Home Health Care Nearly three-quarters of late-stage pipeline drugs come from emerging biopharma, report finds

Nearly three-quarters of late-stage pipeline drugs come from emerging biopharma, report finds

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Growing biopharma companies accounted for nearly two-thirds of the patents on drugs launched in 2018 and nearly three-quarters of the late-stage drug pipeline, according to a new report. Meanwhile, a growth in the number of registration studies with an active control arm appears to reflect growing desire for comparative-effectiveness data among payers.

The report, by Durham, North Carolina-based IQVIA – a health information technology and contract research firm formed through the 2016 merger of IMS Health and global CRO Quintiles – showed that emerging biopharma companies were responsible for registering 47 percent of the new drugs launched. Moreover, emerging biopharma companies accounted in 2018 for 72 percent of the late-stage pipeline, compared with 65 percent in 2013 and 52 percent in 2003.

In total, 2018 saw the approval and launch of 59 new drugs – more than in any of the last five years – with cancer drugs accounting for 27 percent of the total and infectious diseases accounting for 20 percent.

The 2,891 drugs that were under late-stage development last year, those for cancers represented a 39 percent growth over the past five years, with cancer drugs in particular seeing growth of 63 percent. What the report called next-generation biotherapeutics – referring to cell therapies, gene therapies and nucleotides – doubled despite representing less than 10 percent of the late-stage pipeline.

Currently, two cell therapies are on the market in the US, both CAR-Ts: Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), both initially approved in 2017. Kymriah was first approved for pediatric acute lymphoblastic leukemia, followed by last year’s adult diffuse large B-cell lymphoma. Yescarta, initially made by Kite Pharma before Gilead’s acquisition of the company, is approved for DLBCL alone. 2017 also witnessed the first approval of a gene therapy, Spark Therapeutics’ – acquired this year by Roche for $4.8 billion – Luxturna (voretigene neparvovec), for a rare form of blindness. Other cell and gene therapies on their way to regulatory decisions include bluebird bio’s Zynteglo for beta-thalassemia, which is likely to soon win approval in Europe, and the same company’s bb2121, a CAR-T for multiple myeloma that the US Food and Drug Administration will decide on next year and that it is developing with Celgene. A $74 billion deal for Celgene’s acquisition by Bristol-Myers Squibb passed votes by both companies’ shareholders earlier this month.

Among the 59 new drugs approved in 2018, 12 stratify patient selection based on predictive biomarkers, while four were approved with a companion diagnostic, and 16 were for cancers. Perhaps the most prominent of these was Vitrakvi, from Loxo Oncology, which Eli Lilly & Co. acquired for $8 billion in January. The drug received accelerated approval in November for any solid tumor that displays an NTRK fusion, based on data showing that while the prevalence of NTRK fusions is spread thinly across numerous cancers, its presence greatly increases the chances of an NTRK-targeting drug being efficacious.

Forty-six percent of those 59 drugs were approved based on trials with fewer than 500 subjects, and 15 percent on trials with fewer than 200. Still, the vast majority of those approvals, 52, included a randomized, controlled trial. Among those, 27 included an active-control trial, representing a 20 percent increase over 2016 and a growing interest among payers in comparative-effectiveness data. By contrast, only seven approvals were based solely on a Phase I or Phase II study.

Photo: Stas_V, Getty Images

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