Novartis H1N1 Vaccine Gets German Approval
http://online.wsj.com/article/SB10001424052748704013004574516902061645852.html
ZURICH -- Swiss drug maker Novartis said Thursday it received regulatory approval in Germany to sell a new swine-flu vaccine made in cell cultures, marking an important milestone in gaining acceptance for newer, rapid ways of producing vaccines.
GSK wins U.S. approval for swine flu vaccine
http://www.reuters.com/article/marketsNews/idCNLA52274320091110?rpc=44
GlaxoSmithKline has won U.S. marketing approval to sell an unadjuvanted H1N1 swine vaccine, allowing it to ship relatively modest amounts of scarce vaccine to the United States next month.
The British company said on Tuesday the Food and Drug Administration had approved a modified version of its FluLaval seasonal flu vaccine containing the new H1N1 strain.
The 7.6 million doses of Glaxo's unadjuvanted vaccine, which is being manufactured in Canada, is just a small fraction of the 250 million doses ordered by the U.S. government.
Glaxo said it expected to start shipping its vaccine in December and complete deliveries by the end of the year.
New Drug for H1N1 Flu Offers Hope
http://www.nytimes.com/2009/11/06/business/06drug.html?scp=5&sq=drug%20development&st=cse
Athena Gurno thought her allergies were acting up when she started coughing in early October. But within days, Ms. Gurno, the 30-year-old mother of a young girl, was in a Seattle hospital, close to death from the H1N1 flu. Desperate, her doctors tried a still-experimental drug called peramivir. After getting her second dose, Ms. Gurno started to recover, though she is still in intensive care, according to her father, John Spikowski.
Peramivir might also be a life saver for its developer, BioCryst Pharmaceuticals, an unprofitable biotechnology company in Birmingham, Ala., that was founded in 1986 but has not yet had a drug reach the market.
On Thursday, the federal government ordered, on an emergency basis, 10,000 treatment courses of peramivir for its national stockpile. It is paying $22.5 million, or about $2,250 a patient. Shares of BioCryst rose nearly 13 percent, to $11.39.
Peramivir is given intravenously, making it usable by hospitalized patients who are too ill to take two approved flu drugs that work against the virus in similar ways — Tamiflu by Roche, which is typically given as a pill, or Relenza from GlaxoSmithKline, which is inhaled.
Late Thursday, the government announced orders for intravenous versions of Tamiflu and Relenza, which are much cheaper — a development that could force shares of BioCryst to give up some of their gains on Friday.
Peramivir, still being tested in clinical trials, is not approved by the Food and Drug Administration for general use. But on Oct. 23, the F.D.A. granted authority for the drug to be used in emergencies for patients hospitalized with H1N1 flu who cannot take or do not benefit from Tamiflu or Relenza.
Before that, peramivir had been available only through a more cumbersome “compassionate use” procedure. Of the 32 patients who received the drug that way, 29 were still alive, BioCryst said in late October.
Although there are still questions about peramivir’s true effectiveness, some critics say the government moved too slowly to make the drug available, and that even now, access is too restricted. For each patient, doctors must call an 800 number or fill out a form on a Web site run by the Centers for Disease Control and Prevention. The drug is then sent overnight from a central stockpile.
New Flu Victim: Blood Supply
http://online.wsj.com/article/SB10001424052748703808904574525570410593800.html
The swine-flu pandemic is creating unexpected problems for the nation's blood supply—shrinking the number of blood donors and raising questions about whether the flu can be spread through a transfusion.
A number of blood centers are reporting an unusual drop in collections because too many potential donors are sick with the H1N1 virus, or swine flu. Some blood drives in high schools and corporate offices have had to be scaled back or canceled because of high levels of absenteeism.
Another problem: Some centers say a growing number of donors are calling a day or two after giving blood to say they've come down with flu-like symptoms, forcing the centers to dispose of the blood as part of government regulations. Researchers in a government-funded study are testing samples of these donors' blood for viremia, the medical term for virus in the blood.
Unlike infectious diseases such as HIV/AIDS, hepatitis C and West Nile virus, colds and flu aren't believed to be transmitted by blood. But some studies indicate that more virulent strains can be present in the blood before flu symptoms show up. "When you get into strains that are pandemic, the rules don't necessarily apply," says Matthew Kuehnert, director of the Office of Blood, Organ and other Tissue Safety at the Centers for Disease Control and Prevention.
So far, medical officials say there is enough blood to comfortably supply the 15 million units used annually in trauma units, operating rooms and elsewhere. But blood centers have begun working with the federal government and hospitals to put emergency planning measures in place, such as allocating blood only to the sickest patients, should the pandemic worsen or return in a more virulent form next spring.
"We are very worried about the impact of swine flu," says Marsha Springel, donor resources manager at the Miller-Keystone Blood Center in Bethlehem, Pa., which serves eight counties in Pennsylvania and New Jersey. "Right now we have an ample supply, but if this hits as big as they are predicting, we will lose the schools, and they are a large proportion of our donor base," she says.
