Beerse, Belgium (December 5, 2014) – Janssen Infectious Diseases-Diagnostics BVBA (Janssen) announced today that INCIVO® (telaprevir), one of the first direct-acting antiviral (DAA) agents and a new therapeutic class for the treatment of genotype 1 chronic hepatitis C (HCV), has received the International Prix Galien award.
The International Prix Galien Award, which is presented every two years to a medicine that has previously won a national Prix Galien, recognizes the pharmaceutical industry's outstanding achievement in the development of new medicines. An internationally recognized award, the Prix Galien was founded in France in 1969 by French pharmacist Roland Mehl and is considered the highest accolade for pharmaceutical research and development.
“It is a tremendous honor for Janssen to be recognized with the International Prix Galien Award for telaprevir,” said Mircea Cubillos, Hepatitis Disease Area Commercial Leader at Janssen after accepting the award on behalf of the company. "This achievement is testament to the remarkable contributions of hundreds of colleagues who worked tirelessly to bring telaprevir to patients affected by hepatitis C."
"For many years, in collaboration with our partner Vertex, our team conducted world class research and development which culminated in the launch of this lifesaving medicine,” added Gaston Picchio, Hepatitis Research and Development Leader. "Bringing together the best science with a dedicated team of researchers continues to be a foundation to make a real and lasting impact on patients’ lives."
The availability of new DAAs like telaprevir transformed treatment options for HCV since it was first approved in 2011. Telaprevir, used in combination with pegylated-interferon and ribavirin, acts directly on the viral enzymes and stops the virus from replicating unlike previously approved treatments. Telaprevir has played a significant role in improving treatment outcomes with more than 140,000 patients treated with telaprevir combination therapy worldwide . The significant unmet need and groundbreaking science was characterized by accelerated approvals by health authorities worldwide and the publication of six of its late stage studies in the New England Journal of Medicine.
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is major global public health concern. Approximately 170 million people are infected with hepatitis C worldwide and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.
Telaprevir previously won the national Prix Galien in Belgium, France, United Kingdom, Poland, United States (Vertex) and Canada (Vertex).
This latest International Prix Galien award is Janssen’s fourth international award. Janssen is now one of the most awarded companies having been previously recognized for STELARA® (Ustekinumab) (2012), VELCADE® (Bortezomid) (2006) and RISPERDAL® (Risperidone) (1996).
About INCIVO® (telaprevir)
INCIVO® (telaprevir), in combination with peginterferon alfa and ribavirin (PR), is indicated for the treatment of genotype-1 chronic HCV in adult patients with compensated liver disease (including cirrhosis) who are treatment naïve, and who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders. INCIVO® is a small molecule, selective inhibitor of the HCV serine protease, and a member of the class of medicine for the treatment of genotype-1 chronic HCV, direct acting antivirals (DAAs). Unlike treatments approved before 2011, DAAs act directly on viral enzymes and prevent the virus from replicating. INCIVO® was approved by the European Commission on the 19th September 2011.
INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (BID) with food. Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food. The total daily dose is 6 tablets (2,250 mg).
Telaprevir was developed by Janssen Infectious Diseases-Diagnostics BVBA, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex Pharmaceuticals Incorporated (Vertex) and Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe Pharma). It was first approved by the U.S. Food and Drug Administration (FDA) in May 2011, marketed by Vertex Pharmaceuticals under the brand name INCIVEK™, and by the European Commission in September 2011, marketed by Janssen Pharmaceutical Companies under the brand name INCIVO®.
Important Safety Information
Please see full Summary of Product Characteristics or visit http://www.emea.europa.eu for more details.
The overall safety profile of telaprevir is based on the Phase II/III clinical development programme containing 3,441 patients who received a telaprevir based regimen. In clinical trials, the incidence of adverse events of at least moderate intensity was higher in the telaprevir group than in the placebo group (both groups receiving peginterferon alfa and ribavirin). The most frequently reported adverse reactions (incidence ≥ 5.0%) of at least grade 2 in severity were anemia, rash, pruritus, nausea, and diarrhoea during the telaprevir treatment phase, and the most frequently reported adverse reactions (incidence ≥ 1.0%) of at least Grade 3 were anemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea. INCIVO® prescribing information includes special warnings and pre-cautions for use with regards to rash including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and Stevens - Johnson syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), where INCIVO, peginterferon alfa and ribavirin should be immediately and permanently discontinued and a specialist in dermatology consulted. In cases of mild and moderate rash discontinuation of INCIVO® is not always required and patients are advised to consult with a healthcare professional. In cases of severe rash immediate discontinuation of INCIVO® is required and consultation with a specialist in dermatology is recommended. 
Rash events were reported in 55% of patients with a telaprevir based regimen compared to 33% of patients treated with peginterferon alfa and ribavirin only and more than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir combination treatment in 4.8% of patients. Rash led to discontinuation of telaprevir alone in 5.8% of patients and 2.6% of patients discontinued telaprevir combination treatment for rash events compared to none of those receiving peginterferon alfa and ribavirin. 
Hemoglobin values of < 10 g/dl were observed in 34% of patients who received telaprevir combination treatment and in 14% of patients who received peginterferon alfa and ribavirin. In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued telaprevir alone due to anemia, and 0.9% of patients discontinued INCIVO combination treatment due to anemia compared to 0.5% receiving peginterferon alfa and ribavirin.
About Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Infectious Diseases-Diagnostics BVBA is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
- Casey L C, Lee W M. Hepatitis C Virus Therapy Update 2013. Curr Opin Gastroenterol. 2013;29(3):243-249.
- Janssen data on file.
- INCIVO® Summary of Product Characteristics updated 2014.
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