October 17th, 2004

Hepatitis C Virus Linked to Non-Hodgkin's Lymphoma
Source: American Association for Cancer Research

SEATTLE--Patients infected with the hepatitis C virus (HCV) are six times as likely to develop non-Hodgkin's lymphoma (NHL) than individuals that are virus free, according to research presented today at the Third Annual Frontiers in Cancer Prevention Research meeting.

HCV infected patients have a seventeen fold higher risk for developing diffuse large B-Cell lymphoma, researchers from British Columbia documented. Diffuse large B-cell lymphoma is the most common variety of NHL, comprising approximately 30 percent of all NHL patients.

Compared to Europe and Japan, incidence of hepatitis C viral infection is fairly low in North America, and previous studies from Canada and the United States have not shown an association between the virus and development of NHL, said Ms Agnes Lai, lead author for the research. The British Columbia study examined HCV status in 550 NHL cases and 205 population controls. The study had the strength of numbers of patients to ascertain an association between HCV and NHL, confirming the viral-cancer link suspected in studies from other areas of the world where the virus is more prevalent.

"People who have been exposed to the virus comprise a high risk group for developing non-Hodgkin's lymphoma, particularly diffuse b-cell lymphoma," said John Spinelli, a cancer researcher from the British Columbia Cancer Agency, Vancouver, BC, and principal investigator of the research study.

The spread of hepatitis C in the United States has dropped significantly since the 1980s. Currently, the number of new cases per year is around 25,000. Approximately 3.8 million Americans have been infected with the virus. The most common means of infection in the past was blood transfusion, and in recent years is among drug users who share needles.

Approximately 53,000 patients were diagnosed with NHL in the United States in 2003. There were 23,000 deaths from the disease that year.

Spinelli and Lai conducted their research with colleagues Randy Gascoyne, Joseph Connors, Pat Lee, Rozmin Janoo-Galani, and Richard Gallagher, BC Cancer Agency; Anton Andonov, Health Canada National Microbiology Laboratories, Winnipeg, Manitoba, and Darrel Cook, British Columbia Centre for Disease Control.

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Merrill Lynch initiated coverage of Valeant Pharmaceuticals (nyse: VRX - news - people ) with a "buy" rating and said the specialty pharmaceutical company has a "potential blockbuster" in its hepatitis C drug, Viramidine, currently in Phase III trials. "This drug could become the 'gold standard' treatment and generate more than $1 billion in annual sales," Merrill Lynch said. The research firm placed a $32 target price for the stock and said Phase II data indicates Viramidine has a similar efficacy to Ribavirin, which it calls "the current gold standard," but with lower rates of anemia. Ribavirin, originally developed by Schering Plough (nyse: SGP - news - people ), is currently marketed by Teva Pharmaceutical Industries (nasdaq: TEVA - news - people ). Merrill Lynch expects Valeant's Phase III trials to be completed by late 2006 and a mid-2007 launch. The firm projects 2004 and 2005 earnings-per-share estimates at 6 cents and 23 cents, respectively

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October 18th, 2004


Diabetes Hikes Risk for Liver, Pancreatic Cancers
SourceURL:http://www.medicalnews today.com

People with diabetes mellitus have three to four times the risk of developing liver cancer, and more than twice the risk of developing pancreatic cancer than non-diabetic individuals, according to research presented today at the Third Annual Frontiers in Cancer Prevention Research Meeting in Seattle.

Marie-Claude Rousseau, lead author on the study, compared 3,288 men diagnosed with 12 different cancer types to 509 healthy individuals, in order to determine whether those reporting a prior diagnosis of diabetes were more likely to have cancer.

"Among those who reported being diabetic, there was a three-fold increased risk for liver cancer," said Rousseau, a postdoctoral fellow in Epidemiology at the Université de Montreal, Montréal, Canada. "When we looked at the individuals who reported taking medication for their diabetes, the risk for liver cancer increased to almost four-fold, compared to individuals who were not diabetic." Rousseau noted that these findings were independent of the body mass index of the individuals.

In this study, diabetics did not have increased risks for other cancer types, including melanoma, non-Hodgkin's lymphoma, cancers of the esophagus, stomach, colon, rectum, lung, prostate, bladder, and kidney.

