Product
Incivek
Approval Date
May 23, 2011
Release Date
June 2011
Company
Vertex Pharmaceuticals
Class
Protease inhibitor
Indication
For use with peginterferon alfa and ribavirin to treat chronic hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment
Active Ingredient
Telaprevir
Agency Roster
AbelsonTaylor (professional, US)
echoTorre Lazur (ex-US)
Marketing Strategy/Execution
Vertex has put a marketing staff of 175 in the field, including a 115-strong sales force, averaging 14 years of pharma industry experience and eight years in antivirals. The second-to-market treatment for hepatitis C is going head to head with Victrelis, which is being co-promoted by Merck and Roche. Both cocktails have a proven cure rate and manageable side effects. Incivek is easier to use than its rival and has been shown to clear the virus in a greater percentage of patients, attributes the firm uses to justify a higher price tag of $49,200 for a 12-week course, almost double the wholesale cost of a 24-week course of Victrelis. Incivek’s aggressive pricing could mean fewer patients use the drug, some of whom move over to Victrelis, according to a research note from Wolters Kluwer inThought. Analyst estimates have Victrelis taking a quarter of the market and Incivek, the more potent of the two, grabbing the rest. Other Incivek marketing tactics include an unbranded patient education site, BetterToKnowC.com, with a 24/7 nurse hotline, along with a professional education site at HCVInsights.com.
Physician Outlook
Vertex’s Incivek (telaprevir) is the second of two groundbreaking new oral agents to be approved in May 2011 by the FDA for the treatment of certain patients with chronic hepatitis C ((HCV) infection. In combination with peginterferon alpha and ribavirin, Incivek, a protease inhibitor, achieved a sustained viral response (SVR) in 79% in patients naïve to treatment versus 46% of those in the control group who received alpha interferon and ribavirin alone, the current standard of care (SOC). Additionally, some of the Incivek patients achieved SVR in only 24 weeks versus 48 weeks for the control group. Incivek’s key competitor out of the gate will be Victrelis (boceprevir), another protease inhibitor entrant manufactured by Merck. The lackluster SVR rates of current SOC make Incivek very appealing to physicians who anticipate saving more lives with the triple combo therapy. However, physicians greatly look forward to the future when treatment for HCV is oral only and patients can avoid the injections and side effects of interferon alpha as well as the contraindications of ribavirin.
-Will Leskin, Senior Vice President, Research and Consulting, GfK HealthCare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: DEB-025
Manufacturer:Novartis
Indication: Hepatitis C
Active ingredient: Alisporivir
Phase: III
Drug: BI 201335 NA
Manufacturer:Boehringer Ingelheim
Indication: Hepatitis C
Active ingredient: BI 201335
Phase: III (Fast Track)
Drug: TMC-435
Manufacturer:Tibotec BVBA
Indication: Hepatitis C
Active ingredient: Simeprevir
Phase: III
Source: Wolters Kluwer Pharma Solutions
Recent MM&M Coverage
Vertex ready to put 200 in field for hep. C drug launch
Vertex versus Goliaths in HCV drug duel
Vertex to put 200 in field for launch
Roche to co-promote Merck’s Victrelis in US
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
