Linda Ficken contracted Hepatitis C in a Kansas hospital, but last month she sued UPMC Presbyterian in Pittsburgh for gross negligence.
Now two other people from Kansas have also filed suit
Monday, October 1, 2012
Video- Hepatitis C Victims File Suit Against UPMC
PITTSBURGH (KDKA) - Oct 1 2012
Linda Ficken contracted Hepatitis C in a Kansas hospital, but last month she sued UPMC Presbyterian in Pittsburgh for gross negligence.
Now two other people from Kansas have also filed suit
http://pittsburgh.cbslocal.com/2012/10/01/hepatitis-c-victims-file-suit-against-upmc/
Linda Ficken contracted Hepatitis C in a Kansas hospital, but last month she sued UPMC Presbyterian in Pittsburgh for gross negligence.
Now two other people from Kansas have also filed suit
Achillion Pharmaceuticals moves up as a contender in the HCV market
Achillion Pharmaceuticals moves up as a contender in the HCV market
Written by Dr. Ramya Kartikeyan, GlobalData's senior healthcare analyst covering infectious diseases.
GlobalData- October 1 2012
On September 27, Achillion Pharmaceuticals released news of positive results surrounding Phase Ia trials testing ACH-3102, an NS5A inhibitor drug created to treat chronic Hepatitis C Virus (HCV) infections. In the past few months, developers in this space have faced serious concerns. Bristol-Myers Squibb’s HCV drug candidate BMS-986094, another NS5A inhibitor, recently caused the death of a patient during Phase IIb trials as a result of heart failure. The FDA, in response to this adverse event, moved to halt clinical trials on competitor Idenix Pharmaceuticals’ HCV NS5A inhibitor, IDX184.
Written by Dr. Ramya Kartikeyan, GlobalData's senior healthcare analyst covering infectious diseases.
GlobalData- October 1 2012
On September 27, Achillion Pharmaceuticals released news of positive results surrounding Phase Ia trials testing ACH-3102, an NS5A inhibitor drug created to treat chronic Hepatitis C Virus (HCV) infections. In the past few months, developers in this space have faced serious concerns. Bristol-Myers Squibb’s HCV drug candidate BMS-986094, another NS5A inhibitor, recently caused the death of a patient during Phase IIb trials as a result of heart failure. The FDA, in response to this adverse event, moved to halt clinical trials on competitor Idenix Pharmaceuticals’ HCV NS5A inhibitor, IDX184.
Currently, the leading drugs on the market, Vertex’s Incivek (telaprevir) and Merck’s Victrelis (boceprevir) are only indicated with the use of Pegasys (pegylated interferon-alpha) and ribavirin, which fall short on multiple counts. Most important, however, are the toxicity issues associated with the use of ribavirin and Pegasys, and the fact these treatments do not intrinsically eliminate the virus, but instead stimulate the immune system to help deal with the viral infection. Both Incivek and Victrelis are NS5A inhibitors, which offer a glimpse into the market possibilities for a drug like Achillion’s ACH-3102. In contrast, Achillion has stated that further trials will test ACH-3102 in combination with ribavirin but not Pegasys. Nevertheless, this approach keeps in line with the trend of using NS5A inhibitors in combination with other Direct-Acting Antiviral (DAA) therapies.
In developing ACH-3102, Achillion focused on creating a drug that targets multiple genotypes of HCV. The different HCV genotypes pose a problem within the general population, where treatment towards a specific genotype of HCV is less likely to treat infections against other HCV genotypes.
Currently, there are 11 known genotypes of HCV, which makes the pan-genotypic treatment option of a drug like ACH-3102 very appealing to physicians and patients alike. Achillion’s research would appear to address the unmet need of drugs capable to treat multiple genotypes, in addition to creating drugs that deal with resistant strains of HCV. While seemingly a sound investment in research and development funds, it is interesting to note that many other players in this market still have active research programs focused upon treating HCV 1a.
The current HCV pipeline continues to be robust and growing. With most companies doubling down on their investments, research includes concurrent development in NS5A inhibitors, NS3 protease inhibitors, nucleotide inhibitors and polymerase inhibitors. With the pipeline leaning heavily in favor of polymerase and protease inhibitors, it would appear that the current marketed drugs have had a large role in determining the research focus of the newer products. More importantly, as products move to a fixed-dose combinatorial therapy, as seen in the HIV market, more companies are involved in expanding their pipeline to include different drug options and eliminate a split in potential drug revenue.
A growing population segment within the HCV therapeutics market is patients co-infected with HIV. This segment, largely seen as a growth market in countries with high prevalence of HIV, might allow companies to realize large profits within the seven major markets (US, UK, France, Italy, Germany, Spain and Japan), where prevalence of HIV is higher than its incidence. As companies such as Bristol-Myers Squibb, Gilead, Vertex and Abbott develop new HCV drugs, a likely secondary indication would be in patients infected with HIV.
