December 22, 2011

Dec. 16, 2011, 8:00 a.m. EST

NEWTON, Mass., Dec 16, 2011 (BUSINESS WIRE) -- Galectin Therapeutics Inc., the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin proteins, today announced that it presented a poster at the European Association for the Study of the Liver (EASL) Special Conference on Liver Transplantation in Lisbon, Portugal. The data show that galectin inhibitor candidate GR-MD-02 reversed fibrosis in mouse models of steatohepatitis and prevented collagen deposits in groups treated before fibrotic cells were present. The data suggest that patients with non-alcoholic steatohepatitis (NASH), also referred to as fatty liver disease, may benefit from galectin inhibition and that GR-MD-02 could drive in a reduction of steatosis, necrosis, inflammation and collagen deposits. Currently, liver transplantation is the only option for patients afflicted with liver fibrosis or cirrhosis, and many times the condition recurs in the patient's new liver, creating the need for a safer and more efficacious treatment. The data presented provide promising evidence for advancing GR-MD-02 into clinical studies for the treatment of NASH.

"Galectin Therapeutics has previously demonstrated the robust ability of our galectin inhibitor compounds to arrest and reverse liver fibrosis in preclinical studies," said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. "We have now expanded that data to include promising results in preclinical models of NASH, offering hope that a new treatment option could be on the horizon and expanding the potential indications for Galectin Therapeutics to pursue in the clinic. The broad effect of GR-MD-02 on all parameters of NASH liver injury, including fat deposition, liver cell death, inflammation, and fibrosis makes this a particularly attractive drug candidate."

The data presented at EASL Special Conference highlight two carbohydrate-based galectin inhibitors, GM-CT-01 and GR-MD-02, in preclinical mouse models of steatohepatitis. Mice are injected with streptozotocin to induce diabetes and then fed a high fat diet. Subsequently, these mice develop fatty liver (steatosis), liver cell death, inflammation between 5 weeks of age, and then, fibrosis by 9 weeks of age. To assess the ability of galectin inhibitors to prevent or reduce fibrosis, mice were separated into early or late treatment groups. Early treatment groups began receiving either GM-CT-01 or GR-MD-02 twice daily at 6 weeks of age, or before fibrosis is evident, until 9 weeks of age. Late treatment groups received either GM-CT-01 or GR-MD-02 twice daily at 9 weeks of age, or when fibrosis is established, until 12 weeks of age. GR-MD-02 demonstrated greater improvements in steatosis, hepatocellular degeneration and inflammation. In the early treatment group, GR-MD-02 prevented the development of collagen deposition, or fibrosis, and was able to completely reverse fibrosis in the late treatment group back to levels of normal mice. GM-CT-01 did show a moderate effect on reducing collagen deposition. Importantly, GR-MD-02 was able to reverse steatohepatitis and fibrosis without having an effect on the diabetic condition of the mice. To view the complete poster presentation, please go to the Galectin Therapeutics' web site at www.galectintherapeutics.com .

About NASH

NASH is a common disease of the liver, affecting 9 to 15 million people in the United States and is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with NASH can develop fibrosis, or scarring of the liver, that can lead to cirrhosis, a severe liver disease where transplantation is the only current treatment available. Galectin Therapeutics is developing drug candidates as an alternative to transplantation and lead candidates have reversed fibrosis in preclinical disease models.

About Galectin Therapeutics

Galectin Therapeutics is developing promising carbohydrate-based therapies for fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com .

Forward Looking Statements

This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

SOURCE: Galectin Therapeutics

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December 16, 2011

Chronic hepatitis B virus (HBV) infection almost doubles the risk of AIDS or death in people diagnosed with HIV infection, compared with those only living with HIV, according to a new paper published ahead of print in The Journal of Infectious Diseases (JID). These important findings, the authors write, “may have implications for many aspects of HBV coinfection, including early diagnosis and, foremost, prevention of hepatitis B.”

