ABBV: FDA Re-labelling of Viekira Pak

Richard
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Richard Evans / Scott Hinds / Ryan Baum / Hardy Evans

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October 23, 2015

ABBV: FDA Re-labelling of Viekira Pak

FDA’s re-labelling of Viekira Pak to include severe adverse events is likely to be fatal for the brand, at least in the US

New products tend to receive more adverse event reports (AER’s) than older products, so it’s important to view AER’s on a lifecycle month adjusted basis. On that basis, according to recently released adverse event data, Viekira Pak has a substantially higher rate of AER’s per prescription than either Sovaldi, or Harvoni (Exhibits 1, 2)

Before the AER data and associated re-labelling, Viekira Pak’s only viable brand strategy was to seek exclusive formulary positions. Viekira Pak was a medically legitimate alternative to Harvoni that docs would prescribe if Harvoni wasn’t covered; however when and where Harvoni was covered both docs and patients inevitably would prefer it because of its marginally greater convenience, and marginally greater tolerability

Now that Viekira Pak has been shown to have a greater rate of serious adverse events, it’s no longer medically legitimate to cover only Viekira Pak, but not Harvoni

This is plainly bearish for ABBV and their partner ENTA, and bullish for GILD and MRK (who have an HCV regimen scheduled for regulatory action in 1Q16). The benefit to GILD should not be overstated, because we expect MRK’s regiment to essentially step in to the void left by Viekira Pak, keeping price / volume pressure on Harvoni

For reference, Exhibit 3 compares efficacy rates (sustained viral response rates) for GILD, ABBV, and MRK regimens by patient type, for trials consisting largely or exclusively of genotype 1 patients. In the subgroups most relevant to US demand, namely the treatment naïve, no cirrhosis / treatment naïve, and genotype 1a subgroups the MRK regimen appears marginally inferior to both GILD and ABBV. That said, we believe the MRK regimen is sufficiently close to the GILD regimen to produce the same degree of price / volume pressure that ABBV brought to GILD

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