With an early win, Achillion faces a long and turbulent path to the finish line. In the face of other bigger pharma players, Achillion might be seen as a potential acquisition or licensing opportunity, and given the debacle with Bristol-Myers Squibb’s HCV drug candidate, Achillion might not even think twice about offsetting some of the risk associated with the continued development of this drug. With a diverse HCV and antibacterial portfolio, Achillion is undoubtedly research-rich. Without assessing Achillion’s corporate strategy, the company will face important decisions with respect to marketing and commercialization approaches it chooses to adopt for their leading candidate drugs. However, as long as their drugs continue to trend positively, Achillion will enjoy the privilege of being courted by Big Pharma and seeking an alliance strongly in their favor.
Medivir-Simeprevir (TMC435) Data Will Be Presented at the Upcoming AASLD Meeting
STOCKHOLM--(BUSINESS WIRE)--Oct 1, 2012 - Regulatory News: Medivir AB (STO:MVIRB), announced today that four abstracts related to simeprevir (TMC435), have been accepted for presentation at the 63nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from November 9-13 in Boston, USA.
Simeprevir is a once daily potent HCV NS3/4A protease inhibitor in phase III clinical development for the treatment of chronic hepatitis C jointly developed by Medivir and Janssen Research & Development Ireland (Janssen).
AASLD PRESENTATIONS
Two of the abstracts will be presented as oral presentations and two as posters at the Hynes Convention Center in Boston.
ORAL PRESENTATIONS
Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 16:45-18:15
Clinical HCV 1, Poster Hall, November 11, 08:00-17:30
About Simeprevir (TMC435)
Simeprevir is a once daily potent HCV NS3/4A protease inhibitor jointly developed by Medivir and Janssen Research & Development Ireland (Janssen) to treat chronic hepatitis C virus infections.
Simeprevir is being developed both in combination with PegIFN/RBV and in combination with other Direct-acting Antiviral (DAA) agents in an all oral Interferon (IFN) free regimen, with or without Ribavirin (RBV).
Simeprevir is currently being evaluated in three global phase III studies, QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior PegIFN/RBV-treatment. In parallel to these trials, phase III studies for simeprevir in Japan, in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients, are ongoing.
In parallel with the ongoing global phase III-studies, simeprevir is currently in three phase II Interferon free trials with or without Ribavirin.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The World Health Organization estimates that nearly 170 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC (Centers for Disease Control and Prevention) has reported that more than three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is simeprevir (TMC435), a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Research & Development Ireland.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia and today Medivir has a broad product portfolio with prescription pharmaceuticals in the Nordics.
Medivir's first product, the unique cold sore product Xerese®/Xerclear®, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.
Medivir's IPO was in 1996 and currently the company has around 180 employees.
For more information about Medivir, please visit the Company's website: www.medivir.com
Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people's lives.
This information was brought to you by Cision http://www.cisionwire.com
Contact: Medivir
Direct: +46 8 440 6550
or
Rein Piir
EVP Corporate Affairs & IR
Mobile: +46 708 537 292
or
M:Communications
medivir@mcomgroup.com
Europe:
Mary-Jane Elliott
or Amber Bielecka
or Hollie Vile
+44(0)20 7920 2330
Simeprevir is a once daily potent HCV NS3/4A protease inhibitor in phase III clinical development for the treatment of chronic hepatitis C jointly developed by Medivir and Janssen Research & Development Ireland (Janssen).
AASLD PRESENTATIONS
Two of the abstracts will be presented as oral presentations and two as posters at the Hynes Convention Center in Boston.
ORAL PRESENTATIONS
Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 16:45-18:15
- Efficacy and tolerability of TMC435 150 mg once daily with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials) Fred Poordad, Michael W. Fried, Stefan Zeuzem, Peter Ferenci, Oliver Lenz, Rekha Sinha, Katleen Callewaert, Monika Peeters, Maria Beumont-Mauviel
- No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus Sivi Ouwerkerk-Mahadevan, Alexandru Simion, Steven Mortier, Monika Peeters, Maria Beumont Mauviel
Clinical HCV 1, Poster Hall, November 11, 08:00-17:30
- Safety and tolerability of TMC435 in combination with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naïve and -experienced patients (Phase IIb PILLAR and ASPIRE trials) Michael W. Fried, Fred Poordad, Stefan Zeuzem, Peter Ferenci, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Monika Peeters, Rekha Sinha, Maria Beumont-Mauviel
- No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone Sivi Ouwerkerk-Mahadevan, Maria Beumont-Mauviel, Kurt Spittaels, Alexandru Simion, Monika Peeters
About Simeprevir (TMC435)
Simeprevir is a once daily potent HCV NS3/4A protease inhibitor jointly developed by Medivir and Janssen Research & Development Ireland (Janssen) to treat chronic hepatitis C virus infections.
Simeprevir is being developed both in combination with PegIFN/RBV and in combination with other Direct-acting Antiviral (DAA) agents in an all oral Interferon (IFN) free regimen, with or without Ribavirin (RBV).
Simeprevir is currently being evaluated in three global phase III studies, QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior PegIFN/RBV-treatment. In parallel to these trials, phase III studies for simeprevir in Japan, in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients, are ongoing.
In parallel with the ongoing global phase III-studies, simeprevir is currently in three phase II Interferon free trials with or without Ribavirin.
- In the first trial simeprevir is evaluated in combination with GS7977 (Gilead) in null responder hepatitis C genotype-1 infected patients.
- In the second trial simeprevir is evaluated in combination with daclatasvir (BMS) in treatment-naïve or previous null responder hepatitis C genotype-1 infected patients.