Much like in people coinfected with HIV and hepatitis C virus (HCV), there is no shortage of evidence suggesting that HIV infection negatively affects HBV-related liver disease progression, including increased risks of end-stage liver disease and liver cancer. And while it is generally believed that chronic HCV infection doesn’t directly affect HIV disease progression—thought it can mean complex drug interactions between hepatitis C and HIV meds and hasten liver toxicity while using ARVs—it hasn’t been clear whether chronic HBV infection is an independent risk factor for HIV disease progression or death.

Unfortunately, the JID study results authored by Helen Chun, MD, of the National Naval Medical Center in Bethesda and her colleagues confirm earlier suggestions that HBV does negatively impact HIV outcomes.

The results come from the U.S. Military HIV Natural History Study, which has the advantage of including people who test positive for HIV while receiving care through a variety of Army- and Navy-based medical facilities throughout the country. This allowed Chun and her colleagues to focus specifically on 2,352 individuals whose date of HIV infection could be estimated within three years—thereby allowing the researchers to circumvent a common problem in disease progression studies, notably accounting for significant variations in patient duration of HIV infection—and whose HBV infection status was known or determined with two years of becoming infected with HIV.

Each patient’s HBV status was classified as being chronic (active infection), resolved (earlier infection followed by clearance and immunity), or no evidence of past or current infection.

Of the 2,352 recent HIV seroconverters in the study, 20 percent had resolved HBV infection and 3 percent had chronic HBV infection. Roughly 74 percent had no evidence of HBV infection. An additional 3 percent tested positive for hepatitis B “core” antibodies (HBcAb) alone, in the absence of other antibodies, which comes with a number of possible interpretations and generally requires more extensive testing.

HIV-positive study subjects classified as having chronic HBV were twice as likely to die or develop an AIDS-defining illness, compared with those who were HBV negative. Even participants with resolved HBV infection or isolated HBcAb faced elevated risks of HIV disease progression or death, compared with HBV-negative individuals. Among those with resolved HBV infection, the relative risk was increased 35 percent. Among those with isolated HBcAb, the relative risk was increased 54 percent.

When Chun and her colleagues adjusted the data for confounding factors—for example, the date of HIV infection, given that nearly half of those included in the study were infected with HIV before 1996 when AIDS-related illnesses and death were much more common—the relative risk of developing an AIDS-related illness or dying among those with chronic HIV/HBV coinfection was still 80 percent higher compared with HIV-positive, HBV-negative individuals in the study. Increases in the relative risks of AIDS-related illness or death were also documented in those with resolved HBV infection and isolated HBcAB in the adjusted analysis, but these increases were not statistically significant; they could have been due to chance.

Of note, HCV infection was also associated with an increased risk of developing an AIDS-related illness or death in the study. However, resolved or chronic HCV infection was uncommon in the cohort—only 1.7 percent were positive for HCV antibodies—and, thus, no firm conclusions could be drawn from this finding.

The reasons for the higher risks of AIDS-related illnesses and deaths were not apparent to Chun’s team. Chronic HBV infection did not appear to increase average viral load levels, in the absence of ARV treatment, nor did it appear to be associated with lower CD4 cell counts. In turn, the authors note, it is still necessary to determine “whether hepatitis B is a surrogate of poorer outcome or whether it has a direct harmful impact on HIV disease progression.”

While key questions remain, there are important lessons to be learned from this study, according to an accompanying editorial written by Philip Peters, MD, and Barbara Marston, MD, of the U.S. Centers for Disease Control and Prevention. “The analysis of [Chun’s group] moves us further toward an understanding of the increased mortality among persons with HIV/HBV coinfection. Although we remain with questions about whether HIV disease is indeed progressing more rapidly in these patients, there is no need to wait for answers before we amplify our response.”
Examples listed by Peters and Marston include stepped-up HBV vaccination efforts and the careful use of medications active against both HIV and HBV—such as Epivir (lamivudine), Emtriva (emtricitabine), Viread (tenofovir) or Truvada (tenofovir/emtricitabine)—in ARV drug regimens.

“There are undeniable barriers to achieving high rates of HBV vaccination and optimal treatment of HIV/HBV coinfection, both in the United States and internationally,” the CDC commentators note. “However, effective interventions exist and can be integrated into public health practice and clinical care.”

