Merck, J&J’s New Hepatitis C Treatments Fetch $31,000 in France

[Guest guest]

http://www.bloomberg.com/news/2011-04-03/merck-j-j-s-new-hepatitis-c-treatments-\

fetch-31-000-in-france.html

Merck, J & J’s New Hepatitis C Treatments Fetch $31,000 in France

By Naomi Kresge and Carol Matlack -

Apr 3, 2011

New hepatitis C drugs from Merck & Co. and & (JNJ) are being

sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say

may limit access after the medicines are approved throughout Europe.

J & J and Vertex Pharmaceuticals Inc. (VRTX)’s telaprevir costs 22,000 euros under

a French program for seriously ill patients for whom there is no other effective

treatment on the market, according to patient association SOS Hepatites. Merck &

Co. said its boceprevir costs 30,000 euros under the same program.

The price may drop once the drugs are approved for the broader market, Merck and

J & J executives said. Still, the French model shows the new drugs may triple the

cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely

to delay use or restrict which patients are allowed access, said Craxi,

director of gastroenterology and internal medicine at the University of Palermo.

“It may be that we can’t use it at all until the price comes down,” Mark Thursz,

professor of hepatology at Imperial College London, said in an interview at a

conference in Berlin over the weekend. “It’s not the best economic environment

to launch an expensive new drug.”

The U.K.’s National Institute for Health and Clinical Excellence may restrict

the new drugs to patients who have tried existing treatments without success,

Thursz said. The agency may also require genetic tests to determine whether

patients are likely to respond to the medicines, he said at the meeting of the

European Association for the Study of the Liver.

Italy and Spain also may delay or restrict use, Craxi said. Italy spends about

350 million euros a year on existing hepatitis C treatments, he said. “If you

triple the cost, that would be more than 1 billion euros,” he said.

Under Review

The new drugs are being reviewed by regulators at theEuropean Medicines Agency.

Both are scheduled for U.S. Food and Drug Administration hearings at the end of

this month.

In France, telaprevir and boceprevir received special temporary authorization in

December, under a program designed for seriously ill patients for whom there is

no other effective treatment on the market, according to French pharmaceutical

regulator AFSSAPS. This allowed the drugs to bypass the usual approval

procedures, the regulator said.

About 500 patients are being treated in France now, said Michel Bonjour,

spokesman for SOS Hepatites. The new drugs are prescribed together with the

current standard therapy of interferon and generic ribavirin, and the total cost

of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per

patient, Bonjour said in an interview. The cost is covered in full by France’s

national health insurance program.

‘Cost Effective’

“It’s not a good indication of price elsewhere,” Bergstedt, senior vice

president for vaccines and infectious diseases at Whitehouse Station, New

Jersey-based Merck, said in an interview.

The very sick patients in the French program get 44 weeks of treatment with

boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he

said. There’s a “high likelihood” the eventual commercial price for a course of

treatment will be less than the 30,000 euros Merck charges under the French

program, he said.

“It’s black and white that these drugs are cost-effective,” Bergstedt said. “The

challenge will be how do you stratify treatment, and how do you use these drugs

responsibly to ensure the patients with the greatest need are treated first.”

12-Week Treatment

Vertex, based in Cambridge, Massachusetts, referred questions to partner J & J,

which will market telaprevir inEurope. J & J hasn’t decided on a final price, said

Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New

Brunswick, New Jersey-based company’s Tibotec Therapeutics unit.

Patients take telaprevir for 12 weeks together with standard treatment, then

continue on the older standard drugs for a total of six months to a year of

therapy.

Both new hepatitis C drugs are protease inhibitors crafted from the same

technologies that led to discoveries in HIV research. Used in addition to

existing therapies, they boost the chance of a cure from half of patients to

between two-thirds and three-quarters of those treated, studies have shown.

In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates

Liang, a Boston-based analyst at Leerink Swann & Co.

“A cure saves a lot of money down the road,” Liang said in an interview. “It’s a

shock to physicians, but I think it can be justified because it’s a cure.”