A Big Splash From an Upstart Medical Center
http://www.nytimes.com/2009/11/12/giving/12SICK.html?pagewanted=1&_r=1&sq=drug%20development&st=cse&scp=1
TO many people who suffer from the poorly understood illness called chronic fatigue syndrome, a recent study linking the disorder to a virus was a victory for the little guys.
At least one million Americans have chronic fatigue syndrome, which causes severe fatigue, muscle and joint pain, sleep problems, difficulty concentrating and other problems. Its cause is unknown, symptoms can last for years and there is no effective treatment. Women outnumber men as patients, and many people with the syndrome feel stigmatized and brushed off as neurotic by doctors. Andrea Whittemore-Goad, who is 31, has had a severe case of the syndrome for 20 years.
An Science article published last month pointed to a physical cause for an illness that the medical establishment had often snidely dismissed as psychosomatic.
Widely Used Cholesterol-lowering Drug May Prevent Progression Of Parkinson's Disease
http://www.sciencedaily.com/releases/2009/10/091029211647.htm
Simvastatin, a commonly used, cholesterol-lowering drug, may prevent Parkinson's disease from progressing further. Neurological researchers at Rush University Medical Center conducted a study examining the use of the FDA-approved medication in mice with Parkinson's disease and found that the drug successfully reverses the biochemical, cellular and anatomical changes caused by the disease.
Approved lymphoma drug shows promise in early tests against bone cancer
http://www.eurekalert.org/pub_releases/2009-11/uorm-ald110409.php
A drug already approved for the treatment of lymphoma may also slow the growth of the most deadly bone cancer in children and teens, according to an early-stage study published online today in the International Journal of Cancer. The study drug, Bortezomib, was found to be effective against bone cancer in human cancer cell studies and in mice. While key experiments were in animals, the cancer studied closely resembled the human form and the drug has already been proven to be safe in human patients.
In the current study, researchers sought to use Bortezomib (Velcade®) against osteosarcoma, an aggressive cancer that starts in bone, spreads quickly and responds poorly to current chemotherapies. The drug, a proteasome inhibitor developed by Millennium Pharmaceuticals and Johnson & Johnson, was approved by the FDA for the treatment of a rare, aggressive form of non-Hodgkin's lymphoma in 2006 and for multiple myeloma in 2008.
"Our most clinically relevant finding is that a drug already proven safe and effective in treating the most common cancers of the blood may be equally effective in suppressing bone cancer," said Roman Eliseev, M.D., Ph.D., research assistant professor within the Center for Musculoskeletal Research and the James P. Wilmot Cancer Center, both within the University of Rochester Medical Center. "Bortezomib caused osteosarcoma cells to self destruct, and prevented their spread. While further studies are needed, our findings suggest that this drug may represent a new treatment option for a devastating disease and an effective complement to current chemotherapies."
Concert Starts HIV Trial, Bags $12M From Glaxo to Help Challenge Gilead’s Once-Daily Pill
http://www.xconomy.com/boston/2009/11/09/concert-starts-hiv-trial-bags-12m-from-glaxo-to-help-challenge-gileads-once-daily-pill/
Concert Pharmaceuticals, the Lexington, MA-based company that chemically modifies existing drugs to make them more attractive, has started human testing of an HIV medication which it hopes will help GlaxoSmithKline wrestle back market share it has been losing to Gilead Sciences, the world’s largest maker of HIV drugs.
Concert will receive a $12 million payment from GlaxoSmithKline for starting the trial of a drug it calls CTP-518. It’s one small piece of the collaboration announced in June that could be worth more than $1 billion over time to the smaller company. I heard about this bit of news, and what it means strategically to Concert, when I visited CEO Roger Tung at the company’s office last week.
The basic idea is to take a common protease inhibitor, Bristol-Myers Squibb’s atazanavir (Reyataz), and swap out a few hydrogen atoms on the molecule with deuterium atoms. This is supposed to retain the drug’s viral killing punch, while making it last longer in the body. That’s desirable because it could allow doctors to quit prescribing a booster drug from Abbott Laboratories called ritonavir that adds cost, complexity, and hassles, Tung says. If the Concert drug is able to remain potent long enough in the bloodstream on its own, then it could be combined with other antivirals to create a convenient once-daily pill to compete with Gilead Sciences’ efavirenz emtricitabine tenofovir (Atripla), a drug that has helped Gilead surpass Glaxo as the world’s leading maker of HIV drugs the past couple of years.
Thursday, November 12, 2009
Industry News (11/05 – 11/11)
Regeneron Pharmaceuticals and Sanofi Aventis expand drug partnership
http://www.biospace.com/news_story.aspx?NewsEntityId=162454&Source=TopBreaking
Sanofi-aventis will increase its annual funding commitment from $100M to $160 million beginning in 2010, and the research funding will now extend through 2017. The companies aim to advance an average of four to five antibodies into clinical development each year. In addition to its VelocImmune(®) technology, Regeneron will contribute to the collaboration its next generation technologies related to antibody generation.
