101_015899.htm
Drug Industry Wins, Pharmacy Benefit Managers and Device Makers Lose in the Senate Finance Committee Health Reform Bill: The $80 billion deal struck between the White House, the Finance Committee, and PhRMA will likely be preserved, which is a win for drugmakers. Compared to the $4 trillion in drug spending that will take place over the next 10 years, limiting PhRMA’s contribution to health care reform to $80 billion is a bargain according to certain lawmakers. Pharmacy benefit managers would lose as they would have to disclose rebates from drugmakers if they participate in Medicare Part D or in new health insurance exchanges. In the past, managers pocketed much of the rebates they received from drug manufacturers and retail pharmacies. The medical-device industry would be forced to pay $4 billion in annual fees starting in 2010 under the Finance Committee bill. It’s a mixed picture for insurers: The individual mandate would bring them more customers but tax penalties for those who fail to get insurance have been weakened. Baucus’s bill does not include a public health insurance option. This is relevant because, assuming the Senate bill is passed, the deal that benefits PhRMA could be preserved and included in the final health reform bill that will be signed by President Obama.
http://www.bloomberg.com/apps/news?pid=20601103&sid=a1WUMHwwB6UY
http://bloomberg.com/apps/news?pid=20601202&sid=a1WUMHwwB6UY
Study Shows Patients Can Ward-Off Heart Attacks and Reduce Medical Expenses with a Simple Generic Drug Regimen: By some estimates, only 25% of medicine provided has been proven to be truly effective—this is billions of dollars wasted in health care spending. In a Kaiser Permanente study, patients with diabetes or heart disease were given a low-cost regimen of aspirin, a generic cholesterol-lowering drug, and a blood-pressure drug. Compared with similar patients not taking the combination, these patients had 60%-80% fewer heart attacks and strokes in a two-year period. The approach saved hundreds of dollars per patient. The study was started when Kaiser began wondering if it was treating the wrong population with an expensive cholesterol drug from Merck. This is relevant because it shows that simple, low-cost generic drug regimens could produce increased health benefits and cost savings compared to using expensive brand-name drugs.
http://www.businessweek.com/bwdaily/dnflash/content/oct2009/db2009101_015899.htm
Drug Industry Wins, Pharmacy Benefit Managers and Device Makers Lose in the Senate Finance Committee Health Reform Bill: The $80 billion deal struck between the White House, the Finance Committee, and PhRMA will likely be preserved, which is a win for drugmakers. Compared to the $4 trillion in drug spending that will take place over the next 10 years, limiting PhRMA’s contribution to health care reform to $80 billion is a bargain according to certain lawmakers. Pharmacy benefit managers would lose as they would have to disclose rebates from drugmakers if they participate in Medicare Part D or in new health insurance exchanges. In the past, managers pocketed much of the rebates they received from drug manufacturers and retail pharmacies. The medical-device industry would be forced to pay $4 billion in annual fees starting in 2010 under the Finance Committee bill. It’s a mixed picture for insurers: The individual mandate would bring them more customers but tax penalties for those who fail to get insurance have been weakened. Baucus’s bill does not include a public health insurance option. This is relevant because, assuming the Senate bill is passed, the deal that benefits PhRMA could be preserved and included in the final health reform bill that will be signed by President Obama.
http://www.bloomberg.com/apps/news?pid=20601103&sid=a1WUMHwwB6UY
Corporate news (Week 2)
Sanofi Will Sell its Own Generic Version of Plavix: Sanofi will begin to manufacture and sell a generic version of its own drug, Plavix, this week, analysts reported on Monday. Plavix is the #1 prescription anti-platelet medicine, and aids in the prevention of heart attack and stroke. The drug is marketed by a joint collaboration effort between Sanofi-Aventis and Bristol Myers Squibb. The patent is scheduled to expire in 2011. This news is relevant because it highlights newfound interest in the generics market by a major pharmaceutical company. Big Pharma has traditionally shied away from participating in this marketspace for several strategic and logistical reasons; ventures like this one and Novartis’s Sandoz acquisition indicate that the generics market is no longer forbidden territory. There was no information given regarding the generic Plavix launch.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aWXQKtUgjr9A
http://www.reuters.com/article/rbssHealthcareNews/idUSL564810320091005
Quintiles sees doubling of Asian business: Quintiles, the world’s largest pharmaceutical services company, has indicated that the company expects to double its Asian business in the next five-to-ten years. Dennis Gillings, the CEO of the privately held American company, noted that pharmaceutical companies are eager to shift resources to Asia because that is precisely where economies are growing. This news is relevant because it further highlights the slow, but apparent industry shift from Western economies into developing world markets. Quintiles is speculated to earn over $3bn in revenues annually.
