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
Tecfidera Biogen MS therapy  2013 1.72
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
Source: EvaluatePharma.

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)
Tecfidera Biogen MS therapy  2013 1,719
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
Neulasta Amgen Neutropaenia therapy  2002 897
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
Source: EvaluatePharma.

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.

To contact the writer of this story email Amy Brown in London at AmyB@epvantage.com or follow @ByAmyBrown on Twitter

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