Next Generation

Hepatitis C, spread through contact with infected blood, is a virus that often

lingers as a chronic condition, causing nausea and exhaustion as it destroys the

liver over the course of years or decades. About 170 million people are

infected, according to the World Health Organization.

Meanwhile, the next generation of drugs with even higher cure rates and fewer

side effects is likely to reach the market within three years, Liang said.

Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a

competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH,

Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. are among a dozen

companies aiming for drug cocktails to replace the existing interferon

combination.

Looming competition leaves Merck, Vertex and J & J without much time to recoup

their investment, said Gore, president of the Geneva-based patient

advocacy group World Hepatitis Alliance.

“There is no easy answer to this,” Gore said in an interview. “We’ve got to have

a way to give people access but incentivize the drug companies to research in

this area.”

To contact the reporters on this story: Naomi Kresge in Berlin at

nkresge@...; Carol Matlack in Paris at cmatlack@...

To contact the editors responsible for this story: Phil Serafino at

pserafino@...;

[Guest guest]

http://www.bloomberg.com/news/2011-04-03/merck-j-j-s-new-hepatitis-c-treatments-\

fetch-31-000-in-france.html

Merck, J & J’s New Hepatitis C Treatments Fetch $31,000 in France

By Naomi Kresge and Carol Matlack -

Apr 3, 2011

New hepatitis C drugs from Merck & Co. and & (JNJ) are being

sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say

may limit access after the medicines are approved throughout Europe.

J & J and Vertex Pharmaceuticals Inc. (VRTX)’s telaprevir costs 22,000 euros under

a French program for seriously ill patients for whom there is no other effective

treatment on the market, according to patient association SOS Hepatites. Merck &

Co. said its boceprevir costs 30,000 euros under the same program.

The price may drop once the drugs are approved for the broader market, Merck and

J & J executives said. Still, the French model shows the new drugs may triple the

cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely

to delay use or restrict which patients are allowed access, said Craxi,

director of gastroenterology and internal medicine at the University of Palermo.

“It may be that we can’t use it at all until the price comes down,” Mark Thursz,

professor of hepatology at Imperial College London, said in an interview at a

conference in Berlin over the weekend. “It’s not the best economic environment

to launch an expensive new drug.”

The U.K.’s National Institute for Health and Clinical Excellence may restrict

the new drugs to patients who have tried existing treatments without success,

Thursz said. The agency may also require genetic tests to determine whether

patients are likely to respond to the medicines, he said at the meeting of the

European Association for the Study of the Liver.

Italy and Spain also may delay or restrict use, Craxi said. Italy spends about

350 million euros a year on existing hepatitis C treatments, he said. “If you

triple the cost, that would be more than 1 billion euros,” he said.

Under Review

The new drugs are being reviewed by regulators at theEuropean Medicines Agency.

Both are scheduled for U.S. Food and Drug Administration hearings at the end of

this month.

In France, telaprevir and boceprevir received special temporary authorization in

December, under a program designed for seriously ill patients for whom there is

no other effective treatment on the market, according to French pharmaceutical

regulator AFSSAPS. This allowed the drugs to bypass the usual approval

procedures, the regulator said.

About 500 patients are being treated in France now, said Michel Bonjour,

spokesman for SOS Hepatites. The new drugs are prescribed together with the

current standard therapy of interferon and generic ribavirin, and the total cost

of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per

patient, Bonjour said in an interview. The cost is covered in full by France’s

national health insurance program.

‘Cost Effective’

“It’s not a good indication of price elsewhere,” Bergstedt, senior vice

president for vaccines and infectious diseases at Whitehouse Station, New

Jersey-based Merck, said in an interview.

The very sick patients in the French program get 44 weeks of treatment with

boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he

said. There’s a “high likelihood” the eventual commercial price for a course of

treatment will be less than the 30,000 euros Merck charges under the French

program, he said.