- In the third trial simeprevir is evaluated in combination with TMC647055 (Janssen R&D) and ritonavir in low doses in treatment-naïve, relapser or null responder hepatitis C genotype-1 infected patients.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The World Health Organization estimates that nearly 170 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC (Centers for Disease Control and Prevention) has reported that more than three million people in the United States are chronically infected with HCV.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is simeprevir (TMC435), a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Research & Development Ireland.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia and today Medivir has a broad product portfolio with prescription pharmaceuticals in the Nordics.
Medivir's first product, the unique cold sore product Xerese®/Xerclear®, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.
Medivir's IPO was in 1996 and currently the company has around 180 employees.
For more information about Medivir, please visit the Company's website: www.medivir.com
Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people's lives.
This information was brought to you by Cision http://www.cisionwire.com
Contact: Medivir
Direct: +46 8 440 6550
or
Rein Piir
EVP Corporate Affairs & IR
Mobile: +46 708 537 292
or
M:Communications
medivir@mcomgroup.com
Europe:
Mary-Jane Elliott
or Amber Bielecka
or Hollie Vile
+44(0)20 7920 2330
New Hepatitis C Data from Boehringer Ingelheim to be Presented at AASLD Annual Meeting
New Hepatitis C Data from Boehringer Ingelheim to be Presented at AASLD Annual
Meeting
RIDGEFIELD, Conn., Oct. 1, 2012 /PRNewswire/ -- New data from Boehringer Ingelheim's hepatitis C virus (HCV) clinical development program, HCVersoTM, have been accepted for presentation at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 9 - 13 in Boston, MA.
Results from all arms of SOUND-C2, a Phase 2b trial evaluating an investigational interferon-free HCV treatment, along with other analyses of the trial program will be presented at the meeting. The data will include results of a comparison of SVR4, 12 and 24 from the SOUND-C2 study, and virologic and pharmacokinetic evaluations. SVR is defined as sustained viral response after treatment ends, and is considered viral cure after 24 weeks. Collectively, these data underscore the company's focus on finding answers to the challenges faced by HCV patients and treaters.
"We are looking forward to sharing the full results of our Phase 2 interferon-free trial, and other HCVersoTM clinical trial data, at the upcoming AASLD meeting in November," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Through a robust HCV development program, BI is striving to deliver new solutions with real-life patient needs at the core."
Boehringer Ingelheim's abstracts can be accessed through the AASLD website today, www.aasld.org.
About Boehringer Ingelheim in Hepatitis C Virus (HCV)In partnership with the scientific community, our clinical trial program, HCVersoTM, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat.
Faldaprevir, also known as BI 201335, is an investigational oral HCV NS3/4A protease inhibitor that may improve cure rates as compared to PegIFN/RBV therapy alone, and has completed clinical trials through Phase 2b (SILEN-C studies). The ongoing multi-study Phase 3 STARTVersoTM trial program, evaluating faldaprevir combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV, is near clinical completion. BI 207127 is an NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVersoTM trials investigating this regimen will commence later this year.
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Chronic HCV leads to an estimated 8,000 to 10,000 deaths annually in the United States.
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.
RIDGEFIELD, Conn., Oct. 1, 2012 /PRNewswire/ -- New data from Boehringer Ingelheim's hepatitis C virus (HCV) clinical development program, HCVersoTM, have been accepted for presentation at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 9 - 13 in Boston, MA.
Results from all arms of SOUND-C2, a Phase 2b trial evaluating an investigational interferon-free HCV treatment, along with other analyses of the trial program will be presented at the meeting. The data will include results of a comparison of SVR4, 12 and 24 from the SOUND-C2 study, and virologic and pharmacokinetic evaluations. SVR is defined as sustained viral response after treatment ends, and is considered viral cure after 24 weeks. Collectively, these data underscore the company's focus on finding answers to the challenges faced by HCV patients and treaters.
"We are looking forward to sharing the full results of our Phase 2 interferon-free trial, and other HCVersoTM clinical trial data, at the upcoming AASLD meeting in November," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Through a robust HCV development program, BI is striving to deliver new solutions with real-life patient needs at the core."
Boehringer Ingelheim's abstracts can be accessed through the AASLD website today, www.aasld.org.
