It's the hope of every drug developer to create a billion-dollar-per-year blockbuster therapy, but with 90% of drugs failing in clinical trials, few drug companies successfully do it. Bristol-Myers Squibb (NYSE:BMY), Pfizer (NYSE:PFE), and AbbVie (NYSE:ABBV), however, appear to have beaten those long odds, because each has a drug that's on pace to eclipse blockbuster status in the coming year.
Bristol-Myers Squibb: Opdivo
Bristol-Myers' immuno-oncology drug Opdivo, which costs about $12,500 per month, trounced industry watchers' estimates in the third quarter. Revenue from Opdivo clocked in at $305 million, and that was nicely higher than the $238 million that had been expected.
Opdivo's sales success stems from a massive R&D effort from Bristol-Myers to establish it as a go-to anti-cancer therapy that can be used both alone and in combination with other widely used drugs to make them work better.
So far, Opdivo has been approved for use as a monotherapy in the treatment of advanced melanoma and lung cancer and alongside another Bristol-Myers drug, Yervoy, in a specific genetic variation of metastatic melanoma.
More approvals are likely, too, because Bristol-Myers is conducting more than 50 studies across a variety of cancer indications. For example, Bristol-Myers recently reported that the FDA had awarded breakthrough therapy designation to Opdivo for use in kidney cancer.
Overall, Opdivo's potential to act as a building-block cancer therapy could clear the way for it to be a megamultibillion-dollar blockbuster, and as it stands today, the drug is on pace to surpass the billion-dollar sales mark in the coming year.
Ibrance is Pfizer's recently approved therapy for the treatment of breast cancer, and sales of the drug are outpacing projections. In the third quarter, Ibrance sales totaled $230 million, and while that isn't a billion-dollar run rate (yet), it's likely that Ibrance momentum will continue to boost its sales above that magic threshold soon.
According to Pfizer, 15,000 patients have been treated with Ibrance, which costs almost $10,000 per month, up from 9,000 patients in Q2 and 2,000 patients in Q1. Also, 4,000 doctors are now prescribing Ibrance, up from 3,000 doctors exiting the second quarter and 800 doctors in Q1, and as a result, Ibrance has already grabbed 27% of the market in first-line treatment.
Ibrance's commercial success isn't too surprising, given that the drug performed very well in trials (leading to an FDA approval roughly two months ahead of schedule) and because roughly 1 million of the 1.7 million people diagnosed with breast cancer in the U.S. every year possess the genetic markers Ibrance targets.
Since Ibrance is already approaching a billion-dollar run rate and with an EU approval is looming, it seems it's destined to become a blockbuster in 2016, too.
When AbbVie acquired Pharmacyclics in a massive $21 billion deal earlier this year, it did so to get its hands on Imbruvica, a fast-growing drug that costs roughly $11,000 per month and is used to treat blood-related cancers, including chronic lymphocytic leukemia, or CLL, and Waldenstrom's macroglobulinemia.
Since winning approval last year for use in CLL patients, Imbruvica, which was co-developed by Johnson & Johnson, sales have taken off. In Q3, AbbVie reports that Imbruvica revenue jumped to $304 million, giving it a $1.2 billion annualized run rate. That revenue consists of $267 million in U.S. sales and $37 million tied to its profit-sharing agreement with J&J in other markets.
Imbruvica's script volume could continue to grow next year, especially since AbbVie has filed a supplemental application for approval in treatment-naive CLL patients. In trials, Imbruvica outperformed chemotherapy in these patients, suggesting that an approval could vault it from a leading second-line therapy into a leading first-line treatment. Overall, Pharmacyclics had previously estimated that Imbruvica's addressable patient population could expand from 40,000 in 2014 to 374,000 over time, and if that assessment is correct, then Imbruvica could become one of the top-selling oncology drugs on the market.
Tying it together
All three of these fast-growing medicines are cancer drugs, and each of these therapies has been priced at levels that make them among the industry's most expensive treatments. Recently, payer pushback on pricing has led many to wonder whether oncology companies are likely to take a hit on their top and bottom line, but while it's likely that some changes may occur in drug pricing, I'm not convinced that they'll derail the blockbuster potential of these drugs, because each is a game-changer in its ability to extend patient lives.
Todd Campbell has no position in any stocks mentioned. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.