Biotech Values

[DewDiligence]

AMGN—Evenity (romosozumab) BLA on hold due to CV-safety signal in ARCH study (the PDUFA date had been 7/19/17); regulatory submissions in other jurisdictions similarly affected:

https://finance.yahoo.com/news/amgen-ucb-announce-top-line-220000570.html

An imbalance in positively adjudicated cardiovascular serious adverse events was observed as a new safety signal (2.5 percent Evenity versus 1.9 percent alendronate at 12 months).

…the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit:risk profile for Evenity," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of these data."

…Regulatory submissions for Evenity based on the FRAME study results are currently under review with the U.S. Food and Drug Administration (FDA), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Amgen has agreed with the FDA that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization, and as a result the Company does not expect approval of Evenity in the U.S. to occur in 2017. Engagement with PMDA and Health Canada will occur as part of the ongoing review process. The preparation for the European regulatory submission will continue as planned. Further analysis of the Phase 3 ARCH study data is ongoing and will be submitted to a future medical conference and for publication.