Thursday, November 09, 2006
DIABETES ARTICLES - Merck Wins U.S. Approval for a New Diabetes Drug
DIABETES ARTICLES
Merck Wins U.S. Approval for a New Diabetes Drug
Federal drug regulators yesterday approved a new diabetes medicine from Merck that is expected to become a blockbuster treatment used by millions of people worldwide.
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Merck
Januvia, the new medicine, is a once-daily pill that has fewer severe side effects than existing diabetes medications and does not cause weight gain, according to clinical trials. The Food and Drug Administration said Januvia could be prescribed either on its own or in addition to other medicines.
It is aimed at Type 2 diabetes, the most common form, which affects nearly 21 million Americans — 7 percent of the population — and more than 200 million people globally.
Merck said Januvia would cost just under $5 a day, or about $145 a month, comparable to existing treatments. Merck shares rose slightly after the approval was announced yesterday morning, which had been expected.
Many doctors say they believe Januvia — and Galvus, a similar drug from Novartis that is expected to be approved later this year — will be valuable for many patients with diabetes, most of whom have dangerously high levels of blood sugar despite existing treatments.
“I can’t wait to put people on the drug,” Dr. James Underberg, a clinical assistant professor at New York University medical school who participated in a clinical trial of Januvia. Januvia is the third major new diabetes drug approved since the summer of 2005, and potentially the most important, analysts and doctors say. The drug works in a different way than existing treatments, and its pill form makes it more convenient than Byetta, a treatment approved last year that has some of the same benefits as Januvia but must be taken by injection.
Analysts predict that Januvia, either as a stand-alone treatment or in combination with an existing diabetes drug called metformin, will have worldwide sales of nearly $2 billion by 2010. Merck hopes to win approval for that combined drug early next year.
Optimism about Januvia has helped push Merck shares up 38 percent this year, compared with an 11 percent gain for the average large drug stock. Merck shares closed yesterday at $43.96, up 20 cents — at their highest level since the company withdrew its arthritis drug Vioxx in September 2004 after a study linked Vioxx to heart attacks and strokes.
Executives at Merck declined to comment on their plans for advertising Januvia to consumers. Unlike several other major drug makers, Merck has not committed to waiting at least six months before advertising new drugs so that doctors have a chance to learn about new therapies before patients begin asking for them.
But physicians like Dr. Underberg are already enthusiastic. “It doesn’t cause weight gain, it doesn’t cause episodes of hypoglycemia, and the side effects otherwise are pretty moderate,” he said.
Hypoglycemia is a potentially dangerous condition in which blood sugar levels drop too fast. In severe instances, it can cause fainting or even coma. Several older diabetes drugs can cause hypoglycemia by pushing the pancreas to produce large amounts insulin quickly.
In contrast, Januvia and Galvus are the first in a newer class of drugs called DPP-IV inhibitors, which work by enhancing levels of a natural protein called GLP-1. The protein stimulates the pancreas to produce insulin and discourages the liver from making glucose. But the DPP-IV inhibitors work only when blood sugar levels are already elevated, such as after a meal, sharply lowering the risk for hypoglycemia.
“The approval of Januvia marks an important advance in the fight against diabetes,” Dr. Steven Galson, director of the F.D.A.’s center for drug evaluation and research, said in a statement. “We now have another new option that treats the disease in an entirely new way.”
Diabetes is a disease in which blood sugar rises uncontrollably from a lack of, or resistance to, insulin, a hormone normally produced in the pancreas. In Type 1 diabetes, the pancreas is unable to produce insulin.
Type 2 diabetes is linked to obesity and inactivity. Typically, the disease progresses over several years as the pancreas gradually loses the ability to produce insulin, and drug treatments lose their effectiveness. Eventually, many patients wind up injecting themselves with insulin to control their blood sugar. Severe, late-stage diabetes sharply raises the risks of many medical problems, including heart attacks, strokes, kidney disease and blindness.
Jay Galeota, general manager of Merck’s global diabetes division, said Merck planned to ship Januvia to pharmacies and offer samples to doctors’ offices quickly. The company expects to market Januvia to both doctors and patients almost immediately, he said.
“We’re confident that we’re going to communicate the science of Januvia in a very wide way,” he said. “We’re expecting very rapid uptake right away.”
While there are several major classes of diabetes medicines already on the market, many have side effects that discourage patients from taking them, including weight gain and nausea. As a result, the market is ripe for new treatments, doctors and analysts say.
In clinical trials that examined Januvia in 2,719 patients, the most common side effects were sore throat, diarrhea and colds, the F.D.A. said.
Richard Evans, an analyst at Sanford C. Bernstein & Company, said he expected Januvia and Galvus to rapidly replace an older class of drugs called sulfonylureas. The newer drugs are similarly effective but much less likely to cause weight gain and hypoglycemia, he said.
“Everybody knows that sulfonylureas are kind of a losing game,” he said. While Galvus and Januvia are very similar, Januvia may have an edge because it clearly works as a once-a-day pill, while Galvus was initially formulated to be taken twice daily, Mr. Evans said. Novartis, the manufacturer of Galvus, now claims that its drug is effective when taken once daily, but doctors may be skeptical of that claim, he said.