“It’s black and white that these drugs are cost-effective,” Bergstedt said. “The

challenge will be how do you stratify treatment, and how do you use these drugs

responsibly to ensure the patients with the greatest need are treated first.”

12-Week Treatment

Vertex, based in Cambridge, Massachusetts, referred questions to partner J & J,

which will market telaprevir inEurope. J & J hasn’t decided on a final price, said

Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New

Brunswick, New Jersey-based company’s Tibotec Therapeutics unit.

Patients take telaprevir for 12 weeks together with standard treatment, then

continue on the older standard drugs for a total of six months to a year of

therapy.

Both new hepatitis C drugs are protease inhibitors crafted from the same

technologies that led to discoveries in HIV research. Used in addition to

existing therapies, they boost the chance of a cure from half of patients to

between two-thirds and three-quarters of those treated, studies have shown.

In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates

Liang, a Boston-based analyst at Leerink Swann & Co.

“A cure saves a lot of money down the road,” Liang said in an interview. “It’s a

shock to physicians, but I think it can be justified because it’s a cure.”

Next Generation

Hepatitis C, spread through contact with infected blood, is a virus that often

lingers as a chronic condition, causing nausea and exhaustion as it destroys the

liver over the course of years or decades. About 170 million people are

infected, according to the World Health Organization.

Meanwhile, the next generation of drugs with even higher cure rates and fewer

side effects is likely to reach the market within three years, Liang said.

Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a

competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH,

Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. are among a dozen

companies aiming for drug cocktails to replace the existing interferon

combination.

Looming competition leaves Merck, Vertex and J & J without much time to recoup

their investment, said Gore, president of the Geneva-based patient

advocacy group World Hepatitis Alliance.

“There is no easy answer to this,” Gore said in an interview. “We’ve got to have

a way to give people access but incentivize the drug companies to research in

this area.”

To contact the reporters on this story: Naomi Kresge in Berlin at

nkresge@...; Carol Matlack in Paris at cmatlack@...

To contact the editors responsible for this story: Phil Serafino at

pserafino@...;

[Guest guest]

http://www.bloomberg.com/news/2011-04-03/merck-j-j-s-new-hepatitis-c-treatments-\

fetch-31-000-in-france.html

Merck, J & J’s New Hepatitis C Treatments Fetch $31,000 in France

By Naomi Kresge and Carol Matlack -

Apr 3, 2011

New hepatitis C drugs from Merck & Co. and & (JNJ) are being

sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say

may limit access after the medicines are approved throughout Europe.

J & J and Vertex Pharmaceuticals Inc. (VRTX)’s telaprevir costs 22,000 euros under

a French program for seriously ill patients for whom there is no other effective

treatment on the market, according to patient association SOS Hepatites. Merck &

Co. said its boceprevir costs 30,000 euros under the same program.

The price may drop once the drugs are approved for the broader market, Merck and

J & J executives said. Still, the French model shows the new drugs may triple the

cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely

to delay use or restrict which patients are allowed access, said Craxi,

director of gastroenterology and internal medicine at the University of Palermo.

“It may be that we can’t use it at all until the price comes down,” Mark Thursz,

professor of hepatology at Imperial College London, said in an interview at a

conference in Berlin over the weekend. “It’s not the best economic environment

to launch an expensive new drug.”

The U.K.’s National Institute for Health and Clinical Excellence may restrict

the new drugs to patients who have tried existing treatments without success,

Thursz said. The agency may also require genetic tests to determine whether

patients are likely to respond to the medicines, he said at the meeting of the

European Association for the Study of the Liver.

Italy and Spain also may delay or restrict use, Craxi said. Italy spends about

350 million euros a year on existing hepatitis C treatments, he said. “If you

triple the cost, that would be more than 1 billion euros,” he said.

Under Review

The new drugs are being reviewed by regulators at theEuropean Medicines Agency.

Both are scheduled for U.S. Food and Drug Administration hearings at the end of

this month.

