Johnson & Johnson's hepatitis C virus (HCV) drug Olysio (simeprevir) reached blockbuster status during the second quarter, clocking about $1.2 billion in sales for the first six months of the year. Sales ramped up steeply in the second quarter, climbing to $831 million from $354 million in the prior quarter, the drug's first on the market.
Given the massive momentum behind Gilead Sciences Inc.'s nucleotide NS5B polymerase inhibitor Sovaldi (sofosbuvir) – it racked up $2.27 billion in first quarter sales – it's a creditable performance, particularly given the limitations attached to the use of Olysio. The NS3/4A protease inhibitor, which J&J in-licensed from Medivir AB, cannot be taken by patients infected with HCV genotype 1a (GT1a) strains carrying the Q80k polymorphism. That occurs in about 25 percent of U.S. patients affected with GT1, the most prevalent and the most problematic of the seven major HCV genotypes, and in a smaller but still substantial percentage of European GT1-infected patients.
But in the continued absence of interferon-free regimens for GT1-infected patients – the first are expected to reach the market late in 2014 – J&J, of New Brunswick, N.J., was able to make hay while the sun shone. "What is driving the strong growth rate right now are the medical society guidelines, which have supported strong adoption in the first half of this year," Ronan Collins, J&J's director of global communications and public affairs, infectious diseases and vaccines, told BioWorld Today.
The American Association for the Study of Liver Diseases and the Infectious Disease Society of America are strong influencers of clinical practice in the U.S., where J&J has focused most of its sales activity to date. However, treatment recommendations are very much a moving target, given the rapidity with which the HCV landscape has altered since 2011, when the first two protease inhibitors, Victrelis (boceprevir) and Incivek (telaprevir), gained approval for treatment of GT1 infections in combination with pegylated interferon plus ribavirin (PR).
The latter, the more competitive of the two drugs, was a short-lived blockbuster. It attained $1.16 billion in sales in 2012, but the total dropped to $466.3 million a year later, as patients delayed receiving therapy in anticipation of the approval of both Olysio and Sovaldi. The sales momentum of Olysio probably will peter out as well. "It's very unlikely to continue into 2015 – that's the reality," Collins said.
JOSTLING FOR POSITION
Currently, Sovaldi is only approved in interferon-free regimens for the treatment of GT2 and GT3 infections. It is administered in combination with ribavirin in each setting. Foster City, Calif.-based Gilead has an Oct. 10 PDUFA date for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir plus sofosbuvir. That would enable the vast majority of GT1-infected patients – assuming they can get access to the high-cost product – to have a curative treatment without the burden of side effects associated with concomitant PR therapy.
J&J is among several other firms jostling for position in that space as well. On Tuesday, it received a priority review from the FDA for its supplemental new drug application on the use of Olysio in combination with Sovaldi in adults with GT1 HCV infection. The filing was completed on the basis of data from the phase II Cosmos trial, in which the combination performed well in HCV-infected patients with advanced fibrosis, including cirrhosis. A phase III trial in 300 patients is ongoing.
Although Gilead has no plans to promote that product pairing, that has not deterred J&J. "It's up to the physicians to prescribe those medicines together in combination," Collins said. "We don't require the active engagement or involvement of Gilead." An undiscounted combination of the two products would be costly, however, whereas Gilead would have more control over the pricing of its in-house combination. "We're evaluating what other agents we can work with," Collins said.
Also in the running are North Chicago-based Abbvie Inc., which received an FDA priority review in June for its triple regimen comprising protease inhbitor ABT-450 (+ritonavir), NS5A inhibitor ombitasvir (ABT-267) and non-nucleoside polymerase inhibitor dasabuvir (ABT-333), which can be administered with or without ribavirin. The therapy is also undergoing accelerated assessment in Europe.
Last week, New York-based Bristol-Myers Squibb Co. disclosed that its interferon-free therapy comprising Daklinza (daclatasvir), a pan-genotypic NS5A replication complex inhibitor, and Sunvepra (asunaprevir), an NS3/4A protease inhibitor, received approval in Japan for treating GT1 infections. The dual regimen is under regulatory review at the FDA. Daklinza is on course for approval in Europe in early September, having received a positive recommendation from the EMA's Committee for Medicinal Products for Human Use in late June. That would pave the way for its use with other agents.
Shares in Medivir (STOCKHOLM:MVIR) peaked at SEK148.50 (US$21.78) during trading Tuesday, but ended the day at SEK135, down almost 5 percent from the stock's previous close of SEK142.