"This collaboration expansion demonstrates sanofi-aventis' commitment to become a key player in the field of monoclonal antibodies and our confidence in our partner Regeneron," declared Marc Cluzel, Executive Vice President, R&D, sanofi-aventis. "It will further fuel our product pipeline and will allow us to bring multiple antibody product candidates into the clinic, thereby significantly increasing the chance of providing patients access to innovative drugs in various therapeutic areas."
Pfizer closing local R&D operations
http://blogs.wsj.com/health/2009/11/09/which-rd-sites-is-pfizer-closing/
http://abclocal.go.com/wtvd/story?section=news/national_world&id=7108473
The plan, announced Monday, will bring the closure of six of their 20 research facilities - including ones in Research Triangle Park and Sanford. The company will reorganize and consolidate others, and cut the jobs of up to 2,000 scientists and laboratory technicians.
New York-based Pfizer solidified its position as the world's biggest drugmaker with its $68 billion purchase of drug and vaccine maker Wyeth on Oct. 15, diversifying overnight by adding Wyeth's biotech drugs and consumer and animal health division.
The two executives heading the combined research operation told The Associated Press exclusively that integrating and reorganizing the two companies' laboratories will boost research productivity and save money as well…
http://www.biospace.com/news_story.aspx?NewsEntityId=162454&Source=TopBreaking
Sanofi-aventis will increase its annual funding commitment from $100M to $160 million beginning in 2010, and the research funding will now extend through 2017. The companies aim to advance an average of four to five antibodies into clinical development each year. In addition to its VelocImmune(®) technology, Regeneron will contribute to the collaboration its next generation technologies related to antibody generation.
"This collaboration expansion demonstrates sanofi-aventis' commitment to become a key player in the field of monoclonal antibodies and our confidence in our partner Regeneron," declared Marc Cluzel, Executive Vice President, R&D, sanofi-aventis. "It will further fuel our product pipeline and will allow us to bring multiple antibody product candidates into the clinic, thereby significantly increasing the chance of providing patients access to innovative drugs in various therapeutic areas."
Pfizer closing local R&D operations
http://blogs.wsj.com/health/2009/11/09/which-rd-sites-is-pfizer-closing/
http://abclocal.go.com/wtvd/story?section=news/national_world&id=7108473
The plan, announced Monday, will bring the closure of six of their 20 research facilities - including ones in Research Triangle Park and Sanford. The company will reorganize and consolidate others, and cut the jobs of up to 2,000 scientists and laboratory technicians.
New York-based Pfizer solidified its position as the world's biggest drugmaker with its $68 billion purchase of drug and vaccine maker Wyeth on Oct. 15, diversifying overnight by adding Wyeth's biotech drugs and consumer and animal health division.
The two executives heading the combined research operation told The Associated Press exclusively that integrating and reorganizing the two companies' laboratories will boost research productivity and save money as well…
Policy News (11/05 – 11/11)
Health Care Overhaul Plan Passes House
http://www.nytimes.com/2009/11/08/health/policy/08health.html?ref=policy&pagewanted=print
On November 7th, the House narrowly approved an overhaul of the nation’s health care system. Lawmakers voted 220 to 215 to approve a plan that would cost $1.1 trillion over 10 years.
After the vote, Mr. Obama issued a statement praising the House and calling on the Senate to follow suit. “I am absolutely confident it will,” he said, “and I look forward to signing comprehensive health insurance reform into law by the end of the year.”
Major issues in the bill:
1. Abortion restrictions: The bill blocks the use of federal money for “any health plan that includes coverage of abortion,” except in the case of rape or incest or if the life of a pregnant woman is in danger.
2. Government health insurance program: The bill includes a government health insurance program that would extend coverage to 36 million people now without insurance. It would end negative insurance company practices such as not covering pre-existing conditions or dropping people when they become ill.
3. Employers provide coverage for employees: Most employers would have to provide coverage or pay a tax penalty of up to 8 percent of their payroll. The bill would significantly expand Medicaid and would offer subsidies to help moderate-income people buy insurance from private companies or from a government insurance plan. It would also set up a national insurance exchange where people could shop for coverage.
4. Legal immigrants coverage: More than one million legal permanent residents and about seven million illegal immigrants who currently have no health insurance would be excluded from coverage
House Health Care Debate Heads Home
http://prescriptions.blogs.nytimes.com/2009/11/10/house-health-care-debate-heads-home/
Republican House members are preparing for town hall-style meetings in their home districts during the Veterans Day recess between Nov. 10 and the week after, hoping to undermine support for a health care overhaul.
Representative Mike Pence has issued 16 pages of talking points urging fellow Republicans to use the recess to tell their constituents that the House bill would destroy the economy and the health insurance system
Democrats, on the other hand, will be out pushing the bill at their own town hall-style meetings, press conferences and business round tables. They want to make sure they keep the support they have in the House, and even try to expand it when the House votes on final legislation after the Senate passes its version.