In France, telaprevir and boceprevir received special temporary authorization in

December, under a program designed for seriously ill patients for whom there is

no other effective treatment on the market, according to French pharmaceutical

regulator AFSSAPS. This allowed the drugs to bypass the usual approval

procedures, the regulator said.

About 500 patients are being treated in France now, said Michel Bonjour,

spokesman for SOS Hepatites. The new drugs are prescribed together with the

current standard therapy of interferon and generic ribavirin, and the total cost

of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per

patient, Bonjour said in an interview. The cost is covered in full by France’s

national health insurance program.

‘Cost Effective’

“It’s not a good indication of price elsewhere,” Bergstedt, senior vice

president for vaccines and infectious diseases at Whitehouse Station, New

Jersey-based Merck, said in an interview.

The very sick patients in the French program get 44 weeks of treatment with

boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he

said. There’s a “high likelihood” the eventual commercial price for a course of

treatment will be less than the 30,000 euros Merck charges under the French

program, he said.

“It’s black and white that these drugs are cost-effective,” Bergstedt said. “The

challenge will be how do you stratify treatment, and how do you use these drugs

responsibly to ensure the patients with the greatest need are treated first.”

12-Week Treatment

Vertex, based in Cambridge, Massachusetts, referred questions to partner J & J,

which will market telaprevir inEurope. J & J hasn’t decided on a final price, said

Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New

Brunswick, New Jersey-based company’s Tibotec Therapeutics unit.

Patients take telaprevir for 12 weeks together with standard treatment, then

continue on the older standard drugs for a total of six months to a year of

therapy.

Both new hepatitis C drugs are protease inhibitors crafted from the same

technologies that led to discoveries in HIV research. Used in addition to

existing therapies, they boost the chance of a cure from half of patients to

between two-thirds and three-quarters of those treated, studies have shown.

In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates

Liang, a Boston-based analyst at Leerink Swann & Co.

“A cure saves a lot of money down the road,” Liang said in an interview. “It’s a

shock to physicians, but I think it can be justified because it’s a cure.”

Next Generation

Hepatitis C, spread through contact with infected blood, is a virus that often

lingers as a chronic condition, causing nausea and exhaustion as it destroys the

liver over the course of years or decades. About 170 million people are

infected, according to the World Health Organization.

Meanwhile, the next generation of drugs with even higher cure rates and fewer

side effects is likely to reach the market within three years, Liang said.

Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a

competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH,

Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. are among a dozen

companies aiming for drug cocktails to replace the existing interferon

combination.

Looming competition leaves Merck, Vertex and J & J without much time to recoup

their investment, said Gore, president of the Geneva-based patient

advocacy group World Hepatitis Alliance.

“There is no easy answer to this,” Gore said in an interview. “We’ve got to have

a way to give people access but incentivize the drug companies to research in

this area.”

To contact the reporters on this story: Naomi Kresge in Berlin at

nkresge@...; Carol Matlack in Paris at cmatlack@...

To contact the editors responsible for this story: Phil Serafino at

pserafino@...;

[Guest guest]

http://www.bloomberg.com/news/2011-04-03/merck-j-j-s-new-hepatitis-c-treatments-\

fetch-31-000-in-france.html

Merck, J & J’s New Hepatitis C Treatments Fetch $31,000 in France

By Naomi Kresge and Carol Matlack -

Apr 3, 2011

New hepatitis C drugs from Merck & Co. and & (JNJ) are being

sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say

may limit access after the medicines are approved throughout Europe.

J & J and Vertex Pharmaceuticals Inc. (VRTX)’s telaprevir costs 22,000 euros under

a French program for seriously ill patients for whom there is no other effective

treatment on the market, according to patient association SOS Hepatites. Merck &

Co. said its boceprevir costs 30,000 euros under the same program.

The price may drop once the drugs are approved for the broader market, Merck and

J & J executives said. Still, the French model shows the new drugs may triple the

cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely

to delay use or restrict which patients are allowed access, said Craxi,

director of gastroenterology and internal medicine at the University of Palermo.