Rousseau, who is funded by the Canadian Cancer Society through the National Cancer Institute of Canada, conducted this research with her colleagues Jack Siemiatycki at the Université de Montréal, and Marie-Elise Parent, at the INRS-Institut Armand-Frappier, Laval, Quebec, Canada.

Contact: Warren Froelich
communications@aacr.org
206-219-4772
American Association for Cancer Research

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October 19th, 2004

Although hepatitis C has often been called the "silent epidemic" (since 75 percent of people who carry the virus don't know it), with at least 4 million people in the U.S. now infected, hep C is starting to make itself heard.

"It's clear it's a significant public health problem that hasn't received the attention it needs," said Georges Benjamin, executive director of the American Public Health Association. "When I was in medical school it wasn't even talked about. We called it 'non A or B hepatitis' and it was this gray area that wasn't thought to be a big deal. It turns out it's a very big deal."

Such a big deal that former U.S. Surgeon General C. Everett Koop calls hepatitis C "an even graver threat to our public health" than AIDS. Nearly four times as many Americans are infected with the hepatitis C virus (HCV) as with HIV. Each year, 8,000-10,000 Americans die from hep C-related disease.

Some people carry the virus throughout their lives and never experience symptoms. Others will develop serious, even fatal liver disease. According to figures from the Centers for Disease Control, out of every 100 people infected with HCV, up to 85 percent may develop chronic liver disease; and anywhere from five to 20 people may develop cirrhosis over one or two decades. Up to 5 percent of infected people will die.

Those who become ill can require costly treatment regimens and in some cases liver transplants, of which hep C is the leading cause. With a shortage of donor livers, many patients die before receiving a transplant (the American Liver Foundation says more than 18,000 people are currently awaiting a liver transplant). As if these concerns weren't enough, researchers at the University of British Columbia have just discovered a link between hepatitis C and cancer, with HCV-positive individuals six times more likely to develop non-Hodgkin's lymphoma.

Unlike other forms of hepatitis, there is no vaccine for hepatitis C.

'C' Is For Confusion
The virus that causes hepatitis C was only discovered in 1989, so awareness is still slowly growing. Doctors and health promoters are doing their best to break the silence around the epidemic, believing that increased testing and education about prevention and management are crucial to stemming its spread. Education is also vital for those who are infected, since the harmful effects of this slowly progressing disease can be greatly reduced if it is detected and treated early on.

So how do people get hep C? Only through direct contact with contaminated blood—" from syringes, unsterilized tattoo needles or contaminated inks, unsterilized manicure equipment, during accidents, and from blood transfusions prior to 1992. The virus cannot be spread through casual contact, and is only rarely transmitted through sexual contact.

Injection drug users—who, contrary to stereotypes, are a diverse group of people not confined to low-income communities—" are at particularly high risk of contracting the disease from shared needles. Healthcare workers and others who come into contact with blood in the course of their work are also at risk. And hep C is running rampant in prisons, with the rate of infection in some prisons estimated at more than 80 percent.

Like most communicable diseases, the spread of hepatitis C could be greatly reduced through public awareness-raising, testing and subsidized treatment. But public health professionals agree there is a serious lack of emphasis placed on hepatitis C by government and private bodies, including a lack of funding for its prevention, treatment and education.

While hep C is an equal opportunity virus, crossing class and race lines to affect a wide range of people, the CDC says the disease is more prevalent among low-income people and people of color, with African-Americans the hardest hit group, followed by Native Americans, Hispanics and whites.

Slowing the Progression
Drug treatment, most often using a combination of the drug interferon and ribavirin, can significantly slow the progression of the disease and in some cases actually cure it. However this regimen costs up to $30,000 year, so it isn't an option for many uninsured or underinsured people, and community health providers note that many low-income people who could benefit from the treatment are steered away from it or never even told it exists.

"It is not my experience, in nearly 10 years of HCV and needle exchange work, that interferon is easy to get," said Laura Jones, a health worker with the group Test Positive Aware Network in Chicago. "We work with pretty marginalized people, and it's expensive, no one really wants to spend that much money on many of the folk who come through our needle exchange even if it would be beneficial to them."

Uninsured or underinsured people are also far more likely than insured people to forego checkups and delay treatment until absolutely necessary. Therefore they often aren't even diagnosed until their disease is in the later stages. Interferon therapy is not considered advisable in patients with advanced cirrhosis (scarring of the liver).

"Someone who doesn't have insurance and doesn't go to the doctor for regular checkups is more likely to find out about the disease when it's too late to do anything," noted Georges Benjamin.

