The biggest winners--and losers--in the 2015 race for new drug approvals

Print 13 January 2016
John Carroll / FierceBiotech

Let's start with the good news.

In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs.

The new generational high, easily lapping last year's list of 41 approvals, marks a new peak following a surge by the R&D side of the business, which continues to recover from a lengthy period of marked weakness. The FDA has helped, proving more than willing to come through with faster approvals, particularly in oncology. And the science around drug development has improved markedly as our understanding of the genetic drivers of disease continues to make real progress.

But here's the catch: Higher approval numbers don't necessarily translate into market-moving opportunities. Throw another me-too drug into a pack of rivals and even the best sales force can't do much with it, particularly if cheap generics dominate a disease. And in the patent cliff environment that has persisted for several years now, it takes blockbuster gains to make a big difference for the Big Pharma companies that dominate the industry.

So who came out of 2015 a big winner?

Novartis ($NVS) walked away with that crown. Not only did Novartis score a chart-topping four new approvals, but two of its new drugs--Entresto (LCZ696, peak sales estimate $5 billion-plus) and Cosentyx (a potential franchise dominator in psoriasis)--could have the kind of market impact needed to move the revenue dial in its favor.

Novartis has a big pipeline and can be incredibly focused for a Big Pharma, so it's no huge surprise to see them dominate on that score. What was remarkable was the presence of Pfizer ($PFE), Sanofi ($SNY), AstraZeneca ($AZN) and Amgen ($AMGN) among the list of top winners for the year.

Sanofi finally made the list of winners at the FDA thanks to a prescient decision to invest heavily in Regeneron ($REGN)--a key Big Biotech with one of the top reputations in drug R&D--while the pharma's in-house pipeline shows little sign of life. That strategic partnership gave Sanofi an approval for Praluent (alirocumab), which is now battling Repatha for market share in the new, multibillion-dollar PCSK9 arena. The approvals leave Amgen in the winner's circle as well, with two approvals for the year, though few have high hopes for its second win, for Corlanor, in the heart market.

AstraZeneca CEO Pascal Soriot

AstraZeneca, long absent from the winner's circle, scored two green lights. The significant one was Tagrisso (AZD9291), which beat its troubled rival at Clovis to the market and gave CEO Pascal Soriot something to really cheer about as he continues to make the case that the pharma giant has truly turned the corner.

That jury is still out, particularly as its PD-L1 program has been falling further and further behind the leaders on the checkpoint pack. But a win is a win, and this one was big.

Then there was Pfizer, practically notorious for executing megamergers that never paid off. Pfizer not only gained an approval for the cancer drug Ibrance (palbociclib), it also won the accelerated approval on Phase II data. And Pfizer's been clear that even as it pursues its latest Moby Dick in the Allergan (three new drug approvals, though none of major proportions) acquisition, it expects to follow up with more fast-paced programs in cancer.

We'll see how that works out.

Rounding out the big winners are J&J ($JNJ), with Darzalex (the multiple myeloma "breakthrough" daratumumab, also under an accelerated approval), and Novo Nordisk's long-delayed diabetes drug Tresiba, both of which have major league potential.

So who came out a loser?

FDA's Richard Pazdur

Once again, Eli Lilly ($LLY) found itself at the end of the line, which wasn't unexpected. Its approval for Portrazza, another marginal cancer drug priced high, didn't impress many analysts. Lilly primarily found itself defending the wholesale cost of the drug against physicians who are growing weary of prescribing therapies with little ability to significantly help patients. What passes muster at the FDA's cancer group, dominated by Richard Pazdur, does not always incite enthusiasm in medicine.

Lilly, by the way, has promised to provide multiple product launches every year for the foreseeable future and leaned on a biosimilar OK to keep its promise in 2015. (Lilly execs never did say the new approvals would be big.) Meanwhile, a failure for the CETP drug evacetrapib continued to raise doubts about Lilly's ability to deliver a market-moving drug. The stakes on solanezumab, now going through its second Phase III Alzheimer's program, keep rising higher and higher.

Merck ($MRK) didn't have much to boast about in the NDA arena for 2015, gaining an approval for Bridion after a 7-year odyssey at the FDA that included three rejections. Merck, though, is still working furiously on Keytruda, its big breakthrough in 2014, which will continue to gain plaudits as the pharma giant works on its late-stage pipeline.

GlaxoSmithKline ($GSK), meanwhile, managed one new drug OK: Nucala. That drug, like others at GSK, also enters a crowded field, which has tripped up other drugs at the pharma giant that were meant to fill the revenue gap created as Advair loses ground to generics.

Overall, new drug approvals present a puzzle to the industry that will be hard to work out in favor of the biggest players. The cost of drug development has been reaching higher and higher for Big Pharma while peak sales estimates sink lower and lower, as Deloitte recently noted.

About 6 years ago, the industry was doing considerable soul-searching about R&D, vowing to tear down the research silos and connect with the broader biotech/academic ecosystem. Many of the Top 10 pharmas came up with new strategies, like GSK's Discovery Performance Units, which are all but forgotten now as analysts shake their heads over the prospects of near-term catalysts. The industry is left looking to find ways to imitate the more nimble Big Biotechs like Gilead ($GILD) and Celgene ($CELG), which look for fewer late-stage shots on goal, but a higher percentage of scores.

That takes focus, discipline and plenty of cash. So look for a lot more deals in the year ahead as bigger companies compete for the top prospects at the end of Phase II.

Now, here's the full list of new drugs approved by the FDA in 2015, in chronological order. 

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