Democratic leaders have prepared notebooks packed with statistics to help their members explain to voters in detail exactly how an overhaul would help the uninsured, older people, small businesses and others in each Congressional district.
A.M.A. Backs Gay-Rights Issues
http://www.nytimes.com/2009/11/11/us/11brfs-AMABACKSGAYR_BRF.html?ref=policy
The American Medical Association voted to oppose the military’s “don’t ask, don’t tell” policy, and declared that same-sex marriage bans contribute to health disparities. The association would seek to overturn marriage bans. Doctors who pushed the group to oppose “don’t ask, don’t tell” say the policy forcing gay service members to keep their sexual orientation secret has “a chilling effect” on open communication between them and their doctors. The health disparities policy is based on evidence showing that married couples are more likely to have health insurance.
http://www.nytimes.com/2009/11/08/health/policy/08health.html?ref=policy&pagewanted=print
On November 7th, the House narrowly approved an overhaul of the nation’s health care system. Lawmakers voted 220 to 215 to approve a plan that would cost $1.1 trillion over 10 years.
After the vote, Mr. Obama issued a statement praising the House and calling on the Senate to follow suit. “I am absolutely confident it will,” he said, “and I look forward to signing comprehensive health insurance reform into law by the end of the year.”
Major issues in the bill:
1. Abortion restrictions: The bill blocks the use of federal money for “any health plan that includes coverage of abortion,” except in the case of rape or incest or if the life of a pregnant woman is in danger.
2. Government health insurance program: The bill includes a government health insurance program that would extend coverage to 36 million people now without insurance. It would end negative insurance company practices such as not covering pre-existing conditions or dropping people when they become ill.
3. Employers provide coverage for employees: Most employers would have to provide coverage or pay a tax penalty of up to 8 percent of their payroll. The bill would significantly expand Medicaid and would offer subsidies to help moderate-income people buy insurance from private companies or from a government insurance plan. It would also set up a national insurance exchange where people could shop for coverage.
4. Legal immigrants coverage: More than one million legal permanent residents and about seven million illegal immigrants who currently have no health insurance would be excluded from coverage
House Health Care Debate Heads Home
http://prescriptions.blogs.nytimes.com/2009/11/10/house-health-care-debate-heads-home/
Republican House members are preparing for town hall-style meetings in their home districts during the Veterans Day recess between Nov. 10 and the week after, hoping to undermine support for a health care overhaul.
Representative Mike Pence has issued 16 pages of talking points urging fellow Republicans to use the recess to tell their constituents that the House bill would destroy the economy and the health insurance system
Democrats, on the other hand, will be out pushing the bill at their own town hall-style meetings, press conferences and business round tables. They want to make sure they keep the support they have in the House, and even try to expand it when the House votes on final legislation after the Senate passes its version.
Democratic leaders have prepared notebooks packed with statistics to help their members explain to voters in detail exactly how an overhaul would help the uninsured, older people, small businesses and others in each Congressional district.
A.M.A. Backs Gay-Rights Issues
http://www.nytimes.com/2009/11/11/us/11brfs-AMABACKSGAYR_BRF.html?ref=policy
The American Medical Association voted to oppose the military’s “don’t ask, don’t tell” policy, and declared that same-sex marriage bans contribute to health disparities. The association would seek to overturn marriage bans. Doctors who pushed the group to oppose “don’t ask, don’t tell” say the policy forcing gay service members to keep their sexual orientation secret has “a chilling effect” on open communication between them and their doctors. The health disparities policy is based on evidence showing that married couples are more likely to have health insurance.
Product News (11/05 – 11/11)
FDA Approves Gloucester Pharmaceuticals, Inc.'s ISTODAX(R) for Patients with Cutaneous T-cell Lymphoma
http://www.biospace.com/news_story.aspx?NewsEntityId=162002
Gloucester Pharmaceuticals (across the street from MIT) has been developing a histone deacetylase inhibitor molecule to treat cutaneous T-cell lymphoma, which is a cancer of the immune cells. This drug was approved last week by the FDA and will be on the market in January 2010. This is the 2nd drug in the class of HDAC inihibitors to be approved by the FDA. Clinical trials were performed on patients who had previously received some other form of systemic therapy or skin-directed therapy, with an objective response rate of 35% of patients showing 50% or better response to the drug, where 6% of the patients were completely cured.
Elan, Biogen change Tysabri label due to PML risk
http://www.reuters.com/article/marketsNews/idCNL718499120091107?rpc=44
As mentioned two weeks ago, the increasing cases of PML (progressive multifocal leukoencephalopathy) in patients taking Tysabri has led to a review by European regulators on the drug. Elan and Biogen have decided to modify the label for Tysabri to include the warning that the drug may cause an increased risk of contracting PML, which is a deadly brain infection. However, they say that this is still the same as the 1 in 1000 rate that they have seen in clinical trials.
