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1TC Treasury Convention 2021
02.03.2021
Online
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We’re committed to connecting the world of treasury and finance. Here’s how: our exclusive annual 1TC Treasury Convention. 2021 sees the first virtual 1TC from 02.03-04.03 and the addition of business spend management (BSM) solutions and expertise to the event.

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DKF 2021, 10. D-A-CH Kongress für Finanzinformationen
04.05.2021
Munich
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We will again be represented at the DKF this year and look forward to your visit to our stand.

Further information will be available here soon or on the official DKF 2021 website.

19th COPS Usertreff
24.06.2021
Rust
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As in previous years, COPS invites to their annual COPS user meeting this year from 24 to 25 June 2021 at the Seehotel Rust in Rust on Neusiedlersee.

The customers can expect a versatile and varied program, ranging from innovations in software solutions, successful project reports to practical application examples.

As a strategic partner, COPS gives us the opportunity to present our company and our solutions and show-case the cooperation with COPS.

On site, our colleagues Catherine Hanek, Achim Beisswenger and Sebastian Ullrich will be available for a lively exchange of ideas.

You can find further information here...

DEBS 2021
28.06.2021
Milan
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28.06. - 02-07-2021

Over the past decade, the ACM International Conference on Distributed and Event‐based Systems (DEBS) has become the premier venue for cutting-edge research in the field of event processing and distributed computing, and the integration of distributed and event-based systems in relevant domains such as Big Data, AI/ML, IoT, and Blockchain. The objectives of the ACM International Conference on Distributed and Event‐Based Systems (DEBS) are to provide a forum dedicated to the dissemination of original research, the discussion of practical insights, and the reporting of experiences relevant to distributed systems and event‐based computing. The conference aims at providing a forum for academia and industry to exchange ideas through its tutorials, research papers, and the Grand Challenge.

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23.11.2020 GlobeNewswire: Idorsia announces positive results of the two Japanese registration studies with clazosentan

Idorsia announces positive results of the two Japanese registration studies

with clazosentan Clazosentan demonstrates significant reduction of

vasospasm-related morbidity and all-cause mortality in patients following

aneurysmal subarachnoid hemorrhage (aSAH) Clazosentan demonstrates significant

reduction of all-cause morbidity and mortality in patients following aSAH in a

pre-planned pooled analysis of data from both studies. Idorsia Japan to file

New Drug Application (NDA) with the Japanese Pharmaceuticals and Medical

Devices Agency (PMDA) in the first half of 2021 Global Phase 3 study “REACT”

investigating the efficacy and safety of clazosentan for the prevention of

clinical deterioration due to vasospasm-related delayed cerebral ischemia in

adult patients following aSAH continues to actively recruit

 

Allschwil, Switzerland – November 23, 2020

Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the

Japanese registration program investigating clazosentan in adult Japanese

patients post-aSAH.

 

The program consisted of two double-blind, randomized, placebo-controlled

studies assessing the efficacy and safety of clazosentan in reducing

vasospasm-related morbidity and all-cause mortality events in adult Japanese

patients following aSAH. Patients were randomized to receive continuous

infusion of either 10 mg/hr clazosentan or placebo for up to 15 days following

the onset of aSAH. The two studies followed the same study design, with one

enrolling 221 patients whose aneurysm was secured by surgical clipping and the

other enrolling 221 patients whose aneurysm was secured by endovascular

coiling.

 

Both studies demonstrated that clazosentan reduced the occurrence of cerebral

vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH

with statistical significance (p < 0.01 for both studies). Cerebral

vasospasm-related morbidity and all-cause mortality was blindly adjudicated by

an independent committee and defined by at least one of the following: All

Death / New cerebral infarction due to cerebral vasospasm / Delayed Ischemic

Neurologic Deficit (DIND) due to cerebral vasospasm. Clazosentan showed a

numerical reduction of all-cause morbidity and mortality in both studies. The

effect of clazosentan on this endpoint was significant (p < 0.05) in a

pre-planned pooled analysis. Further analysis is ongoing including additional

pooled analysis of data from both studies.

 

The studies confirmed the well documented safety profile of clazosentan which

has now been administered to over 2000 patients around the globe. In these

registration studies in Japanese patients post-aSAH there were no unexpected

safety findings. Treatment emergent adverse events occurring >5% in the

clazosentan group with a difference of >2% compared to placebo were vomiting

and signs of hemodilution or fluid retention (i.e. hyponatremia,

hypoalbuminemia, anemia, pleural effusion, brain and pulmonary edema).

 

Satoshi Tanaka, Dr Med Sci. and President of Idorsia Pharmaceuticals Japan,

commented:

 

 

“I want to start by thanking the investigators and their highly skilled staff

for the excellent conduct of the study. I also thank the Idorsia Japan team,

many of whom have worked on clazosentan for many years and never doubted the

benefit that it could bring to the patients, I’m very proud of the whole team.