Oral Presentations
| ||
Title
|
Lead Author
|
Presentation Details
|
Efficacy and safety of the interferon (IFN)-free combination of BI 201335 + BI 207127 +/- ribavirin (RBV) in treatment-naive patients with HCV genotype (GT) 1 infection and compensated liver cirrhosis: Results from the SOUND-C2 study
|
V. Soriano
|
ID# 84
Parallel Session 12: HCV New Agents: Hard to Treat Patients
Date: Sun, Nov. 11
Time: 6:00 - 6:15 PM ET
Location: Hynes: Ballroom B&C
|
Interferon (IFN)-free combination treatment with the HCV NS3/4A protease inhibitor BI 201335 and the nonnucleoside NS5B inhibitor BI 207127 +/- ribavirin (R): Final results of SOUND-C2 and predictors of response
|
S. Zeuzem
|
ID# 232
Parallel Session 34: HCV Clinical Trials: New Agents and Interferon-free
Date: Tues, Nov. 13
Time: 11:30 - 11:45 AM ET
Location: Auditorium
|
Poster Presentations
| ||
Title
|
Lead Author
|
Presentation Details
|
SOUND-C2: SVR4, 12, and 24 concordance in genotype (GT) 1 HCV patients receiving interferon (IFN)-free treatment with the HCV NS3/4A protease inhibitor BI 201335 and the NS5B polymerase inhibitor BI 207127
|
S. Zeuzem
|
ID# 778
Session: Clinical HCV 1
Date: Sun, Nov. 11
Time: 8:00 AM - 5:30 PM ET
Location: Poster Hall
|
HCV NS3 and NS5B variants that emerged in patients with virologic breakthrough and relapse from the Phase II SOUND-C2 trial investigating interferon-free BI 201335 and BI 207127 therapy +/- ribavirin
|
A. Cote-Martin
|
ID# 788
Session: Clinical HCV 1
Date: Sun, Nov. 11
Time: 8:00 AM - 5:30 PM ET
Location: Poster Hall
|
Pharmacokinetics of the interferon-free combination of BI 207127 and BI 201335 plus ribavirin in treatment naive patients with genotype (GT) 1 HCV: Results from the SOUND-C1 study
|
J. Sabo
|
ID# 777
Session: Clinical HCV 1
Date: Sun, Nov. 11
Time: 8:00 AM - 5:30 PM ET
Location: Poster Hall
|
Analysis of baseline polymorphisms and persistence of emergent variants from Phase Ib and II trials evaluating the HCV NS3 protease inhibitor BI 201335
|
K. Berger
|
ID# 785
Session: Clinical HCV 1
Date: Sun, Nov. 11
Time: 8:00 AM - 5:30 PM ET
Location: Poster Hall
|
Addition of the NS5B polymerase inhibitor BI 207127 to pegylated interferon and ribavirin (PegIFN/RBV) for 4 weeks followed by PegIFN/RBV for 44 weeks improves SVR24 rates in treatment-naive patients with HCV genotype (GT) 1 and is well tolerated
|
A. Lohse
|
ID# 767
Session: Clinical HCV 1
Date: Sun, Nov. 11
Time: 8:00 AM - 5:30 PM ET
Location: Poster Hall
|
About Boehringer Ingelheim in Hepatitis C Virus (HCV)In partnership with the scientific community, our clinical trial program, HCVersoTM, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat.
Faldaprevir, also known as BI 201335, is an investigational oral HCV NS3/4A protease inhibitor that may improve cure rates as compared to PegIFN/RBV therapy alone, and has completed clinical trials through Phase 2b (SILEN-C studies). The ongoing multi-study Phase 3 STARTVersoTM trial program, evaluating faldaprevir combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV, is near clinical completion. BI 207127 is an NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVersoTM trials investigating this regimen will commence later this year.
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Chronic HCV leads to an estimated 8,000 to 10,000 deaths annually in the United States.
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.
Merck to Present New Data for VICTRELIS®(boceprevir) and MK-5172 at The American Association for the Study of Liver Diseases 2012 Annual Meeting
Merck to Present New Data for VICTRELIS®(boceprevir) and MK-5172 at The American Association for the Study of Liver Diseases 2012 Annual Meeting
.
WHITEHOUSE STATION, N.J.--()--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that new data from Phase III studies of VICTRELIS® (boceprevir) 200 mg Capsules, the company’s oral hepatitis C virus (HCV) NS3/4A protease inhibitor will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). The meeting will take place November 9-13 in Boston.
More than 20 abstracts highlighting Merck medicines and investigational therapies for chronic HCV will be presented at AASLD, including two oral presentations and six posters on VICTRELIS. New data will also be presented on the efficacy and safety of MK-5172, Merck’s investigational, once-daily, second generation oral HCV NS3/4A protease inhibitor, in patients chronically infected with HCV genotype 1.
“We are pleased to present new data on VICTRELIS that provides healthcare professionals with information that may better inform them as they consider VICTRELIS combination therapy for appropriate patients,” said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. "We also look forward to continued discussions with the global scientific and patient communities about Merck's investigational medicines for chronic hepatitis C, as we remain committed to reducing the burden of this serious disease worldwide."
The abstracts were published today and can be accessed on the AASLD website. For program information, please visit https://www.aasld.org.
Key presentations for VICTRELIS (boceprevir)
Boceprevir (BOC) Combined with Peginterferon alfa-2b/Ribavirin (P/RBV) in Treatment-Naïve Chronic HCV Genotype 1 Patients with Compensated Cirrhosis: Sustained Virologic Response (SVR) and Safety Subanalyses From the Anemia Management Study. Lawitz, F. et al. Oral Presentation: Sunday, Nov. 11, 3:15 p.m.-3:30 p.m., Hynes Convention Center, Ballroom B/C.
Timing and Magnitude of Ribavirin Dose Reduction (RBV DR) Do Not Impact Sustained Virologic Response Rates with Boceprevir (BOC) + Peginterferon alfa-2b / Ribavirin (P/RBV) in the Anemia Management Study in Chronic HCV Genotype 1 Patients. Poordad, F. et al. Oral Presentation: Monday, Nov. 12, 3:45 p.m.-4:00 p.m., Hynes Convention Center, Ballroom B/C.