“It may be that we can’t use it at all until the price comes down,” Mark Thursz,

professor of hepatology at Imperial College London, said in an interview at a

conference in Berlin over the weekend. “It’s not the best economic environment

to launch an expensive new drug.”

The U.K.’s National Institute for Health and Clinical Excellence may restrict

the new drugs to patients who have tried existing treatments without success,

Thursz said. The agency may also require genetic tests to determine whether

patients are likely to respond to the medicines, he said at the meeting of the

European Association for the Study of the Liver.

Italy and Spain also may delay or restrict use, Craxi said. Italy spends about

350 million euros a year on existing hepatitis C treatments, he said. “If you

triple the cost, that would be more than 1 billion euros,” he said.

Under Review

The new drugs are being reviewed by regulators at theEuropean Medicines Agency.

Both are scheduled for U.S. Food and Drug Administration hearings at the end of

this month.

In France, telaprevir and boceprevir received special temporary authorization in

December, under a program designed for seriously ill patients for whom there is

no other effective treatment on the market, according to French pharmaceutical

regulator AFSSAPS. This allowed the drugs to bypass the usual approval

procedures, the regulator said.

About 500 patients are being treated in France now, said Michel Bonjour,

spokesman for SOS Hepatites. The new drugs are prescribed together with the

current standard therapy of interferon and generic ribavirin, and the total cost

of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per

patient, Bonjour said in an interview. The cost is covered in full by France’s

national health insurance program.

‘Cost Effective’

“It’s not a good indication of price elsewhere,” Bergstedt, senior vice

president for vaccines and infectious diseases at Whitehouse Station, New

Jersey-based Merck, said in an interview.

The very sick patients in the French program get 44 weeks of treatment with

boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he

said. There’s a “high likelihood” the eventual commercial price for a course of

treatment will be less than the 30,000 euros Merck charges under the French

program, he said.

“It’s black and white that these drugs are cost-effective,” Bergstedt said. “The

challenge will be how do you stratify treatment, and how do you use these drugs

responsibly to ensure the patients with the greatest need are treated first.”

12-Week Treatment

Vertex, based in Cambridge, Massachusetts, referred questions to partner J & J,

which will market telaprevir inEurope. J & J hasn’t decided on a final price, said

Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New

Brunswick, New Jersey-based company’s Tibotec Therapeutics unit.

Patients take telaprevir for 12 weeks together with standard treatment, then

continue on the older standard drugs for a total of six months to a year of

therapy.

Both new hepatitis C drugs are protease inhibitors crafted from the same

technologies that led to discoveries in HIV research. Used in addition to

existing therapies, they boost the chance of a cure from half of patients to

between two-thirds and three-quarters of those treated, studies have shown.

In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates

Liang, a Boston-based analyst at Leerink Swann & Co.

“A cure saves a lot of money down the road,” Liang said in an interview. “It’s a

shock to physicians, but I think it can be justified because it’s a cure.”

Next Generation

Hepatitis C, spread through contact with infected blood, is a virus that often

lingers as a chronic condition, causing nausea and exhaustion as it destroys the

liver over the course of years or decades. About 170 million people are

infected, according to the World Health Organization.

Meanwhile, the next generation of drugs with even higher cure rates and fewer

side effects is likely to reach the market within three years, Liang said.

Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a

competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH,

Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. are among a dozen

companies aiming for drug cocktails to replace the existing interferon

combination.

Looming competition leaves Merck, Vertex and J & J without much time to recoup

their investment, said Gore, president of the Geneva-based patient

advocacy group World Hepatitis Alliance.

“There is no easy answer to this,” Gore said in an interview. “We’ve got to have

a way to give people access but incentivize the drug companies to research in

this area.”

To contact the reporters on this story: Naomi Kresge in Berlin at

nkresge@...; Carol Matlack in Paris at cmatlack@...

To contact the editors responsible for this story: Phil Serafino at

pserafino@...;