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Research could solve donor liver shortage

16/12/2011 03:49:00

Research from Curtin University could see bio-engineered liver tissue used instead of donor tissue for liver transplants.

The research aims to address the increasing burden of liver disease and shortage of donor organs occurring in all Western countries.

Dr Nina Tirnitz-Parker, research fellow at Curtin’s School of Biomedical Sciences, has spent the past eight years developing a method of bio-engineering liver cells, or hepatocytes, to replace tissue lost to disease or injury.

“More and more people die while on the waiting list for donor livers,” Dr Tirnitz-Parker said.

“So there’s an urgent need to develop new treatments for liver diseases and avoid the need of a liver transplant.”

Her research is based on the liver’s ability to restore itself with stem cell-like liver progenitor cells (LPCs) in chronic liver injury conditions such as alcoholic liver disease or hepatitis C virus infection.

LPCs contribute to liver regeneration by moving to injury sites where there is a loss of functional liver mass, and then differentiating into required hepatocytes and bile duct cells.

However, there are good and bad aspects to LPCs.

“LPCs interact with cells that drive scarring of the liver, which is known as liver fibrosis,” Dr Tirnitz-Parker said.

“We need to understand how we make these cells secrete the right signals that prevent fibrosis from occurring, which may in turn stop the onset of liver cirrhosis and liver cancer.”

Dr Tirnitz-Parker’s ongoing investigations include the role of LPCs in hepatitis C patients after liver transplantation, and the relationship of LPCs to cancer stem cells.

“Our research aims are twofold. Firstly, we want to develop a safe method of liver tissue engineering using LPCs and secondly, we would like to understand the role of LPCs in the carcinogenic pathway, including how to regulate their growth and prevent tumours developing,” Dr Tirnitz-Parker said.

Dr Tirnitz-Parker is working closely with Professor John Olynyk, a renowned clinical gastroenterologist at Fremantle Hospital and deputy director of the Western Australian Institute for Medical Research (WAIMR), and Professor George Yeoh, Head of WAIMR’s laboratory for Liver Disease and Carcinogenesis.

The research into the therapeutic potential of LPCs is progressing from the WAIMR team’s discovery that a protein known as TWEAK stimulates the growth of LPCs.

In addition to Professor Olynyk, who is also an Adjunct Professor within the Curtin Health Innovation Research Institute (CHIRI), the research collaboration includes researchers from the University of Western Australia, the Queensland Institute of Medical Research, the University of Sydney and Loma Linda University, in California.

As part of this work Dr Tirnitz-Parker, Professor Olynyk and Associate Professor Grant Ramm from the Queensland Institute for Medical Research were also recently awarded $600,000 in nationally competitive research funding from the National Health and Medical Research Council Australia to investigate “The Role Of Hepatic Stellate Cell And Liver Progenitor Cell Interactions In The Regulation Of Wound Healing And Liver Regeneration

Contact:

Dr Nina Tirnitz-Parker, Research Fellow, School of Biomedical Sciences, Curtin University

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Spike Seen in Transplants for Fatty Liver Disease

By Charles Bankhead, Staff Writer, MedPage Today
Published: December 20, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

The frequency of liver transplantation for nonalcoholic steatohepatitis (NASH) increased six-fold over the past 15 years and recipients live longer compared with other liver transplant patients, a review of a national database showed.

Consistent with the obesity epidemic, the proportion of liver transplants involving patients with nonalcoholic steatohepatitis (NASH) increased from 1.2% from 1997 to 2003 to 7.4% in 2010, making NASH the fourth most common reason for liver transplantation.

Post-transplant survival of NASH patients proved superior to that of all but four other types of recipients: primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, and hepatitis B infection (HBV), according to an article published online in Liver Transplantation.

The authors pointed to a reduced mortality from graft failure as a possible explanation for the improved survival of NASH patients after liver transplantation.

"Only 8.6% of deaths in patients with NASH were caused by graft failure compared with 16.6% of deaths in patients without NASH," wrote Anita Afzali, MD, of the University of Washington in Seattle, and co-authors. "This is likely due to lower rates of recurrence of NASH and cirrhosis in transplanted livers as compared to recurrence of other diseases such as hepatitis C and hepatitis B."

