Bristol-Myers Squibb Co., a drugmaker increasingly focused on developing new cancer treatments, beat third-quarter profit estimates on better-than-expected revenue from its oncology drug Opdivo and the start of U.S. sales for its hepatitis C drug.
Third-quarter earnings, excluding one-time items, were 39 cents a share, beating the 35-cent average of analysts’ estimates compiled by Bloomberg. Sales rose 3.7 percent from a year earlier to $4.07 billion. Analysts had estimated $3.86 billion on average.
The New York-based company also raised its full-year sales forecast to a range of $16 billion to $16.4 billion, from a prior projection of $15.5 billion to $15.9 billion, and increased its full-year adjusted earnings forecast to $1.85 to $1.90 a share, from a previous estimate of $1.70 to $1.80 a share. It’s the third time Bristol-Myers has raised its earnings projections this year.
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Showing posts with label BMS. Show all posts
Showing posts with label BMS. Show all posts
Tuesday, October 27, 2015
Friday, June 26, 2015
Bristol-Myers Squibb Co Undergoes Major US Business Revamp
Bristol-Myers Squibb Co (NYSE:BMY) announced Thursday it will be halting early-stage discovery work in virology research, including hepatitis B and HIV. The company will be laying off around 100 employees as it shuts down two research centers.
"Consistent with the evolution of the company's R&D strategic focus, which was announced in 2013, the Discovery organization will discontinue its research efforts in virology. This includes early research in hepatitis B (HBV) and HIV...Approximately 100 Discovery positions will be eliminated as a result of these changes,” the company stated.
Bristol-Myers, however, noted that ongoing development work on advanced virology treatments including HIV attachment inhibitor BMS-663068, the HIV maturation inhibitor BMS-955176, beclabuvir and the anti-PD-L1 compound BMS-936559, will continue. Also, the company’s marketed virology drugs such as Baraclude (entecavir), Reyataz (atazanavir)/Evotaz (atazanavir and cobicistat), Sustiva (efavirenz), Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), Daklinza (daclatasvir) and Sunvepra (asunaprevir), will not be affected by the consolidation.
Friday, May 29, 2015
Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibb’s PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma
- Interim results show favorable safety profile of Opdivo, and durable responses in previously-treated patients
- Overall survival rate of 62% at 12 months observed at this interim analysis
- Hepatocellular carcinoma is the second most frequent cause of cancer-related death worldwide and remains an area of significant unmet medical need
- Patients with hepatocellular carcinoma who have relapsed or have disease progression, following standard of care, have a median survival with best supportive care of ~7 to 8 months
“Hepatocellular carcinoma is an aggressive and fatal cancer, comprising 90 percent of all liver cancer in adults worldwide with limited therapeutic options for patients with advanced stage disease; no treatment advances have been made for patients who fail to respond or progress on the current standard of care,” said Anthony B. El-Khoueiry, MD, lead study author and associate professor of clinical medicine and phase I program director at the University of Southern California Norris Comprehensive Cancer Center. “These preliminary data are encouraging and support the ongoing evaluation of nivolumab in this patient population, as they show promising preliminary survival data, and durable partial or complete response in one out of five nivolumab-treated patients, with many others experiencing stable disease.”
More than 700,000 people around the world are diagnosed with HCC each year with a majority of all HCC cases caused by infection with the hepatitis B virus (HBV) or hepatitis C virus (HCV), making HBV/HCV the most common risk factor for liver cancer worldwide. Patients with advanced HCC receiving the current standard of care have a median overall survival of less than 1 year. For patients who have relapsed or have disease progression, median survival with best supportive care is approximately 7 to 8 months.
“Bristol-Myers Squibb’s experience in hepatitis and Immuno-Oncology make us poised as leaders to advance Opdivo into additional studies of hepatocellular carcinoma,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Opdivo has demonstrated improvements in survival in a number of different tumor types. We are excited that this trial has shown the potential that this may extend to advanced liver cancer and hope to confirm these findings in future trials.”
