You can thank the Committee for Medicinal Products for Human Use, or CHMP, for the majority of this week's news. CHMP, which is Europe's equivalent of the Food and Drug Administration's advisory panel, took a closer look at three drugs this past week, divvying out two positive and one negative recommendation.
The end of the week brought fantastic news for shareholders in Avanir Pharmaceuticals (NASDAQ: AVNR ) who witnessed the CHMP recommending approval for Nuedexta, it's already U.S.-approved treatment for psuedobulbar affect. An approval in Europe would be a key win for Avanir as Nuedexta currently makes up the majority of its revenue. In addition, it's worth noting that the European Medicine Agency's panel recommended two dosing regimens, potentially broadening in patient reach. Shares reacted notably higher but tapered off by the end of the day on Friday. Although the EMA isn't required to follow the recommendation of its panel, this would be a case where I'd be mildly surprised if it didn't.
Conversely, the EMA's advisory panel didn't deliver what the doctor ordered (in a metaphorical sense) for Pfizer's (NYSE: PFE ) moderate-to-severe rheumatoid arthritis pill, Xeljanz. The CHMP delivered a negative opinion on the RA pill, noting that its benefits failed to outweigh the risks. Pfizer is planning to appeal the decision and get its drug reexamined by the CHMP. Already approved in the U.S., Xeljanz could get a more receptive audience in due time, but it appears the approximately $500 million in EU sales that ISI Group analyst Mark Schoenebaum was looking for by 2018, according to an interview with Bloomberg, could be in jeopardy.