- Expands Viatris' Portfolio of Innovative Assets by
Immediately Adding Two Phase 3 Assets, Selatogrel and Cenerimod,
Both With Blockbuster Revenue Potential
- Includes Future Optionality to Expand Collaboration With
Additional Innovative Assets
- Combines Viatris' Financial Strength and Worldwide
Operational Infrastructure With Idorsia's Proven,
Highly Productive Drug Development Team and Innovation Engine
- Deal Structure Reinforces Viatris' Disciplined Approach to
Capital Allocation
- Viatris Announces R&D Event to be Held March 27, 2024
PITTSBURGH, Feb. 28, 2024 /PRNewswire/ -- Viatris
Inc. (NASDAQ: VTRS), a global healthcare company, and Idorsia
Ltd (SIX: IDIA) today announced they have entered into agreements
for a significant global research and development collaboration
under which Viatris will receive exclusive global development and
commercialization rights to two Phase 3 assets as well as the
potential to add additional innovative assets in the future.
The collaboration includes selatogrel, a potential life-saving
self-administered medicine for patients with a history of acute
myocardial infarction (AMI), or heart attack, and builds on
Viatris' existing global cardiovascular franchise and specialty
infrastructure, as well as its knowledge, leadership, and
distribution capabilities for self-administered medication for
acute life-threatening conditions.
The collaboration also includes cenerimod, a novel immunology
asset that has the potential to be a first-in-class oral therapy
for the treatment of systemic lupus erythematosus (SLE), the most
common form of lupus. Through lifecycle management, this asset also
has the potential for broad application across multiple autoimmune
diseases in a specialist-driven category with attractive market
dynamics for oral therapies and could be a cornerstone asset in
Viatris' immunology platform.
Viatris CEO Scott A.
Smith said: "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.
Smith continued: "As I have said previously, in addition to
continuing to develop the three core therapeutic areas that we
identified—ophthalmology, dermatology and GI—we are also going to
be opportunistic in seeking out assets that we believe fit our
company well and have the potential to contribute significantly to
our future revenue growth. Entering into this type of global
research and development partnership structure with Idorsia is a
great example of our disciplined approach to capital
allocation."
Viatris Chief R&D Officer Philippe
Martin said: "I am excited to have the opportunity to work
with Idorsia's talented drug development team who are essential to
the execution of these clinical programs. Both selatogrel and
cenerimod have the potential to be important medicines by providing
significant advances for patients suffering with life-altering
disease. Selatogrel has the potential to become the first
self-administered treatment for recurring AMI that fills the
medical gap during the pre-hospital phase of a life-threatening
condition. Cenerimod has the potential to fill the need for a more
tolerable and effective treatment for SLE, in combination with
standard therapy, earlier in disease progression."
Idorsia CEO Jean-Paul Clozel, MD, said: "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."
Terms of the Transaction
Under the terms of the
agreements, the development programs and certain personnel for
selatogrel and cenerimod will be transferred to Viatris in exchange
for an upfront payment to Idorsia of $350
million, potential development and regulatory milestone
payments, and certain contingent payments of additional sales
milestone payments and tiered royalties in the mid-single to
low-double digit percentages on annual net sales. Viatris and
Idorsia will both contribute to the development costs for 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) and intends
to utilize its Global Healthcare
Gateway® infrastructure to bring access to patients
worldwide. A joint development committee will oversee the
development of the ongoing Phase 3 programs through regulatory
approval. The agreements also provide Viatris a right of first
refusal and a right of first negotiation for certain other assets
in Idorsia's pipeline. The closing of the transaction is subject to
certain limited closing conditions, but no additional regulatory or
shareholder approvals are required. The transaction is expected to
close at the end of March.
Citi is acting as financial advisor to Viatris.
R&D Event
Viatris will hold an R&D Event on
March 27, 2024, from 10 a.m. to noon ET, in New York City. The event will include
presentations from Viatris executives discussing the global
research and development collaboration with Idorsia and other
elements of the Company's pipeline, as well as presentations from
two expert thought leaders. The presenters will be available to
answer questions at the end of the presentations.
Expert thought leaders presenting at the event are:
- Dr. Deepak L. Bhatt, MD, MPH, a top expert in
cardiovascular medicine and interventional
cardiology, Director of Mount Sinai Heart. Dr. Bhatt is highly
recognized for his significant breakthroughs in the field of
cardiology, including interventional cardiology, heart disease
prevention, vascular medicine and heart failure.