About the CA209-040
CA209-040 is a Phase I/II dose-ranging trial that evaluated the safety and anti-tumor activity of Opdivo in patients with HCC, the majority of whom had received prior treatment. The trial included 47 HCC patients who were enrolled into one of three treatment arms depending on whether or not they were infected with HCV or HBV. Patients enrolled in the trial received Opdivo doses ranging from 0.1 – 10 mg/kg intravenously every 2 weeks for up to 2 years. The primary objective was safety, tolerability, dose limiting toxicities, and maximum tolerated dose. Anti-tumor activity was a secondary objective (using RECIST 1.1 criteria), and overall survival was an exploratory objective.
As of this interim analysis, 62% of patients in the study were still alive after 12 months. Eight (19%) patients (of 42 evaluable patients) achieved a complete or partial response, meaning that the size of their tumors measured at baseline decreased by 30–100% with Opdivo treatment. In patients with response, duration of response ranged from more than 1.4 – 12.5 months. Seventeen patients remained on study treatment and 30 discontinued treatment due to progressive disease (n=26), complete response (n=2), or adverse events (n=2).
CA209-040 is the first trial to characterize the safety profile of Opdivo monotherapy in patients with HCC, including those with HCV and HBV infections. In the trial, safety and tolerability were well-characterized, with the frequency and intensity of treatment-related adverse events (AEs) being consistent across Opdivo dose levels. The majority of side effects were mild to moderate in nature with abnormal liver enzymes (19% AST and 15% ALT), rash (17%) and elevation of amylase (15%) and lipase (17%) being the most common; the abnormal liver enzymes and elevated amylase and lipase were not accompanied by any significant clinical symptoms. Grade 3–4 treatment-related AEs were infrequent (19%). There were no treatment-related deaths reported.
About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide.
Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the U.S. Food and Drug Administration (FDA) granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Read complete press release here
Thursday, April 30, 2015
Study results promising for hepatitis C patients awaiting or completing liver transplant
Public Release:
SAN ANTONIO (April 30 2015) -- A number of new, highly effective oral treatments for various types of hepatitis C have been approved in the past few years. However, two groups who have not benefitted from the new treatments are patients with hepatitis C who have advanced liver disease and patients who have received a liver transplant but the advanced liver disease has returned because of hepatitis C.
"The problem for these patients is that unless the hepatitis C is cured, the virus continues circulating in their blood infecting the new liver, usually within a few months of transplant. One-third of them have cirrhosis again within five years," explained Fred Poordad, M.D., clinical professor of medicine and chief of hepatology at The University of Texas Health Science Center at San Antonio.
"This puts these patients back at high risk of dying from chronic hepatitis C or liver disease," said Dr. Poordad, principal investigator of the ALLY-1 study, who presented the results April 25 at The International Liver CongressTM of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The Phase III clinical trial evaluated a 12-week course of daclatasvir - the new drug being evaluated - combined with sofosbuvir and ribavirin for patients with chronic hepatitis C. Patients accepted into the trial either had a liver transplant with returning hepatitis C or had hepatitis C with advanced cirrhosis (scarring of the liver).
Study results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis.
The study's primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patients with advanced cirrhosis being cured 12 weeks after treatment. Patients with other genotypes of the disease were enrolled as well, with benefits seen in all groups.
Genotypes are subgroups or strains of a disease, such as hepatitis C. There are many subtypes of hepatitis C based on the geographic regions where the strain is most prevalent. Over time, each strain evolved differently so that treatments are based on the genotype of the disease. For example, genotype 1 is the type of hepatitis C most common in the United States and is the most difficult to treat.
The study regimen was well tolerated and showed few serious side effects. "Transplant patients take a variety of medications to prevent organ rejection that can complicate the treatment of hepatitis C. In ALLY-1, we saw no drug-to-drug interactions between transplant and hepatitis C therapies and no need to make close adjustments to patients' transplant-related drugs while they received the hepatitis C regimen," Dr. Poordad said.
