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Novartis plots to retain hives patients with monoclonal antibody that outshines Xolair

After the loss of patent protection on its Roche-partnered hives therapy Xolair, Novartis $NVS has found its experimental monoclonal antibody ligelizumab surpassed Xolair in a mid-stage hives trial, allowing the company to shepherd it along to Phase III trials.

The blockbuster biologic Xolair, which is approved for hives as well as allergic asthma, is vulnerable to competition after losing patent protection, particularly in the United States and Europe. So far no copycats have hit the market, although there at least two are in development. India’s Glenmark recently reported early-stage data from a US trial, while partners Sorrento and MabTech are testing their version in an ongoing Phase III study in China.

Both Novartis and Roche have contingency plans in place for eventual Xolair competition in patients with chronic spontaneous urticaria (CSU), an unpredictable skin condition that is characterized by spontaneous swelling and itchy hives. Novartis has ligelizumab, while Roche is developing fenebrutinib, which it is currently testing in a Phase II trial for CSU.

Novartis’ mid-stage trial tested ligelizumab against Xolair in CSU patients who did not derive adequate benefit from antihistamines. Data showed the experimental drug outperformed Xolair, but Novartis did not reveal the magnitude of improvement in a release it issued on Tuesday, except to say that ligelizumab is now ready to be tested in twin Phase III trials — PEARL 1 and PEARL 2 — at sites across 48 countries.


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