UPDATE 3-U.S. FDA panel backs Merck hepatitis drug
* Advisers vote 18-0 to recommend boceprevir's approval
* FDA to make final decision as early as May
* Rival Vertex drug faces panel on Thursday
* Merck shares up 1.6 pct, Vertex gains 5 pct (Adds panel member, analyst comments)
By Lisa Richwine
SILVER SPRING, Md., April 27 (Reuters) -
A Merck & Co hepatitis C drug moved closer to the market on Wednesday as U.S. advisers unanimously urged approval and called it a major advance against a hard-to-treat disease.
The Merck drug and a rival from Vertex Pharmaceuticals Inc are expected to change the treatment of a virus that can destroy the liver. Analysts project blockbuster sales for each of the new pills, with the Vertex drug dominating a multibillion-dollar market. About 170 million people around the world are infected with hepatitis C.
A Food and Drug Administration advisory panel voted 18-0 to urge approval of Merck's drug, boceprevir. The FDA usually clears medicines that win panel support.
"This is a tremendous advance and is going to give a lot of people hope," said Dr. Robert Knodell, a panelist and gastroenterologist at the Veterans Administration Medical Center in Baltimore.
The advisory panel will consider the Vertex drug, telaprevir, on Thursday.
Merck shares rose 1.6 percent to close at $35.63 on the New York Stock Exchange. Vertex shares gained nearly 5 percent to close at $55.54 on Nasdaq.
Industry analysts expect both drugs to win approval as early as May. The Vertex pill is projected to draw more patients after showing a higher cure rate in clinical trials.
Jon LeCroy, an analyst with Hapoalim Securities, said boceprevir had been unfairly overshadowed by the Vertex medicine. "If both drugs get approved, both will be decent sellers," he said.
TWO BIG SELLERS
Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new medicines, which still must be taken in combination with older hepatitis drugs. The new medicines work by blocking a protein called protease that the virus needs to replicate.
In the United States, 3.2 million people have hepatitis C, a blood-borne disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. The infection is spread mainly through sharing needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. Many people who are infected do not know they have the virus and show no symptoms.
Morningstar analyst Damien Conover predicted a 60-40 sales split in favor of the Vertex drug, a more bullish view for boceprevir than the 70-30 split others have predicted.
Merck's large sales force and its entrenchment in the space because of its pegylated interferon drug for hepatitis will help boceprevir, Conover said. Merck acquired boceprevir and the interferon drug, which must be used in combination with the new antivirals, with its 2009 purchase of Schering-Plough.
Conover sees boceprevir sales quickly hitting $600 million in 2012 and climbing to $1 billion by 2014, with more room to grow. The proposed brand name is Victrelis.
Boceprevir's cure rate reached 66 percent in Merck's studies, an improvement over the 40 percent seen with current drugs, but less than the 79 percent reported for newly treated patients given the Vertex drug, telaprevir.
Both the Merck and Vertex medicines cured some patients in half the time of the current combination therapy of the injectable drug interferon and a pill called ribavirin. The older drugs require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.
Members of the FDA panel appeared to support shorter treatment for patients who show early responses to boceprevir, Dr. Jeffrey Murray, deputy director of the FDA's antiviral drugs division, told reporters.
Boceprevir's main risk is blood disorders such as anemia, a lack of red blood cells that causes fatigue and other symptoms, FDA reviewers said. Panelists said the problems needed monitoring but were manageable and usually not severe.
The committee was split on whether boceprevir should be given to patients who failed to respond to earlier treatment.
Some voiced concern that patients would find it challenging to stick with the three-times-a-day dosing for boceprevir on top of the two older medicines.
"When it gets too complicated we are shooting ourselves in the foot," said Dr. Lawrence Friedman, medicine department chair at Newton-Wellesley Hospital in Newton, Massachusetts. (Reporting by Lisa Richwine in Silver Spring, Maryland, and Bill Berkrot in New York; Editing by Maureen Bavdek, Carol Bishopric, Phil Berlowitz)
Related On The Blog;
Telaprevir April 28th View The "Live Webcast" From The FDA Advisory Panel
Wednesday, April 27, 2011
Telaprevir April 28th View The "Live Webcast" From The FDA Advisory Panel
As we all know Today the FDA advisory panel recommended the approval of boceprevir
Telaprevir is up for review tomorrow/April 28th by the FDA advisory panel, you can view the live webcast here from the FDA’s website.