Detailed screening of transplantation candidates for cardiovascular disease might have excluded more high-risk patients with NASH, they added.

Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the U.S., affecting almost 30% of the population. In 15% to 20% of cases, NAFLD progresses to NASH, according to the authors.

Central obesity and insulin resistance are the most common factors in NAFLD and NASH. Given the growing prevalence of obesity, as many as 25 million Americans could have NASH, which can progress to cirrhosis, hepatocellular carcinoma, and liver failure.

Some authorities have predicted that NASH will become the leading indication for liver transplantation within 10 to 20 years, surpassing the current leader, hepatitis C virus (HCV) infection.

Patients with NAFLD/NASH have an increased risk of cardiovascular morbidity and mortality because of associated risk factors. The heightened cardiovascular risk could adversely affect post-transplantation survival. However, NASH patients might also have improved survival because of a reduced risk of disease recurrence, the authors continued.

No studies have examined recent national trends in liver transplantation for NASH-related reasons. To address the gap in data, Afzali and colleagues analyzed data from the United Network for Organ Sharing (UNOS).

The investigators sought out all adults who had first-time cadaveric liver transplantations in the U.S. from 1997 to 2010. The analysis yielded 53,738 patients, of whom 1,810 had NASH as the indication for transplantation.

During 1997 to 2003, NASH accounted for 1.2% of all liver transplantations. Thereafter, the proportion of transplantations involving NASH increased until NASH represented the fourth most common reason, trailing only hepatocellular carcinoma (HCC), HCV, and alcohol-related liver disease.

From 2008 to 2010, the proportion of liver transplantations involving patients with NASH exceeded those involving patients with cryptogenic cirrhosis. The proportion of liver transplants performed for NASH was 7.4% in 2010.

The proportion of transplantations for NASH and cryptogenic cirrhosis combined increased steadily after 2003, suggesting the increase in NASH-related indications was not a reflection of "diagnostic transfer," the authors noted.

Patients with NASH or cryptogenic cirrhosis tended to be older, white, female, obese, and diabetic, as compared with transplant recipients with other types of liver disease. Other clinical and laboratory characteristics were similar for patients with and without NASH or cryptogenic cirrhosis, as were donor characteristics.

As compared with liver recipients with other types of liver disease, those with NASH or cryptogenic cirrhosis did not have an increased mortality (HR 0.94 for NASH, HR 0.97 for cryptogenic cirrhosis). Nor did they have increased risk of graft failure (HR 0.89 for NASH and HR 0.95 for cryptogenic cirrhosis).

Adjustment for donor characteristics alone had little impact on survival or graft failure. Adjustment for donor and recipient characteristics resulted in significantly reduced risks of death and graft failure among patients with NASH and cryptogenic cirrhosis:

  • NASH death: adjusted HR 0.75, 95% CI 0.66 to 0.85
  • NASH graft failure: adjusted HR 0.76, 95% CI 0.68 to 0.85
  • Cryptogenic cirrhosis death: adjusted HR 0.86, 95% CI 0.80 to 0.93
  • Cryptogenic cirrhosis graft failure: adjusted HR 0.90, 95% CI 0.84 to 0.96

The results did not change significantly in a separate analysis of the years 2004 to 2010.

Patients with NASH or cryptogenic cirrhosis had a one-year survival of 87.6%, three-year survival of 82.2%, and five-year survival of 76.7%. The survival was superior to that of patients with HCC, HCV, alcoholic liver disease, acute hepatic necrosis, hemochromatosis, and cryptogenic liver disease.

"Our study demonstrates that post-transplantation survival in patients with NASH is excellent and comparable to patients with all other liver diseases combined," the authors wrote in conclusion. "Post-transplantation survival in patients with NASH is, in fact, superior to the post-transplantation survival of patients with other common indications for transplantation."

A study limitation was that the diagnosis of liver disease in the UNOS database was based on reporting by the transplantation center so the accuracy of the data could not be confirmed. Also, reported causes of death may have been inaccurate.