Other key Merck presentations
Safety and Sustained Viral Response of MK-5172 for 12 Weeks in Combination with Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks in HCV Genotype 1 Treatment-Naïve Noncirrhotic Patients. Marcellin, P. et al. Poster 766. Sunday, Nov. 11, 8:00 a.m.-5:30 p.m., Hynes Convention Center Poster Hall.
MK-5172, A Potent Second-Generation HCV NS3/4a Protease Inhibitor, Retains Potent in vitro Activity Against a Panel of Boceprevir Resistant HCV G1a and G1b Patient Isolates. Ogert, R.A. et al. Poster 1724. Tuesday, Nov. 13, 8:00 a.m.-12:00 p.m., Hynes Convention Center Poster Hall. Selected as a Presidential Poster of Distinction.
Indications and usage for VICTRELIS
VICTRELIS is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (PR), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
All contraindications to PR also apply since VICTRELIS must be administered with PR. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with PR is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers, where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca®(tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and/or Neutropenia -- The addition of VICTRELIS to PR is associated with an additional decrease in hemoglobin concentrations compared to PR alone and/or may result in worsening of neutropenia associated with PR therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of PR.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with PR were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for PR alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with PR alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2011 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf.
VICTRELIS® is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio® and Adcirca®are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Contacts
.
WHITEHOUSE STATION, N.J.--()--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that new data from Phase III studies of VICTRELIS® (boceprevir) 200 mg Capsules, the company’s oral hepatitis C virus (HCV) NS3/4A protease inhibitor will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). The meeting will take place November 9-13 in Boston.
More than 20 abstracts highlighting Merck medicines and investigational therapies for chronic HCV will be presented at AASLD, including two oral presentations and six posters on VICTRELIS. New data will also be presented on the efficacy and safety of MK-5172, Merck’s investigational, once-daily, second generation oral HCV NS3/4A protease inhibitor, in patients chronically infected with HCV genotype 1.
“We are pleased to present new data on VICTRELIS that provides healthcare professionals with information that may better inform them as they consider VICTRELIS combination therapy for appropriate patients,” said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. "We also look forward to continued discussions with the global scientific and patient communities about Merck's investigational medicines for chronic hepatitis C, as we remain committed to reducing the burden of this serious disease worldwide."
The abstracts were published today and can be accessed on the AASLD website. For program information, please visit https://www.aasld.org.
Key presentations for VICTRELIS (boceprevir)
Boceprevir (BOC) Combined with Peginterferon alfa-2b/Ribavirin (P/RBV) in Treatment-Naïve Chronic HCV Genotype 1 Patients with Compensated Cirrhosis: Sustained Virologic Response (SVR) and Safety Subanalyses From the Anemia Management Study. Lawitz, F. et al. Oral Presentation: Sunday, Nov. 11, 3:15 p.m.-3:30 p.m., Hynes Convention Center, Ballroom B/C.
Timing and Magnitude of Ribavirin Dose Reduction (RBV DR) Do Not Impact Sustained Virologic Response Rates with Boceprevir (BOC) + Peginterferon alfa-2b / Ribavirin (P/RBV) in the Anemia Management Study in Chronic HCV Genotype 1 Patients. Poordad, F. et al. Oral Presentation: Monday, Nov. 12, 3:45 p.m.-4:00 p.m., Hynes Convention Center, Ballroom B/C.
Other key Merck presentations
Safety and Sustained Viral Response of MK-5172 for 12 Weeks in Combination with Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks in HCV Genotype 1 Treatment-Naïve Noncirrhotic Patients. Marcellin, P. et al. Poster 766. Sunday, Nov. 11, 8:00 a.m.-5:30 p.m., Hynes Convention Center Poster Hall.
MK-5172, A Potent Second-Generation HCV NS3/4a Protease Inhibitor, Retains Potent in vitro Activity Against a Panel of Boceprevir Resistant HCV G1a and G1b Patient Isolates. Ogert, R.A. et al. Poster 1724. Tuesday, Nov. 13, 8:00 a.m.-12:00 p.m., Hynes Convention Center Poster Hall. Selected as a Presidential Poster of Distinction.
Indications and usage for VICTRELIS
VICTRELIS is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (PR), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
- VICTRELIS must not be used as monotherapy and should only be used in combination with PR.
- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
- VICTRELIS in combination with PR has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with PR. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with PR alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to PR therapy.
- Poorly interferon responsive patients who were treated with VICTRELIS in combination with PR have a lower likelihood of achieving a sustained virologic response (SVR), and higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to PR.
All contraindications to PR also apply since VICTRELIS must be administered with PR. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with PR is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers, where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca®(tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and/or Neutropenia -- The addition of VICTRELIS to PR is associated with an additional decrease in hemoglobin concentrations compared to PR alone and/or may result in worsening of neutropenia associated with PR therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of PR.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with PR were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for PR alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with PR alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2011 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf.
