Article appearing in the online "news" section of the journal Nature, discussing how the best in HCV treatment - and prevention of resistance - may be yet to come with drugs currently in the development pipeline. Companies mentioned are Pharmasset, BMS and iTherX.
New drug targets raise hopes for hepatitis C cure
As the first targeted therapies edge towards regulatory approval, attention turns to the next drugs in line.
Heidi Ledford
A cocktail of tailored drugs will be needed to defeat the hepatitis C virus.
This week, a panel of advisers to the US Food and Drug Administration (FDA) will decide whether the regulator should approve the first therapies tailored to target the hepatitis C virus (HCV). The drugs, called protease inhibitors, are expected to win approval, but observers say that they are only the beginning of a revolution in HCV treatment.
The most exciting developments for patients, they say, may still be in the drug-development pipeline. Researchers are working on drugs that target many aspects of the virus's biology. Used in combination, these might thwart HCV's ability to evolve resistance.
About 3% of the world's population is infected with HCV, an RNA virus that can cause chronic liver disease. Current therapy — a year-long regimen of the antiviral compounds interferon-alpha and ribavirin — cures only about half of cases. Side effects of this treatment can be severe: interferon-alpha can cause flu-like symptoms, fatigue, anaemia and depression.
On 27 and 28 April, the FDA's Antiviral Drugs Advisory Committee will meet to discuss the first anti-HCV drugs to target HCV proteins. Both these drugs — boceprevir, made by pharmaceutical giant Merck, headquartered in Whitehouse Station, New Jersey, and telaprevir from Vertex Pharmaceuticals, based in Cambridge, Massachusetts — target a protein called the NS3-4A protease, which is required to make essential viral proteins.
Each drug, when combined with standard therapy, boosts the cure rate to about 75%.
"I am very excited," says Michael Houghton, a virologist at the University of Alberta in Edmonton, who was a member of the team that discovered the virus in 1989. "These drugs are great news for HCV patients."
The long road to a blockbuster
Nevertheless, these drugs are only the beginning. "These first-generation protease inhibitors will enjoy their day in the sun for maybe two or three years," says Raymond Chung, head of hepatology at the Massachusetts General Hospital in Boston. "But I don't see them having staying power once we have many more of these targeted drugs getting into the game."
The hope is to eventually use several drugs in combination, avoiding the need for interferon-alpha while staving off drug resistance. Houghton estimates, based on mathematical models and clinical studies, that it will take a cocktail of three targeted therapies to prevent drug resistance.
There are about 60 compounds in preclinical and clinical development as companies jostle to grab a slice of a multi-billion-dollar market.
In 2010, researchers at Bristol-Myers-Squibb's lab in Wallingford, Connecticut, reported their discovery of an HCV protein called NS5A that is essential for the assembly of infectious viral particles and the amplification of viral RNA1. In early clinical trials of an NS5A inhibitor, the level of HCV RNA in the blood dropped almost 2,000-fold after only one day of treatment. This drug is now in phase 2 clinical trials.
Combining the NS5A inhibitor with a protease inhibitor wiped out the virus in four of 11 patients whose infections had not responded to standard therapy. The virus remained undetectable for at least 24 weeks.
These latest results, presented at the International Liver Congress annual meeting in Berlin on 1 April, are exciting because they suggest that interferon may eventually be dispensable, says Chung. He anticipates a flurry of such combination studies in the next few years.
Access denied
Another approach is to stop HCV spreading inside patients by targeting its ability to enter cells. "To contain the virus in a subset of cells rather than allowing it to spread would be a huge boost for containing liver damage," says Michael Gale, a virologist at the University of Washington in Seattle.
In a study published in Nature Medicine on 24 April, a team led by virologist Thomas Baumert of the University of Strasbourg, France, reports that HCV relies on a cellular receptor protein, the epidermal growth factor receptor (EGFR), to enter human cells2. EGFR inhibitors are already on the market as cancer therapies and Baumert's team plans to begin clinical trials of the EGFR inhibitor erlotinib in HCV patients by the end of the year.
Another drug that blocks entry, ITX-5061, is being developed by iTherX, a pharmaceutical company based in San Diego, California, and is in phase 2 clinical trials.
Chung, meanwhile, believes that drugs called nucleoside polymerase inhibitors, which prevent the virus from copying its genome, will be a key ingredient of any future HCV drug cocktail. These compounds set a high barrier for the virus, he notes, and early tests suggest that resistance to them is rare.