The ALLY-1 study was conducted at five major transplant centers in San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and Seattle, Wash.
Hepatitis C is a liver disease found worldwide that is spread though contact with blood or semen, such as shared drug injection needles, inadequate sterilization of medical equipment, unscreened blood and blood products, accidental needle sticks in the health profession, and sexual intercourse with a person who has hepatitis C. The disease also can be passed from mothers to their children through the birthing process.
According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80 percent do not have symptoms. Nonetheless, it is a serious disease that can lead to long-term health problems such as liver damage, liver failure, liver cancer and death. It is often discovered later, after significant liver damage has occurred.
In the U.S., people born between 1945 and 1965 have the highest risk of hepatitis C due to higher drug use. People in this age group are urged to have a one-time blood test for hepatitis C to detect the virus and begin receiving treatment, if necessary, before significant liver damage occurs. There is no vaccine to prevent hepatitis C.
Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved in Europe in 2014 for use with other medications for genotypes 1 through 4 for the treatment of chronic hepatitis C in adults. It is also approved in Japan as well as many countries in Central and South America, the Middle East and Asia Pacific. Daclatasvir regimens also have been included in the EASL's recommendations for the treatment of hepatitis C in Europe.
The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.
For current news from the UT Health Science Center San Antonio, please visit our news release website, like us on Facebook or follow us on Twitter.
The University of Texas Health Science Center at San Antonio, one of the country's leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 29,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways "We make lives better®," visit http://www.
The Texas Liver Institute's mission is to set the standard of excellence in care and innovative research in the field of liver disease. The institute is affiliated with The University of Texas Health Science Center at San Antonio. The physicians are professors and teach at University Hospital of the University Health System and are involved with the liver transplantation program of the University Transplant Center, a partnership of the Health Science Center and the University Health System. For more information, visit http://www.
UT Health Science Center San Antonio doctor presents results of daclatasvir regimen
University of Texas Health Science Center at San Antonio
SAN ANTONIO (April 30 2015) -- A number of new, highly effective oral treatments for various types of hepatitis C have been approved in the past few years. However, two groups who have not benefitted from the new treatments are patients with hepatitis C who have advanced liver disease and patients who have received a liver transplant but the advanced liver disease has returned because of hepatitis C.
"The problem for these patients is that unless the hepatitis C is cured, the virus continues circulating in their blood infecting the new liver, usually within a few months of transplant. One-third of them have cirrhosis again within five years," explained Fred Poordad, M.D., clinical professor of medicine and chief of hepatology at The University of Texas Health Science Center at San Antonio.
"This puts these patients back at high risk of dying from chronic hepatitis C or liver disease," said Dr. Poordad, principal investigator of the ALLY-1 study, who presented the results April 25 at The International Liver CongressTM of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The Phase III clinical trial evaluated a 12-week course of daclatasvir - the new drug being evaluated - combined with sofosbuvir and ribavirin for patients with chronic hepatitis C. Patients accepted into the trial either had a liver transplant with returning hepatitis C or had hepatitis C with advanced cirrhosis (scarring of the liver).
Study results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis.
The study's primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patients with advanced cirrhosis being cured 12 weeks after treatment. Patients with other genotypes of the disease were enrolled as well, with benefits seen in all groups.
Genotypes are subgroups or strains of a disease, such as hepatitis C. There are many subtypes of hepatitis C based on the geographic regions where the strain is most prevalent. Over time, each strain evolved differently so that treatments are based on the genotype of the disease. For example, genotype 1 is the type of hepatitis C most common in the United States and is the most difficult to treat.
The study regimen was well tolerated and showed few serious side effects. "Transplant patients take a variety of medications to prevent organ rejection that can complicate the treatment of hepatitis C. In ALLY-1, we saw no drug-to-drug interactions between transplant and hepatitis C therapies and no need to make close adjustments to patients' transplant-related drugs while they received the hepatitis C regimen," Dr. Poordad said.