On the flip side, interferon treatment often has severe side effects—some patients say the cure is worse than the disease, and complain that doctors prescribed interferon therapy without disclosing how rough it would be.

The Herbal Route
After her husband Kevin was diagnosed with advanced liver disease resulting from hepatitis C infection 10 years ago and told he didn't have long to live, Patty Krueger devoted her life to spreading awareness of HCV. Her husband decided to forego drug treatment, having heard horror stories about interferon's side effects. After some lifestyle changes, including quitting drinking and taking a medically approved herbal regimen, his health greatly improved. (Since some herbs, such as mate tea and pennyroyal, are toxic to the liver, doctors recommend doing thorough research before taking herbs or other natural remedies.)

Krueger said she gets calls from many people who have had bad experiences with interferon and feel they weren't adequately warned of the risks and side effects.

"It can be really nasty for some patients," she said. "We encourage people to get a second opinion and get all the information they can."

Krueger said when they started trying to publicize the disease, they met resistance from both governmental agencies and the general public.

"[Potential funders] would tell us hepatitis C isn't 'hip' yet," she said. "And it's a hard thing to raise money for. We'll have bake sales and people shy away, they act like we're giving out free samples of it or something!"

"There's a terrible lack of funding for hep C education, prevention, testing and treatment," added Tracy Swan, the Coinfection Project Director at the Treatment Action Group in New York. "We don't even have the money for surveillance of chronic and acute cases."

Free needle exchanges are considered to be one of the most effective ways to prevent the spread of the disease. Yet there is a federal ban on funding these programs, and there is often political and community pressure against allowing them to locate in a given community, because of the stigma and the erroneous belief that they encourage drug use.

With the death toll from hepatitis C expected to triple in the next 10 to 20 years, the "silent epidemic" could become a major burden on the health care system. Fortunately, there is some hope on the horizon.

"I think the pharmaceutical industry has realized that hepatitis C is a very common problem, and they're now pouring the resources into it that they poured into HIV and AIDS some years ago," said Dr. Adrian Di Bisceglie, medical director of the American Liver Foundation. "I think it will be a few years before we see the first of those drugs, though."

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October 20th, 2004

Clinical Trial: Recombinant Factor Viia for Upper GI Bleeding in Patients with Cirrhosis - A Randomized, Double-Blind Trial
Source: www.gastrohep.com

Administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding, reports October's Gastroenterology in a recent clinical trial.

Upper gastrointestinal bleeding (UGIB) is a severe and frequent complication of cirrhosis.

Recombinant coagulation factor VIIa (rFVIIa) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB.

This trial aimed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB.

A total of 245 cirrhotic patients (Child-Pugh < 13; Child-Pugh A = 20%, B = 52%, C = 28%) with UGIB (variceal = 66%, nonvariceal = 29%, bleeding source unknown = 5%) were randomized equally to receive 8 doses of 100 μg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment.

The primary end point was a composite including:

(1) failure to control UGIB within 24 hours after first dose, or
(2) failure to prevent rebleeding between 24 hours and day 5, or
(3) death within 5 days.

Baseline characteristics were similar between rFVIIa and placebo groups. rFVIIa showed no advantage over standard treatment in the whole trial population.

No significant differences in mortality between rFVIIa and placebo groups—Gastroenterology

Exploratory analyses, however, showed that rFVIIa significantly decreased the number of failures on the composite end point (P = 0.03) and the 24-hour bleeding control end point (P = 0.01) in the subgroup of Child-Pugh B and C variceal bleeders.

There were no significant differences between rFVIIa and placebo groups in mortality (5- or 42-day) or incidence of adverse events including thromboembolic events.

Although no overall effect of rFVIIa was observed, exploratory analyses in Child-Pugh B and C cirrhotic patients indicated that administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding.

Dosing with rFVIIa appeared safe.

Further studies are needed to verify these findings.

Gastroenterology; 2004: 127: (4): 1123

AIDS activists issued a strong letter to the CEOs of seven major pharmaceutical companies demanding a price freeze in the United States for medications used to treat AIDS and hepatitis C. The letter, addressed to the CEOs of each company and signed by 200 AIDS service organizations, hospitals, faith-based groups, and HIV provider groups across the country, opens with a strong call to action: "the time has come for a drastic change in your company's drug pricing practices in the United States." The letter points to continuing company pricing practices that have resulted in mammoth profits, in the face of soaring health insurance premiums and decreased funding for lifesaving HIV/AIDS medications for people who cannot otherwise afford them.