Pharmasset, a pharmaceutical firm in Princeton, New Jersey, has several such drugs in development. One called RG7128 is in phase 2 clinical trials and is being developed by Pharmasset together with the Swiss drug giant Roche, based in Basel.
"We used to live in a monochromatic world," says Chung. "Now we realize there are several roads to the same destination."
References
1.Gao, M. et al. Nature 465, 96-100 (2010).
2.Lupberger, J. et al. Nature Med. doi:10.1038/nm.2341 (2011).
Showing posts with label DAAs. Show all posts
Showing posts with label DAAs. Show all posts
Tuesday, April 26, 2011
Sunday, April 24, 2011
Boston Globe article on Vertex's challenges in becoming a full-fledged commercial entity...
Good article by Boston Globe's Robert Weisman on the catalysts and challenges of Vertex Pharmaceuticals becoming a full fledged commercial pharmaceutical company with the pending launch of Telaprevir. Clearly the largest challenge to the successful launch of Telaprevir (aside from Vertex's shuffling of leadership positions late in the game) is the formidable marketing prowess of Merck behind Boceprevir coupled with the company's long-running experience in the Hepatitis C marketplace. This battle will be a compelling one to watch as both companies almost simultaneously launch ground-breaking drugs that will forver change the way Hepatitis C is treated. The Merck/Vertex battle is almost certainly destined to shape the playbooks of drug marketing/manufacturing mavens and become a case study of choice in business schools around the globe.
Rearranging the Corporate DNA
On the verge of its first blockbuster drug, can Vertex transform itself into a money-making enterprise?
By Robert Weisman
Globe Staff / April 24, 2011
CAMBRIDGE — This week, a Food and Drug Administration advisory panel in Silver Spring, Md., is scheduled to make a recommendation critical to the future of Vertex Pharmaceuticals Inc. The advisers will rule on whether the FDA should approve the first drug developed solely by the biotechnology company in its 22 years of existence.
Approval for telaprevir — a drug aimed at curing hepatitis C — would hasten Vertex’s transition from a research and development company that invested some $4 billion in drug discovery over the past two decades to an integrated research and commercial organization. It also would become, for the first time, a company that consistently makes money.
“Vertex’s plan has always been to be a fully capable company, and that’s still the plan,’’ said Joshua Boger, who founded the biotech company in 1989 and retired two years ago. “This is the fulfillment of that aspiration.’’
In a warren of former industrial buildings in Cambridgeport that make up the Vertex corporate campus, the company’s transition is well underway. Chief executive Matthew Emmens, the biotechnology veteran tapped in 2009 to create a sales and marketing force, has hired more than 200 people for Vertex’s fledgling commercial team.
Overall, the company now has about 1,800 employees, 25 percent more than at the start of last year. That includes about 1,200 in the Boston area and 175 field representatives preparing to promote telaprevir — which will be given a more consumer-friendly brand name — if it wins final FDA approval in May.
Vertex is still hiring and currently has 150 job openings. In February, it unveiled plans to add 500 more employees and build a new headquarters in the Fan Pier waterfront development area in South Boston. That move, which includes $60 million in incentives from the state, is contingent on approval of telaprevir. Vertex also is moving forward with clinical trials of a drug to treat cystic fibrosis.
“It’s just a golden era right now for this company,’’ said Emmens, 59, former chief executive of British drug maker Shire PLC, who worked with Boger years ago at pharmaceutical giant Merck & Co. in New Jersey. “Some of the best researchers in the world are here, and we’re building a commercial presence. You’ve got millions of patients waiting for a drug that can save their life.’’
Vertex’s market value has climbed to $9.8 billion, second only to Weston-based Biogen Idec Inc. among Massachusetts biotechnology companies, largely on investor anticipation of its new drug that, if approved, would enter a market projected at $3.3 billion a year starting in 2012.
But it might not have that market to itself. The day before the FDA advisory committee takes up telaprevir on Thursday, it will consider a competing hepatitis C virus treatment from Merck. Both are protease inhibitors, a class of drugs that act to prevent viral infections. They target a US population that includes hundreds of thousands of patients treated unsuccessfully by current drugs and tens of thousands “warehoused’’ by doctors — patients infected with hepatitis C but not yet experiencing symptoms — until the Vertex and Merck drugs are available.