"Our study suggests that patients with NASH-related cirrhosis should continue to be considered as potentially good candidates for liver transplantation and will likely account for an increasingly prominent proportion of liver transplantations in the United States," they added.

The authors had no relevant disclosures.

Primary source: Liver Transplantation
Source reference:
Afzali A, et al "Excellent posttransplantation survival in patients with nonalcoholic steatohepatitis in the United States" Liver Transpl 2011.

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You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On December 20, 2011, the Food and Drug Administration approved changes to the Intron A (Interferon alfa-2b) product labeling to more accurately reflect recommendations for initiating and monitoring alpha interferon treatment in patients with histories of psychiatric and substance use disorders.

Specifically the following changes were made:

WARNING AND PRECAUTION

Neuropsychiatric Disorders
DEPRESSION AND SUICIDAL BEHAVIOR INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HOMICIDAL IDEATION, AND AGGRESSIVE BEHAVIOR SOMETIMES DIRECTED TOWARDS OTHERS, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALPHA INTERFERONS, INCLUDING INTRON A THERAPY. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period.

INTRON A should be used with caution in patients with a history of psychiatric disorders. INTRON A therapy should be discontinued for any patient developing severe psychiatric disorder during treatment. Obtundation and coma have also been observed in some patients, usually elderly, treated at higher doses. While these effects are usually rapidly reversible upon discontinuation of therapy, full resolution of symptoms has taken up to 3 weeks in a few severe episodes. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with INTRON A be discontinued and the patient followed, with psychiatric intervention as appropriate. Narcotics, hypnotics, or sedatives may be used concurrently with caution and patients should be closely monitored until the adverse effects have resolved. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% vs 1%) during treatment and off-therapy follow-up. Cases of encephalopathy have also been observed in some patients, usually elderly, treated with higher doses of INTRON A.

Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.

Intron A is a product of Schering Corp.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Bristol-Myers: Liver cancer drug failed in study

LINDA A. JOHNSON | December 22, 2011 05:54 PM EST

TRENTON, N.J. — A key experimental liver cancer drug that Bristol-Myers Squibb Co. has been testing did not meet the main goal of a late-stage study, the company said late Thursday.

However, Bristol-Myers said three other late-stage studies of brivanib are continuing as planned.

In the study just ended, brivanib was being tested against dummy pills in liver cancer patients who had tried the cancer drug sorafenib and either couldn't tolerate it or had their cancer worsen.

The study was meant to show whether giving brivanib after patients failed on that drug would increase overall survival. It did not.

"The treatment options for patients with (liver cancer) following failure of sorafenib are limited, and thus we are disappointed that the primary endpoint was not met," Dr. Brian Daniels, the company's senior vice president for global development and medical affairs, said in the statement. "We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer."

The company intends to present detailed results of the study, including how the drug fared on secondary goals, at an upcoming scientific meeting.

Daniels noted that an ongoing study of brivanib as an initial treatment for liver cancer is expected to finish next year.

Bristol-Myers executives had said in June that they planned to apply next year for U.S. and European Union approval of brivanib.

Cancer is a key product area for Bristol-Myers Squibb. The New York-based company sells the widely used breast cancer drug Taxol, a second breast cancer drug called Ixempra, Sprycel for chronic myeloid leukemia, Vumon for a type of childhood leukemia and Yervoy, approved earlier this year for advanced melanoma. It also sells Erbitux, for head and neck cancers, jointly with Eli Lilly & Co.

In addition, liver disease is an important research focus for the company, including liver cancer and two types of hepatitis, B and C.

Brivanib is a pill that blocks receptors involved in the growth of cancerous and other cells. So far, it's been tested in 29 studies that have included more than 4,000 patients around the world.

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CDC reports hepatitis C transmission via transplants

Posted at 03:10 PM ET, 12/22/2011

By Jennifer LaRue Huget

The CDC reported Thursday that organs and tissue taken from the body of a middle-aged Kentucky man turned out to have been infected with hepatitis C virus and cited four instances in which transplant recipients became infected with that virus.