VICTRELIS® is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio® and Adcirca®are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Contacts
Merck
Media:
Pamela Eisele, 908-423-5042
Lainie Keller, 908-423-4187
or
Investors:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
Media:
Pamela Eisele, 908-423-5042
Lainie Keller, 908-423-4187
or
Investors:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
Vertex Announces Presentation of New Data from Hepatitis C Development Program at AASLD Annual Meeting
October 1, 2012
Vertex Announces Presentation of New Data from Hepatitis C Development Program at AASLD Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 11 abstracts from its hepatitis C research and development program will be presented at The Liver Meeting®, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 9 to 13, 2012. Presentations will include data on INCIVEK® (telaprevir) tablets, Vertex's approved medicine for the treatment of genotype 1 chronic hepatitis C, and two of the company's hepatitis C treatments in development: VX-222, a non-nucleoside polymerase inhibitor, and ALS-2200 (VX-135), a uridine nucleotide analogue pro-drug.
These accepted abstracts are now available on the AASLD website at: https://www.aasld.org/lm2012.
ALS-2200 (VX-135) Presentations
1. "ALS-2200, a Novel Once-Daily Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity over 7 Days in Treatment-Naïve Genotype 1 (GT1) Patients." November 11, 2012, 5:00 p.m. EST. Oral Presentation #86
2. "Preclinical Characterization of ALS-2200, a Potent Nucleotide Polymerase Inhibitor for the Treatment of Chronic Hepatitis C." November 13, 2012, 8:00 a.m. - 12:00 p.m. EST. Poster Presentation #1882
3. "Analysis of ALS-2200, a Novel Potent Nucleotide Analog, Combination Drug Interactions in the Hepatitis C Virus (HCV) Subgenomic Replicon System." November 13, 2012, 8:00 a.m. - 12:00 p.m. EST. Poster Presentation #1887
INCIVEK (telaprevir) Presentations
1. "Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results." November 11, 2012, 4:15 p.m. EST. Oral Presentation #54
2. "Evaluation of Liver and Plasma HCV RNA Kinetics and Telaprevir Levels in Genotype 1 HCV Patients Treated with Telaprevir using Serial Fine Needle Aspirates." November 13, 2012, 9:00 a.m. EST. Oral Presentation #215
3. "The Safety of Telaprevir in the Absence of Interferon and/or Ribavirin: Analysis of On-Treatment Data from the ZENITH Trial." November 11, 2012, 8:00 a.m. - 5:30 p.m. EST. Poster Presentation #786
4. "Factors Predictive of Anemia Development in Treatment-Experienced Patients Receiving Telaprevir (TVR) Plus Peginterferon/Ribavirin (PR) in the REALIZE Trial." November 11, 2012, 8:00 a.m. - 5:30 p.m. EST. Poster Presentation #771
5. "Rate of Disappearance of Telaprevir Resistant Variants Using Clonal and Population Sequence Data from Phase 3 Studies." November 11, 2012, 8:00 a.m. - 5:30 p.m. EST. Poster Presentation #756
6. "Deep Sequencing of the HCV NS3/4A Region Confirms Low Prevalence of the Telaprevir-Resistant Variants Both at Baseline and End of Study." November 11, 2012, 8:00 a.m. - 5:30 p.m. EST. Poster Presentation #1091
VX-222 Presentations
1. "VX-222, Telaprevir and Ribavirin in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C: Results of the ZENITH Study Interferon-Free Regimen." November 13, 2012, 11:15 a.m. EST. Oral Presentation #231
2. "Effect of Hepatic Impairment on the Pharmacokinetics of VX-222: Results From a Multicenter Phase 1 Study." November 13, 2012, 8:00 a.m.- 12:00 p.m. EST. Poster Presentation #1880
About ALS-2200 (VX-135) and VX-222
ALS-2200 (VX-135) is a uridine nucleotide analogue pro-drug that appears to have a high barrier to drug resistance based on in vitro studies. It is designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. In vitro studies of the compound showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.
Vertex gained worldwide rights to ALS-2200 through an exclusive worldwide licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research program.
VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. Vertex has worldwide commercial rights for VX-222.
About INCIVEK
INCIVEK® (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.
INCIVEK was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and by Health Canada in August 2011 for use in combination with pegylated-interferon and ribavirin for adults with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK is approved for people who are new to treatment, and for people who were treated previously with interferon-based treatment but who did not achieve a sustained viral response, or viral cure (relapsers, partial responders and null responders).
Vertex developed telaprevir in collaboration with Janssen and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK (in-SEE-veck). Janssen has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In September 2011, telaprevir was approved in the European Union and Switzerland. Telaprevir is known as INCIVO® in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries. In September 2011, telaprevir was approved in Japan and is known as Telavic®.
IMPORTANT SAFETY INFORMATION
Indication
INCIVEK® (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, up to 5 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9,10 Hepatitis C is four times more prevalent in the United States compared to HIV.10 The majority of people with hepatitis C in the United States were born between 1945 and 1965, accounting 82 percent of people with the disease.11 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 15,000 deaths annually.12,13 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.10
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and for three years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences
Vertex's press releases are available at www.vrtx.com.
(VRTX-GEN)
References:
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf Updated June 2010. Accessed September 21, 2012.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Chak, E, et. al. Hepatitis C Virus Infection In USA: An Estimate of True Prevalence. Liver Intl. 2011;1096 -1098.
10 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx Updated January 11, 2010. Accessed September 21, 2012.
