Idorsia and Viatris enter into a significant global research and
development collaboration
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 P2Y12 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 S1P1 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
S1P1 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
+41 58 844 10 10
investor.relations@idorsia.com
media.relations@idorsia.com
www.idorsia.com
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and anticipated expenditures in connection therewith, descriptions
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cause the actual results, performance or achievements of the
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or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those
described herein as anticipated, believed, estimated or
expected.
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