http://www.ft.com/cms/s/0/b1e1f4ae-aea8-11de-96d7-00144feabdc0.html?nclick_check=1
Lilly Settles Lawsuit with South Carolina over Zyprexa: Eli Lilly reached a tentative agreement with the State of South Carolina over its ostensibly improper marketing practices of Zyprexa, an antipsychotic drug. In January of 2009, Lilly had agreed to pay the US Federal government $1.42 billion due to similar charges, including $362 million to some, but not all, U.S. states. The lawsuit centers around Eli Lilly’s alleged improper marketing of the drug for unapproved uses, and also withheld information about the drug’s side effects. The news is relevant because it illustrates yet another example of stringent ethical marketing standards within the drug industry.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aYB4kyniMWuM
AstraZeneca Promoted Seroquel as ‘Weight Neutral’: AstraZeneca was found to have been promoting Seroquel, an anti-psychotic drug, as being weight-neutral for the past 4 years despite knowledge that the drug causes “clinically significant” weight gain. The company is currently facing about 9,000 lawsuits claiming that marketing failed to warn users of significant health issues that may be caused by the drug. The news is relevant because it highlights the importance of drug companies presenting both positive and negative data about their product in an objective fashion. Seroquel is the company’s second-biggest product, generating approximately $4.4 billion in annual revenues as of 2008.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aplfa8pUrUsM
Teva’s Copaxone Drug Halves Risk of Full-Blown Multiple-Sclerosis in a Recent Study: Teva’s Copaxone (chemically known as glatiramer acetate), was shown to decrease the incidence of two of more episodes of MS by about half over a three-year period. This makes Copaxone about as effective as MS drugs currently offered by biogen idec, Merck, and Bayer. Copaxone is Teva’s top selling product, earning approximately $2.3 billion in revenues in 2008. The news is relevant because it highlights Teva, traditionally a manufacture of generics, as a strong player in the novel drug therapies market.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aKRDOhorFyvU
Bayer Labels’ Cancer-Fighting Claim Draws Suit: A non-profit group, the Center for Science in the Public Interest, has filed a lawsuit against Bayer’s claim that the company mislead consumers in its claim that One-a-Day Vitamins may reduce male’s risk of prostate cancer. The company has been trying to better market its One-a-Day franchise to male consumers. Again, this news is relevant because it illustrates the importance of marketing both prescription and OTC health products using valid, scientifically founded claims.
http://www.nytimes.com/2009/10/02/business/media/02bayer.html?ref=health
http://www.bloomberg.com/apps/news?pid=20601202&sid=aWXQKtUgjr9A
http://www.reuters.com/article/rbssHealthcareNews/idUSL564810320091005
Quintiles sees doubling of Asian business: Quintiles, the world’s largest pharmaceutical services company, has indicated that the company expects to double its Asian business in the next five-to-ten years. Dennis Gillings, the CEO of the privately held American company, noted that pharmaceutical companies are eager to shift resources to Asia because that is precisely where economies are growing. This news is relevant because it further highlights the slow, but apparent industry shift from Western economies into developing world markets. Quintiles is speculated to earn over $3bn in revenues annually.
http://www.ft.com/cms/s/0/b1e1f4ae-aea8-11de-96d7-00144feabdc0.html?nclick_check=1
Lilly Settles Lawsuit with South Carolina over Zyprexa: Eli Lilly reached a tentative agreement with the State of South Carolina over its ostensibly improper marketing practices of Zyprexa, an antipsychotic drug. In January of 2009, Lilly had agreed to pay the US Federal government $1.42 billion due to similar charges, including $362 million to some, but not all, U.S. states. The lawsuit centers around Eli Lilly’s alleged improper marketing of the drug for unapproved uses, and also withheld information about the drug’s side effects. The news is relevant because it illustrates yet another example of stringent ethical marketing standards within the drug industry.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aYB4kyniMWuM
AstraZeneca Promoted Seroquel as ‘Weight Neutral’: AstraZeneca was found to have been promoting Seroquel, an anti-psychotic drug, as being weight-neutral for the past 4 years despite knowledge that the drug causes “clinically significant” weight gain. The company is currently facing about 9,000 lawsuits claiming that marketing failed to warn users of significant health issues that may be caused by the drug. The news is relevant because it highlights the importance of drug companies presenting both positive and negative data about their product in an objective fashion. Seroquel is the company’s second-biggest product, generating approximately $4.4 billion in annual revenues as of 2008.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aplfa8pUrUsM
Teva’s Copaxone Drug Halves Risk of Full-Blown Multiple-Sclerosis in a Recent Study: Teva’s Copaxone (chemically known as glatiramer acetate), was shown to decrease the incidence of two of more episodes of MS by about half over a three-year period. This makes Copaxone about as effective as MS drugs currently offered by biogen idec, Merck, and Bayer. Copaxone is Teva’s top selling product, earning approximately $2.3 billion in revenues in 2008. The news is relevant because it highlights Teva, traditionally a manufacture of generics, as a strong player in the novel drug therapies market.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aKRDOhorFyvU
Bayer Labels’ Cancer-Fighting Claim Draws Suit: A non-profit group, the Center for Science in the Public Interest, has filed a lawsuit against Bayer’s claim that the company mislead consumers in its claim that One-a-Day Vitamins may reduce male’s risk of prostate cancer. The company has been trying to better market its One-a-Day franchise to male consumers. Again, this news is relevant because it illustrates the importance of marketing both prescription and OTC health products using valid, scientifically founded claims.
