The biggest drug launches – hep C dominates but Tecfidera stands out
Not all blockbusters make a big splash from the start – but initial demand is a pretty good indicator of future success. A look at which novel drugs hit the ground running the fastest over the past 20 years throws up a list dominated by more recent launches, namely the hepatitis C antivirals.
The record holder is Harvoni, which pulled in an eye-watering $10.1bn in its first four quarters on the US market. Hepatitis C therapies occupy the four top places, though a handful of older products also put in impressive debut performances (see tables below).
This analysis was conducted using historical quarterly sales data from EvaluatePharma, with the first full four quarters on the US market summed to create the ranking tables. Excluded were generics and vaccines, as their purchasing patterns tend to look very different from novel acute or chronic therapies.
|Hitting the ground running – top 10 launches|
|Product||Company||Drug type||US launch||US sales over 1st full four qtrs ($bn)|
|Harvoni||Gilead Sciences||Hepatitis C antiviral||2014||10.09|
|Sovaldi||Gilead Sciences||Hepatitis C antiviral||2013||8.51|
|Epclusa||Gilead Sciences||Hepatitis C antiviral||2016||3.13|
|Olysio||Johnson & Johnson||Hepatitis C antiviral||2013||1.94|
|Incivek||Vertex||Hepatitis C antiviral||2011||1.56|
|Celebrex||Pharmacia||Cox-2 inhibitor – pain||1999||1.55|
|Genvoya||Gilead Sciences||HIV antiviral||2015||1.30|
|Ibrance||Pfizer||CDK 4 & 6 inhibitor – breast cancer||2015||1.10|
|Vioxx||Merck & Co||Cox-2 inhibitor – pain||1999||1.01|
The analysis shows how unique the relatively short-lived hepatitis C revolution was. The highly successful launches of these agents demonstrated how swiftly healthcare systems – at least in wealthy countries – will embrace a curative therapy.
Holding the crown outside hep C is Biogen’s multiple sclerosis therapy Tecfidera. The oral pill not only offered patients convenience and efficacy, its safety profile was comparatively benign compared with existing therapies, driving huge interest from the start.
It will be interesting to see whether Tecfidera’s biggest competitive threat will rob it of this accolade; Roche’s Ocrevus, approved last year, has achieved sales of $686m in its first two full US quarters, pointing to a performance that could match the Biogen pill if all continues to plan.
Elsewhere in the analysis, the Cox-2 inhibitors too were stand-out successes, until the real safety profile of Vioxx emerged. That drug was ultimately withdrawn after around five years on the market, though Celebrex remains available, albeit capturing only a third of its original revenues.
More recent success stories include Pfizer’s Ibrance, the first CDK4/6 inhibitor to reach the market and whose mechanism has swiftly become the first-line option in Her2-negative, HR-positive breast cancer.
The true top 10?
The success of drugs like Tecfidera, Ibrance and the Cox-2 inhibitors is even more notable when considering that they were the first of their kind on the market.
Products like Harvoni and Epclusa represented real treatment advancements, but they arguably did not have as much work to do as the first to launch in this field, Incivek. The same is true for Gilead’s HIV therapy Genvoya, a quad therapy that rode the wave of the company’s existing HIV franchise.
Looking at the top 10 products outside the combination antivirals brings in Lipitor, the most commercially successful drug to date, which was also a hit from the start.
|Outside the antivirals – biggest drug launches|
|Product||Company||Drug type||US launch||US sales over 1st full four qtrs ($m)|
|Celebrex||Pharmacia||Cox-2 inhibitor – pain||1999||1,553|
|Ibrance||Pfizer||CDK 4 & 6 inhibitor – breast cancer||2015||1,102|
|Vioxx||Merck & Co||Cox-2 inhibitor – pain||1999||1,008|
|Lipitor||Pfizer||Statin – high cholesterol||1997||990|
|Eylea||Regeneron||VEGFr kinase inhibitor – eye disease||2011||838|
|Opdivo||Bristol-Myers Squibb||Anti-PD1 antibody – cancer||2014||823|
|Lucentis||Roche||Anti-VEGF antibody – eye disease||2006||790|
|Avastin||Roche||Anti-VEGF antibody – cancer||2004||714|
This analysis also illustrates how successful VEGF-targeting agents have become, commercially and medically, spanning cancer and eye diseases. As essentially the same asset, Roche’s victories with Avastin and Lucentis are particularly notable. The inclusion of these as separate entities knocks Merck & Co’s Januvia from the table, putting it in 11th place; this would have provided the league table with its only diabetes treatment.
Finally, the recent immuno-therapy wave gets an entrant in Opdivo, launched in the US in the last few days of 2014. Bristol-Myers Squibb's product was actually beaten to the market by Merck & Co's rival PD-1 antibody Keytruda by three months, but still managed to engineer a much more successful launch. An already established I-O presence with Yervoy presumably gave Bristol an advantage in the early days, an edge that it is struggling to maintain.
With several closely watched and very highly valued assets nearing pivotal readouts in immunotherapy, many hope that this field will yield further big launches. For the hepatitis C records to be broken, however, another special case will surely have to emerge.