View the draft questions to the advisory community.
Click here for more information on the webcast
From Reuters 4-26
Excerpt;
Vertex's telaprevir eliminated the hepatitis C virus in 79 percent of newly treated patients, FDA reviewers said. That was higher than the 75 percent Vertex reported earlier because the FDA used a different cure rate calculation.
Analysts said the higher effectiveness, plus few FDA safety concerns, meant an advisory panel would likely recommend approval of the drug on Thursday.
"We now expect telaprevir to get a relatively clean recommendation (and hence approval) with no significant exclusions, restrictions, warnings or caveats," Sanford Bernstein analyst Geoffrey Porges said in a research note.
Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate, with only about a 40 percent success rate. Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.
WAITING FOR TREATMENT
Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new anti-virals, which still must be taken in combination with the older drugs ribavirin and interferon.
Hepatitis C is a bloodborne liver disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. It is spread mainly through reuse of needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. About 3.2 million Americans and 170 million people worldwide have the disease.
Analysts widely expect the Vertex pill to dominate the market with its greater effectiveness. Telaprevir's 79 percent success rate compares with up to 66 percent for Merck's drug, boceprevir, in previously untreated patients. It also had a higher cure rate than the Merck drug in patients who had failed to be helped by prior therapy.
"Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings," FDA staff said in a summary prepared for the advisory panel of outside experts.
The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.
Telaprevir is up for review tomorrow/April 28th by the FDA advisory panel, you can view the live webcast here from the FDA’s website.
View the draft questions to the advisory community.
Click here for more information on the webcast
From Reuters 4-26
Excerpt;
Vertex's telaprevir eliminated the hepatitis C virus in 79 percent of newly treated patients, FDA reviewers said. That was higher than the 75 percent Vertex reported earlier because the FDA used a different cure rate calculation.
Analysts said the higher effectiveness, plus few FDA safety concerns, meant an advisory panel would likely recommend approval of the drug on Thursday.
"We now expect telaprevir to get a relatively clean recommendation (and hence approval) with no significant exclusions, restrictions, warnings or caveats," Sanford Bernstein analyst Geoffrey Porges said in a research note.
Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate, with only about a 40 percent success rate. Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.
WAITING FOR TREATMENT
Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new anti-virals, which still must be taken in combination with the older drugs ribavirin and interferon.
Hepatitis C is a bloodborne liver disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. It is spread mainly through reuse of needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. About 3.2 million Americans and 170 million people worldwide have the disease.
Analysts widely expect the Vertex pill to dominate the market with its greater effectiveness. Telaprevir's 79 percent success rate compares with up to 66 percent for Merck's drug, boceprevir, in previously untreated patients. It also had a higher cure rate than the Merck drug in patients who had failed to be helped by prior therapy.
"Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings," FDA staff said in a summary prepared for the advisory panel of outside experts.
The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.
"Yes" FDA advisory panel recommends approval of boceprevir
FDA advisory panel recommends approval of boceprevir
AP) WASHINGTON - Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
HCV New Drugs Quick Notes;
Mentioned by the panel is the concern for the complexity of prescribing the new Hepatitis C drug. The other concerns are safety, risk, and resistance variance.
Labeling;
The panelists were split on using boceprevir in (null responder) patients. These patients were not included in Phase III trials, therefore no data is available. Also raised was the concern over the labeling allowing for treatment in advanced liver damage; Grade 3 Stage 4 patients .
Longer treatment duration was discussed in the difficult to treat patients; African Americans, patients with liver damage and for those people who have failed prior standard therapy.
The FDA will make the final approval decision
From The WSJ
FDA Panel Backs Merck Hepatitis C Drug
By JENNIFER CORBETT DOOREN
The agency isn't required to follow the advice of its advisory panels, but it usually does.
