Protease inhibitors. Hepatitis C viruses use an essential enzyme called protease (pro-tee-aze) during their replication process. Certain drugs can interfere with this enzyme which stops the virus' ability to copy itself.
Telaprevir Clinical Development Plan
To date, more than 2,500 people with hepatitis C have received telaprevir-based regimens as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together, these studies enrolled people with genotype 1 hepatitis C who had not been treated for their disease previously as well as people who had been treated before but did not achieve a sustained viral response, or viral cure. The telaprevir clinical development program is the largest conducted to date for any investigational direct-acting antiviral hepatitis C therapy. Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration in the fourth quarter of 2010.
Vertex reveals that one of its drugs proved effective for hepatitis C patients who did not benefit from any other treatment.
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Telaprevir, the company’s experimental drug, helped 65 percent of hepatitis C patients whose prior therapies were unsuccessful.
This was the last of 3 major phases of telaprevir conducted by Vertex and partner Johnson & Johnson(JNJ), previous ones released in May and August this year.
“This last phase III study, dubbed "Realize," was set up to confirm previous, earlier findings that showed telaprevir could cure a significant number of hepatitis C patients without treatment options because they failed to respond to the current standard of care”, the officials revealed.
Details of the trial looked at 662 hepatitis C patients whose bodies seemed to be resistant to all other treatments.
The participants were divided in 3 groups
The total treatment period was extended to 48 weeks from the regular 24 weeks as these patients have a form of the hepatitis C virus that is more stubborn or harder to treat.
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Dividing the results into the different groups, 86 percent of re-lapsers were cured after telaprevir treatment compared to 24 percent in the control arm.
Among the second group, the cure rate for the telaprevir-treated patients was 57 percent compared to 15 percent for the control arm.
Finally, in the last group which consisted of the most difficult to treat patients, telaprevir achieved a 31 percent cure rate compared to 5 percent for the control arm.
Results across all three patients types were statistically significant in favor of telaprevir over standard of care, officials report.
REALIZE
The Cambridge, MA-based biotech company, which has significant operations in San Diego, is announcing today that a combination of standard treatment and its novel drug for hepatitis C was able to cure two-thirds of patients who had failed to respond to a prior round of the standard drugs alone.
That response rate for patients on Vertex's telaprevir (65%) far exceeded that of the comparison group, in which just 17% of patients were cured after getting the usual combination of pegylated interferon alpha and ribavirin. Vertex is making the announcement today, based on findings from more than 660 patients who enrolled in a study called "Realize."
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"The Realize data represent a major milestone in the development of new treatments for hepatitis C," Stefan Zeuzem, a professor of medicine at the JW Goethe University Hospital in Frankfurt, Germany and principal investigator of the trial, said in a Vertex statement. "These results may provide hope to people who have not been cured and who are in need of new treatment options."
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This is the third major batch of study results from Vertex this year, and part of its quest to shake up the standard of care for patients with hepatitis C, a chronic liver disease. The company showed back in May, in a study of more than 1,000 patients, that about three-fourths of people getting their first round of treatment were considered cured after getting telaprevir in combination with the standard meds.
A second study, released last month, showed that the drug could cut the treatment time in half, which is important because it means patients don't have to endure the flu-like symptoms caused by the other drugs in the regimen for nearly as long. And today's announcement reinforces findings from small trials that say the telaprevir-based regimen has far greater ability to kill the virus in the toughest patients to treat.
recap from The Street.com
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The Phase 3 ILLUMINATE Study
"The viral cure rates seen in ILLUMINATE showed that there was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people
From HIV and Hepatitis.com
Data ILLUMINATE
Vertex Press Release :Phase 3 ILLUMINATE Study Supports 24-Week Telaprevir-Based Therapy Within a Response-Guided Regimen for People with Hepatitis C Who Had Not Received Prior Treatment
Vertex Pharmaceuticals Incorporated today announced results from the Phase 3 ILLUMINATE study, which was designed to evaluate whether there was any benefit to extending therapy from 24 to 48 weeks in people whose hepatitis C virus (HCV) was undetectable at weeks 4 and 12 of treatment (extended rapid viral response or eRVR).
Rapid Viral Response (RVR)
People in the trial who met these eRVR criteria and who remained on treatment were then randomized at week 20 to receive 24 or 48 weeks of total treatment.
People who did not meet these criteria were assigned to 48 weeks of pegylated-interferon and ribavirin therapy.
.Sustained viral response (SVR or viral cure) rates of 92% and 88% were observed in the randomized 24 and 48-week telaprevir-based treatment groups, respectively. 72% of all 540 people treated with telaprevir in the study achieved a viral cure. The safety and tolerability profile of the telaprevir-based regimen was consistent with results reported previously from the pivotal Phase 3 ADVANCE study.
;"The viral cure rates seen in ILLUMINATE showed that there was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people," said Kenneth Sherman, M.D., Ph.D., Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and Principal Investigator of the trial. "Patients who had a rapid response to telaprevir-based regimens at weeks 4 and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy."
;"Data from ILLUMINATE and ADVANCE support our belief that the use of 24-week telaprevir-based therapy within a response-guided regimen may provide an important future treatment option for people with hepatitis C," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex.
mTelaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Results from the ILLUMINATE study are expected to supplement data obtained from ADVANCE and REALIZE - the two pivotal Phase 3 studies of telaprevir - as part of a New Drug Application submission to the U.S. Food and Drug Administration planned for the fourth quarter of 2010.