Tony Butler, an industry analyst at Lehman Brothers, said he expected that Januvia would have sales of $271 million next year, rising to $1.1 billion by 2010. Mr. Butler said sales of the Januvia-metformin combination pill would be $500 million more in 2010.
by Alex Berenson at The New York Times, Published: October 18, 2006
Merck Wins U.S. Approval for a New Diabetes Drug
Federal drug regulators yesterday approved a new diabetes medicine from Merck that is expected to become a blockbuster treatment used by millions of people worldwide.
Skip to next paragraph
Merck
Januvia, the new medicine, is a once-daily pill that has fewer severe side effects than existing diabetes medications and does not cause weight gain, according to clinical trials. The Food and Drug Administration said Januvia could be prescribed either on its own or in addition to other medicines.
It is aimed at Type 2 diabetes, the most common form, which affects nearly 21 million Americans — 7 percent of the population — and more than 200 million people globally.
Merck said Januvia would cost just under $5 a day, or about $145 a month, comparable to existing treatments. Merck shares rose slightly after the approval was announced yesterday morning, which had been expected.
Many doctors say they believe Januvia — and Galvus, a similar drug from Novartis that is expected to be approved later this year — will be valuable for many patients with diabetes, most of whom have dangerously high levels of blood sugar despite existing treatments.
“I can’t wait to put people on the drug,” Dr. James Underberg, a clinical assistant professor at New York University medical school who participated in a clinical trial of Januvia. Januvia is the third major new diabetes drug approved since the summer of 2005, and potentially the most important, analysts and doctors say. The drug works in a different way than existing treatments, and its pill form makes it more convenient than Byetta, a treatment approved last year that has some of the same benefits as Januvia but must be taken by injection.
Analysts predict that Januvia, either as a stand-alone treatment or in combination with an existing diabetes drug called metformin, will have worldwide sales of nearly $2 billion by 2010. Merck hopes to win approval for that combined drug early next year.
Optimism about Januvia has helped push Merck shares up 38 percent this year, compared with an 11 percent gain for the average large drug stock. Merck shares closed yesterday at $43.96, up 20 cents — at their highest level since the company withdrew its arthritis drug Vioxx in September 2004 after a study linked Vioxx to heart attacks and strokes.
Executives at Merck declined to comment on their plans for advertising Januvia to consumers. Unlike several other major drug makers, Merck has not committed to waiting at least six months before advertising new drugs so that doctors have a chance to learn about new therapies before patients begin asking for them.
But physicians like Dr. Underberg are already enthusiastic. “It doesn’t cause weight gain, it doesn’t cause episodes of hypoglycemia, and the side effects otherwise are pretty moderate,” he said.
Hypoglycemia is a potentially dangerous condition in which blood sugar levels drop too fast. In severe instances, it can cause fainting or even coma. Several older diabetes drugs can cause hypoglycemia by pushing the pancreas to produce large amounts insulin quickly.
In contrast, Januvia and Galvus are the first in a newer class of drugs called DPP-IV inhibitors, which work by enhancing levels of a natural protein called GLP-1. The protein stimulates the pancreas to produce insulin and discourages the liver from making glucose. But the DPP-IV inhibitors work only when blood sugar levels are already elevated, such as after a meal, sharply lowering the risk for hypoglycemia.
“The approval of Januvia marks an important advance in the fight against diabetes,” Dr. Steven Galson, director of the F.D.A.’s center for drug evaluation and research, said in a statement. “We now have another new option that treats the disease in an entirely new way.”
Diabetes is a disease in which blood sugar rises uncontrollably from a lack of, or resistance to, insulin, a hormone normally produced in the pancreas. In Type 1 diabetes, the pancreas is unable to produce insulin.
Type 2 diabetes is linked to obesity and inactivity. Typically, the disease progresses over several years as the pancreas gradually loses the ability to produce insulin, and drug treatments lose their effectiveness. Eventually, many patients wind up injecting themselves with insulin to control their blood sugar. Severe, late-stage diabetes sharply raises the risks of many medical problems, including heart attacks, strokes, kidney disease and blindness.
Jay Galeota, general manager of Merck’s global diabetes division, said Merck planned to ship Januvia to pharmacies and offer samples to doctors’ offices quickly. The company expects to market Januvia to both doctors and patients almost immediately, he said.
“We’re confident that we’re going to communicate the science of Januvia in a very wide way,” he said. “We’re expecting very rapid uptake right away.”
While there are several major classes of diabetes medicines already on the market, many have side effects that discourage patients from taking them, including weight gain and nausea. As a result, the market is ripe for new treatments, doctors and analysts say.
In clinical trials that examined Januvia in 2,719 patients, the most common side effects were sore throat, diarrhea and colds, the F.D.A. said.
Richard Evans, an analyst at Sanford C. Bernstein & Company, said he expected Januvia and Galvus to rapidly replace an older class of drugs called sulfonylureas. The newer drugs are similarly effective but much less likely to cause weight gain and hypoglycemia, he said.
“Everybody knows that sulfonylureas are kind of a losing game,” he said. While Galvus and Januvia are very similar, Januvia may have an edge because it clearly works as a once-a-day pill, while Galvus was initially formulated to be taken twice daily, Mr. Evans said. Novartis, the manufacturer of Galvus, now claims that its drug is effective when taken once daily, but doctors may be skeptical of that claim, he said.
Tony Butler, an industry analyst at Lehman Brothers, said he expected that Januvia would have sales of $271 million next year, rising to $1.1 billion by 2010. Mr. Butler said sales of the Januvia-metformin combination pill would be $500 million more in 2010.
by Alex Berenson at The New York Times, Published: October 18, 2006