From The Boston Globe;
Panel recommends FDA approval of Merck drug
By Robert Weisman, Globe Staff
Silver Spring, Md. --- A scientific advisory panel today unanimously recommended that the Food and Drug Administration approve a Merck & Co. drug candidate for hepatitis C that is expected to compete with a rival drug from Vertex Pharmaceuticals Inc. of Cambridge.
The vote to recommend the approval of the Merck drug, called boceprevir, followed a day-long hearing in which physicians warned of possible side effects and concerns about what might happen if patients developed anti-viral resistance.
But panel members said the benefits of the drug outweighed those concerns.
Continue Reading....
New updates will be posted. Watch for the transcripts of the meeting.
.
AP) WASHINGTON - Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck’s boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group’s recommendation, though it usually does. A final decision is expected mid-May.
On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
(Copyright 2011 by The Associated Press. All Rights Reserved.)
HCV New Drugs Quick Notes;
Mentioned by the panel is the concern for the complexity of prescribing the new Hepatitis C drug. The other concerns are safety, risk, and resistance variance.
Labeling;
The panelists were split on using boceprevir in (null responder) patients. These patients were not included in Phase III trials, therefore no data is available. Also raised was the concern over the labeling allowing for treatment in advanced liver damage; Grade 3 Stage 4 patients .
Longer treatment duration was discussed in the difficult to treat patients; African Americans, patients with liver damage and for those people who have failed prior standard therapy.
The FDA will make the final approval decision
From The WSJ
FDA Panel Backs Merck Hepatitis C Drug
By JENNIFER CORBETT DOOREN
WASHINGTON—A Food and Drug Administration panel backed the use of Merck & Co.'s hepatitis C drug boceprevir, calling the product a game-changing advance in the treatment of the disease.
The panel of outside medical experts voted yes by a margin of 18-0 on the question of whether the available data support approval of the product in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the FDA approve boceprevir, which Merck has proposed marketing under the brand name Victrelis. The agency isn't required to follow the advice of its advisory panels, but it usually does.
Indeed, FDA staff members suggested the agency was leaning toward approving boceprevir and a similar product, telaprevir, from Vertex Pharmaceuticals Inc. Telaprevir will be reviewed Thursday by the same FDA panel... Continue Reading..
Panel recommends FDA approval of Merck drug
By Robert Weisman, Globe Staff
Silver Spring, Md. --- A scientific advisory panel today unanimously recommended that the Food and Drug Administration approve a Merck & Co. drug candidate for hepatitis C that is expected to compete with a rival drug from Vertex Pharmaceuticals Inc. of Cambridge.
The vote to recommend the approval of the Merck drug, called boceprevir, followed a day-long hearing in which physicians warned of possible side effects and concerns about what might happen if patients developed anti-viral resistance.
But panel members said the benefits of the drug outweighed those concerns.
Continue Reading....
New updates will be posted. Watch for the transcripts of the meeting.
.
Boceprevir "Live Feed" From The FDA Advisory Panel
Boceprevir is up for review today by the FDA advisory panel watch the live webcast here from FDA’s website, telaprevir is tomorrow.
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Merck/Boceprevir: FDA Hep C Panel "Live Blog" From The Street
The streets Adam Feuerstein is live and reporting on Boceprevir which is up for review today by the FDA advisory panel , telaprevir is tomorrow. Check it out here
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In a preliminary review of boceprevir posted to its web site Monday, the FDA agreed with Merck's clinical data demonstrating that the drug increases cure rates for hepatitis C over standard treatment. The FDA did raise some concerns about boceprevir's safety, including higher rates of anemia and reported psychiatric problems.You can read the FDA briefing documents here:
The FDA advisory panel will end Wednesday's meeting with a vote on whether to recommend approval of boceprevir. FDA makes the final approval decision. The agency is expected to issue its ruling in early May.
