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!
Thursday, October 29, 2009
Product News (10/22-28)
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.
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.
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:
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