New York,(PRWEB) October 20, 2004 - In a stunning move today, AIDS activists issued a strong letter to the CEOs of seven major pharmaceutical companies demanding a price freeze in the United States for medications used to treat AIDS and hepatitis C. The letter, addressed to the CEOs of each company and signed by 200 AIDS service organizations, hospitals, faith-based groups, and HIV provider groups across the country, opens with a strong call to action: "the time has come for a drastic change in your company's drug pricing practices in the United States." Citing price increases since 2003 that range from 4.8% to 400%, the AIDS Treatment Activists Coalition (ATAC) points to continuing company pricing practices that have resulted in mammoth profits, in the face of soaring health insurance premiums and decreased funding for lifesaving HIV/AIDS medications for people who cannot otherwise afford them.

"Why are newer, 'second-generation' drugs approved just 6 months ago increasing in price by 5% or more? Why should the price of a drug approved in 1996, which has netted millions in profits, suddenly increase by 400%?" asked Jen Curry, an ATAC member, who works on drug development and pricing policy. SAVE ADAP (the AIDS Drug Assistance Program) member and co-author of the letter, Lei Chou commented: "Companies charge obscenely high prices for medications in the US, and then they continue to increase their profit margin each year by taking 4% to 6% price increases, or in some cases 10% increases, on these drugs. These price increases are largely invisible, but have profound cumulative impact on programs like Medicaid and ADAP. This is an abuse of free enterprise and an inequity that unnecessarily burdens healthcare consumers."

HIV-treating physician Ben Young, who represents an organization of HIV healthcare providers, said "This is an important attempt to be proactive. The time has come for pharmaceutical companies to exercise corporate responsibility in their drug pricing policies." Signed by several investment corporations, as well as faith-based AIDS groups and ministries across the country, this letter represents a broad coalition effort on behalf of people living with HIV/AIDS, and the organizations, doctors, hospitals, and ministries that serve them.

This letter should not come as a surprise to these companies, noted Anne Donnelly, Director of Public Policy at Project Inform in San Francisco. "Several of them have negotiated price freezes in the past with groups like the Fair Pricing Coalition, but agreements have been temporary and limited to single payers. In the past two years, we've seen freezes expire and a decreased capacity for programs like Medicaid, ADAP, prisons, and other public payers to absorb the costs."

Indeed, the letter points out that when people with AIDS and hepatitis C cannot access the benefit of therapy, they eventually become sick with life-threatening illnesses, further burdening the public healthcare system. In the last couple of years, members of the HIV community across the US have died while on waiting lists to receive publicly funded medications.

Activists fear that the death toll will rise as the number of people unable to access lifesaving medication grows. They also say that growing numbers of uninsured individuals in the US and the soaring costs of health insurance are in part a result of the reckless pricing policies of pharmaceutical companies. The letter demands immediate price freezes on medications to treat AIDS and hepatitis C, a disease afflicting as many as a third of people living with AIDS. A notable exception to the demand is the clear request that two companies, Abbott and Roche, reduce the price of their respective drugs Norvir and Fuzeon, which activists say are so exorbitantly priced.

The AIDS Treatment Activists Coalition (www.atac-usa.org) is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS. The price freeze letter is currently available online at www.atac-usa.org/price.html#ceo.

Contact Information
Jen Curry
AIDS Treatment Activists Coalition (ATAC)
http://www.atac-usa.org
212-213-6376

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October 22nd , 2004


Schering-Plough Initiates Two Major Hepatitis C Studies with PegIntron(R) plus Rebetol(R) Combination Therapy in Difficult to Treat Patients SourceURL:http://www.newratings.com

- International Clinical Trials To Assess PegIntron in Patients with Unmet Medical Needs

Schering-Plough announced today that it is initiating two large international clinical trials to evaluate the use of PegIntron(R) (peginterferon alfa-2b) and Rebetol(R) (ribavirin) combination therapy in patients chronically infected with hepatitis C virus (HCV) genotype 1 who have specific unmet medical needs. The first study will involve patients identified as "slow" responders to HCV therapy; the second study will involve patients who were non-responders to previous treatment with Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) (Hoffmann-La Roche, Inc.) combination therapy. Currently, there are no approved products for treating these patient populations.

