Z FOR IMMEDIATE RELEASE

FOR IMMEDIATE RELEASE
Cardiorentis AG and Roche Announce Collaboration to Establish Therapeutic Impact of
Ularitide
Z
UG and ROTKREUZ, Switzerland – October 16,
2014 -- Cardiorentis AG, a privately held biopharmaceutical company, today announced a collaboration with
Roche to establish the therapeutic efficacy and safety of
Ularitide, the Company’s investigational drug for acute
heart failure (AHF). Under the terms of the collaboration,
Cardiorentis will incorporate Roche’s advanced in vitro
diagnostic tests into its TRUE-AHF Phase III Study to
characterize the pharmacological properties of Ularitide,
evaluate its benefit-risk profile and the appropriate clinical application in patients.
“Roche is the world leader in in vitro diagnostics and has
been consistently recognized for its breakthrough medical
innovations for the treatment of cardiovascular diseases.
This collaboration allows us to incorporate the most
advanced biomarkers into our TRUE-AHF trial and we are
hopeful it will result in proven outcome benefits for patients
with acute heart failure,” stated Johannes Holzmeister,
M.D. Chief Executive Officer and Chief Medical Officer,
Cardiorentis.
“Our in vitro diagnostic tests provide critical clinical
information addressing doctor’s needs to guide the patient’s
treatment regime. Incorporating these tests into the TRUEAHF trial will enable us to further validate their clinical value
in a large patient population but more importantly advance
the development of new treatment options for acute heart
failure,” added Prof. Christian Zaugg, Head of Disease Area
Strategy at Roche Professional Diagnostics.
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 persistence or worsening of heart failure within the first
48 hours after treatment initiation. The second co-primary
endpoint is cardiovascular mortality.
About Ularitide
Ularitide is a natriuretic peptide in Phase III development as
an intravenous 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 homeostasis. 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 in­
creased blood flow.
About AHF
Heart failure is a growing problem worldwide. More than
26 million people around the world are affected.[1],[2]
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
ang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S.,1979 to 2004. J Am Coll Cardiol
F
2008;52(6):428-34.
2
McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J
1998; 19 Suppl P:P9. [http://www.uptodate.com/contents/epidemiology-and-causes-of-heart-failure/abstract/8 ]
1
www.cardiorentis.com
the primary diagnosis in countries across the globe[3]. 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 dis­
tended jugular vein along the side of the neck.
About Cardiorentis Ltd.
Cardiorentis is a private biopharmaceutical company
headquartered in Zug, Switzerland. Cardiorentis is com­
mitted 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 Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in
oncology, immunology, infectious diseases, ophthalmology
and neuroscience. Roche is also the world leader in in vitro
diagnostics and tissue-based cancer diagnostics, and a
frontrunner in diabetes management. Roche’s personalised
healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health,
quality of life and survival of patients. Founded in 1896,
Roche has been making important contributions to global
health for more than a century. Twenty-four medicines
developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them
life-saving antibiotics, anti-malarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people
worldwide, invested 8.7 billion Swiss Francs in R&D and
posted sales of 46.8 billion Swiss Francs. Genentech, in the
United States, is a wholly owned member of the Roche
Group. Roche is the majority shareholder in Chugai
Pharma­ceutical, Japan. For more information, please visit
www.roche.com.
3
rganisation for Economic Co-operation and Development.
O
Health care utilisation – Hospital discharges by diagnostic
categories – All causes (http://stats.oecd.org/)
www.cardiorentis.com
All trademarks used or mentioned in this release are protected by law.
Contacts:
For Cardiorentis:
Kellie Walsh
1-914-315-6072
kwalsh@kwmcommunications.com
For Roche:
Daniel Fleiter, Senior Public Relations Manager
+41 41 79 85990
daniel.fleiter@roche.com
Gabriela Bucklar-Suchankova, Global Medical Leader CVD
+41 41 792 3255
gabriela.bucklar-suchankova@roche.com