The donor died in March 2011 two days after suffering traumatic brain injury from an all-terrain-vehicle accident. At the time, his father reported that his son had not been a user of intravenous drugs, but it later became clear that the two had not been in close contact during the year before the man’s death, so the father may not have been aware of his son’s recent behaviors or health condition. The man had a history of substance use and had been incarcerated for five months 10 years before his death; he received blood transfusions shortly before he died.

The organs and tissue taken from his body were tested before transplantation, but those tests were initially deemed negative. Only after two recipients became infected, six months after their transplants, was it discovered that one of the tests had wrongly been recorded as negative when in fact the tissue had tested positive for hepatitis C virus.

Recipients of infected organs included a 41-year-old-man receiving a kidney, a 46-year-old woman, also receiving a kidney, and a 51-year-old man, who received a liver. The liver recipient had a history of hepatitis C before receiving the organ. A fourth patient had received a cardiopulmonary patch; this is the first known instance in which hepatitis C virus was transmitted via a cardiopulmonary patch, the CDC says.

Before being transplanted, organs are subjected only to a test to detect antibodies in the blood, indicating an infection. Tissue is subjected to both a blood test and a nucleic acid test; it was that report that was misread. A tissue sample from the donor was retested and the positive finding confirmed.

The CDC report notes that the case highlights opportunities to improve the system, by perhaps required nucleic acid testing for organs, reducing the risk of error in reading lab test results, and promoting more efficient communication among involved parties when an infection is discovered.

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December 22, 2011 04:57 PM Eastern Time

EXTON, Pa.--(BUSINESS WIRE)--Six months post-launch of Vertex’s Incivek (telapravir) and Merck/Roche’s Victrelis (boceprevir), specialists report a significant increase in usage of both products in their genotype 1 HCV patients compared to one month post-launch. Incivek remains the market share leader, though the gap in preference for Incivek over Victrelis is beginning to narrow compared to previous waves of research. Surveyed hepatologists reported using significantly more Incivek than infectious disease specialists.

In LaunchTrends®: Victrelis (boceprevir) and Incivek (telapravir) Wave 3 BioTrends surveyed a total of 83 physicians (gastroenterologists, hepatologists, and infectious disease specialists) and conducted in-depth qualitative interviews with a subset of the respondents about their current perceptions, early experience and anticipated future use of these products. In addition, feedback around patient type, product satisfaction, patient influence, obstacles to use, and promotional activities is captured.

The recent uptake results mostly from growth in the prescriber base as well as an increased adoption from existing protease inhibitor prescribers; indicating that protease inhibitor triple therapy is becoming the new standard of care for genotype 1 HCV patients. At six months post-launch, more than 80% of physicians report having tried Incivek up from about 50% at one month post launch. Incivek is viewed as performing significantly better than Victrelis on use in treatment naïve patients, simplicity of regimen, shorter duration of therapy and no lead in required. Of the surveyed respondents, nearly three-quarters would prefer to use Incivek in a treatment naïve patient due to the lack of a lead in period.

Not all Genotype 1 patients are being treated with this new standard of care, however. Patient resistance to being re-treated with any interferon regimen is still quite high. On the flip side, 49% of the surveyed physicians do report trial for the protease inhibitors in other genotypes despite a lack of supportive clinical data. With regards to products in development, surveyed physicians report the greatest familiarity with Pharmasett’s PSI-7977, an investigational nucleoside polymerase inhibitor that is currently being tested in a phase 3 clinical trial without the use of interferon.

About LaunchTrends

LaunchTrends®: Incivek and Victrelis is a series of three post-launch syndicated reports designed to track the uptake of Merck’s Victrelis and Vertex’s Incivek at one month, three months and six months following launch. LaunchTrends®assesses trial and use of new products, barriers to use, reasons to use, typical patient types, line of therapy, product perceptions, promotional efforts/messages and product satisfaction.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks of their respective holders.

Contacts

BioTrends Research Group, LLC
Todd Samuelson, 781-993-2673
tsamuelson@bio-trends.com
or
Decision Resources Group
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

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