Europe halts Xeljanz progress

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The European Medicines Agency put a temporary hold on Xeljanz's market expectations Thursday when it rejected Pfizer's RA drug for a failing to show a favorable risk-benefit profile. The decision, delivered by the EMA's Committee for Medicinal Products for Human Use (CHMP), took Bernstein analyst Tim Anderson by surprise. He noted in a Friday report that “it is the US that does not approve products when Europe does,” and cast it as an upset, especially given that Japan's regulator is also on board with the drug.

Pfizer said in a statement that CHMP "did not believe that a consistent reduction in disease activity and structural damage had been sufficiently demonstrated." Pfizer also said the agency was concerned about "serious infections, gastrointestinal perforations and malignancies" observed in the trials.

Humira-dependent AbbVie did not hail this setback as a boon for its share of the European market during Friday's earnings call. SVP John Leonard told investors the RA market is a hard one to break into, regardless of geography. AbbVie also noted during the call that dermatology and gastroenterology are key avenues for increasing the biologic's reach -- more than RA, which continues to grow, but more slowly than do sales on the drug's other indications.

Anderson has modest hopes for the drug in Europe – the analyst wrote that his global forecast was around 21% of Xeljanz sales in 2020, from a total $2.5 billion projection for overall sales.

Leerink Swann analyst Seamus Fernandez wrote in his Friday research note that he expects Pfizer will eventually get Europe's OK, but says that the Phase III ORAL Start clinical trial results, which compared Xeljanz to methotrexate, will do little to assuage the regulator's efficacy concerns. Pfizer shared what Fernandez called “interim” data from the Phase III trial, and keyed in this point brought up by CHMP: that Pfizer's candidate was meant for patients who had already used at least two other disease-modifying anti-rheumatic drugs. The gap is that around 60% of the patients in the Oral program had not been previous DMARD patients.“It seems unlikely that efficacy data from ORAL Start will confirm or deny the conclusions of the initial opinion around structure effects in DMARD failures,” he wrote. Fernandez predicted that it will take at least another three years before Xeljanz hits the European market.

ISI analyst Mark Schoenebaum wrote Thursday that “history teaches the odds are against [Pfizer]” in terms of appealing CHMP's decision, partly because Pfizer won't be able to supplement data the regulator already has. To fill out the data profile, Pfizer would have to move beyond an appeal and shoot for a new filing.

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