Medical need & Marketing potential


Medical need & Marketing potential

Isofol’s primary target market for arfolitixorin is the treatment of metastatic colorectal cancer, mCRC, which is a treatment area with a substantial medical need and numerous patients.

The market comprises the treatments with 5-FU currently administered to colorectal patients, and where Isofol’s candidate drug, arfolitixorin, can be used to enhance the treatment’s efficacy. The primary markets comprise the USA, EU5 (France, Germany, Italy, Spain and the UK), and Japan. In these markets alone, a quarter of a million patients are treated with 5-FU every year for metastatic colorectal cancer. If all colorectal cancer patients treated annually are included, this figure rises by approx. 120,000 in the form of the patients who receive adjuvant therapy with the 5-FU-based treatment combination as a supplementary treatment after surgical intervention in stages I-III, i.e. when the tumour has not yet spread. Arfolitixorin could potentially make an important contribution to increased treatment efficacy for this group too, and could, potentially, result in more patients being completely cured. The company also calculates that there is a substantial global medical need, over and above the quantified markets, primarily in countries such as the rest of Europe, South Korea, and South East Asia, and in other developing countries such as China and India.

Huge potential in other treatment areas

Isofol is seeking approval for the treatment of advanced colorectal cancer and is conducting a pivotal study of patients with metastatic forms of the disease (mCRC). There is also considerable potential for expanding the use of arfolitixorin to other types of cancer.

Treatments with 5-FU

Other treatment areas include the solid tumours currently treated with 5-FU. These include pancreatic and stomach cancers, of which there are over 100,000 new cases every year in the USA and EU5. Other substantial areas of need include breast cancer, cancers of the head and neck, all of which are areas where 5-FU is used.

Rescue therapy in conjunction with high-dose treatment with Methotrexate

Arfolitixorin can also be used in rescue therapy after high-dose chemotherapy treatment with Methotrexate of cancer types such as osteosarcoma (bone cancer), acute lymphatic leukaemia (ALL), Burkitt’s lymphoma, and lymphomas of the central nervous system (a lymphoma is a cancer of the lymph/lymphatic system). Isofol has already conducted clinical studies of patients with osteosarcoma and considerable potential exists for a future expansion of the use of arfolitixorin into the field of rescue therapy, too.

“Blockbuster” Market potential – billion dollar market

Isofol currently has a clear and established picture of the number of patients who can potentially be treated with arfolitixorin. Isofol has also, in collaboration with payers and pricing experts in the pharmaceutical sector, conducted a number of surveys in order to build up a picture of possible pricing strategies. Arfolitixorin’s market potential, based on the number of patients, anticipated price, and treatment duration, is consequently a multibillion dollar one in the treatment of patients with metastatic colorectal cancer alone. The USA is expected to be the biggest and most important market, followed by the Europa and Japan.

Low introduction threshold

The introduction threshold for arfolitixorin in the treatment of colorectal cancer is adjudged to be low. There would be no need for the medical sector to revise its treatment methods because arfolitixorin does not require any changes to the way in which colorectal cancer patients are currently treated. Arfolitixorin could, therefore, become an integral part of the current 5-FU-based treatment combination. Patient hospitalisation times would not, therefore, increase, and care providers could administer arfolitixorin in combination with 5-FU in the same way as they currently do when treating with leucovorin.

High medical need and few competitors

Isofol calculates that the choice of study area – first line treatment of metastatic colorectal cancer – is an area with a particularly high medical need, since the existing treatment alternatives have not been improved since the mid 2000. Arfolitixorin has few competitors in first and second line treatment and is expected to become an integral part of today’s standard 5-FU-based treatment. Interest in arfolitixorin and in participating in the pivotal study, AGENT (ISO-CC-007), is considerable amongst both leading Key Opinion Leaders (KOLs) and hospitals as few new drugs are being developed for first and second line treatment of mCRC patients.