What puts a new drug launch in line for victory? Ask Gilead, Biogen and J&J

Drugmakers spend billions on R&D every year, hoping to create a drug that can throw a commercial punch. It’s never perfectly clear which projects will reach the market, much less deliver big sales, but a new report offers some clues.

In its first drug index, consultancy firm Trinity Partners analyzed three years of data on drugs approved by the FDA back in 2013, ranking them 1 through 22 after considering “commercial success relative to therapeutic value and R&D effort.”

What separated those at the top of the list from the laggards? The most successful meds advanced treatment significantly. In essence, they were clearly different from existing drugs. But Trinity's analysis also showed that a strong marketing strategy—and commercial execution—could put less innovative meds over the top. And price made a difference, too, with more-expensive specialty drugs outperforming less pricey primary care meds.

Not surprisingly, Gilead’s hep C wonder drug Sovaldi outperformed all contenders. It was the first med to treat hep C without intense side effects, and its cure rate was much higher, key factors that set it apart from older rivals. Sovaldi reaped $8.5 billion in 2014 sales, its first full year on the market, and though Gilead's hep C franchise has slowed since, it's still a hefty contributor to the company's top line. It also came out of the gate with an $84,000 price tag, later eroded by payer rebates.

Meds behind Sovaldi in the 2013 launch class are Johnson & Johnson/AbbVie’s blood cancer med Imbruvica and Biogen’s multiple sclerosis drug Tecfidera, Trinity found. AbbVie was so confident in Imbruvica that it spent $21 billion on maker Pharmacyclics last year, a price called “lofty,” “staggering,” and “astronomical” at the time by analysts. Imbruvica brought in $730 million in 2014 for Pharmacyclics.

Hotly anticipated for its impressive trial data—and its oral formulation in a field where injectables historically dominated—Tecfidera reeled in a total of $2.9 billion in 2014, its first full year on the market. It's still delivering blockbuster sales, though it too has slowed recently as safety concerns cropped up and new rivals made their debut.

Primary care meds, such as those in COPD and diabetes, didn’t perform as well in the analysis as a whole. They showed “weaker differentiation and limited commercial performance, exacerbated by significant R&D expense,” the consultants wrote. Drugmakers in those markets have seen intense payer pressure in recent years, and differentiation matters when negotiating rebates and discounts.

Intended to be a follow-up to Advair, GlaxoSmithKline's Breo ranked toward the bottom of the list at No. 19. It's suffered from a lack of significant differentiation and failed a trial in COPD in which GSK thought it might hold an advantage over its predecessor. Its launch has heated up recently, however, though it's a long way from filling Advair's enormous shoes. The med brought in $110 million for GSK in 2014, compared with Advair's whopping $8 billion.

A graph included in Trinity's report demonstrates a positive correlation between therapeutic value and commercial success of a drug.

Johnson & Johnson’s Invokana was an exception in that group. It came in at No. 4 in the overall performance list thanks to a “new mechanism with novel attributes” that enabled it to steal share in a crowded diabetes market. Invokana was the first in the SGLT2 class of diabetes meds, which have given older diabetes drugs, including the DPP-4 class, a run for their money. Eli Lilly and Boehringer's Jardiance, another SGLT2, recently won an FDA panel's acknowledgement that the med can reduce risk of cardiovascular death; it's a significant strength that could benefit the entire class.

When companies launch a drug with significant “therapeutic value,” Trinity found that commercial success is likely to follow. But, they said, strong commercial execution and strategy could make up for drugs that don’t differentiate themselves therapeutically.

An example of such an “overachievement” is Celgene’s Pomalyst, which “has seen strong commercial performance relative to its perceived therapeutic value,” according to the report. And this despite head-to-head competition from Amgen's Kyprolis and a newer competitor from Novartis, Farydak.

That’s because in its market, multiple myeloma, high prices are the norm and patients have few options. Pomalyst itself made FiercePharma's list of the most expensive drugs of 2013. Therefore, “even absent a truly game-changing product profile, there was opportunity … for a home run, or, at the very least, a base hit,” the consultants concluded.