Bristol-Myers Squibb Company Buys Rights to Rheumatoid Arthritis Drug from Alder Biopharmaceuticals Inc. for Potenially $1 Billion
http://finance.yahoo.com/news/BristolMyers-signs-apf-3430744848.html?x=0&.v=2
BMS will pay Alder 85 million upfront with up to 1 billion dollars in future payments for the exclusive rights to develop and commercialize Alder’s drug to treat rheumatoid arthritis. This drug, ALD518, is a human monoclonal antibody that targets interleukin-6, which causes inflammation in the joints of RA patients, leading to stiffness and pain.
FDA won't accept Merck's application for new cholesterol drug
http://news.yahoo.com/s/ap/20091102/ap_on_bi_ge/us_merck_drug_rejected
FDA has refused to file a New Drug Application that Merck submitted for a combination pill. This drug would combine Pfizer’s Lipitor, which goes off patent in 2 years, with Zetia, a Merck and Schering-Plough partner drug that also helps lower cholesterol. The FDA said that it wants more data on the manufacturing and stability of the drug before it will accept the application.
http://www.biospace.com/news_story.aspx?NewsEntityId=162002
Gloucester Pharmaceuticals (across the street from MIT) has been developing a histone deacetylase inhibitor molecule to treat cutaneous T-cell lymphoma, which is a cancer of the immune cells. This drug was approved last week by the FDA and will be on the market in January 2010. This is the 2nd drug in the class of HDAC inihibitors to be approved by the FDA. Clinical trials were performed on patients who had previously received some other form of systemic therapy or skin-directed therapy, with an objective response rate of 35% of patients showing 50% or better response to the drug, where 6% of the patients were completely cured.
Elan, Biogen change Tysabri label due to PML risk
http://www.reuters.com/article/marketsNews/idCNL718499120091107?rpc=44
As mentioned two weeks ago, the increasing cases of PML (progressive multifocal leukoencephalopathy) in patients taking Tysabri has led to a review by European regulators on the drug. Elan and Biogen have decided to modify the label for Tysabri to include the warning that the drug may cause an increased risk of contracting PML, which is a deadly brain infection. However, they say that this is still the same as the 1 in 1000 rate that they have seen in clinical trials.
Bristol-Myers Squibb Company Buys Rights to Rheumatoid Arthritis Drug from Alder Biopharmaceuticals Inc. for Potenially $1 Billion
http://finance.yahoo.com/news/BristolMyers-signs-apf-3430744848.html?x=0&.v=2
BMS will pay Alder 85 million upfront with up to 1 billion dollars in future payments for the exclusive rights to develop and commercialize Alder’s drug to treat rheumatoid arthritis. This drug, ALD518, is a human monoclonal antibody that targets interleukin-6, which causes inflammation in the joints of RA patients, leading to stiffness and pain.
FDA won't accept Merck's application for new cholesterol drug
http://news.yahoo.com/s/ap/20091102/ap_on_bi_ge/us_merck_drug_rejected
FDA has refused to file a New Drug Application that Merck submitted for a combination pill. This drug would combine Pfizer’s Lipitor, which goes off patent in 2 years, with Zetia, a Merck and Schering-Plough partner drug that also helps lower cholesterol. The FDA said that it wants more data on the manufacturing and stability of the drug before it will accept the application.
Wednesday, November 4, 2009
Policy news (10/29-11/4)
Why read when you can watch?
Democrat House Speaker Nancy Pelosi introduces the House Healthcare Reform Bill: http://www.youtube.com/watch?v=4Ccy1qMGiz8
Republican Senate Minority Leader Mitch McConnel addresses the Senate: http://www.youtube.com/watch?v=Q1odu8nH0zM
Democrat Senate Majority Leader Harry Reid: http://www.youtube.com/watch?v=J7U4z8pfqGURepublican Senator Joe Lieberman on the Public Option: http://www.youtube.com/watch?v=9mzCG7GPJxk
Obama Strategy on Health Care Legislation Appears to Pay Off
Democratic leaders and senior White House officials are sounding increasingly confident that Mr. Obama will sign legislation overhauling the nation’s health care system — a goal that has eluded American presidents for decades... The bills have advanced further than many lawmakers expected. Five separate measures are now pared down to two. But the legislative progress has come at a price. In the absence of specific guidance from the White House, it has moved ahead in fits and starts... Mr. Obama said early on that he would not repeat the mistakes of Mr. Clinton, who wrote his own detailed plan, only to see it fall flat on Capitol Hill. Instead, the president set out broad principles — an approach that the House speaker, Nancy Pelosi of California, acknowledged at a rally last week, when she thanked Mr. Obama for “the intellectual contributions” he had made to the legislation.
