Celltrion announced on February 19 that it has received approval from Health Canada for the additional indication of inflammatory bowel disease (IBD) for its autoimmune disease treatment Ramsima SC (U.S. trade name: Zymfentra, component name: Infliximab).
IBD is a chronic, incurable bowel disease in which the immune system targets the large or small intestine, causing multiple ulcers, bleeding, diarrhea and abdominal pain, and is estimated to be a global market of approximately $25.56 billion this year, according to global market research firm The Business Research Company.
The IBD indication approval is based on a global Phase 3 study that included 343 patients with Crohn's disease (CD) and 438 patients with ulcerative colitis (UC). In the trial, Ramsima SC demonstrated statistically superior efficacy and similar safety to placebo in the primary endpoints of clinical remission (CD and UC) and endoscopic response rate (CD), as well as all key secondary endpoints.
Ramsima SC is the only biologic approved to convert infliximab from its traditional intravenous (IV) formulation to subcutaneous (SC). In addition to significantly improving the convenience of treatment by allowing patients to inject directly at their own location without visiting a hospital, Ramsima SC has shown promise in the clinic by demonstrating advantages over the existing IV formulation.
In a post-hoc analysis of the global Phase 3 Ramsima SC study presented at an international meeting, Celltrion demonstrated that Ramsima SC was effective in restoring efficacy at the escalated dose (240 mg) compared to the original dose (120 mg), with no significant difference in safety. In addition, Ramsima SC alone achieved similar levels of efficacy and safety compared to the immunosuppressant combination.
In fact, based on these strengths, Ramsima SC's market share in five major European countries (Germany, UK, France, Italy, and Spain) was approximately 20% as of the third quarter of last year, with a steep rise to 37% in Germany and 26% in France. Together with the original Ramsima in IV formulation, the market share of infliximab in the five major European countries is approximately 72%.
In Canada, the geographical size of the country relative to the population is expected to increase patient convenience with self-administration. Celltrion Canada plans to leverage its extensive prescribing data from Europe and elsewhere to spread the word and position Ramsima SC as a leading treatment for IBD.
In addition, Celltrion plans to accelerate its North American market penetration with the acquisition of the IBD indication in Canada and the launch of Zymfentra in the U.S. this year. In particular, the company has established a direct sales structure to maximize profitability in both the U.S. and Canada.