The Race Is On For Hepatitis C Treatment
On Friday August 13, 2010, 6:57 pm EDT
How's this for a biopharmaceutical market opportunity? Prospective patients in need: 170 million. That's 3% of the world's population.
The disease is hepatitis C, a contagious, slow-developing, blood-borne disease that can make 80% of those infected vulnerable to severe liver problems, including cirrhosis and cancer.
Hepatitis C wasn't even identified until 1987. A blood test for it became available in 1992.
Now a score of companies are racing to bring new treatments on stream. Out front are Merck (NYSE:MRK - News) with boceprevir, and a partnership of Vertex Pharmaceuticals (NMS:VRTX) and Johnson & Johnson (NYSE:JNJ - News) with telaprevir.
The market will be pretty much evenly split between the two, says Damien Conover, a strategist and senior pharmaceutical analyst at rating firm Morningstar. Telaprevir may have a slight edge, he says.
Both drugs are protease inhibitors, which prevent a virus from replicating itself. While they treat the same disease, they are different in both results and side effects.
Used on patients who have had no previous treatment, boceprevir and telaprevir beat down the hepatitis C virus to undetectable levels in 66% and 75% of patients respectively, Conover says.
Both drugs are likely to go to the Food and Drug Administration for a verdict by the end of the year. That means both could reach the market next year.
"Right now it's hard to tell who's in the lead," Conover said.
Meanwhile, Merck and Vertex-J&J appear to be competing for headlines.
A week ago, the British-based Lancet medical journal carried a Merck-funded study showing that boceprevir brought the virus down to undetectable levels in 66% of patients over 48 weeks of treatment in combination with drugs in use now.
The next day, Aug. 10, Vertex reported study results showing that some patients did so well after a 24-week course of telaprevir (plus the current drugs in use) that they got no added benefit from a 48-week course of treatment. The message: Telaprevir does the job in half the time.
Merck acquired boceprevir with its $41 billion purchase of Schering-Plough in 2009. Vertex developed telaprevir with money from J&J in return for marketing rights.
Whether one or both of the drugs get FDA approval, the hepatitis market is about to undergo a "major paradigm shift," said Steven Silver, an analyst at Standard & Poor's.
"We've gone many years without a new drug on the landscape," he said.
It's hard to know which drug will do better in real life and in the market because they have not been tested head-to-head.
That's a long-standing problem in the drug-development industry. Prospective new products are tested either against a placebo (sugar pills) or, as in the cases of boceprevir and telaprevir, against the current standard of care.
For hepatitis C, that standard is a combination of interferon and ribavirin. It's a hit-or-miss treatment.
In simple terms, ribavirin is an antiviral medication that stops the virus that causes hepatitis C from spreading. Interferon prevents viral replication in surrounding cells.
According to the National Center for Biotechnology Information, it's not known if treatment with ribavirin and interferon actually cures hepatitis C infection, prevents liver damage caused by hepatitis C or keeps hepatitis C from spreading to other people. The standard hepatitis C treatment results in a reduction of the virus to undetectable levels in fewer than half of cases, according to WebMD (NMS:WBMD). Boceprevir and telaprevir are protease inhibitors. In brief, they attack the hepatitis C virus itself, WebMD says.
Without head-to-head tests, with the same dosing regimen and with the same kind of patient population, it's hard for investors to figure out whether boceprevir or telaprevir will be the greater success, assuming both get FDA approval, Conover says.
But head-to-head studies "are often not in the best interest of the company," he said.
They can show one drug so superior as to make the other unmarketable. "Head-to-head studies can backfire," Conover said.
According to Silver, the investment community "is trying to ballpark the information released to date."
He sees Vertex prevailing with telaprevir: "It's poised to be the market leader."
Data collected on real world use of these drugs are still some years off.
The market will be watching boceprevir and telaprevir for the next three or four years, Silver says.
An important factor will be the success rate of the drugs on people who have previously failed to respond to the standard of care.
That's not how clinical trials are run. They are usually conducted with patients who have not had therapy, the so-called treatment-naive. Using treatment-naive patients creates a baseline but does not approximate real-life conditions.
Most people with a disease have tried one or more drugs, ratcheting up from least to most powerful and expensive.
Another real-life issue will be the side effects. Newly diagnosed patients may find the side effects of either drug, plus interferon and ribavirin, intolerable.
The most common telaprevir side effect is a rash, Stevens says.
Boceprevir's predominant side effect is anemia. That raises the prospect that another drug will need to be added to the regimen, perhaps Epogen, the anemia-fighting biologic from Amgen (NMS:AMGN).
It's available as a generic in Europe, but remains branded in the U.S.
Another reason to think telaprevir has the inside track is the likelihood that it will require a shorter period of treatment, Silver says.
"At the end of the day, this race will be data-driven," he said.
While there's been no head-to-head trial, the existing data should become available for close comparison at a meeting of the American Association for the Study of Liver Diseases in Boston starting Oct. 28.
By most counts, the global market for hepatitis C products is now $4 billion a year. According to a report from the commercial analysis firm Research & Markets, that should rise to $8.5 billion by 2016.
The reasons for the growth: the increasing number of cases and the new drugs in the pipeline that will make treatment more accessible and tolerable.
http://finance.yahoo.com/news/The-Race-Is-On-For-Hepatitis-ibd-1385572000.html?x=0&.v=1
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