Most of all I want to thank the patients who have taken part in this study and

their families, they can all be very proud of being part of this very important

advancement for Japanese patients whose lives are so impacted by this

devastating consequence of aSAH. My team will now rapidly analyze the study in

full detail with the objective to file the NDA with the PMDA in the first half

of 2021 and make the full results available through scientific publication.”

 

Teiji Tominaga, M.D., Ph.D., Professor & Chairman, Department of Neurosurgery,

Tohoku University Graduate School of Medicine commented:

“The clinical consequences of the vasospasm that can follow aSAH can be far

reaching, ranging from neurological to other physical problems that can be very

severe in nature. aSAH is a significant problem in Japan with an incidence

around twice as high as in other countries around the world. This makes the

medical need particularly high in Japan and the discovery of a new therapeutic

option that can help Japanese patients to overcome the consequences of this

devastating condition is important. I have worked with the team to develop

clazosentan since the first studies, it is very rewarding to see the years of

research come to fruition with these great results.”

 

Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:

“I would like to congratulate the Japanese team, which under the leadership of

Dr. Satoshi Tanaka, has driven the development of clazosentan with such

enthusiasm, determination, and scientific excellence. The results are highly

clinically relevant and bring significant advancement for patients while

confirming a safety profile that should not limit the use of the drug. The data

are very impressive and give us further reason to intensify our efforts to

finish the recruitment into the global REACT study as soon as possible.”

 

Jean-Paul concluded on a personal note:

“Martine and I have worked on the role of endothelin and the potential of

endothelin receptor antagonism in aSAH for more than 25 years, with the first

publication back in 1993. We had a very clear goal; to help patients following

aSAH, who are often young adults and whose lives can be devastated by the

terrible consequences of cerebral vasospasm. Thanks to the creation of Idorsia,

to the confidence of its investors, and determination of the team, we are now

on a good track to bring a major breakthrough therapy to these patients. This

is immensely rewarding for all of us.”

 

About the global registration program “REACT”

In February 2019, Idorsia initiated REACT, a prospective, multicenter,

double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to

investigate the efficacy and safety of clazosentan for the prevention of

clinical deterioration due to vasospasm-related delayed cerebral ischemia in

adult patients following aSAH. The Phase 3 study builds upon the learnings from

the previous clazosentan studies to identify patients at high risk of vasospasm

and delayed cerebral ischemia, the optimal dose, the best measure to

demonstrate efficacy and an optimized patient management guideline to ensure

patient safety.

 

Approximately 400 patients – treated either with microsurgical clipping or

endovascular coiling – are being enrolled at approximately 95 sites across 15

countries. Patients are randomized to receive continuous infusion of either

clazosentan (15 mg/hr) or placebo prophylactically, on top of local standard of

care, for a period of up to 14 days. REACT is enrolling aSAH patients

identified as being at high risk of developing vasospasm and subsequent delayed

cerebral ischemia because of high-volume hemorrhage, as assessed by CT scan on

hospital admission. Patients experiencing asymptomatic cerebral vasospasm, as

measured by angiography, within 14 days of aSAH may also be included.

Completion of the study is targeted for the second half of 2022.

 

Notes to the editor

 

Available data in Japanese patients

A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr of

clazosentan administered by continuous intravenous infusion significantly

reduced vasospasm and vasospasm-related morbidity and mortality events. The

results are published in Cerebrovascular Diseases (Fujimura M, et al.

Cerebrovasc Dis 2017;44:59–67). On that basis, a registration program was

initiated with clazosentan in Japan in May 2016.

 

About aneurysmal subarachnoid hemorrhage and cerebral vasospasm

Aneurysmal subarachnoid hemorrhage is a rare condition involving sudden

life-threatening bleeding occurring in the subarachnoid space. It is caused by

the rupture of an aneurysm – a weak, bulging spot on the wall of a cerebral

artery. Emergency surgical repair (endovascular coiling or microsurgical

clipping) is required to stop the hemorrhage.

 

The bleeding and the release of a vasoconstrictor (endothelin) by the

neighboring vascular endothelium can lead to cerebral vasospasm (constriction

of arteries in the brain) usually occurring between four and fourteen days

after aSAH. This diminishes blood flow to the brain and about one third of

patients consequently experience worsening of their neurological condition.

Cerebral vasospasm is one of the leading secondary causes of disability and

death in those that experience aSAH.

 

The prevalence of aSAH is estimated to be between 6 and 9 per 100,000

worldwide and is a significant problem in Japan with an incidence around twice

as high as in many other countries of the world.

