Ad hoc announcement pursuant to Art.

GNW-Adhoc: Idorsia and Viatris enter into a significant global research and development collaboration. 53 LR * Viatris and Idorsia will collaborate on the global development and commercialization of two Phase 3 assets, selatogrel and cenerimod.

Ad hoc announcement pursuant to Art. 53 LR
  * Viatris and Idorsia will collaborate on the global development and
    commercialization of two Phase 3 assets, selatogrel and cenerimod.
  * Idorsia to receive an upfront payment of USD 350 million, potential
    development and regulatory milestone payments, additional sales milestone
    payments and tiered royalties on annual net sales.
  * Viatris and Idorsia will both contribute to the development costs for both
    programs.
  * Includes future optionality to expand collaboration with additional pipeline
    assets.
  * Combines Viatris' financial strength and worldwide operational
    infrastructure with Idorsia's proven, highly productive drug development
    team and innovative engine.
Allschwil, Switzerland - February 28, 2024
Idorsia Ltd (SIX: IDIA) today announced that it has entered into agreements for
a significant global research and development collaboration with Viatris Inc.
(NASDAQ: VTRS), a global healthcare company, for the global development and
commercialization of two Phase 3 assets - selatogrel and cenerimod - for an
upfront payment of USD 350 million, potential development and regulatory
milestone payments, and certain contingent payments of additional sales
milestone payments and tiered royalties from mid-single- to low double-digit
percentage on annual net sales.
A joint development committee will oversee the development of the ongoing Phase
3 programs for selatogrel and cenerimod through regulatory approval. Idorsia
will contribute up to USD 200 million in the next 3 years and will transfer to
Viatris at closing the dedicated personnel to both programs.
Viatris will have worldwide commercialization rights for both selatogrel and
cenerimod (excluding, for cenerimod only, Japan, South Korea and certain
countries in the Asia-Pacific region).
Idorsia has also granted Viatris a Right of First Refusal and First Negotiation
for certain other pipeline assets.
The company expects to close the transaction by the end of March, subject to
customary closing conditions, but no additional regulatory or shareholder
approvals are required.
Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented:
"I'm delighted that with Viatris we have found a strong partner to secure and
accelerate the development programs for both selatogrel and cenerimod by
leveraging the strength of Viatris' global infrastructure. From the first
meeting, it was clear that the team at Viatris shares the same excitement and
engagement for our innovations. This global collaboration allows us to share the
costs of the ongoing Phase 3 programs whilst retaining long-term shareholder
value, by sharing the rewards for success through the milestones and royalties."
Scott A. Smith, Chief Executive Officer of Viatris, commented:
"I am extremely pleased with our global research and development collaboration
with Idorsia. We are connecting Idorsia's proven, highly productive drug
development team and innovation engine with Viatris' strong global
infrastructure and experience to focus on two late-stage potential blockbuster
assets with long-dated patent protection. I believe that together we will be
able to execute on the potential of these global assets and any future assets as
we work to deliver on our goal of building a more durable, predictable portfolio
on the foundation of our strong base business, and that selatogrel and cenerimod
can become meaningful components of Viatris' business over the long term."
André C. Muller, Chief Financial Officer of Idorsia, commented:
"In the coming weeks and months, we have many inflection points ahead, namely
the FDA and CHMP decisions for aprocitentan, as well as expanded access and
availability of QUVIVIQ (daridorexant) in the US, Canada and across Europe."
André continued:
"The upfront payment of USD 350 million gives us much needed liquidity. We've
repeatedly explained that we have many balls in the air, we've now caught the
first one and continue to work on others to secure Idorsia's future. We are
working on several funding options, including business development
opportunities, equity, and equity-linked deals to significantly extend our cash
runway."
Notes to the editor
About selatogrel
Selatogrel is a potent, fast-acting, reversible, and highly selective
P2Y(12) inhibitor, being developed for the treatment of acute myocardial
infarction (AMI), in patients with a history of AMI. It is intended to be self-
administered subcutaneously via a drug delivery system (autoinjector). This
novel, self-administered emergency agent has the potential to protect heart
muscle in the very early phase of an AMI - in the crucial time between symptom
onset and first medical attention - so as to treat the ongoing AMI and prevent
early death.
Idorsia is enrolling patients into a large international, double-blind,
randomized, placebo-controlled Phase 3 study - Selatogrel Outcome Study in
suspected Acute Myocardial Infarction (SOS-AMI) - to assess the clinical
efficacy and safety of selatogrel 16 mg when self administered (on top of
standard of care) upon the occurrence of symptoms suggestive of AMI. The primary
efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI,
after self-administration of the study treatment.
A Special Protocol Assessment has been agreed with the FDA, indicating its
concurrence with the adequacy and acceptability of critical elements of overall
protocol design for a study intended to support a future marketing application.
In addition, the FDA designated the investigation of selatogrel for the
treatment of suspected AMI as a "fast-track" development program. This
designation is intended to promote communication and collaboration between the
FDA and pharmaceutical companies for drugs that treat serious conditions and
fill an unmet medical need.
About cenerimod
Cenerimod, the result of 20 years of research in Idorsia's labs, is a highly
selective S1P(1) receptor modulator, given as an oral once-daily tablet.
Cenerimod potentially offers a novel approach for the treatment of systemic
lupus erythematosus (SLE), a disease with a significant impact on patients and
limited treatment options.
In December 2022, Idorsia initiated the OPUS program (Oral S1P(1) Receptor
ModUlation in SLE), which consists of two multicenter, randomized, double-blind,
placebo-controlled, parallel-group Phase 3 studies to evaluate the efficacy,
safety, and tolerability of cenerimod in adult patients with moderate to severe
SLE on top of background therapy. The main objectives of the program are to
evaluate the effectiveness of cenerimod 4 mg in reducing disease activity, as
well as controlling the disease, compared to placebo. The primary endpoint is
response on SRI-4 at month 12 compared to baseline. Secondary endpoints include
response on BICLA at month 12 compard to baseline and - for the first time in a
lupus registration study - measures of sustained disease control: time to first
confirmed 4-month sustained mSLEDAI-2K response and time to first confirmed 4-
month sustained response in mucocutaneous manifestations (i.e. rash, alopecia,
mucosal ulcers).
The investigation of cenerimod for the treatment of SLE has been designated as a
"fast-track" development program by the FDA. This designation is intended to
promote communication and collaboration between the FDA and pharmaceutical
companies for drugs that treat serious conditions and fill an unmet medical
need.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned
to bridge the traditional divide between generics and brands, combining the best
of both to more holistically address healthcare needs globally. With a mission
to empower people worldwide to live healthier at every stage of life, we provide
access at scale, currently supplying high-quality medicines to approximately 1
billion patients around the world annually and touching all of life's moments,
from birth to the end of life, acute conditions to chronic diseases. With our
exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind
global supply chain designed to reach more people when and where they need them,
and the scientific expertise to address some of the world's most enduring health
challenges, access takes on deep meaning at Viatris. We are headquartered in the
U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn
more at viatris.com and investor.viatris.com, and connect with us on LinkedIn,
Instagram, YouTube and X (formerly Twitter).
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 20-year
heritage of drug discovery, a broad portfolio of innovative drugs in the
pipeline, an experienced team of professionals covering all disciplines from
bench to bedside, and commercial operations in Europe and North America - the
ideal constellation for bringing innovative medicines to patients.
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.
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
[phone]
[e-mail] (mailto:[e-mail])
[e-mail] (mailto:[e-mail])
www.idorsia.com (http://www.idorsia.com)
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