Morningstar | UCB's Evenity for Osteoporosis Receives Negative Opinion From CHMP Over Safety Concerns
We don't anticipate any changes to our EUR 72 per share fair value estimate for no-moat UCB after the company announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a negative opinion regarding the potential approval of UCB and Amgen's Evenity (romosozumab) for the treatment of severe osteoporosis.This decision by the advisory body comes as somewhat of a surprise, given that Evenity was approved by the U.S. Food and Drug Administration in April 2019 in postmenopausal women at high risk for fracture, and the drug is approved in Canada and parts of Asia, as well. However, the FDA originally rejected the drug because of increased cardiovascular risk, which the CHMP cited as the reason for its negative opinion. The company intends to submit for reexamination, based on the positive late-stage results from three phase 3 trials. This setback follows generally positive news for the company, including solid phase 2b results for bimekizumab for ankylosing spondylitis patients, as well as the recent approval of UCB's midazolam nasal spray for epilepsy, which UCB acquired in 2018. While we've lowered our probability of approval for Evenity in Europe as well as our estimated uptake due to these safety concerns, this was offset in our model by the approval of midazolam and the time value of money.
UCB is a global biopharmaceutical company focused on severe diseases in two therapeutic areas, namely central nervous system disorders and immunology. In the area of central nervous system disorders, Co. is focused on advanced Parkinson's disease, epilepsy, restless legs syndrome and epilepsy. In the area of immunology disorders, Co. is focused on rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, post-menopausal osteoporosis, systemic lupus erythematosus and immunological diseases.
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