The Pipeline Report 2013: Late-Stage Standouts

The Pipeline Report 2013: Late-Stage Standouts
The Pipeline Report 2013: Late-Stage Standouts

Spotlighting 196 agents, with profiles on 15 advances vying to be better, safer or cheaper than standard of care. Marc Iskowitz reports

Despite hand-wringing over the decrease in R&D productivity relative to the 1990s, it continues to be a fruitful period for pharma and biotech organizations. The concern nowadays is that a lot of the new, interesting products that get a regulatory OK don't find a very large market.

“Attention in the industry seems to have shifted from, ‘Will we get this approved?' to ‘How do we create a successful drug if we get it approved? How do we maximize its revenue potential?'” notes Dr. Ben Weintraub, director of research at inThought Research, part of Symphony Health Solutions.

The writing is on the wall in cardiovascular disease, where the various ACE and ARB inhibitors have had a hard time competing, and in diabetes, where newer DPP-IV products have struggled to gain sales. Now, says Weintraub, case studies of somewhat lackluster performers are piling up in multiple sclerosis (See: Novartis' Gilenya) and in rheumatoid arthritis (See: J&J's Simponi and UCB's Cimzia).

The answer to ever more skeptical physicians, patients and payers? “When gearing up to go into competitive markets, companies must design trials to show which specific subsets of patients will benefit,” Weintraub says.

They must also prove superior to standard of care. Even in hepatitis C therapy, where Merck's Victrelis and Vertex's Incivek boosted the response rate of injectable interferon from 40% to almost 80%, their sales are giving way as the field looks to Abbott's and Gilead's late-stage hep. C hopefuls, which promise to boost cure rates even further, while giving patients, for the first time, an FDA-sanctioned, all-oral regimen that doesn't require interferon.

In cancer, companies have gotten a lot better at finding the right niche for drugs. Take Roche's Herceptin, a mainstay of therapy for HER2+ breast cancer for over a decade. Now T-DM1, awaiting FDA approval, has the goal of “building a better Herceptin,” says Kantar Health analyst Dr. Stephanie Hawthorne. Similarly, Bristol-Myers Squibb's Phase III agent BMS-936558 is an immuno-therapy like melanoma drug Yervoy, with seemingly better tolerability.

Both cancer contenders are profiled here, plus potential first-in-class products, ranging from Merck's anacetrapib and BMS/AstraZeneca's dapagliflozin—inhibitors of CETP and SGLT2, respectively, for treating atherosclerosis and diabetes—to AZ/Rigel's fostamatinib and Merck's odanacatib, blockers of SYK and CatK enzymes, respectively, for RA and osteoporosis. You'll also read about a biosimilar in development that could become a cheaper TNF inhibitor than Merck's Remicade, scheduled to go off patent in the US in 2015.

In addition to the cardiovascular, infectious disease, metabolic, rheumatology and oncology sectors, this report highlights neurology and orphan therapies, including Eli Lilly's solanezumab for Alzheimer's disease and Biogen Idec's long-acting clotting factors for hemophilia, as well as outlining late-stage agents in the respiratory and women's health areas, plus some in mid-stage, too.

Consistent with our methodology the last several years, profiled agents are based on consultation with inThought, Adis R&D Insight, GfK HealthCare and various other experts. Original analysis is updated to reflect the latest data sets (as of press time), and is complemented by revenue forecasts, lists of other key products and, where available, the estimated month of approval, plus a quick way to gauge the likelihood of an FDA OK called the inThought Approvability Index (anything above 50% stands a good chance).


Infectious Disease





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