Buoyant Democrats Unveil Health Care Legislation
House Democrats said the health care overhaul legislation could reach the floor next week. “We will have the votes to pass it,” said Representative Allyson Y. Schwartz of Pennsylvania. To secure additional votes, House Democratic leaders tweaked the bill in several ways: reducing the number of high-income people who would be hit by a new surtax; exempting more small business from a requirement to provide coverage; and stipulating that a new government insurance plan negotiate rates with doctors and hospitals, rather than using Medicare rates set by the government. The House bill includes a new provision that would require the secretary of health and human services to negotiate drug prices on behalf of Medicare beneficiaries. The proposal is anathema to pharmaceutical companies. The bill would require most Americans to obtain insurance and would require employers to provide coverage to workers or pay a penalty. Small businesses would be exempt from the employer mandate if they had payrolls of less than $500,000 a year, double the threshold in the Democrats’ original bill... But the budget office said the premiums in the government plan would be “somewhat higher than the average premiums” charged by private insurers, in part because the public plan would probably attract less healthy people and would be less aggressive in managing care.
House Democrats said the health care overhaul legislation could reach the floor next week. “We will have the votes to pass it,” said Representative Allyson Y. Schwartz of Pennsylvania. To secure additional votes, House Democratic leaders tweaked the bill in several ways: reducing the number of high-income people who would be hit by a new surtax; exempting more small business from a requirement to provide coverage; and stipulating that a new government insurance plan negotiate rates with doctors and hospitals, rather than using Medicare rates set by the government. The House bill includes a new provision that would require the secretary of health and human services to negotiate drug prices on behalf of Medicare beneficiaries. The proposal is anathema to pharmaceutical companies. The bill would require most Americans to obtain insurance and would require employers to provide coverage to workers or pay a penalty. Small businesses would be exempt from the employer mandate if they had payrolls of less than $500,000 a year, double the threshold in the Democrats’ original bill... But the budget office said the premiums in the government plan would be “somewhat higher than the average premiums” charged by private insurers, in part because the public plan would probably attract less healthy people and would be less aggressive in managing care.
Democrats are trying to revive the idea of a government-run health plan
When Mrs Pelosi revealed, on October 29th, the House's version of a health-reform bill, there were no real suprises; as expected, a public plan featured prominently. The real suprise had come three days earlier. Until very recently, it had looked as though the proposal to tack on a public plan was, despite fervent support among the left, politically doomed. First came Barack Obama’s slippery but clear efforts to back away from it. Then came a crucial vote of the Senate Finance Committee, which rejected the public plan. The final congressional health bill must reconcile the versions coming out of the full House and Senate, and the powerful Finance Committee’s rejection had appeared to be a final nail in the coffin. But this week Harry Reid, the leader of the Senate Democrats and an ardent fan of the proposal, dropped a bombshell. During the process of reconciling the output of the Senate’s Health and Finance Committees, he overruled the wishes of the latter. So the health bill that the full Senate is likely to consider over the next few weeks now looks likely to include a public plan.
Senate, House Move Closer on Health Bills as Battle Goes Public
Top Democrats are moving legislation closer to the political center of their party, cutting the overall cost and choosing a watered-down version of a government-run health insurance program. They may have to bend even further to get enough votes for passage, especially in the Senate. If both the House and Senate pass legislation, they will work together on a compromise. And once again leaders will probably turn to a small group of influential lawmakers, said Mark McClellan, a Bloomberg Television contributor and the former head of the Centers for Medicare and Medicaid Services.
GOP offers alternative to Democrat healthcare reform bill
The current Republican version from the House [which has no chance of passing] addresses conservative issues that would address the high costs of healthcare. The GOP proposal includes:
• Increased incentives on health savings accounts
• Caps non-economic jury awards in malpractice cases at $250,000
• Offers incentives for states that will aim to drive down premium costs
• Allows health insurance to be sold across state lines, increasing competition and lowering premium costs
• Increased incentives on health savings accounts
• Caps non-economic jury awards in malpractice cases at $250,000
• Offers incentives for states that will aim to drive down premium costs
• Allows health insurance to be sold across state lines, increasing competition and lowering premium costs
• Includes a permanent ban on any federal funding for abortions (except in cases of rape, incest or threat to the life of the mother)
Product news (10/29-11/4)
Human Genome Science’s lupus drug successful in second Phase III trial
Systemic lupus erythematosus is a chronic autoimmune connective tissue disease that affects approximately 325,000 Americans. Human Genome Sciences in partnership with GlaxoSmithKline has developed belimumab (Benlysta), a human monoclonal antibody that specifically inhibits the biological activity of B-cell activating factor, a transmembrane glycoprotein that signals proliferation of B lymphocytes. Benlysta achieved its second Phase III trial success when a high dose administration demonstrated a statistically superior response compared to placebo. If approved by the FDA in early 2010, Benlysta will represent the first new drug for the disease in more than 40 years. An approval will also mark the first drug on the market for Human Genome Sciences, a genomics company founded in 1992. The company’s stock reached a year high as shares increased by $6.59 to $25.28. As recently as last March, the stock sold for only 45 cents a share, but investors are optimistic as company president announced a price tag of around $20,000 a year for therapy in a market with over 200,000 American candidates. The company’s market value now exceeds $4 billion.
The first clinical trial for Benlysta took place in Eastern Europe, South America, and Asia, and resulted in one in ten patients having an improvement in symptoms. The second trial held in American and Western Europe was not as successful. Analysts believe the effects may not be as prominent due to better medical care in western facilities. These results are a demonstration of the large market potential resulting from even small increases in efficacy for indications with unmet medical need.