"We have made great advances over the past decade in the effective treatment of chronic hepatitis C, one of the most common blood borne infections in the world," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "Still, specific patient populations with difficult-to-treat forms of the disease remain resistant to therapy and need improved treatment options. Schering-Plough is undertaking these studies because it is critical to develop new strategies for improving treatment outcomes for these patients."

Of the six distinct known hepatitis C genotypes, HCV genotype 1 is the most common worldwide (about 70% of patients). It is considered the most difficult-to-treat strain of the virus and is associated with higher resistance to treatment (lower response rates) when compared with HCV genotypes 2 and 3.

Adjusting Treatment Duration for "Slow" Responders
Schering-Plough is sponsoring the SUCCESS trial: "A Study to Assess Treatment with PegIntron and Rebetol in Naive Patients with Genotype 1 Chronic Hepatitis C and Slow Virological Response," that will evaluate whether extending treatment to 72 weeks instead of the standard 48 weeks will improve efficacy in genotype 1 chronic hepatitis C patients who respond slowly to treatment. Slow responders are defined as those patients who still have detectable virus levels after 12 weeks of treatment (PCR positive), but do show a significant (2 log10) drop in viral load. Such patients may ultimately achieve undetectable virus levels (PCR negative) between weeks 12 and 24, and may benefit from a longer overall course of therapy (72 weeks) than the current recommended duration of 48 weeks.

This prospective, controlled, randomized, parallel-group multicenter study is expected to enroll 1,200 previously untreated patients with chronic hepatitis C at more than 100 sites in Europe, Eastern Europe, Israel and Canada. The study hypothesis is that patients who become HCV-RNA negative (achieve undetectable levels of the virus) between treatment weeks 12 and 24 (slow responders) may need a longer period with undetectable virus to successfully clear the virus and ultimately achieve a sustained virologic response (SVR). SVR is defined as having undetectable virus 24 weeks after completing therapy. In the study, patients who achieve a late response to therapy (as measured at week 24) will be randomized at the end of 48 weeks of therapy with 1:1 ratio to either stop treatment or extend the trial to 72 weeks.

"Success in treating patients with chronic hepatitis C depends on a number of factors, with genotype considered one of the most important predictors for achieving sustained virologic response," said Professor Maria Buti Ferret, M.D., co-lead investigator of the study with Professor Rafael Esteban Mur, M.D., both of Vall d'Hebron Hospital, Barcelona, Spain. "We know from previous clinical studies that patients with HCV genotype 2 or 3 can achieve SVR with shorter 24-week courses of treatment. Conversely, this study will help us to determine if a longer 72-week course of PegIntron and Rebetol benefits those patients with difficult-to-treat genotype 1 who are slow to respond."

PegIntron plus Rebetol in Non-Responders to Pegasys plus Ribavirin
In the ESPECIAL trial: "Efficacy and Safety of PegIntron plus Rebetol in Subjects with Chronic Hepatitis C Genotype 1 Non-Responder to Pegasys plus Ribavirin," patients infected with HCV genotype 1 who did not respond or relapsed following an initial course of treatment with Pegasys (180 mcg/wk) plus Copegus (1,000/1,200 mg/day) will be treated with weight-based PegIntron (1.5 mcg/kg/wk) plus Rebetol (800-1,400 mg/day) combination therapy for 48 weeks. This international multicenter clinical trial will involve 200 patients.

"The therapeutic goal of treatment for chronic hepatitis C is the eradication of the virus with a halt in the progression of the disease," said Professor Stefan Zeuzem, M.D., Saarland University, Homburg, Germany, and lead investigator of the study. "We need effective alternatives for the sizable number of patients who did not clear the virus with initial treatment. PegIntron and Pegasys are different drugs, with different pharmacokinetic and pharmacodynamic properties. Patients who did not respond or relapsed to Pegasys plus Copegus may respond to PegIntron plus Rebetol," he said.

The primary endpoint of the study will be the proportion of patients who have achieved sustained virological response (SVR) at 24 weeks after the end of treatment. Secondary endpoints of the study include early virological response (EVR), defined as undetectable virus levels (PCR negative) at week 12 of treatment; the response rate at the end of 48 weeks of treatment (EOT); and sustained virological response (SVR) rates based on subject weight, viral load, presence of cirrhosis, insulin resistance status and creatinine clearance status.