 

Available clinical data with clazosentan

Previously, clazosentan was investigated for the prevention of angiographic

vasospasm in patients with aSAH in a Phase 2 study, CONSCIOUS-1, which

demonstrated dose-dependent prevention of vasospasm.

 

This study was followed by two Phase 3 studies, CONSCIOUS-2 and CONSCIOUS-3,

to assess the effect of clazosentan on the incidence of cerebral

vasospasm-related morbidity and all-cause mortality. The dose of clazosentan (5

mg/h) used in CONSCIOUS-2 did not allow a statistically significant treatment

effect to be observed, resulting in the premature termination of CONSCIOUS-3.

However, an exploratory analysis of the data collected in CONSCIOUS-3 showed

that a higher dose of clazosentan, i.e. 15 mg/h, significantly reduced cerebral

vasospasm-related morbidity and all-cause mortality, with a 44% relative risk

reduction (p=0.0074).

 

The 15 mg/h dose also significantly reduced the incidence of delayed ischemic

neurological deficit with a 54% relative risk reduction (p=0.0038). In

addition, clazosentan reduced the need for rescue therapy for vasospasm.

Clazosentan did not show any effect of clazosentan on long-term clinical

outcome.

 

A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr of

clazosentan significantly reduced vasospasm and vasospasm-related morbidity and

mortality events.

 

A pilot study evaluating the early effect of clazosentan on reversing

established cerebral vasospasm in large proximal cerebral artery segments at

three hours post-initiation suggests that clazosentan has the potential to

improve large vessel vasospasm upon early administration. In a post-hoc

analysis of the effect of clazosentan on reversing established cerebral

vasospasm in the entire cerebral vasculature, including smaller distal vessel

segments and the cerebellar arteries, a clearly visible improvement in vessel

diameter at three and 24 hours could be observed.

 

The above studies have also established an extensive safety profile with over

2,000 patients treated. The side effects of clazosentan are managed based on

clear protocol guidelines: hypotension can be mitigated using blood pressure

control with vasopressors in the ICU, while lung complications (such as

pulmonary edema) can be managed by aiming to maintain euvolemia by avoiding

excessive fluid administration.

 

Key literature

Fujimura M, et al. Cerebrovasc Dis 2017; 44:59–67

Macdonald R L, et al. Stroke. 2012; 43(6):1463-9.

Macdonald R L, et al. The Lancet. Neurology, 2011; 10(7):618-625.

Macdonald R L, et al. Stroke 2008; 39:3015-3021.

Vajkoczy P, et al. Journal of Neurosurgery 2005; 103:9-17.

Roux S. et al. J Pharmacol Exp Ther 1997; 283:1110-1118.

Clozel M, Watanabe H, Life Sciences 1993; 52(9):825-834

 

About Idorsia

Idorsia Ltd is reaching out for more - We have more ideas, we see more

opportunities and we want to help more patients. In order to achieve this, we

will develop Idorsia into one of Europe’s leading biopharmaceutical companies,

with a strong scientific core.

 

Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is

specialized in the discovery and development of small molecules, to transform

the horizon of therapeutic options. Idorsia has a broad portfolio of innovative

drugs in the pipeline, an experienced team, a fully-functional research center,

and a strong balance sheet – the ideal constellation to bringing R&D efforts to

business success.

 

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June

2017 and has over 800 highly qualified specialists dedicated to realizing our

ambitious targets.

 

About Idorsia Pharmaceuticals Japan

Idorsia Pharmaceuticals Japan was established, under the leadership of Dr

Satoshi Tanaka, in 2018 to conduct clinical development and prepare the

commercialization of Idorsia's innovative and promising compounds for patients

in Japan.

 

For further information, please contact

Andrew C. Weiss

Senior Vice President, Head of Investor Relations & Corporate Communications

Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil

+41 (0) 58 844 10 10

www.idorsia.com

 

The above information contains certain 'forward-looking statements', relating

to the company's business, which can be identified by the use of

forward-looking terminology such as 'estimates', 'believes', 'expects', 'may',

'are expected to', 'will', 'will continue', 'should', 'would be', 'seeks',

'pending' or 'anticipates' or similar expressions, or by discussions of

strategy, plans or intentions. Such statements include descriptions of the

company's investment and research and development programs and anticipated

expenditures in connection therewith, descriptions of new products expected to

be introduced by the company and anticipated customer demand for such products

and products in the company's existing portfolio. Such statements reflect the

current views of the company with respect to future events and are subject to

certain risks, uncertainties and assumptions. Many factors could cause the

actual results, performance or achievements of the company to be materially

different from any future results, performances or achievements that may be

expressed or implied by such forward-looking statements. Should one or more of

these risks or uncertainties materialize, or should underlying assumptions

prove incorrect, actual results may vary materially from those described herein

as anticipated, believed, estimated or expected.

 

 

 

Anhang Medienmitteilung PDF

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