The ALLY-1 study was conducted at five major transplant centers in San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and Seattle, Wash.
Hepatitis C is a liver disease found worldwide that is spread though contact with blood or semen, such as shared drug injection needles, inadequate sterilization of medical equipment, unscreened blood and blood products, accidental needle sticks in the health profession, and sexual intercourse with a person who has hepatitis C. The disease also can be passed from mothers to their children through the birthing process.
According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80 percent do not have symptoms. Nonetheless, it is a serious disease that can lead to long-term health problems such as liver damage, liver failure, liver cancer and death. It is often discovered later, after significant liver damage has occurred.
In the U.S., people born between 1945 and 1965 have the highest risk of hepatitis C due to higher drug use. People in this age group are urged to have a one-time blood test for hepatitis C to detect the virus and begin receiving treatment, if necessary, before significant liver damage occurs. There is no vaccine to prevent hepatitis C.
Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved in Europe in 2014 for use with other medications for genotypes 1 through 4 for the treatment of chronic hepatitis C in adults. It is also approved in Japan as well as many countries in Central and South America, the Middle East and Asia Pacific. Daclatasvir regimens also have been included in the EASL's recommendations for the treatment of hepatitis C in Europe.
The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.
###
For current news from the UT Health Science Center San Antonio, please visit our news release website, like us on Facebook or follow us on Twitter.
The University of Texas Health Science Center at San Antonio, one of the country's leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 29,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways "We make lives better®," visit http://www.
The Texas Liver Institute's mission is to set the standard of excellence in care and innovative research in the field of liver disease. The institute is affiliated with The University of Texas Health Science Center at San Antonio. The physicians are professors and teach at University Hospital of the University Health System and are involved with the liver transplantation program of the University Transplant Center, a partnership of the Health Science Center and the University Health System. For more information, visit http://www.
Thursday, March 12, 2015
FDA to review re-submitted Bristol-Myers hepatitis C drug
(Reuters) - U.S. regulators have accepted Bristol-Myers Squibb Co's re-submitted marketing application for an experimental hepatitis C treatment after the drugmaker was forced last year to withdraw its initial request.
Bristol-Myers on Thursday said the U.S. Food and Drug Administration will review daclatasvir, its so-called NS5A inhibitor, for use in combination with Gilead Sciences Inc's potent and widely used Sovaldi treatment. It said the FDA is expected to make its decision within six months.
Bristol-Myers originally had sought FDA permission to market daclatasvir in combination with another Bristol drug, asunaprevir. But it abandoned that application due to potential competition from more potent drugs, leaving the FDA without data to gauge the effectiveness of daclatasvir as part of a combination regimen.
Read more...
Bristol-Myers on Thursday said the U.S. Food and Drug Administration will review daclatasvir, its so-called NS5A inhibitor, for use in combination with Gilead Sciences Inc's potent and widely used Sovaldi treatment. It said the FDA is expected to make its decision within six months.
Bristol-Myers originally had sought FDA permission to market daclatasvir in combination with another Bristol drug, asunaprevir. But it abandoned that application due to potential competition from more potent drugs, leaving the FDA without data to gauge the effectiveness of daclatasvir as part of a combination regimen.
Read more...
Thursday, February 26, 2015
ALLY Trial Demonstrates 97% Hepatitis C Cure Rates Among Patients Coinfected with HIV After Ribavirin-Free Investigational 12-Week Regimen of Daclatasvir and Sofosbuvir
Daclatasvir-sofosbuvir 12-week regimen resulted in:
Thursday, February 26, 2015 3:15 pm EST
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection.