The SUCCESS and ESPECIAL trials are consistent with Schering-Plough's research strategy to conduct and support clinical studies with weight-based PegIntron and Rebetol combination therapy in hepatitis patients with unmet medical needs, particularly for better efficacy in patients with difficult-to-treat forms of the disease such as HCV genotype 1, the most common genotype worldwide.

About PegIntron and Rebetol Combination Therapy
PegIntron and Rebetol combination therapy for chronic hepatitis C was approved in the European Union (EU) in March 2001, and is indicated in naive patients as well as in patients who have previously responded to interferon alpha monotherapy but who have subsequently relapsed. PegIntron is indicated in the EU as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C. The recommended dose in the EU for combination therapy is PegIntron 1.5 mcg/kg once weekly plus Rebetol 800-1,200 mg daily, adjusted to body weight.

PegIntron, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to patient body weight that is designed to achieve an effective balance between antiviral activity and elimination half-life. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity.

Chronic hepatitis C is estimated to affect more than 10 million people in major world markets. In Europe, chronic hepatitis C is a leading cause of chronic liver disease and one of the most common reasons for liver transplant.

Schering-Plough Europe, based in Brussels, Belgium, is part of Schering-Plough Corporation (NYSE: SGP) of Kenilworth, N.J., USA.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com.

Note to Editors:
PegIntron and Rebetol are licensed to Aesca in Austria, Essex Pharma in Germany and Essex Chemie in Switzerland.

Web site: http://www.schering-plough.com

Schering-Plough
Media - Robert J. Consalvo, +1-908-298-7409,
Investors - Alex Kelly, +1-908-298-7450, Janet M. Barth, +1-908-298-7417.

NOTE TO EDITORS:
Schering-Plough press releases are available on the company's Web site at http://www.schering-plough.com. Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswirecom/comp
/777050.html

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Schering-Plough Announces PEG-INTRON(R) Approved in Japan for Use in Combination With REBETOL(R) for Chronic Hepatitis C
Source: prnewswire

First and Only Peginterferon Combination Therapy Approved in Japan—More Than 1 Million Japanese Infected With Hepatitis C Virus

KENILWORTH, N.J., Oct. 22 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's subsidiary in Japan, has received marketing approval for PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL(R) (ribavirin) Capsules for the treatment of chronic hepatitis C. PEG-INTRON and REBETOL combination therapy is the first and only pegylated interferon-based combination therapy approved in Japan. An estimated 1 to 2 million Japanese are chronically infected with hepatitis C.

The approval by the Ministry of Health, Labor and Welfare (MHLW) follows a priority review. PEG-INTRON will become available in Japan upon National Health Insurance Reimbursement price listing.

"The introduction of PEG-INTRON and REBETOL combination therapy represents a significant development in the treatment of hard-to-treat chronic hepatitis C, a major public health problem in Japan," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "This approval, and the supporting clinical data, further underscore the value of individualized, weight-based PEG-INTRON used in combination with REBETOL in treating chronic hepatitis C."

PEG-INTRON, which is administered once weekly in combination with REBETOL daily for 48 weeks, is indicated in patients chronically infected with hepatitis C virus (HCV) genotype 1 (genotype 1a or 1b) and high viral load. HCV genotype 1 is considered the most difficult-to-treat form of hepatitis C and is the most common form in Japan, accounting for approximately 60 percent of all HCV infections there.

Importantly, PEG-INTRON is the only peginterferon product approved in Japan for which a blood test is not required before every injection.

In the Japanese clinical study supporting the approval, 48 weeks of PEG-INTRON and REBETOL combination therapy achieved a sustained virologic response (SVR)(1) rate of 48% in patients with HCV genotype 1 and high viral loads. An SVR rate of 63 percent was achieved with PEG-INTRON and REBETOL in the portion of these patients who had relapsed following previous interferon treatment.

Hepatitis C is the leading cause in Japan of chronic liver disease, cirrhosis, and hepatocellular carcinoma, which is associated with more than 30,000 deaths there annually. Hepatitis C is the most common reason for liver transplant in major world markets, including Japan, according to the World Health Organization (WHO).

SOURCE Schering-Plough Corporation
Web Site: http://www.schering-plough.com

Company News On Call: Company News On-Call: http://www.prnewswire.com/comp
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