11 Smith, BD, et al. Hepatitis C Virus Antibody Prevalence, Correlates and Predictors among Persons Born from 1945 through 1965, United States, 1999-2008. AASLD 2011 Annual Meeting.
12 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
13 S.D. Holmberg, K.N. Ly., et.al. The Growing Burden of Mortality Associated with Viral Hepatitis in the United States, 1999-2007. AASLD 2011 Annual Meeting.
Vertex Pharmaceuticals Incorporated
Media:
Erin Emlock or Zach Barber, 617-444-6992
mediainfo@vrtx.com
or
Investors:
or
News Provided by Acquire Media
New HCV drugs in development - Highlights Of The EASL-AASLD Special Conference
A special report provided by EASL of the EASL-AASLD Conference on - Therapy of Hepatitis C: Clinical Application and Drug
Development held this month in Prague, Czech Republic, is now available for viewing - Download PDF.
Highlights Include:
Therapy of Hepatitis C:Clinical Application and Drug Development
HCV transmission and therapeutic intervention
One year of triple combination therapy New HCV drugs in development
Overcoming resistance and treatment failure
New ways to search for novel anti-HCV drugs
*New HCV drugs in development (provided below)
New HCV drugs in development
“We have come a long way with interferon treatment since it was
first introduced in 1991 to the use of pegylated interferon as part
of triple HCV therapy today. Some are predicting therapy will be
interferon-free. But we need all the tools we can get to improve the
management of HCV and novel interferons and IFN inducers may
have an important role in some patient subgroups,” said Dr. Michael
Manns, Medical School of Hannover, Germany.
He suggested that
interferon-based therapies have several potential advantages compared
to direct antiviral agents:
• No viral resistance
• Comparatively low cost
• Vast clinical experience
• Potential use in other viral infections such as HBV.
For the future, INF-based therapy may be appropriate for easy to treat
patients, but new interferons have to be developed that are much safer
and better tolerated than current options.
Newer NS3/4A protease inhibitors in combination with peg-IFN and
ribavirin achieve high rates of SVR with simpler dosing schedules and
generally better tolerability than older agents, according to Dr. Michael
Fried, University of North Carolina, USA. He said that two years of clinical
experience with the currently available PIs have shown that ribavirin
is required for achieving SVR, rapid virological response is associated
with highest SVR and adverse events can generally be managed but
that certain populations are less responsive. New PIs in development
include simeprevir and faldeprevir (phase 3) and asuneprevir and ABT-
450/r (phase 2), mostly with peg-INF + RBV backbone. Trials so far show
encouragingly high rates of SVR and generally good tolerability, but we
have to wait for more data, he concluded.
“It’s becoming clear that nucleoside/nucleotide analogues provide
a very strong backbone for future HCV therapies,” argued Dr. David
Nelson, University of Florida, USA. They work by causing premature chain
termination during viral nucleic acid synthesis. The active binding site in
the target – NS5B RNA-dependent RNA polymerase – is highly conserved
across HCV genotypes, conferring pangenotypic activity and there is a
high barrier to resistance. Three agents are currently in development:
sofosbuvir (phase 3), mericitabine (phase 2) and ALS-2200 (phase 2),
while some others have been put on hold due to toxicity.
“Sofosbuvir (previously GS-7977) will be the most important compound
during the next 2-4 years,” predicted Professor Wedemeyer. He noted
that sofosbuvir therapy was successful in various IFN-free regimens and
may also help to shorten IFNa-based therapies. “However, we have
learned over the last few months that there will be no ‘one-size-fits-all’
regimen with sofosbuvir.”
Non-nucleoside inhibitors of HCV RNA polymerase have no role in
monotherapy and limited role in triple therapy, but they may be useful in
quadruple therapy, suggested Dr. Paul Pockros, La Jolla, USA. Reviewing
the available data, he noted that these agents have low to moderate
potency, a low barrier to resistance and are unlikely to have crossgenotype
activity. “Of the 13 non-nucleoside inhibitors in development in
2008, a lot have given disappointing results, with only six remaining,” he
said. Of these, Vx-222 is the most potent, achieving a 3.4 log10 reduction
in viral load (at a dose of 400mg bid) and is currently in phase 2. However,
some compounds may still be used in IFN-free treatment regimens if
combined with other highly potent DAAs.
Therapeutic vaccines represent a scientifically valid approach to
treating HCV but there is a long way to go to optimise vaccine response,
suggested Professor Heiner Wedemeyer. He questioned whether
vaccines for HCV are needed at all, with all the new drugs currently in
development, but suggested several reasons why they may be useful.
“First, HCV is not HIV,” he pointed out. “Immune control of HCV is
possible, in contrast to HIV infection.” Clinical observations show – quite
remarkably – that 10-50% of cases of acute hepatitis C are cleared
without treating, suggesting a major role for the immune system.
Combinations including NS5A inhibitors appear likely to address many
of the current unmet medical needs in HCV, especially for patients who
remain difficult to treat with currently available therapies, including
those with cirrhosis and patients undergoing liver transplant, according
to Dr. Stanislas Pol, Hopital Cochin, France. Reviewing the data with
daclatasovir, the first agent in the class, he said it is very potent, has
broad genotypic coverage and has a pharmacokinetic profile supportive
of once daily dosing, making it easy to take. A recent study with
quadruple therapy including daclatasovir, asapravir and peg-interferon/
ribavirin has shown ‘fantastic results,’ he said, with SVR4 of 90-100% in
a difficult to treat group of genotype 1 null responders. Moreover, NS5A
inhibitors are part of many IFN-free treatment regimens.
