By the time AbbVie brought its first drug for hepatitis C to market, in December 2014, it was already too late.
Twelve months earlier, Gilead Sciences had secured U.S. approval for Sovaldi (sofosbuvir), offering hepatitis C patients a once-daily treatment regimen capable of clearing the virus in as little as three months.
Sales eclipsed $10 billion in the first full year, the start of a dominant therapeutic franchise that would earn Gilead more than $50 billion between 2014 and 2017. AbbVie, Merck & Co. and Bristol-Myers Squibb were left as also-rans.
AbbVie's second go at the hepatitis C market, however, has turned out considerably better. Mavyret (glecaprevir/pibrentasvir), approved last August, has widely beat predictions and surged to over $1.8 billion in sales through the first six months of 2018. Its success is particularly surprising since the hepatitis C market has narrowed considerably since Sovaldi, with fewer patients starting treatment due to the high cure rate.
In doing so, Mavyret has also become a central part of AbbVie's push to diversify beyond its top-selling inflammatory disease drug Humira. But, analysts say, the drug is unlikely to continue its to-date rapid growth.
"I think over time there will be slow, steady-state erosion," said Vamil Divan, an equity analyst at Credit Suisse, in an interview. "I'd be surprised if it continued to grow significantly after this very strong start."
Stealing share
Mavyret arrived just as the rapid erosion of Gilead's hepatitis C revenues was becoming readily apparent. Yet AbbVie's drug was able to grab a sizable share of that shrinking market in relatively short order.
Particularly key to that strong start was Mavyret's price. AbbVie set the wholesale acquisition cost for the drug at $26,400 for an eight-week course of treatment, well below the list prices of Gilead's Harvoni (ledipasvir/sofosbuvir) for a longer 12-week regimen. (Although rebates and discounts offered by Gilead likely narrowed that gap.)
And unlike Merck's Zepatier (elbasvir/grazoprevir) — which had taken the role of Gilead's only real competition — Mavyret won an indication covering all six genotypes of hepatitis C, enabling broader uptake.
On recent earnings calls, AbbVie executives say its drug has secured access to to more than three-quarters of covered lives in the U.S., suggesting payers have been broadly receptive to the drug. Supporting that is the clear gains Mavyret has made in prescriptions written.
Just two quarters after launch, weekly new prescriptions of Mavyret had outpaced both Gilead's Harvoni as well as its newer entry Epclusa (sofosbuvir/velpatasvir), according to Iqvia data cited by Cowen. Currently, Mavyret's share of new prescriptions sits at about 50%, neatly counterbalancing the combined share of all of Gilead's offerings.
"Now, the question is how sustainable [that is] given the market dynamics in the space," Divan said.
AbbVie also appears a little uncertain. While the biotech raised its guidance for hepatitis C sales to above $3.5 billion for the year, it predicts a small decline in Mavyret sales during the third quarter. Some of Mavyret's uptake may have initially been due to patients who had failed other antiretroviral therapies, particularly in Japan, or were otherwise waiting for a new treatment option. Those patient starts may ebb, potentially cooling some of Mavyret's growth.
"We've seen those patients waiting for treatment, they've all now been treated. We've got the sales from those patients," explained Oliver Spray, an analyst at Informa Pharma Intelligence. "That is going to cause a step down in Q3, Q4."
Shrinking market
Still, AbbVie appears confident Mavyret will be a cornerstone in its diversification plans for some years to come.
"This is a market that is going to be around for a long, long time," said AbbVie CEO Richard Gonzalez on a conference call in April...
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