Cardiorentis Announces €45 Million Financing with HealthCare Royalty Partners to Fund
Ularitide Registration Program in Acute Heart Failure
ZUG, Switzerland – September 17, 2014 – Cardiorentis AG, a privately held biopharmaceutical company, today announced that it has entered into a €45 million financing agreement with HealthCare Royalty Partners (“HC Royalty”), a U.S. based healthcare investment firm. The proceeds will be used to finance the Company’s registration program for the natriuretic peptide Ularitide in acute heart failure.
“This is a pivotal time for our Company. The team at HC Royalty understood the attractiveness of our program and our financing needs and then developed a structure that would give us a high degree of flexibility but also a sizeable amount of capital to complete our pivotal Phase III trial for Ularitide. We believe we have the financial resources in place to execute on our business strategy to introduce the first therapy with proven outcome benefits for patients with acute heart failure,” stated Johannes Holzmeister, M.D., Chief Executive Officer and Chief Medical Officer, Cardiorentis.
The TRUE-AHF Phase III trial was initiated in August 2012. It is led by the international principal investigator Milton Packer, M.D., University Texas, Southwestern Medical Center in Dallas, Texas and includes over 200 centers across the U.S., Europe, Canada and Latin America. TRUE-AHF is an event driven trial, which may enroll up to 4,000 patients with acute heart failure. There are two co-primary endpoints. The first is a composite endpoint for acute heart failure which assesses a patient’s symptoms and persistent or worsening heart failure within the first 48 hours after treatment initiation. The second co-primary endpoint is cardiovascular mortality.
“We are impressed with the significant clinical progress that Cardiorentis has made with Ularitide. The TRUE-AHF trial is the first of its kind and if successful could produce a first line treatment for acute decompensated heart failure. We are pleased to be Cardiorentis’ capital partner of choice to bring this potential life-saving treatment to patients,” commented Clarke B. Futch, Founding Managing Director at HC Royalty.
Ularitide is a natriuretic peptide in Phase III development as an intravenous (IV) infusion treatment for acute heart failure (AHF) limited by United States law to investigational use only. Ularitide is the chemically synthesized form of urodilatin - a human, natriuretic peptide that is produced in the kidneys and induces excretion of sodium into the urine (natriuresis) and increased urine production (diuresis) to regulate fluid balance and sodium haemostasis. Ularitide induces natriuresis and diuresis by binding to specific natriuretic peptide receptors (NPR-A, NPR-B and other natriuretic peptide receptors), thereby increasing intracellular cyclic guanosine monophosphate (cGMP) helping to relax smooth muscle tissues, leading to vasodilation and increased blood flow.
Heart failure is a growing problem worldwide. More than 26 million people around the world are affected., AHF can be defined as the sudden or gradual onset of the signs or symptoms of heart failure resulting in a need for urgent therapy or hospitalisation. In 2011, there were nearly 3 million hospital admissions with heart failure as the primary diagnosis in countries across the globe. It is a life-threatening condition which requires immediate medical attention. Signs and symptoms of AHF include extreme fatigue and shortness of breath, worsening kidney function, severe swelling, sudden weight gain and a distended jugular vein along the side of the neck.
About Cardiorentis Ltd.
Cardiorentis is a private biopharmaceutical company headquartered in Zug, Switzerland. Cardiorentis is committed to bringing novel therapies to the treatment of heart failure and related cardiovascular diseases. The company's disease-based technology platform integrates expertise in protein biology to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit http://www.cardiorentis.com.
About HealthCare Royalty Partners
HealthCare Royalty Partners is a global healthcare investment firm that provides financing solutions to healthcare companies and royalty owners with interests in pharmaceutical and medical device products. The firm's senior investment team has participated in over 50 royalty financings valued at over $2 billion over the past decade. For more information, visit www.healthcareroyalty.com.
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