Amylin forges $1B weight-loss pact with Takeda
Obesity is a global epidemic affecting over 300 million people. The current global market is estimated at over $1 billion and is being pursued by several late-stage programs out of companies such as Vivus, Arena Pharmaceuticals and Orexigen. Though behind in the clinic, Amylin Pharmacueticals has gained attention for the combination of its diabetes drug, pramlintide, with Amgen’s leptin. Preliminary results demonstrate that patients lost 11 percent of their body weight after taking the highest dose compared with less than 2 percent for those given placebo. Takeda Pharmaceuticals will partner for late-stage and global development of the therapies after agreeing to pay $75 million upfront and more than a billion dollars in commercial and clinical milestone payments plus double-digit royalties. Amylin shares climbed nearly 10 percent, despite an announcement that Roche’s new once-a-week diabetes drug proved better than Amlylin’s Byetta (see separate entry).
The Amylin-Takeda deal comes amid a surge in obesity treatment research and development from the biotechnology industry. It will be interesting to see if Vivus, Arena, or Orexigen will take a similar approach in late-stage development of their therapies. I would imagine that such deals would go for at least twice as much as the Amylin-Takeda deal considering their programs are Phase III and appear to have at least as impressive efficacy and do not carry the four-times-a-day-injection burden of Amylin’s combination therapy. With market values of only $300 million, it seems likely that Orexigen or Arena may simply be acquired. Either way, the obesity drug market appears to be an intriguing investment opportunity.
Byetta’s new diabetes indication comes with FDA warning and proves inferior to Roche’s Taspoglutide
The FDA expanded approval of Amylin’s Byetta as a stand-alone diabetes treatment, however, its warning label now includes details of the reports of altered kidney function. More concerning than 78 cases of kidney damage in over 7 million prescriptions is Roche’s new data on its once-a-week Taspoglutide. The drug outperformed twice-a-day Byetta in its ability to reduce levels of glycated hemoglobin associated with diabetes.
This news is not as bad as it sounds for Amylin. The new label is not a black-box warning and should not affect sales any more than news of the renal failure cases have since 2005, although consumer advocacy groups such as Public Citizen are recommending that people avoid using the drug until at least 2012. I don’t believe the stand-alone approval will increase the market significantly as many doctors have already been prescribing off-label and it will still be difficult for a twice-a-day injection to compete with orally available alternatives. However, the stand-alone status should apply to the once-a-week Byetta, which is currently under FDA review and will certainly offer strong competition to oral medications as well as Roche’s Taspoglutide.
The HCV Race: Novartis drops out, Schering-Plough's hepatitis C drug shows promise, Vertex twice-a-day a success
Another week and more good news in the competitive race for the next big hepatitis C treatment. Schering-Plough (Merck) reported potent anti-viral activity of their Phase IIa protease inhibitor. The drug helped eliminate the virus in about half of patients who did not respond to standard treatments. This result is very similar to that reported by Vertex Pharmaceuticals last week. Since then, Vertex (with J&J) has reported more than 80 percent of patients receiving twice-a-day treatment experienced a sustained viral response. This news resulted in a Vertex share price increase of 14%.
The race between Vertex and Schering-Plough is competitive, and the market is expected to get crowded fast as companies rush to develop more advanced therapies. This news came shortly after Novartis’s announcement that it will not move forward with its option to license Idenix’s HVC drug. Any of the big pharma players could be a potentially good partner for Idenix as the industry eagerly chases the estimated $2.5 billion a year market. The first drug on the market likely will establish its brand with physicians, and capture a larger share of the 300,000 patients who have failed existing therapies for hepatitis C. However, combination therapies may prove to be the real cash cow in the end. This puts even Merck in play for Idenix, who will have to compete with combination therapies in the Vertex, Gilead, and Roche pipelines. The medical community will watch closely as companies continue to test antiviral combinations, and we will see if their success leads to more combinatorial business activity.
Research news (10/29-11/4)
New technology can heal injured lungs, increase probability for transplant
In the latest issue of Science Translational Medicine, researchers with the University Health Network in Toronto have discovered a successful gene therapy method which can heal damaged donor lungs before transplantation. Adenoviral mediated gene therapy allows high concentrations of IL-10, the cytokine responsible for “healing” the lungs, to be expressed in an ex vivo setting; here, the lungs are placed in a glass chamber and perfused with oxygen and required nutrients while the gene therapy is performed. Initial testing was performed in pigs, and this treatment led to lungs with less swelling and better function when transplanted into donor pigs 12 hours later. Similar results were found in human lungs before transplant. This type of gene therapy could greatly increase the efficacy and availability of lung transplants, which currently is a major problem.
