UCB: Phase III Trials Help Maintain Price Momentum
Edison | Jan 27, 2013 11:59PM ET
Much attention rests on UCB’s three recently launched drugs but forthcoming news regarding its Phase III, Amgen-partnered antibody, romosozumab, could help to maintain the current share price momentum. Phase II data show a rapid increase in bone mineral density (BMD) in women with post-menopausal osteoporosis (PMO) that is superior to existing therapies, with no concerning safety signals. Data from the ongoing Phase III trials assessing c 10,000 women with PMO are not expected until 2015. However, new fracture healing data, expected in H113 and Phase III trial initiations, expected this year could provide further indication of its potential.
Better efficacy over competitors...
Top-line Phase II data show a rapid increase in BMD over 12 months at the lumbar spine and hip of women with PMO treated with the anti-sclerostin antibody, romosozumab, that is significantly superior to alendronate (Fosamax) or teriparatide (Forteo). In a meta-analysis, 12 month BMD increases at the lumbar spine compared favourably to increases with 36 month denosumab (Prolia) and zoledronic acid (Reclast) treatment (11.3% vs 8.8% and 6.7% respectively), and 24 month odanacatib treatment (2.3%), Merck’s Phase III bone resorption inhibitor.
...with no significant safety signals
Anti-resorptive agents, largely bisphosphonates (eg Fosamax), dominate the c $8bn global osteoporosis market. However, their prolonged use has been associated with osteonecrosis of the jaw, severe pain and hypocalcaemia. The only FDA-approved bone-builder, Forteo, carries a black box warning against osteosarcoma. So far, the only significant side effect associated with romosozumab is mild injection site reactions, although further studies will assess longer term safety risks including the possibility of abnormal bone formation seen in patients naturally lacking sclerostin.
New Phase III trials to highlight potential
Data from the current Phase III trial is not expected until 2015. However, new data and new Phase III trials should support the anti-sclerostin approach. Positive data on two Phase II romosozumab studies in tibial and hip fracture healing could trigger the start of Phase III trial(s) in this indication this year. Eli Lilly’s direct competitor, blosozumab, at least 12 months behind, could start major Phase III trials this year in PMO, and data from Phase II with this antibody could also be presented.
Valuation: Romosozumab newsflow should buoy shares
UCB shares have risen c 37% in the last year, largely because of rising expectations for three new products: Cimzia, Vimpat and Neupro. UCB now trades on a one year forward P/E of 24x, a 72% premium to its peer group. However, we believe that 2013 romosozumab related newsflow still represents important catalysts for the shares.
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