InDex Pharmaceuticals Holding is planning for self-commercialization of the drug candidate cobitolimod in the US with strategic collaborations in other regions.
Launch is expected in 2027, with the potential for annual sales to reach more than USD 1 billion, in moderate to severe left-sided ulcerative colitis, states the company.
“Provided that CONCLUDE confirms the results of previous positive clinical trials with cobitolimod, patients can get access to a treatment with as good, or higher efficacy, than today’s advanced therapies but without the serious side effects that these may cause. In addition, cobitolimod is easy to self-administer and has an infrequent dosing regimen – in contrast to current market leading products, which require injections at the clinic or at home. With the phase III program up and running we are starting to prepare for commercialization of cobitolimod,” says Peter Zerhouni, CEO of InDex Pharmaceuticals.
InDex estimates that the market segment of moderate to severe left-sided ulcerative colitis will amount to more than USD 5 billion, by the time of cobitolimod’s launch.
“Cobitolimod’s target product profile has been evaluated in several primary market research studies, demonstrating that cobitolimod has strong potential to be positioned as the first treatment option for patients with moderate to severe left-sided ulcerative colitis, that do not respond to conventional treatments. InDex estimates that cobitolimod can reach a market share of 20-30%, corresponding to global peak annual sales of more than USD 1 billion,” the company states.
Strategy for commercialization
InDex has together with external experts analysed the commercialization options for cobitolimod in the US and Europe. The US accounts for approximately 65% of the total market for ulcerative colitis. The conclusion is that the market potential, the required commercial footprint, and the profitability profile in the US respectively are well suited for self-commercialization by a focused commercial organisation to be built closer to launch.
The fragmented European market, as well as other regions, offer attractive opportunities to enter strategic collaborations as cobitolimod advances towards launch, states the company.
Timetable to launch
Results from the ongoing first phase III study with cobitolimod are expected to be available during H2 2023 according to te company. An interim analysis to select the best dose is planned when approximately 30% of the participants have completed the study. The complete phase III program, including a second induction study and a one-year maintenance study, is expected to be completed during 2026. Applications for marketing approval will then be submitted to the regulatory authorities, with an expected launch of cobitolimod in 2027.
The current development is focused on the rectal formulation of cobitolimod for moderate to severe left-sided ulcerative colitis. InDex also sees significant potential for cobitolimod in related indications. For that reason, the development of an oral formulation, as a potential follow-on product, is ongoing in parallel. An oral formulation that enables delivery of cobitolimod to other parts of the gastrointestinal tract would open the possibility to broaden the therapeutic use of cobitolimod and thereby increase the commercial potential severalfold.
Photo of Peter Zerhouni: Kristian Pohl