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Tuesday, April 26, 2011
Atwater Carey First Aid Kit Consumers Regarding Triad Prep Pads
Important Information for Atwater Carey First Aid Kit Consumers Regarding Triad Group’s Povidone Iodine Prep Pads
Contact:
Customer Service
Wisconsin Pharmacal Company
800-558-6614
recall@pharmacalway.com
FOR IMMEDIATE RELEASE - April 21, 2011 - Wisconsin Pharmacal Company, LLC has become aware of a broad United States market recall of Triad Povidone Iodine Prep Pads, manufactured by H&P Industries Inc. and marketed under various brand names including Triad. The Triad Povidone Iodine Prep Pads were included in the Atware Carey First Aid Kits distributed by Wisconsin Pharmacal Company. In the interest of consumer safety, Wisconsin Pharmacal wants to ensure that U.S. consumers using Atwater Carey First Aid Kits are aware of the Triad recall.
The recall of the Triad Povidone Iodine Prep Pad is due to potential contamination of these products with bacteria that could lead to life-threatening infections. Current shipments of Atwater Carey First Aid Kits do not include the Triad Povidone Iodine Prep Pads.
It is important to note, that with the exception of the Triad Povidone Iodine Prep Pad the Atwater Carey First Aid Kits are not contaminated and the First Aid Kits may continue to be used in accordance with the instructions for use upon removal of the Triad Povidone Iodine Prep Pad.
Atwater Carey First Aid Kits that included Triad Povidone Iodine Prep Pads are listed below.
Product Name Brand Name Part Number UPC Code
Personal First Aid Kit Atwater Carey 158A 3 68093 00158 9
Dayhiker First Aid Kit Atwater Carey 159A 3 68093 00159 6
Backpacker First Aid Kit Atwater Carey 160A 3 68093 00160 2
Light & Dry #1 Kit Atwater Carey 273 3 68093 00273 9
Light & Dry #2 Kit Atwater Carey 274 3 68093 00274 6
Light & Dry #3 Kit Atwater Carey 275 3 68093 00275 3
Marine First Aid Kit Atwater Carey 299 3 68093 00299 9
Wisconsin Pharmacal instructs consumers using one of the affected First Aid Kits to immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
Wisconsin Pharmacal is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration.
Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/Recalls/ucm247658.htm1 . Wisconsin Pharmacal will provide additional information when it becomes available.
You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch2 , or call 1-800-FDA- 1088.
About Wisconsin Pharmacal Company
Headquartered in Jackson, Wis., Wisconsin Pharmacal Company is a leader in outdoor health and safety products. The company manufactures a variety of products for outdoor enthusiasts, including insect repellents, water purification tablets, first aid kits, and insect bite relief products. Through its subsidiary, Lake Consumer Products, the company also markets and distributes health and personal care products for women. For additional details, please visit www.pharmacalway.com3 or http://www.lakeconsumer.com4/ .
Contact:
Customer Service
Wisconsin Pharmacal Company
800-558-6614
recall@pharmacalway.com
FOR IMMEDIATE RELEASE - April 21, 2011 - Wisconsin Pharmacal Company, LLC has become aware of a broad United States market recall of Triad Povidone Iodine Prep Pads, manufactured by H&P Industries Inc. and marketed under various brand names including Triad. The Triad Povidone Iodine Prep Pads were included in the Atware Carey First Aid Kits distributed by Wisconsin Pharmacal Company. In the interest of consumer safety, Wisconsin Pharmacal wants to ensure that U.S. consumers using Atwater Carey First Aid Kits are aware of the Triad recall.
The recall of the Triad Povidone Iodine Prep Pad is due to potential contamination of these products with bacteria that could lead to life-threatening infections. Current shipments of Atwater Carey First Aid Kits do not include the Triad Povidone Iodine Prep Pads.
It is important to note, that with the exception of the Triad Povidone Iodine Prep Pad the Atwater Carey First Aid Kits are not contaminated and the First Aid Kits may continue to be used in accordance with the instructions for use upon removal of the Triad Povidone Iodine Prep Pad.
Atwater Carey First Aid Kits that included Triad Povidone Iodine Prep Pads are listed below.