“We’re expecting it to be a very big market initially,’’ said biotechnology analyst Howard Liang, managing director at health care investment bank Leerink Swann in Boston, who projects the new hepatitis C treatments will generate $2.2 billion in revenue for Vertex and $1 billion for Merck in 2012, and even more the following year. “Both drugs are a very significant advance over existing therapies.’’
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Photos
Joshua Boger, founder of Vertex.
A look at the history of
Vertex Pharmaceuticals
* On the long, hard road
to a breakthrough
* Can Vertex transform into
a money-making enterprise?
* Biotech ‘gunslingers’
aim for breakthroughs
* Now comes the hard part:
marketing an unknown
Hepatitis C is believed to kill about 10,000 people a year worldwide, many of whom develop cancer or scarring of the liver. But the virus can be carried for decades before patients become sick, and millions of people are thought to have the virus and not know it. The virus has become an epidemic among baby boomers infected decades ago through injecting drugs or blood transfusions. It may be carried by as many as 3 million people in the United States and 100 million worldwide.
Patients are currently treated with a combination of two drugs: pegylated interferon and ribaviran. Vertex’s telaprevir or Merck’s drug, known as boceprevir, would be added to that “cocktail,’’ boosting its potency and acting directly against the virus in a bid to cure many patients. The drugs are expected to be priced at between $35,000 and $40,000 per patient, Leerink Swann estimates, and taken in combination with the current drugs, they promise to shorten the duration of treatment for large numbers of patients.
Telaprevir, in particular, aims to cut the treatment time in half, from 12 to six months, for about 60 percent of patients with the most serious form of the virus, Leerink’s Liang said. “Our opinion is, telaprevir looks to be a more potent drug,’’ he said. “The cure rate is a little higher, and it’s more likely the duration of treatment will be reduced.’’
But Merck would have some advantages in marketing boceprevir, which it says it would sell under the name Victrelis. Among them, it is likely to market the drug together with its own brands of pegylated interferon and ribaviran, both already on the market. “We would take a franchise approach to this,’’ said Mark Timney, president of Merck’s US Human Health business. “We have a long history and deep scientific and commercial knowledge in treatment of the hepatitis C virus.’’
For Vertex, the challenge would be not only developing the superior product, but selling it to doctors, such as gastroenterologists and hepatologists, with a new sales force. Boger, a scientist, turned over the Vertex management reins to Emmens, an organizational specialist, specifically to build up the commercial side of the business.
“What we did here is we actually had the R&D people interview the people we brought in on the commercial side,’’ Emmens said. “That was one of my ideas, simply because I thought I didn’t want to have an adverse reaction . . . let’s put it that way.’’
If it succeeds, Vertex will become a more prominent player in the Boston area life sciences scene, especially following the recent acquisition of Genzyme Corp. — long the largest biotech in the state — by French drug giant Sanofi-Aventis SA.
“Nature will take its course,’’ Boger said. “As we become a larger company and we shift from a company that consumes capital to a company that creates capital, our footprint will grow.’’
Robert Weisman can be reached at weisman@globe.com.
Rearranging the Corporate DNA
On the verge of its first blockbuster drug, can Vertex transform itself into a money-making enterprise?
By Robert Weisman
Globe Staff / April 24, 2011
CAMBRIDGE — This week, a Food and Drug Administration advisory panel in Silver Spring, Md., is scheduled to make a recommendation critical to the future of Vertex Pharmaceuticals Inc. The advisers will rule on whether the FDA should approve the first drug developed solely by the biotechnology company in its 22 years of existence.
Approval for telaprevir — a drug aimed at curing hepatitis C — would hasten Vertex’s transition from a research and development company that invested some $4 billion in drug discovery over the past two decades to an integrated research and commercial organization. It also would become, for the first time, a company that consistently makes money.
“Vertex’s plan has always been to be a fully capable company, and that’s still the plan,’’ said Joshua Boger, who founded the biotech company in 1989 and retired two years ago. “This is the fulfillment of that aspiration.’’
In a warren of former industrial buildings in Cambridgeport that make up the Vertex corporate campus, the company’s transition is well underway. Chief executive Matthew Emmens, the biotechnology veteran tapped in 2009 to create a sales and marketing force, has hired more than 200 people for Vertex’s fledgling commercial team.
