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

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