Product Name Brand Name Part Number UPC Code
Personal First Aid Kit Atwater Carey 158A 3 68093 00158 9
Dayhiker First Aid Kit Atwater Carey 159A 3 68093 00159 6
Backpacker First Aid Kit Atwater Carey 160A 3 68093 00160 2
Light & Dry #1 Kit Atwater Carey 273 3 68093 00273 9
Light & Dry #2 Kit Atwater Carey 274 3 68093 00274 6
Light & Dry #3 Kit Atwater Carey 275 3 68093 00275 3
Marine First Aid Kit Atwater Carey 299 3 68093 00299 9
Wisconsin Pharmacal instructs consumers using one of the affected First Aid Kits to immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
Wisconsin Pharmacal is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration.
Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/Recalls/ucm247658.htm1 . Wisconsin Pharmacal will provide additional information when it becomes available.
You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch2 , or call 1-800-FDA- 1088.
About Wisconsin Pharmacal Company
Headquartered in Jackson, Wis., Wisconsin Pharmacal Company is a leader in outdoor health and safety products. The company manufactures a variety of products for outdoor enthusiasts, including insect repellents, water purification tablets, first aid kits, and insect bite relief products. Through its subsidiary, Lake Consumer Products, the company also markets and distributes health and personal care products for women. For additional details, please visit www.pharmacalway.com3 or http://www.lakeconsumer.com4/ .
Vertex will utilize AGA Digestive Health Outcomes Registry™ to perform unique data analysis projects.
Research collaboration applies sophisticated analytics to real-world clinical data to support the treatment of gastroenterological diseases
BOWIE, Md., April 26, 2011 /PRNewswire/ -- MedAssurant, Inc., and the American Gastroenterological Association (AGA) today announced that Vertex Pharmaceuticals will utilize the AGA Digestive Health Outcomes Registry™ to perform unique data analysis projects. Powered by MedAssurant's advanced healthcare data analytics, the AGA Registry is the largest of its kind in the field of gastroenterology – focused initially on guidelines-driven management of inflammatory bowel disease (IBD) and effective strategies for colorectal cancer (CRC) prevention, as well as hepatitis C.As a supporter of the AGA Digestive Health Outcomes Registry, Vertex will collaborate with MedAssurant and the AGA to design custom analysis projects that shed light on a variety of topics related to digestive health. The clinical insight gained from this large-scale analysis of real-world data will support development efforts in the treatment of various gastroenterological diseases, including hepatitis C.
"The AGA Digestive Health Outcomes Registry is an important resource for the entire healthcare community," said Ian L. Taylor, M.D., Ph.D., AGAF, president of the AGA Institute. "The registry supports and encourages the efforts of physicians and researchers around the country to innovate and improve health care for patients."
The AGA Digestive Health Outcomes Registry was launched in April 2010 with unprecedented depth and breadth of clinical insight, initially containing clinical data from more than 4.3 million patients with relevant data pertaining to IBD and colorectal cancer (CRC). In the past year, practices throughout the U.S. have prospectively collected AGA-specific data through the AGA Registry, enabling practices to achieve Physician Quality Reporting System incentives for the hepatitis C measures group and meet National Quality Forum-endorsed standards for polyp detection and CRC surveillance intervals.
"Access to high-quality, high-volume clinical datasets has become imperative for improving the efficiency and cost-effectiveness of drug development," said Luis Gutierrez, MedAssurant's Senior Vice President of Pharmaceutical and Life Sciences Operations and head of the company's research registry initiatives. "Registries such as this enable researchers to approach human disease from the macro perspective and to consider complex real-world variables that impact clinical outcomes. This collaboration is a unique opportunity for current and future industry supporters to expand their efforts in drug development beyond the laboratory and the clinic."
For details, please visit www.AGARegistry.org.
About the American Gastroenterological Association
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include more 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org
About MedAssurant, Inc.