“The results of ALLY-2 signal that nearly all HIV-HCV coinfected patients in the study could be cured of hepatitis C with a 12-week regimen on daclatasvir and sofosbuvir,” said David Wyles, M.D., ALLY-2 Lead Investigator and Associate Professor of Medicine in the Department of Medicine, Division of Infectious Diseases at the University of California San Diego. “The trial demonstrated the dosing flexibility afforded by the daclatasvir-sofosbuvir regimen did not require alteration of HIV medications because of potential drug-drug interactions. This is a paramount consideration for clinicians treating this patient population.”
Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase.
“While substantial strides have been made in the battle against hepatitis C, a significant number of patients with complicated disease and treatment histories need additional treatment options to help them achieve hepatitis C cure,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype.”
According to the Centers for Disease Control and Prevention (CDC), about one quarter of HIV-infected persons in the United States - approximately 300,000 people - are also infected with hepatitis C, and HCV infection progresses more rapidly to liver damage in people living with HIV.
In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. African-American patients comprised 34% of study participants; in this patient demographic, SVR12 rates were 98% (n=49/50). ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
Additional safety data demonstrated a low rate of Grade 3/4 lab abnormalities in the study: INR (1%), AST (0.5%), Tbili (4%), Lipase (3%).
About ALLY-2: Study Design
This Phase III open-label clinical trial randomized 151 treatment-naïve and 52 treatment-experienced HCV (genotypes 1-4) patients coinfected with HIV-1 on a broad range of antiretroviral regimens, into 3 cohorts. Among treatment-naïve patients, one cohort received daclatasvir 30, 60, or 90 mg (dose adjusted for concomitant antiretroviral therapy) plus sofosbuvir 400 mg once daily for 12 weeks, and another received the same dosage and combination for 8 weeks.
The treatment-experienced cohort also received daclatasvir 30, 60, or 90 mg plus sofosbuvir 400 mg once daily for 12 weeks. Daclatasvir was dose-adjusted to accommodate concomitant antiretrovirals: 30 mg with ritonavir-boosted PIs, 90 mg with NNRTIs except rilpivirine. All cohorts had follow-up through post-treatment week 24. The primary endpoint was the SVR12 rate among genotype 1 treatment-naïve patients after 12 weeks of treatment. Patients with cirrhosis were permitted.
Read complete press release here:
- 96% hepatitis C cure rate among patients with HVC genotype 1 disease (n=80/83)
- 100% hepatitis C cure rate among patients with HCV genotype 2, 3 and 4 disease (n=26/26)
Thursday, February 26, 2015 3:15 pm EST
"The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype."
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection.
“The results of ALLY-2 signal that nearly all HIV-HCV coinfected patients in the study could be cured of hepatitis C with a 12-week regimen on daclatasvir and sofosbuvir,” said David Wyles, M.D., ALLY-2 Lead Investigator and Associate Professor of Medicine in the Department of Medicine, Division of Infectious Diseases at the University of California San Diego. “The trial demonstrated the dosing flexibility afforded by the daclatasvir-sofosbuvir regimen did not require alteration of HIV medications because of potential drug-drug interactions. This is a paramount consideration for clinicians treating this patient population.”
Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase.
“While substantial strides have been made in the battle against hepatitis C, a significant number of patients with complicated disease and treatment histories need additional treatment options to help them achieve hepatitis C cure,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype.”
According to the Centers for Disease Control and Prevention (CDC), about one quarter of HIV-infected persons in the United States - approximately 300,000 people - are also infected with hepatitis C, and HCV infection progresses more rapidly to liver damage in people living with HIV.
In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. African-American patients comprised 34% of study participants; in this patient demographic, SVR12 rates were 98% (n=49/50). ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
Additional safety data demonstrated a low rate of Grade 3/4 lab abnormalities in the study: INR (1%), AST (0.5%), Tbili (4%), Lipase (3%).
