CardioKine Inc., just 2 years old, is ready to move its lead product, Lixivaptan, into Phase III trials, and it raised $50 million to do so.
The Series B preferred share financing will cover the costs of three Phase III trials to begin this summer testing the compound in hyponatremia in patients with heart failure, cirrhosis and syndrome of inappropriate antiduretic hormone (SIADH).
"It allows us to complete the Phase III trials and move forward with our plans over the next couple of years," said David Brand, president and CEO of CardioKine, adding that the funds also will help the company to "embark on our partnership strategy with respect to looking for co-promotion and co-development partners."
Founded in March 2004, Philadelphia-based CardioKine raised $37 million shortly after being launched, and its total raised to date is $87 million. It currently has 16 employees, but that should increase to 20 by the end of the year, and 25 by the end of 2007 - about the time the Phase III trials are completed.
If the data look good, CardioKine expects to submit a new drug application by the second quarter of 2008.
In-licensed from Madison, N.J.-based Wyeth, Lixivaptan is a selective V2 vasopressin receptor antagonist that has shown promising activity in treating hyponatremia, an imbalance of sodium and water in the body. It contributes to morbidity and poor outcomes in disorders such as heart failure, cirrhosis and SIADH, a condition associated with certain cancers and surgical procedures.
Hyponatremia is the most common electrolyte disorder of hospitalized patients. A product like Lixivaptan would address a population of 1.2 million hospitalized patients globally, and another 1.5 million of chronically ill patients.
"In terms of dollars, the market has been evaluated to be in the range of $1.5 billion on up to $2.5 billion," Brand told BioWorld Today.
Current therapies include water-restriction saline solutions, but "there's nothing that is really safe and effective," he said.
In December, Astellas Pharma US Inc., of Deerfield, Ill., received FDA approval of Vaprisol (conivaptan hydrochloride injection), an arginine vasopressin antagonist for the intravenous treatment of euvolemic hyponatremia in hospitalized patients. But Vaprisol is available "in injection only," Brand said. "There are no oral therapies on the market at this point."
In addition to CardioKine, two other companies are developing oral therapies for hyponatremia, Paris-based Sanofi Aventis Group and Tokyo-based Otsuka Pharmaceutical Co. Ltd.
Brand estimates that the Phase III trials will enroll somewhere between 500 and 1,000 patients. CardioKine is talking with a number of potential partners. Its strategy is to have a partner address the chronic market in the U.S., and the entire market outside of North America.
"We would look to vertically integrate in the hospital marketplace with our own field force" in the U.S., Brand said.
For the time being, CardioKine has no other products in the pipeline. Although it has evaluated about a dozen possibilities for in-licensing, it has not found the right one yet. Specifically, the company wants a product that addresses the same prescribers as Lixivaptan, or one that is close to Lixivaptan's launch.
"The nice thing about having Lixivaptan is we can be pretty particular with what we add as the second product," Brand said.
The Series B financing was led by two new investors, London-based Advent Venture Partners and Cambridge, Mass.-based Fidelity Biosciences, which also were joined by new investor Teachers Private Capital, of Toronto.
All of the Series A investors participated: Perseus-Soros Biopharmaceutical Fund, of New York; HealthCare Ventures, of Princeton, N.J.; Care Capital, also of Princeton; CIBC Capital Partners, of New York; and Burrill & Co., of San Francisco.
As part of the agreement, Shahzad Malik, of Advent, and Stephen Knight, of Fidelity, are joining CardioKine's board.