UCB has been boosted by the news that the US Food and Drug Administration has approved Cimzia for the treatment of adults with psoriatic arthritis.
The latest green light for Cimzia (certolizumab pegol) is based on a 409 patient-Phase III trial, which showed that ACR20 (ie a 20% improvement in the condition), 50, and 70 response rates at weeks 12 and 24 were higher for each dose group relative to placebo. Treatment also resulted in improvement in skin manifestations in patients with PsA, although UCB stressed the safety and efficacy of Cimzia in the treatment of plaque psoriasis has not been established.
However the biologic is already available across the Atlantic for rheumatoid arthritis and Crohn's disease. The FDA is also reviewing a filing for Cimzia in the treatment of axial spondyloarthritis, including patients with ankylosing spondylitis. Regulators in Europe are currently reviewing the drug for PsA and earlier this month the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending its use for axSpA.
Iris Loew-Friedrich, UCB's chief medical officer, noted that this latest approval represents the third indication for Cimzia in the USA "and reaffirms the value of our commitment to developing medicines that treat serious, chronic diseases". It is estimated that up to 30% of the 7.5 million psoriasis patients in the USA will develop PsA.
Inflammatory pact with Vectura
Meantime, UCB has linked up with Vectura Group of the UK to develop "an innovative biologic immunomodulatory product" in the area of severe inflammatory respiratory disease.
The partners say that the collaboration will leverage Vectura’s expertise in inhaled therapeutics with UCB’s biologics and immunology assets. It will focus on bringing to proof-of-concept a biological therapy from the Brussels-based group's labs targeting a key molecule in the immune system.
The companies will jointly manage the programme, with UCB focusing on bioprocess and preclinical development and Vectura taking responsibility for the dry powder product through to proof-of-concept. Financial terms of the collaboration have not been disclosed.