It's official: Gilead's Sovaldi zooms past previous records with fastest-ever drug launch

Gilead's Sovaldi

We can officially say that Gilead Sciences pulled off the fastest drug launch on record. First-quarter sales of the company's ($GILD) new hepatitis C drug Sovaldi (sofosbuvir), approved in December, blew past previous records and just kept going. And along the way, it broke the blockbuster barrier, too.

Sovaldi's Q1 total: $2.27 billion.

Many a drugmaker would be thrilled to post $2.27 billion in full-year sales, after a product has had a couple of years to build up market share. That amount for a first full year post-launch? It still breaks the previous record. For a first quarter's worth of sales? That's no racehorse. That's a rocket ship.

Consider the previous record holder, Vertex Pharmaceuticals' ($VRTX) hepatitis C treatment Incivek. That drug, which was hot-to-trot when it made its debut in May 2011, racked up $1.56 billion in sales during its first four quarters on sale. (Thanks to Sovaldi and its forthcoming next-gen rivals, Incivek hasn't done so well lately, but that's another story.)

Before Incivek came along, Pfizer's ($PFE) pain drug Celebrex was the launch champion, with $1.55 billion for its first four quarters. And only two other drugs have ever rung the blockbuster bell in four quarters, EP Vantage research shows. One would be Novo Nordisk's ($NVO) diabetes high-flyer Victoza, with $1.11 billion; it's still on a growth streak four years later.

The other is Merck's ($MRK) pain pill Vioxx. We don't have to tell you that Vioxx went from $1.01 billion in sales its first four quarters... to multibillion-dollar annual sales... and then into exile, after heart-safety problems turned it into a pariah.

Obviously, a big start doesn't mean big sales forever. Analysts see Sovaldi slowing down a bit later this year as some patients hold off on treatment till Gilead's combo pill--or another company's combination therapy--wins approval. The first new hep C cocktails are expected to win FDA's blessing this year, including Gilead's one-pill solution.

Even so, Sovaldi could well be headed for double-digit blockbuster sales this year; that's what many analysts figure. Gilead won't put a number to it, but has said those optimistic analysts are on the right track.

Meanwhile, one more new drug has joined the first-year blockbuster club: Biogen Idec's ($BIIB) multiple sclerosis pill Tecfidera. Approved last April, the drug brought in $876.1 million for 2013, impressive in itself. And its Q1 results for 2014, posted Wednesday, beat analyst estimates handily at $506 million. That's $1.38 billion in four quarters, just a couple hundred million short of Incivek's tally.

- read the release from Gilead

Special Report: Top 15 Drug Launch Superstars - Tecfidera - Victoza

Suggested Articles

After sifting through the data, one analyst figures the latest Opdivo-Keytruda showdown in kidney cancer might come down to commercial execution.

Call it a fall sports bounce. TV ad spending bumped up in August with the partial return of professional sports, and that included pharma buyers.

GI cancers are stubborn, as plenty of oncology drugmakers know. But BMS' Opdivo has broken through with two potentially practice-changing trials.