MedAssurant, Inc., is a leading technology-enabled healthcare solutions provider focused on the importance of healthcare data and its ability to drive dramatic, objective improvement in clinical and quality outcomes, care management and financial performance throughout the healthcare community. Proprietary healthcare datasets, aggregation and analysis capabilities, combined with a national infrastructure of leading-edge technology, clinical prowess and deep human resources, empower MedAssurant's advanced generation of healthcare assessment and improvement through highly informed solutions. Driven by a mission to improve today's healthcare landscape, the employees of MedAssurant proudly apply care, ingenuity and dedication to delivering a new approach to healthcare touching more than 100 million Americans – one driven by data and insight – one resulting in meaningful action. Please visit www.medassurant.com for more information.
Contacts:
Russo Partners LLC on behalf of MedAssurant, Inc.
Tony Russo or Lena Evans
Phone: 212-845-4251
Phone: 212-845-4262
tony.russo@russopartnersllc.com
lena.evans@russopartnersllc.com
MedAssurant, Inc.
Alex Burgess
4321 Collington Road
Bowie, Maryland 20716
Phone: 301-809-4000
aburgess@medassurant.com
American Gastroenterological Association
Aimee Frank
301-941-2620
media@gastro.org
SOURCE MedAssurant, Inc.
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RELATED LINKS
http://www.medassurant.com
Hepatitis C;Phase 3 trials recruiting to evaluate BI 201335 Plus SOC
Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for Lead Hepatitis C Compound
Development program has been granted FDA Fast Track designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development program for BI 201335. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.(2)
"We are pleased to have begun enrolling patients at North American trial sites as we continue development of BI 201335," said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to initiating additional trials later this year in more patient populations, including HCV-HIV coinfected patients, as we continue to advance our HCV portfolio."
BI 201335 U.S. Phase 3 Trials
There are currently three Phase 3 trials enrolling patients around the world that together seek to enroll approximately 1,875 patients. Two of the three trials have U.S. trial sites that together plan to enroll approximately 495 patients.
In the U.S., Study 1220.47 will enroll approximately 370 treatment-naive genotype-1 HCV patients at 95 trial sites. This study will also include additional sites in Canada, Taiwan and Korea. Study 1220.7 will enroll approximately 125 treatment-experienced genotype-1 HCV patients who have failed at least 12 weeks of prior treatment with SOC at 40 trial sites in the U.S. This study also includes additional trial sites around the world. In treatment-naive patients (Study 1220.47), BI 201335 will be dosed once-daily at either 120 mg or 240 mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated interferon and ribavirin, the current HCV SOC. In treatment-experienced patients (Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 48 weeks for prior partial and null responder patients. Patients with prior relapse will be dosed with BI 201335 once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 24 or 48 weeks total duration. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure.(3)
For more information about clinical trials involving BI 201335, please visit www.clinicaltrials.gov.
About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant.(1,4) The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year.(5) Only about 20-45 percent of patients clear the virus in the acute phase.(5) Of the remaining chronically infected patients, 20 percent will develop cirrhosis within a mean of 20 years.(1) The mortality rate after cirrhosis has developed is two to five percent per year.(6) End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.(1)
About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research program for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV. The company has a well established research center in Laval, Canada, dedicated to virology research since the early 1990's, and is committed to developing new therapies for virologic diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim's own research and development, which has completed clinical trials through Phase 2b (SILEN-C studies). This Phase 2 program supports the investigation of BI 201335 in Phase 3 trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase 1 clinical trials. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.
References:
- National Digestive Disease Information Clearing House (NDDICH), NIH. Chronic Hepatitis C: Current Disease Management. http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm.
- U.S. Food and Drug Administration (FDA). Fast Track Designation Request Performance. http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122932.htm.
- American Association for the Study of Liver Disease Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology, April 2009. http://www.natap.org/2009/HCV/aasld.pdf.
- Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for the Public. http://www.cdc.gov/hepatitis/C/cFAQ.htm.
- World Health Organization (WHO): Europe. Hepatitis: Hepatitis C. http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures/hepatitis-c.
- Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009. http://cid.oxfordjournals.org/content/48/3/313.full.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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RELATED LINKS
http://us.boehringer-ingelheim.com
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