AbbVie’s Viekira Pak Clears Another Hurdle, 100% HCV-1b Clearance Rate in Phase III Trial

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June 24, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Chicago-based AbbVie adds another arrow to its quiver in its arsenal of weapons against hepatitis C. The company announced today that its Phase IIIb TURQUOISE-III study showed a 100 percent clearance response with Viekirax and Exviera without ribavirin in genotype 1b (GT1b) chronic hepatitis C virus (HCV).

“Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens,” said Jordan Field, research director and clinician scientist at the Toronto Center for Liver Disease in a statement. “The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks.”

The combination if Viekirax and Exviera is otherwise marketed by AbbVie as Viekira Pak, but the current study suggests that it is effective whether it is prescribed in combination with ribavirin or not.

AbbVie has been in an ongoing price and distribution war with competitor Gilead Sciences, Inc. , which markets competitive hepatitis C treatments, Harvoni and Sovaldi. In January 2015, Gilead inked a definitive distribution agreement with health insurance company Anthem, Inc., which makes Harvoni the primary treatment for genotype 1 hepatitis C, citing better pricing compared to AbbVie’s Viekira Pak.

Earlier in that month, on Jan. 7, Gilead had signed an exclusive deal with CVS Health Corp. to exclusively sell Harvoni and Sovaldi. These deals were in response to AbbVie signing a deal on Dec. 22, 2014, with pharmacy benefit manager Express Scripts Inc. for Express Scripts to only cover Viekira Pak and no longer cover Sovaldi and Harvoni.

At that time, Geoffrey Porges, an analyst with Sanford Bernstein wrote in a note, “We have said before that a price war in the HCV market, with only two major competitors, Gilead and AbbVie, does not make sense for either competitor or for the future market potential of the category. However, it appears that AbbVie has chosen to start a price battle. AbbVie is likely to have had to pay dearly for the privilege of exclusive access plus no restrictions based on fibrosis scores.”

All of the drugs are very expensive A round of Sovaldi treatment runs about $84,000, or about $1,000 per pill. Harvoni’s 12-week course costs about $94,500. Viekira Pak’s 12-week course of treatment runs about $83,319.

Another drug for HCV in the marketplace is Johnson & Johnson ’s Olysio. Olysio was in the news in April when the U.S. Food and Drug Administration (FDA) approved a new Warnings and Precautions label for the drug, which included serious bradycardia when the drug was co-administered with sofosbuvir and amiodarone, as well as liver problems.

The new drug study for AbbVie will probably bolster any efforts the company will make to expand its market or hold ground for HCV. The company was also recently was dubbed the “favorite large-cap pharma name” by two analysts, March Goodman and Ami Fadia, with UBS. Despite the fact AbbVie’s Humira will lose U.S. patent protection in December 2016 and European patent protection in April 2018, they indicated that AbbVie’s pipeline is “even more underappreciated than we had even thought.”


As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be?
Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo.

Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo, a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK).

So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom?

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