Idorsia presents at the 41st J.P. Morgan Healthcare Conference – Achievements
in 2022 provide the foundation for our success in 2023
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland – January 9 , 202 3
Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive
Officer of Idorsia, will present at the 41 st J.P. Morgan Healthcare Conference
on January 9, 2023, at 17:15 Pacific Standard Time / 02:15 Central European
Time. The conference will take place at the Westin St. Francis hotel in San
Francisco, USA.
Jean-Paul will describe how Idorsia is building momentum to become a leading
mid-sized biopharmaceutical company. The presentation will cover the launch of
the company’s first products, PIVLAZ™ (clazosentan) in Japan and QUVIVIQ™
(daridorexant) in the US and Europe. He will also present opportunities for
future growth coming from the clinical development pipeline, including the
recent filing of a new drug application for aprocitentan with the US Food and
Drug Administration (FDA), the eagerly anticipated Phase 3 REACT clinical
results expected in the near-term, and the progress made with other late-stage
assets. Follow this link to access the audio stream and find the presentation
available here .
Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“Our achievements in 2022 provide the foundation for our success in 2023.
QUVIVIQ is on track to become the leading global brand in insomnia. The
feedback from physicians has been overwhelmingly positive. In the US, the team
has done a great job in creating awareness and demand with patients and
physicians alike. We now need to conclude the access discussions in 2023 to
translate the strong and growing demand into revenue. Meanwhile, Germany and
Italy are off to a great start, and we expect to see additional European
countries launching QUVIVIQ during 2023, as well as the regulatory decision in
Canada. Following the excellent Phase 3 results in Japan, I also expect the
filing of the daridorexant Japanese NDA.”
Jean-Paul continued:
“PIVLAZ has had a great start in Japan with around 95% of the target accounts
now ordering and around 25% of patients suffering from an aSAH in November
receiving PIVLAZ. I am very eager to see the results for clazosentan in the
global REACT study which are expected in the coming weeks.”
Expected h ighlight s in 202 3 Secure additional funding through non-equity
dilutive instruments to narrow the funding gap Secure broader payer coverage
for QUVIVIQ (daridorexant) in the US – removing an important barrier to
prescribing † Commercial launch of QUVIVIQ (daridorexant) in additional
European countries, regulatory decision in Canada, and new drug application for
daridorexant in Japan Results of REACT, the Phase 3 study with clazosentan for
the prevention of cerebral vasospasm associated with aneurysmal subarachnoid
hemorrhage outside of Japan Marketing authorization application (MAA) for
aprocitentan for difficult-to-treat hypertension FDA decision for the NDA for
aprocitentan for difficult-to-treat hypertension
† Effective January 15, 2023, QUVIVIQ will be covered at parity to the other
branded dual orexin receptor antagonist (DORA) products for the Express Scripts
National Preferred Formulary (NPF).
Jean-Paul commented on the pipeline :
“The pipeline has also progressed in 2022. The positive results with
aprocitentan were rapidly analyzed and documented to achieve the US NDA before
the end of 2022. This puts us in a good position for other regulatory filings
in the coming months and the decision from the FDA before the end of 2023. Our
Phase 3 SOS-AMI study investigating selatogrel for the treatment of heart
attack has now exceeded 2,800 patients and recruitment will ramp up in 2023, we
are encouraged that the patient education material and device is performing
well. Having opened recruitment into the Phase 3 OPUS program investigating
cenerimod for lupus in December 2022, I expect great interest from patients to
participate and it should take off in 2023.”
Jean-Paul concluded :
“For me, a very important aspect to our long-term success is that our drug
discovery engine continues to deliver innovative products to the clinical
development pipeline. I’m pleased to have a new compound entering the clinic
this year and am very excited by what I see coming through from the drug
discovery team. These highlights are perfect examples of how we have created a
solid foundation in 2022 to succeed in 2023 and for our team to see the fruits
of all our labors.”
Idorsia’s p ortfolio
Compound Mechanism of a ction Target i ndication Status PIVLAZ ™ (c lazosentan
) Endothelin
receptor antagonist Cerebral vasospasm assoc. aSAH Commercially available in
Japan; Global Phase 3 complete – results expected Q1 2023 QUVIVIQ™ (d
aridorexant ) Dual orexin
receptor antagonist Insomnia Commercially available in the US, and the first
countries in Europe; Approved in the UK and Switzerland; Under review in
Canada; Phase 3 in Japan successful – filing expected in H2 2023; Phase 2 in
pediatric insomnia – recruiting Aprocitentan* Dual endothelin
receptor antagonist Difficult-to-control hypertension NDA under review in US,
other country filings in preparation Lucerastat Glucosylceramide
synthase inhibitor Fabry disease Phase 3 primary endpoint not met; Open Label
Extension ongoing Selatogrel P2Y 12 inhibitor Suspected acute
myocardial infarction Phase 3 recruiting Cenerimod S1P 1 receptor
modulator Systemic lupus
erythematosus Phase 3 recruiting ACT-1004-1239 ACKR3 / CXCR7
antagonist Multiple sclerosis Phase 2 in preparation Sinbaglustat GBA2/GCS
inhibitor Rare lysosomal storage disorders Phase 1 complete ACT-1014-6470 C5aR1
antagonist Immune-mediated
disorders Phase 1 ACT-777991 CXCR3 antagonist Recent-onset Type 1
diabetes Phase 1 IDOR-1117-2520 Undisclosed Immune-mediated
disorders Phase 1
* In collaboration with Janssen Biotech to jointly develop aprocitentan,
Janssen Biotech has sole commercialization rights worldwide
Neurocrine Biosciences has a global license to develop and commercialize
ACT-709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker.
ACT-709478 was investigated in a Phase 2 study for the treatment of a rare form
of pediatric epilepsy. The study did not meet the primary endpoint. ACT-709478
was generally well tolerated. Neurocrine continues to analyze the data
generated in the study to determine next steps.
Further details including the current status of each project in our portfolio
can be found in our innovation fact sheet .
Creation of Treasury Shares
The Company today reports that it has created 10,000,000 treasury shares with
a nominal value of CHF 0.05 each, thereby increasing its registered share
capital from CHF 8,848,349.75 to CHF 9,348,349.75. The new shares, created on
January 6, 2023, out of the Company’s authorized share capital, were subscribed
at nominal value by Idorsia Pharmaceuticals Ltd, a wholly owned subsidiary, and
are expected to be listed on the SIX Swiss Exchange on or around January 9,
2023. With this increase, the Company now holds treasury shares that can be
used in a cash preservative manner for potential share-based compensation,
effective fund raising, or business development purposes.
Notes to the editor
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 a leading biopharmaceutical company, with a strong
scientific core.
Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is
specialized in the discovery, development and commercialization of small
molecules to transform the horizon of therapeutic options. Idorsia has a broad
portfolio of innovative drugs in the pipeline, an experienced team of
professionals covering all disciplines from bench to bedside, state-of-the-art
facilities, and a strong balance sheet – the ideal constellation to translate
R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June
2017 and has over 1’200 highly qualified specialists dedicated to realizing our
ambitious targets.
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 58 844 10 10
investor.relations@idorsia.com
media.relations@idorsia.com
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