Cyclophilin inhibitors offer the benefits of a high barrier to resistance
and no cross-resistance with protease or polymerase inhibitors, Professor
Robert Flisiak, Medical University of Bialystok, Poland, told the meeting.
They act on NS5A, NS5B and NS2 HCV viral proteins, as well as preventing
HCV-mediated mitochondrial and endogenous interferon production.
Alisporivir – the most advanced agent in the class – has shown effects
in treatment naïve, previous non-responders and in HIV/HCV coinfected
patients. It has demonstrated antiviral efficacy against the four
most prevalent genotypes (1,2,3 and 4). It is effective in interferon-free
regimens, as well as providing additional antiviral effects in combination
with peg-interferon plus ribavirin, and is well tolerated. However, it is
currently on hold due to toxicity in combination with PEG-IFNa. Future
trials may therefore focus on IFN-free regimens including alisporivir.
Entry inhibitors, which block the entry of HCV into cells, are at an early
stage of development but proof of the concept has been demonstrated
in cell culture and in vivo models, reported Professor Thomas Baumert,
University of Strasbourg, France. They are pangenotypic, prevent
infection with escape variants and provide a complementary mechanism
of action of direct antiviral agents, demonstrating marked synergy. “They
offer a very attractive antiviral strategy for the prevention of liver graft
infection in patients who have undergone transplantation, as well as for
difficult to treat patients and those with multiresistance,” he suggested.
Hepatitis C - Response to Interferon-α/Ribavirin Does Not Decrease on Retreatment
Response to Interferon-α/Ribavirin Does Not Decrease on Retreatment of Hepatitis C
Among study participants with the same end-of-study response status, HCV RNA declines at 4 weeks were similar between treatment-naive patients and treatment-experienced ones.
Among study participants with the same end-of-study response status, HCV RNA declines at 4 weeks were similar between treatment-naive patients and treatment-experienced ones.
Participants in treatment studies of hepatitis C virus (HCV) infection are generally categorized as treatment naive or treatment experienced, based on previous receipt of an interferon-based regimen such as pegylated interferon-α plus ribavirin (P/R). Treatment-experienced individuals with P/R treatment failure can be further subdivided into relapsers, partial responders, and null responders, based on plasma HCV RNA concentrations during and after therapy.
To date, no data have emerged to indicate resistance to interferon-α–based therapy, suggesting that the response rate to P/R should not be lower with retreatment than with initial therapy. To examine this issue, investigators at the FDA examined data for participants in eight earlier trials (2996 treatment-naive and 754 treatment-experienced patients with genotype-1 HCV infection who had completed P/R treatment and had week-4 viral load data available).
In both treatment-naive and treatment-experienced patients, the HCV RNA change from baseline at 4 weeks was strongly correlated with the likelihood of achieving a sustained viral response (i.e., an undetectable viral load 24 weeks after the end of treatment). When therapy response was compared between treatment-experienced patients (stratified according to previous treatment outcomes) and treatment-naive patients (stratified based on end-of-treatment outcomes), the 4-week decline in HCV RNA was similar between the corresponding groups.
Comment: Despite its retrospective nature, this study suggests that responsiveness to Interferon-α/Ribavirin (P/R) does not decrease with retreatment. As the authors point out, this finding has implications for trials of interferon-based triple therapy — P/R plus one of the newer direct-acting antivirals emerging for HCV.
— Neil M. Ampel, MD
Published in Journal Watch Infectious Diseases September 19, 2012
Citation(s):
To date, no data have emerged to indicate resistance to interferon-α–based therapy, suggesting that the response rate to P/R should not be lower with retreatment than with initial therapy. To examine this issue, investigators at the FDA examined data for participants in eight earlier trials (2996 treatment-naive and 754 treatment-experienced patients with genotype-1 HCV infection who had completed P/R treatment and had week-4 viral load data available).
In both treatment-naive and treatment-experienced patients, the HCV RNA change from baseline at 4 weeks was strongly correlated with the likelihood of achieving a sustained viral response (i.e., an undetectable viral load 24 weeks after the end of treatment). When therapy response was compared between treatment-experienced patients (stratified according to previous treatment outcomes) and treatment-naive patients (stratified based on end-of-treatment outcomes), the 4-week decline in HCV RNA was similar between the corresponding groups.
Comment: Despite its retrospective nature, this study suggests that responsiveness to Interferon-α/Ribavirin (P/R) does not decrease with retreatment. As the authors point out, this finding has implications for trials of interferon-based triple therapy — P/R plus one of the newer direct-acting antivirals emerging for HCV.
— Neil M. Ampel, MD
Published in Journal Watch Infectious Diseases September 19, 2012
Citation(s):
Liu J et al. Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: Implications for drug development and clinical decisions. Clin Infect Dis 2012 Sep 1; 55:639.
- Original article (Subscription may be required)
- Medline abstract (Free)
Subscribe to:
Posts (Atom)