About ALLY-2: Study Design
This Phase III open-label clinical trial randomized 151 treatment-naïve and 52 treatment-experienced HCV (genotypes 1-4) patients coinfected with HIV-1 on a broad range of antiretroviral regimens, into 3 cohorts. Among treatment-naïve patients, one cohort received daclatasvir 30, 60, or 90 mg (dose adjusted for concomitant antiretroviral therapy) plus sofosbuvir 400 mg once daily for 12 weeks, and another received the same dosage and combination for 8 weeks.
The treatment-experienced cohort also received daclatasvir 30, 60, or 90 mg plus sofosbuvir 400 mg once daily for 12 weeks. Daclatasvir was dose-adjusted to accommodate concomitant antiretrovirals: 30 mg with ritonavir-boosted PIs, 90 mg with NNRTIs except rilpivirine. All cohorts had follow-up through post-treatment week 24. The primary endpoint was the SVR12 rate among genotype 1 treatment-naïve patients after 12 weeks of treatment. Patients with cirrhosis were permitted.
Wednesday, February 11, 2015
FDA rescinds breakthrough therapy designation for daclatasvir
The FDA has rescinded breakthrough therapy designation status from Bristol-Myers Squibb for daclatasvir for the treatment of hepatitis C virus infection, according to a statement from the manufacturer.
“The FDA has informed Bristol-Myers Squibb that, due to the evolving HCV treatment landscape, the agency intends to rescind the breakthrough therapy designation for certain genotype 1 hepatitis C regimens related to daclatasvir,” the statement from Bristol-Myers Squibb said. “This will not impact our current submission/resubmission timetable of the new drug application for daclatasvir in combination with other antiviral agents for the treatment of hepatitis C.”
Daclatasvir (Bristol-Myers Squibb) was granted breakthrough therapy designation in early 2014 as part of a dual investigational regimen with asunaprevir (Bristol-Myers Squibb) for chronic HCV. BMS withdrew its application for asunaprevir from the FDA in October 2014.
Monday, February 2, 2015
BMS Foundation Awards US$3.5 Million In Hepatitis Grants
AsianScientist (Feb. 2, 2015) - The Bristol Myers Squibb Foundation has in the past month awarded nine new multi-year grants for more than US$3.5 million to strengthen efforts against hepatitis B virus (HBV) and hepatitis C virus (HCV) in India and China, which constitute the most vulnerable populations worldwide.
The grants were made through the Foundation’s Delivering Hope initiative, an independent philanthropic wing of BMS to prevent hepatitis in Asia. These align with the World Health Organization’s (WHO) call for action against the global hepatitis threat with comprehensive strategies for awareness, prevention and treatment. Last year, Delivering Hope established three Centers of Excellence, one in China and two in India, that are focusing on just these goals.
An urgent public health issue, hepatitis is an inflammation of the liver, most commonly caused by a viral infection. The WHO estimates that hepatitis B and C affect over 500 million people worldwide. Viral hepatitis is often referred to as a ‘silent epidemic’ because most people do not realize that they are infected and, over decades, progress to severe liver diseases. This underscores the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy.
Read more from Asian Scientist Magazine at: http://www.asianscientist.com/2015/02/pharma/bms-foundation-awards-us3-5-million-hepatitis-grants/
The grants were made through the Foundation’s Delivering Hope initiative, an independent philanthropic wing of BMS to prevent hepatitis in Asia. These align with the World Health Organization’s (WHO) call for action against the global hepatitis threat with comprehensive strategies for awareness, prevention and treatment. Last year, Delivering Hope established three Centers of Excellence, one in China and two in India, that are focusing on just these goals.
An urgent public health issue, hepatitis is an inflammation of the liver, most commonly caused by a viral infection. The WHO estimates that hepatitis B and C affect over 500 million people worldwide. Viral hepatitis is often referred to as a ‘silent epidemic’ because most people do not realize that they are infected and, over decades, progress to severe liver diseases. This underscores the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy.
Read more from Asian Scientist Magazine at: http://www.asianscientist.com/2015/02/pharma/bms-foundation-awards-us3-5-million-hepatitis-grants/
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