Something is brewing on the other side of Øresund.
Malmø based Ascelia Pharma, with Danish Magnus Corfitzen as its CEO, is looking for funding for a phase 3 study. Among other things, a stock exchange listing is being considered, Magnus Cortfitzen says to MedWatch.
"One of the possibilities that we are exploring is a potential stock exchange listing," says Magnus Corfitzen who also mentions an industrial collaboration or large investors as potential sources of finance.
He estimates that Ascelia Pharma will need "a few hundred million (DKK, -ed.)" for its phase 3 studies, and expects to begin the studies later this year.
The drug that Asceilia Pharma wants to tests in phase 3 is a contrast agent - a diagnostic drug - called Mangoral.
According to the plan, Mangoral will be used to assess whether a cancer has spread to a patient's liver. The active agent in the drug, manganese, lights up in an MRI scan if the patient's liver is healthy but shows dark spots where the cancer has metastasized in the liver.
"In that way you can discover whether a cancer has spread to the liver, which unfortunately is often the case for patients with a cancer diagnosis," says Magnus Corfitzen.
Alternative to controversial contrast agent
There are already a number of different drugs on the market, which can help assessing whether a cancer has spread to the liver. One of the most prominent ones, Omniscan, from GE Healthcare was the center of a controversial case in Denmark ten years ago, which among other things ended with the Danish Medicines Agency acknowledging that they had committed "serious mistakes".
Omniscan and other drugs, which use the active ingredient gadolinium may have incapacitating and potentially deadly side-effects on patients with renal impairment. The side-effect has been named nephrogenic systemic fibrosis (NSF).
The controversy in Denmark was mainly related to whether the Danish Medicines Agency had been too slow at introducing a contraindication for patients with renal impairment, as at least 70 Danes developed NSF.
Today, Omniscan and other gadolinium contrast agents have a contraindication for patients with renal impairment however, those patients lack an alternative to Omniscan and gadolinium, which can trace cancer in the liver, says Cortfitzen.
"Our product is based on manganese - not gadolinium - and thus, by definition we don't have that risk," says Corfitzen.
How sure are you that there are no serious side-effects to manganese?
"Manganese is a mineral, which is part of several vital enzymes in the body. It is something which we get through our diet from things such as pineapple and blueberries, which have a relatively high concentration. So it is not a foreign substance to the body. Of course getting too much of it isn't good. However, we believe that, with the data we have, Mangoral is a safe drug", says Magnus Corfitzen.
Our product is based on manganese - not gadolinium - and thus, by definition we don't have that risk.
Mangoral is a powder, which will be mixed with water and drunk by the patients, whereas for example Omniscan is injected into the veins.
"This means that most of our drug passes through the intestines. It doesn't pass through the blood system in the same way. This, we believe to be a unique security profile. And then it's also more comfortable for the patients that they don't need an injection," says Corfitzen.
Orphan Drug Designation in the US
Ascelia Pharma's Mangoral has just obtained Orphan Drug Designation by the FDA. This entails the FDA offering a number of things such as tax benefits and a longer exclusivity on the market for Mangoral, because the drug will be used to treat a rare condition - patients with renal impairment who needs a scan for metastases in the liver.
"We target a small population that is not able to receive diagnostic treatments with contrast agents today. We are entering a market where there are no approved products today," says Corfitzen.
He explains that Ascelia Pharma expects to complete the phase 3 studies in 2020.
Concurrently, the company is working on developing a tablet version of Pfizer's drug against colon cancer, Camptosar. The drug has been named Oncoral and is currently in phase I.
Ascelia Pharma obtained the drug when the company acquired Danish Oncoral Pharma back in September for DKK 45 million (USD 7.4 million).
Even though the majority of the funding Ascelia Pharma currently seeks will be used for the contrast agent Mangoral, Magnus Corfitzen also hopes for the possibility of using some of the funding on the development of Oncoral.
If the company decides to list on the stock exchange it will be on the Swedish stock exchange, says the CEO who, incidentally used to be part of the venture environment at Sunstone Capital.
Ascelia Pharma was previously known as CMC Contrast.
English Edit: Ida Jacobsen