Overall, the company now has about 1,800 employees, 25 percent more than at the start of last year. That includes about 1,200 in the Boston area and 175 field representatives preparing to promote telaprevir — which will be given a more consumer-friendly brand name — if it wins final FDA approval in May.
Vertex is still hiring and currently has 150 job openings. In February, it unveiled plans to add 500 more employees and build a new headquarters in the Fan Pier waterfront development area in South Boston. That move, which includes $60 million in incentives from the state, is contingent on approval of telaprevir. Vertex also is moving forward with clinical trials of a drug to treat cystic fibrosis.
“It’s just a golden era right now for this company,’’ said Emmens, 59, former chief executive of British drug maker Shire PLC, who worked with Boger years ago at pharmaceutical giant Merck & Co. in New Jersey. “Some of the best researchers in the world are here, and we’re building a commercial presence. You’ve got millions of patients waiting for a drug that can save their life.’’
Vertex’s market value has climbed to $9.8 billion, second only to Weston-based Biogen Idec Inc. among Massachusetts biotechnology companies, largely on investor anticipation of its new drug that, if approved, would enter a market projected at $3.3 billion a year starting in 2012.
But it might not have that market to itself. The day before the FDA advisory committee takes up telaprevir on Thursday, it will consider a competing hepatitis C virus treatment from Merck. Both are protease inhibitors, a class of drugs that act to prevent viral infections. They target a US population that includes hundreds of thousands of patients treated unsuccessfully by current drugs and tens of thousands “warehoused’’ by doctors — patients infected with hepatitis C but not yet experiencing symptoms — until the Vertex and Merck drugs are available.
“We’re expecting it to be a very big market initially,’’ said biotechnology analyst Howard Liang, managing director at health care investment bank Leerink Swann in Boston, who projects the new hepatitis C treatments will generate $2.2 billion in revenue for Vertex and $1 billion for Merck in 2012, and even more the following year. “Both drugs are a very significant advance over existing therapies.’’
* Tweet
*
* Yahoo! Buzz ShareThis
Related
Photos
Joshua Boger, founder of Vertex.
A look at the history of
Vertex Pharmaceuticals
* On the long, hard road
to a breakthrough
* Can Vertex transform into
a money-making enterprise?
* Biotech ‘gunslingers’
aim for breakthroughs
* Now comes the hard part:
marketing an unknown
Hepatitis C is believed to kill about 10,000 people a year worldwide, many of whom develop cancer or scarring of the liver. But the virus can be carried for decades before patients become sick, and millions of people are thought to have the virus and not know it. The virus has become an epidemic among baby boomers infected decades ago through injecting drugs or blood transfusions. It may be carried by as many as 3 million people in the United States and 100 million worldwide.
Patients are currently treated with a combination of two drugs: pegylated interferon and ribaviran. Vertex’s telaprevir or Merck’s drug, known as boceprevir, would be added to that “cocktail,’’ boosting its potency and acting directly against the virus in a bid to cure many patients. The drugs are expected to be priced at between $35,000 and $40,000 per patient, Leerink Swann estimates, and taken in combination with the current drugs, they promise to shorten the duration of treatment for large numbers of patients.
Telaprevir, in particular, aims to cut the treatment time in half, from 12 to six months, for about 60 percent of patients with the most serious form of the virus, Leerink’s Liang said. “Our opinion is, telaprevir looks to be a more potent drug,’’ he said. “The cure rate is a little higher, and it’s more likely the duration of treatment will be reduced.’’
But Merck would have some advantages in marketing boceprevir, which it says it would sell under the name Victrelis. Among them, it is likely to market the drug together with its own brands of pegylated interferon and ribaviran, both already on the market. “We would take a franchise approach to this,’’ said Mark Timney, president of Merck’s US Human Health business. “We have a long history and deep scientific and commercial knowledge in treatment of the hepatitis C virus.’’
For Vertex, the challenge would be not only developing the superior product, but selling it to doctors, such as gastroenterologists and hepatologists, with a new sales force. Boger, a scientist, turned over the Vertex management reins to Emmens, an organizational specialist, specifically to build up the commercial side of the business.
“What we did here is we actually had the R&D people interview the people we brought in on the commercial side,’’ Emmens said. “That was one of my ideas, simply because I thought I didn’t want to have an adverse reaction . . . let’s put it that way.’’
