Cortendo is coming to America. Founded in Sweden, the little biotech has a new CEO who's building the executive team in the Philadelphia area. And he's dropping plans for a listing on the Oslo exchange in favor of a U.S. IPO after raising $11 million in bridge financing.
|Cortendo CEO Matthew Pauls|
The big idea at Cortendo is to take an existing drug--ketoconazole, which is used off-label for Cushing's disease--and tinker with it to make it safer and more effective. HealthCap, the Third Swedish National Pension Fund ("AP3"), Storebrand and Arctic Fund Management are putting up the venture round. And their money is funding an on-going Phase III study designed to make their case with the FDA.
"It is a nice bridge to the U.S. which also allows us from funding perspective to drive that critically important Phase III to closure," says CEO Matthew Pauls, an ex-Shire ($SHPG) and Insmed exec from the commercial side of the industry who joined the company a couple of months ago.
Cushing's is characterized by elevated levels of cortisol, which trigger a host of serious and potentially lethal side effects. The new drug--dubbed COR-003--is designed to hit key enzymes in the cortisol synthesis pathway, using a more targeted segment of ketoconazole.
"We took basically the better half of the molecule and are using it explicitly for Cushing's syndrome," says the CEO. Now Cortendo--which is run by a core team of 6, which Pauls plans to expand--will drive for final late-stage data in 2017, setting up a prospective application with the FDA that could allow the company to proceed with plans to create its own commercial operations.
There are about 20,000 to 25,000 Cushing's patients in the U.S., adds Pauls, with maybe 30,000 to 40,000 in Europe. About half of those patients can expect surgery to address the disease, with the rest candidates for medicinal therapies.
The U.S. represents the company's largest market opportunity, says Pauls. So it makes sense to drop the Oslo listing in favor of a U.S. exchange. Exactly when that filing could come and where, he adds, hasn't been determined yet.
- here's the release