DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/mp3m43/generic_drug) has announced the addition of the "Generic Drug Opportunity Assessment - Boceprevir (Victrelis)" report to their offering.
Boceprevir is a direct acting antiviral drug against the hepatitis C (HCV) virus It is an inhibitor (protease inhibitor) of the HCV non-structural protein 3 (NS3) serine protease. Protease inhibitors are a class of antiviral drugs that are widely used to treat HIV/AIDS and hepatitis caused by hepatitis C virus. Protease inhibitors prevent viral replication by selectively binding to viral proteases (e.g. HIV-1 protease) and blocking proteolytic cleavage of protein precursors that are necessary for the production of infectious viral particles. Boceprevir (Victrelis) and the competing telaprevir (Incivek, Vertex Parmaceuticals) are indicated in combination with peginterferon plus ribavirin for genotype-1 HCV infection, the main HCV genotype worldwide.
The Market
Hepatitis C virus (HCV) is transmitted mainly by blood-to-blood contact, although it may be transmitted through unsafe sex. An estimated 3.9 million (1.8%) in the U.S. have been infected with HCV, of whom 2.7 million are chronically infected. Globally, an estimated 170 million persons are chronically infected with HCV and 3 to 4 million persons are newly infected each year.
Competitive Landscape
Incivek (telaprevir) is supplied by Vertex Pharmaceuticals. Incivek is an orally-administered HCV protease inhibitor for adults with genotype 1 HCV infection that is prescribed in combination with pegylated-interferon, or peg-IFN, and ribavirin, or RBV. Incivek was approved by the FDA, in the second quarter of 2011 and by Health Canada in the third quarter of 2011.
Incivek (telaprevir) is supplied by Vertex Pharmaceuticals. Incivek is an orally-administered HCV protease inhibitor for adults with genotype 1 HCV infection that is prescribed in combination with pegylated-interferon, or peg-IFN, and ribavirin, or RBV. Incivek was approved by the FDA, in the second quarter of 2011 and by Health Canada in the third quarter of 2011. In the third quarter of 2011, Vertex marketing partners Janssen Pharmaceutica, N.V., Mitsubishi Tanabe Pharma obtained marketing approval for telaprevir from the European Commission and the Japanese Ministry of Health, Labor and Welfare, respectively. Janssen markets telaprevir under the brand name INCIVO in Europe and other countries in its territories, and Mitsubishi Tanabe markets telaprevir under the brand name Telavic in Japan.
ANDA P (IV) Certification Activity
The antivirals segment has been one of the more active in recent years in terms of ANDA P 4 filings. There have been thirteen P (IV) patent certifications filed against branded antiviral drugs in the past three years.
The Opportunity
Competition among antivirals is quite high due to the number of alternative therapeutic drugs available and also because of the generally low level of specificity for any given drug in the treatment of a particular viral condition. As a result ANDA first-filers typically have a narrow window in which to work to produce the revenue numbers in their forecasts. In this environment, pre-launch planning and secondary sources of supply for critical materials can be critical to the success of the filing.
Report Highlights:
- Victrelis - The Brand
- Boceprevir - The Product
- Boceprevir - The Market
- Boceprevir - The Opportunity
- Manufacturing and Sourcing
- Victrelis Patents and Exclusivity
- Therapeutic Class P4 Certifications
- Generic First-to-File Revenue Opportunity
- Business Risk Assessment
- First-to-File - Probabilistic Scenario
For more information visit http://www.researchandmarkets.com/research/mp3m43/generic_drug
