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November 6, 2012 10:23 pm

Vertex’s Incivek twice-daily dosing schedule insufficient to entice HCV patients waiting for new drugs

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This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com

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Vertex Pharmaceuticals’ (NASDAQ:VRTX) improved dosing schedule of hepatitis C drug Incivek (telaprevir) will do little to convince currently warehoused patients to initiate therapy, experts said.

These warehoused patients are forgoing treatment now in favor of waiting for the next generation of direct-acting antiviral (DAA) drugs, which are expected to provide still better dosing, improved safety and tolerability, they noted.

Vertex did not return a request for comment.

Incivek was approved in May 2011 for the treatment of genotype 1 hepatitis C virus (HCV) as a triple therapy regimen in combination with pegylated-interferon and ribavirin. The drug, a protease inhibitor, had a rapid takeoff, particularly among patients with advanced disease, as it provided substantially improved sustained virologic response (SVR), or cure rates.

On its 3Q earnings call, the company announced a continued decline in Incivek sales. Total revenues of approximately USD 336m were reported for 3Q12, including net product revenues of approximately USD 254m from Incivek, down from USD 327.7 m in 2Q12. Previously, on its 2Q12 earnings call, Vertex lowered full-year Incivek sales estimates to USD 1.1bn-USD 1.25bn from a prior forecast of USD 1.5bn-USD 1.7bn.

Results of the OPTIMIZE trial, which compared twice daily (BID) versus three times daily (TID) dosing of Incivek, will be presented at the upcoming American Association for the Study of Liver Diseases annual meeting on 12 November. The Phase III, randomized, open-label, international study found BID to be noninferior to TID Incivek in treatment-naive, genotype 1 HCV infected patients, according to the abstract.

Impact of less-frequent dosing

The problem with triple therapy regimens is that, though they produce high response rates, they are also quite burdensome in terms of treatment, given that they are interferon-containing, said Dr Ray Chung, director, Hepatology, Medicine Service, Massachusetts General Hospital. Interferon is dosed as a weekly injection and is associated with flu-like side effects for possibly up to 44 weeks of treatment in a triple therapy regimen.

If a patient can realistically defer treatment, which is true in most cases based on liver disease stage, patients might be better off waiting for new therapies, Chung said. Patients with more advanced disease require treatment more urgently, whereas those with less advanced disease are able to wait.

While a BID dosing schedule is nice, the fundamental cooperative toxicity between interferon, ribavirin and a protease inhibitor must be factored into the mix, Chung added.

BID dosing will not make more patients get treated now, agreed Dr Susannah Naggie, assistant professor of medicine, Infectious Diseases, Duke University. The new regimen will not make a difference for someone who has already decided to wait, she said.

The first patients treated with Incivek were very motivated and did pretty well with the TID regimens, noted Dr Arthur Kim, director, Viral Hepatitis Clinic, Massachusetts General Hospital. For patients still waiting, however, BID dosing is generally not enough of a tipping point to convince them to start therapy now over next generation DAAs, he said.

Even though it has not yet been approved, Dr Eliot Godofsky, infectious disease specialist, University Hepatitis Center, Bradenton, Florida, has already been using the BID regimen in patients where it was thought the Incivek TID regimen would not work. Patients have reported less diarrhea when on the BID regimen, he added, speculating it may be due to the requirement of taking Incivek with a fatty meal. Still, he said, there is likely not enough of a benefit from the BID schedule to sway patients who have already deferred treatment. While BID is better than TID, it is still a complicated regimen, he noted.

Dr Don Jensen, professor of medicine, director, Center for Liver Diseases, University of Chicago, agreed some physicians are likely already using the BID schedule. The BID regimen does make it easier for some patients to manage their therapy, as ribavirin is also dosed BID. Still, he said, this would likely only help Incivek maintain an advantage over Merck’s (NYSE:MRK) fellow first-generation protease inhibitor, Victrelis (boceprevir), rather than next-generation therapies. Victrelis is similarly administered thrice-daily in combination with interferon and ribavirin.

Incivek had 2011 US annual sales of USD 951 m and is estimated to have 2012 sales of USD 1.19bn, according to BioPharm Insight data. Victrelis had 2011US annual sales of USD 139m, with projected 2012 sales of USD 505m.

The Centers for Disease Control and Prevention estimate HCV infection to be the most common chronic bloodborne infection in the US, with approximately 3.2 million people chronically infected. The disease is most prevalent among the baby boomer demographic, with the CDC recently recommending all adults born between 1945 and 1965 should be screened.

Vertex has a current market cap of USD 10bn.

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