FDA panel backs first non-drug treatment: a medical device to treat asthma
An FDA panel has recommended that the agency approves a medical device to treat asthma. While the FDA is not required to take the advice of its panels, it typically does. This would be the first non-drug approval by the FDA, setting a precedent for future approvals. This medical device, called the Alair Bronchial Thermoplasty System (Asthmatix Inc.), is a bronchoscope that is inserted into the patient’s nose into the lungs, and a catheter emits radiofrequency to burn away lung tissue that makes breathing difficult. This device would be administered by health care professionals and would be intended for severe asthma sufferers who get no benefits from existing drugs.
Researchers generate primitive human egg and sperm from stem cells
Published in a recent issue of Nature, researchers at Stanford University have produced primitive sperm and eggs from embryonic stem cells by silencing and overexpressing specific genes. This research has important implications for reproductive issues, as it could eventually lead to therapies to increase fertility. This process of generating sperm and eggs from embryonic stem cells will also lead to important insight into gamete production in humans and may be useful in determining disease mechanisms.
Scientists decode the DNA of a pig
A global collaboration has led to the whole genome sequencing of a domesticated pig. This sequence will be important for agriculture by allowing researchers to determine genes necessary for pork production or immunity. In the wake of the growing swine flu epidemic, this genome sequencing may also hold important clues for developing future swine flu vaccines.
Malaria vaccine undergoing Phase III testing, could reach market in 3 years
A major clinical trial is underway involving children in seven African countries for the malaria vaccine, RTS-S. 5,000 children have already been recruited, and 16,000 are expected to enroll in the study. GSK produces the vaccine and has "committed to keeping the drug affordable" should it reach the market. GSK's CEO is quoted saying he would prefer a pricing mechanism which would "create a financial incentive with a guaranteed price for drugmakers to deliver vaccines to poorer countries."
Corporate news (10/29-11/4)
Medicare to Pay More to Doctors for Avastin
In a recent decision, it was announced that Medicare would now pay more to doctors for administering Avastin to patients. Earlier, Medicare had cut payments for Avastin by 80% and had agreed to pay doctors only $7 per dose which is much lower than the $50 per dose costs incurred by them. In turn, the doctors decided to prescribe the more expensive Lucentis which costs $2000 per dose and is not subject to reimbursement limits!! So, in effect the Medicare policy was costing both the taxpayers and the patients (who now had big copays for the $2000 drug). The only entity benefiting from this was Genentech. Genentech says Lucentis is specially formulated with smaller molecules than Avastin to better penetrate the eye. However, many eye doctors say there is no detectable difference in outcomes for patients. The American Academy of Ophthalmologists estimates about 60 percent of all injections for macular degeneration use Avastin. Now, after this policy reversal, it could cost Genentech money due to decrease in sales of Lucentis. Just shows how short sighted senate policies which do not take the full ramifications into account end up having the counter effect!
http://online.wsj.com/article/SB10001424052748704222704574501771192508500.html
http://www.fiercepharma.com/story/medicare-gives-eye-docs-their-way-avastin/2009-10-28
http://www.technologyreview.com/wire/23826/
U.S. News: Drug Makers Face Tougher Measures
The house health care bill poses more problems for pharmaceutical manufacturers. Apparently this deal could now cost up to $140 billion. In June, the White house and the senate had struck a deal with pharma manufacturers to bear up to $80 billion as the cost of healthcare reform in the next few years (in terms of cost cuts etc.). However, the house representatives have said that they are not bound by this agreement. Industry trade groups are no doubt concerned!
http://online.wsj.com/article/SB125685873503217267.html
http://thehill.com/homenews/house/65409-pelosi-unveils-healthcare-bill-house-moves-toward-floor-vote
In positive(?) news about Swine Flu, Clorox and other companies selling disinfecting products report boosted earnings!
Clorox reported an earnings per share of $1.11 beating the Wall Street expectations of $0.95 per share. This was due to strong sales of its disinfecting products like wipes and bleach. This is in line with the recent trend of strong performance of similar companies such as Ecolab for its line of disinfectants, 3M for masks and Kimberley-Clark for its paper products. In related activity, orange juice demand has picked up strongly and orange juice futures are trading at 22% higher prices.
Looks like at least someone is celebrating in face of the Swine flu pandemic!!
States Sue Amgen over alleged Kickbacks plan
New York, 13 other states and District of Columbia are suing Amgen Corp for false practices to stimulate sales of the anemia drug Aranesp. Aranesp is Amgen's top selling drug making up more than 20% of its 15 Bn$ revenue. WSJ reports that Amgen conspired with other organizations to offer improper kickbacks to medical providers to induce them to prescribe Aranesp. These included sham consultancy agreements, weekend retreats or other services. We have been hearing similar news about other companies all through Fall. Amgen has predictably denied any involvement and referred to its code of conduct - "Do the Right Thing".
What makes this all hte more interesting is the fact that this drug worked no better than placebo in reducing deaths or cardiovascular problems it was thought to prevent, according to a paper published in New England Journal of Medicine. Instead, people who took the drug, Aranesp, were almost twice as likely to have strokes as patients given a dummy pill. No wonder this drug needed some pushing!
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