http://www.nytimes.com/2009/10/02/business/media/02bayer.html?ref=health
Research news (Week 2)
MIT Works Toward Safer Gene Therapy: Researchers at MIT have recently had a successful gene therapy and stem cell experiment using nanotechnology to synthesize biodegradable polymers for genetic transfer. These biodegradable carriers are a safer alternative to previous methods involving viral vectors, which often cause negative health effects. There are currently no methods of gene therapy that have been approved by the FDA, so this breakthrough could potentially open up an entirely novel market in the industry.
http://web.mit.edu/newsoffice/2007/gene-delivery-0907.html
http://www.boston.com/yourlife/health/blog/2007/09/mit_scientists.html
Three Americans Win the 2009 Nobel Prize for Medicine: Three Americans won the 2009 Nobel Prize for Medicine early Monday morning. Elizabeth Blackburn, Carol Greider, and Jack Szostak have focused their research on telomeres (structures at the end of chromosomes), and how these structures prevent chromosomes from eroding away. Their research has suggested that cancer cells may specific enzymes from telomeres (telomerase) to fuel their uncontrolled growth. This enzyme has already been linked to several genetic diseases. The research is relevant because it may lead to new methods to combat cancer. Also, the shortening of telomeres is one of the fundamental reasons why the human body ages, and are play a key role in aging and longevity research.
http://www.nytimes.com/aponline/2009/10/05/health/AP-EU-Nobel-Medicine.html?_r=1&hp
http://nobelprize.org/nobel_prizes/medicine/laureates/2009/index.html
http://www4.utsouthwestern.edu/cellbio/shay-wright/intro/facts/sw_facts.html
http://genetics.mgh.harvard.edu/szostakweb/
http://biochemistry.ucsf.edu/labs/blackburn/
http://www.hopkinsmedicine.org/pharmacology/research/greider.html
Lab-on-Chip Uses Tiny Blood Sample to Assess Breast Cancer Risk: The University of Toronto has developed a prototype device that can quickly measure hormone levels in tiny amounts of fluid. The product may one day be used to analyze risk for breast cancer, steroid use in athletes, and other chemical measurements. If successful, the product may fundamentally change the operations and cost structure of clinical labs. The university researchers are currently looking for partners to help commercialize the product. http://www.bloomberg.com/apps/news?pid=20601202&sid=a06wRVTnxcQ0
http://web.mit.edu/newsoffice/2007/gene-delivery-0907.html
http://www.boston.com/yourlife/health/blog/2007/09/mit_scientists.html
Three Americans Win the 2009 Nobel Prize for Medicine: Three Americans won the 2009 Nobel Prize for Medicine early Monday morning. Elizabeth Blackburn, Carol Greider, and Jack Szostak have focused their research on telomeres (structures at the end of chromosomes), and how these structures prevent chromosomes from eroding away. Their research has suggested that cancer cells may specific enzymes from telomeres (telomerase) to fuel their uncontrolled growth. This enzyme has already been linked to several genetic diseases. The research is relevant because it may lead to new methods to combat cancer. Also, the shortening of telomeres is one of the fundamental reasons why the human body ages, and are play a key role in aging and longevity research.
http://www.nytimes.com/aponline/2009/10/05/health/AP-EU-Nobel-Medicine.html?_r=1&hp
http://nobelprize.org/nobel_prizes/medicine/laureates/2009/index.html
http://www4.utsouthwestern.edu/cellbio/shay-wright/intro/facts/sw_facts.html
http://genetics.mgh.harvard.edu/szostakweb/
http://biochemistry.ucsf.edu/labs/blackburn/
http://www.hopkinsmedicine.org/pharmacology/research/greider.html
Lab-on-Chip Uses Tiny Blood Sample to Assess Breast Cancer Risk: The University of Toronto has developed a prototype device that can quickly measure hormone levels in tiny amounts of fluid. The product may one day be used to analyze risk for breast cancer, steroid use in athletes, and other chemical measurements. If successful, the product may fundamentally change the operations and cost structure of clinical labs. The university researchers are currently looking for partners to help commercialize the product. http://www.bloomberg.com/apps/news?pid=20601202&sid=a06wRVTnxcQ0
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