This week could scarcely be tougher than the last one was for Celgene (Nasdaq: CELG). The US biotech firm lost 10% of its value on the back of news that it plans to discontinue development of the Crohn’s disease candidate GED-0301, or mongersen, and then shares slumped by a further 18% after the company lowered its 2020 sales guidance in its quarterly results.
The firm’s shares were up 2.17$ at $100.28 just after the markets opened this morning.
News on Sunday suggested that this week might indeed be better, with Celgene announcing detailed results from the Phase III RADIANCE Part B trial evaluating the efficacy and safety of ozanimod, another immunology candidate.
‘Novel oral option’
A further Phase III trial of ozanimod in Crohn’s disease is due to begin in the next few months, with the RADIANCE data suggesting that it could be a new option in relapsing multiple sclerosis (RMS).
In the RADIANCE trial, ozanimod demonstrated superiority versus interferon beta-1a, marketed by Biogen (Nasdaq: BIIB) under the brand name Avonex, in reducing annualized relapse rates (ARR) and MRI brain lesions at two years. The results were presented at MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting.
Bruce Cree, associate professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences and an author of the abstract, said: “As physicians, we recognize the increased need for additional effective and safe therapeutic options for use earlier in the treatment of RMS.
“Based on these data, ozanimod has the potential to provide RMS patients and their physicians a novel oral option for treating this debilitating illness.”
The RADIANCE Part B study evaluated two doses (1mg and 0.5mg) of oral ozanimod compared with Avonex in 1,320 patients with RMS in 21 countries treated for two years.
US filing imminent
A significant reduction in ARR was demonstrated for both doses of ozanimod compared with Avonex over the two years, and instances of new or enlarging T2 and gadolinium-enhanced MRI lesions were also significantly lower with the Celgene candidate.
A reduction in brain volume loss, a measure associated with MS disease progression, was observed for both ozanimod doses compared to Avonex.
The higher dose of ozanimod brought greater responses, and overall incidences of serious adverse events were low across treatment arms.
Terrie Curran, president, Celgene Inflammation and Immunology, said: “Given the totality of the data for ozanimod, we believe that the benefit-risk profile supports pursuing ozanimod as a potential new oral therapeutic option and look forward to filing regulatory submissions in the USA by the end of 2017 and in the European Union in the first half of 2018.”
According to Evaluate Pharma, sales of ozanimod could reach more than $2 million by 2020 in MS alone, and if it also comes through in the Crohn’s disease and ulcerative colitis indications, the combined peak sales figure might be $5 billion. Celgene added the drug to its pipeline in 2015 by acquiring Receptos for $7.2 billion.