The Pipeline Report 2016: Big-Time Upside

A peek at 159 aspiring agents, with profiles on 17 that could shoot to stardom. Rebecca Mayer Knutsen has the forecast


Autoimmune                    Oncology      

Cardiology                       Respiratory   

Metabolic              Other            

The most-promising late-stage pipeline drugs are a varied bunch: cancer therapies employing the immune system, PCSK9 inhibitors targeting cholesterol and biosimilars angling to upset biologics' market share. Some will hit the market with a splash, others will crash and burn due to safety/efficacy issues and the rest could fade into obscurity if competitors win the race to market.

When judging the future of clinical candidates, the only important criterion is whether they will change therapy when approved, notes Bernard Munos, senior fellow at FasterCures. Of a potential drug, Munos asks, “Will patients and physicians clamor for it, as they clamor for [Gilead's hep.-C pill] Sovaldi or some of the new cancer drugs?”

These days, changing the standard of care comes with a hefty price tag: The year 2015 saw more industry pricing controversy than ever before—and with the arrival of biosimilars prices may go haywire.

Nonetheless, oncology boasts the most noteworthy R&D innovation of late. “PD-1/L1 inhibitors are the most remarkable accomplishment in years,” says Richard Evans, founder of SSR Health.

Roche is looking to add its PD-L1 inhibitor atezolizumab to the mix, getting a boost with FDA's breakthrough therapy designation for NSCLC. And Eli Lilly's CDK 4/6 inhibitor abemaciclib has shown promise for refractory HR+ advanced or metastatic breast cancer.

CETP inhibitors have been making headlines in the cardiology sector, though not in a good way. Following the lead of Roche and Pfizer, Eli Lilly became the latest company to halt development. Whither Merck's anacetrapib?

Among PCSK9 inhibitors, analysts are waiting to see if Pfizer's bococizumab can replicate Lipitor's tardy—but huge—splash in the market.

In two pivotal studies Roche's ocrelizumab showed remarkable improvements over an MS standard of care. The humanized mAb  could make a real difference if approved.

And R&D dollars are making their way into the orphan-disease space at a greater clip, including BioMarin's agent to generate the muscle protein missing in patients with Duchenne muscular dystrophy.

Advancements in diabetes drugs also grabbed our attention, including Sanofi's lixisenatide/insulin glargine combination.

Perhaps the biggest lingering R&D question involves late-stage biosimilars like Merck/Samsung Bioepis's MK-1293.

“We're still figuring out . . . what the pricing structure will look like for biosimilars in the US,” Evans says.

The candidates profiled in this report are based on consultation with inThought, Adis R&D Insight, GfK HealthCare and others. Each therapeutic area includes the latest in clinical data, revenue forecasts, expected launch dates and success likelihood, where available, of featured products.

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