Cardiorentis Prepares Acute Heart Failure Therapy For Market
This article was originally published in Scrip
Swiss biotech Cardiorentis AG has raised CHF60m ($60m) in a Series B financing round to support regulatory filings this year and initial US commercialization efforts for ularitide, its potential acute decompensated heart failure therapy that is in a late-stage Phase III clinical study.
Cardiorentis was initially set up with funding from a high net worth individual, and the current financing round was led by three high-net-worth private investors, a funding strategy that likely speeds decision-making compared with companies with a number of venture capital investors.
That's important because Cardiorentis is in a close race with Novartis AG, a much larger company expected to refile for approval of its potential acute heart failure therapy, serelaxin, this year. Cardiorentis is already planning to launch ularitide itself: it is preparing to set up a US commercialization infrastructure including sales and marketing operations, CEO Johannes Holzmeister said. Cardiorentis also entered a €45m ($48.8m) financing with HealthCare Royalty Partners in 2014, also to fund ularitide's registration program.
To help commercialization planning, Brent Furse has been recruited as president US and global chief commercial officer, and Reto Wittwer has been hired as chief financial officer. Furse was most recently chief customer officer and executive vice-president at The Medicines Company, where he led the launch of the thrombin inhibitor Angiomax (bivalirudin). Wittwer was most recently vice-president and CFO of Sandoz North America.
Cardiorentis's private individual approach has not affected its ability to raise funding, as the size of its Series B is similar to amounts raised recently by other Swiss biotechs: Geneva-based women's health company ObsEva raised $60m in Nov. 2015 to support the development of its R&D pipeline, and ADC Therapeutics received $80m in a Series B in Sept. 2015 for its antibody-drug conjugates, according to Informa PLC's Strategic Transactions database.
And Cardiorentis is not alone in Europe in attracting significant support from private investors – Germany's Dietmar Hopp and the Strüngmann brothers are important investors in the region's biotech companies.
The treatment of acute heart failure has remained unchanged for years, consisting mainly of diuretics, ACE-inhibitors and other agents, and patients have a poor prognosis. "Our goal is for ularitide to be the first evidence based drug for acute decompensated heart failure," Holzmeister said. "The current standard of care relies on generic agents such as intravenous loop diurectics (furosemide) and vasodilators (nitrates, neseritide) that only address symptoms and not the condition itself. These agents have failed to improve short- and long-term prognosis for patients despite the alleviation of symptoms and hemodynamic impairment."
Ularitide is a synthetic version of the human natriuretic hormone urodilatin, given by intravenous infusion. Completion of the pivotal Phase III TRUE-AHF study of ularitide in acute decompensated heart failure is expected shortly. Top-line results are expected to be available this spring, and regulatory submissions expected in the second half of 2016 in the US and Europe. Just last month, the FDA granted fast-track designation for the development and review of ularitide.
In ularitide's TRUE-AHF study, 2,157 patients have been enrolled in centers in the US, Europe, Canada and Latin America, and two co-primary endpoints are being evaluated – a composite endpoint for ADHF that includes a patient's symptoms and persistent or worsening heart failure in the first 48 hours after initiation of treatment, and a cardiovascular mortality endpoint.
Acute heart failure affects more than 26 million people worldwide, and is a growing problem, according to Cardiorentis. Analysts at Datamonitor Healthcare estimate there are 2.6m new cases every year in the US, Europe's top-five markets and Japan. The number of patients diagnosed with the condition is expected to reach 3.6m by 2034, according to a Datamonitor Healthcare report published Nov. 11 2015.
Novartis's potential acute heart failure therapy RLX030 (serelaxin) was turned down by EU and US regulators in 2013 because of the need for more clinical evidence, that is expected to come this year from the ongoing RELAX-AHF-2 study. The company is already active in the therapeutic area, with the chronic heart failure therapy Entresto (sacubitril plus valsartan) expected to be a blockbuster, although initial sales have been slower than expected.