If it succeeds, Vertex will become a more prominent player in the Boston area life sciences scene, especially following the recent acquisition of Genzyme Corp. — long the largest biotech in the state — by French drug giant Sanofi-Aventis SA.
“Nature will take its course,’’ Boger said. “As we become a larger company and we shift from a company that consumes capital to a company that creates capital, our footprint will grow.’’
Robert Weisman can be reached at weisman@globe.com.
Wednesday, April 6, 2011
Telaprevir, Boceprevir pricing in Europe....
Given the rather large sum of 22,000 euros or $31,271 to treat a patient with HCV in France (under the current expanded access conditions), some experts predict most European countries to restrict the drugs to patients who have failed previous therapy. With a short 2-3 year window of time, Both Vertex and Merck are anxious to recoup their costs and make a profit before the next generation of drugs hit the market. In an economic sense, this is as good a reason as any for commercial for-profit enterprises to charge a premium on their product, especially in an environment of limited competition. All this can lead one to speculate on how much the drugs will cost here in the States and, ultimately, who will have access.
Bloomberg. New hepatitis C drugs from Merck & Co. and Johnson & Johnson (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 Antonio 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 the European 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," Patrick 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 in Europe. 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 Howard 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 Charles 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@bloomberg.net; Carol Matlack in Paris at cmatlack@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net;
Bloomberg. New hepatitis C drugs from Merck & Co. and Johnson & Johnson (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 Antonio 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 the European 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," Patrick 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 in Europe. 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 Howard 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 Charles 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@bloomberg.net; Carol Matlack in Paris at cmatlack@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net;
Tuesday, March 1, 2011
From CROI: Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions
(Jules Levin of NATAP.org reports on a session at CROI looking at Boceprevir drug interactions. Fortunately, with the notable exception of Efavirenz, it looks like BOC is a pretty clean drug in terms of DDI's)
Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - see attached full slide report
Reported by Jules Levin
CROI – March 1, 2011
Boston, MA
C Kasserra, E Hughes, M Treitel,
S Gupta, and E O'Mara
AUTHOR CONCLUSIONS
•Radiolabeled data support a primarily hepatic-mediated clearance of BOC
•CYP3A4 probes
–Marked ↑ in midazolam exposure in the presence of BOC indicates that BOC is a strong, reversible inhibitor of CYP3A4
–↑ exposure to BOC with ketoconazole suggests involvement of another non–CYP3A4-mediated pathway
•Metabolic inhibitors (even in combination) did not alter BOC PK profile substantially to change BOC’s dose or schedule
–Diflunisal (AKR inhibitor) did not alter BOC exposure
–Ritonavir (CYP 3A4 inhibitor) did not substantively affect exposure to BOC
–Clarithromycin (CYP3A4, P-gp inhibitor) did not affect exposure to BOC
•No dosage adjustment is needed for the coadministration of BOC with tenofovir or peginterferon
•Clinical implications of a ↓ mean BOC trough concentration when coadministered with efavirenz will be clearer as data from coinfected populations are obtained
•Boceprevir did not affect the exposure to drospirenone/ ethinylestradiol in a manner that would be anticipated to reduce contraceptive efficacy
Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - see attached full slide report
Reported by Jules Levin
CROI – March 1, 2011
Boston, MA
C Kasserra, E Hughes, M Treitel,
S Gupta, and E O'Mara
AUTHOR CONCLUSIONS
•Radiolabeled data support a primarily hepatic-mediated clearance of BOC
•CYP3A4 probes
–Marked ↑ in midazolam exposure in the presence of BOC indicates that BOC is a strong, reversible inhibitor of CYP3A4
–↑ exposure to BOC with ketoconazole suggests involvement of another non–CYP3A4-mediated pathway
•Metabolic inhibitors (even in combination) did not alter BOC PK profile substantially to change BOC’s dose or schedule
–Diflunisal (AKR inhibitor) did not alter BOC exposure
–Ritonavir (CYP 3A4 inhibitor) did not substantively affect exposure to BOC
–Clarithromycin (CYP3A4, P-gp inhibitor) did not affect exposure to BOC
•No dosage adjustment is needed for the coadministration of BOC with tenofovir or peginterferon
•Clinical implications of a ↓ mean BOC trough concentration when coadministered with efavirenz will be clearer as data from coinfected populations are obtained
•Boceprevir did not affect the exposure to drospirenone/ ethinylestradiol in a manner that would be anticipated to reduce contraceptive efficacy
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