- Dr. Anca Askanase, MD, founder and clinical director of
Columbia University's new Lupus Center
and the Director of Rheumatology Clinical Trials. Dr. Askanase is
an internationally renowned clinician, diagnostician and researcher
with more than 15 years specializing in complex SLE. Dr. Askanase
trained as a rheumatologist at New York
University where she remained for more than 15 years on
faculty, directing clinical trials, training fellows and residents,
and treating challenging cases of SLE at NYU's prestigious hospitals.
Interested parties will be able to access a live webcast of the
event at investor.viatris.com. An archived version will be
available following the live event and can be accessed at the same
location for a limited time.
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 compared 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 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.
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).
Forward-Looking Statements
This press release includes
statements that constitute "forward-looking statements." These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such forward
looking statements may include statements regarding Viatris and
Idorsia entering into a significant global research and development
collaboration; expanding Viatris' portfolio of innovative assets by
immediately adding two Phase 3 assets, selatogrel and cenerimod,
both with blockbuster revenue potential; includes future
optionality to expand collaboration with additional innovative
assets; combines Viatris' financial strength and worldwide
operational infrastructure with Idorsia's proven, highly productive
drug development team and innovation engine; deal structure
reinforces Viatris' disciplined approach to capital allocation;
R&D investor event to be held March 27,
2024; information about selatogrel and cenerimod; cenerimod
could be a cornerstone asset in Viatris' immunology platform; 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; 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; in addition to continuing to develop the
three core therapeutic areas that we identified—ophthalmology,
dermatology and GI—we are also going to be opportunistic in seeking
out assets that we believe fit our company well and have the
potential to contribute significantly to our future revenue growth;
entering into this type of global research and development
partnership structure with Idorsia is a great example of our
disciplined approach to capital allocation; both selatogrel and
cenerimod have the potential to be important medicines by providing
significant advances for patients suffering with life-altering
disease; selatogrel has the potential to become the first
self-administered treatment for recurring AMI that fills the
medical gap during the pre-hospital phase of a life-threatening
condition; cenerimod has the potential to fill the need for a more
tolerable and effective treatment for SLE, in combination with
standard therapy, earlier in disease progression; the development
programs and certain personnel for selatogrel and cenerimod will be
transferred to Viatris in exchange for an upfront payment to
Idorsia of $350 million, potential
development and regulatory milestone payments, and certain
contingent payments of additional sales milestone payments and
tiered royalties in the mid-single to low-double digit percentages
on annual net sales; Viatris and Idorsia will both contribute to
the development costs for 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) and intends to utilize
its Global Healthcare Gateway® infrastructure to
bring access to patients worldwide; a joint development
committee will oversee the development of the ongoing Phase 3
programs through regulatory approval; the agreements also provide
Viatris a right of first refusal and a right of first negotiation
for certain other assets in Idorsia's pipeline; the closing of the
transaction is subject to certain limited closing conditions, but
no additional regulatory or shareholder approvals are required the
transaction is expected to close at the end of March. Because
forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to: the possibility that Viatris may be unable
to realize the intended benefits of, or achieve the intended goals
or outlooks with respect to, its strategic initiatives; the
possibility that Viatris may be unable to achieve intended or
expected benefits, goals, outlooks, synergies, growth opportunities
and operating efficiencies in connection with divestitures,
acquisitions, other transactions or restructuring programs, within
the expected timeframes or at all; goodwill or impairment charges
or other losses related to the divestiture or sale of businesses or
assets; Viatris' failure to achieve expected or targeted future
financial and operating performance and results; the potential
impact of public health outbreaks, epidemics and pandemics; actions
and decisions of healthcare and pharmaceutical regulators; changes
in healthcare and pharmaceutical laws and regulations in the U.S.
and abroad; any regulatory, legal or other impediments to Viatris'
ability to bring new products to market, including but not limited
to "at-risk" launches; Viatris' or its partners' ability to
develop, manufacture, and commercialize products; the scope,
timing and outcome of any ongoing legal proceedings, and the impact
of any such proceedings; any significant breach of data security or
data privacy or disruptions to our information technology systems;
risks associated with international operations; the ability to
protect intellectual property and preserve intellectual property
rights; changes in third-party relationships; the effect of any
changes in Viatris' or its partners' customer and supplier
relationships and customer purchasing patterns; the impacts of
competition; changes in the economic and financial conditions of
Viatris or its partners; uncertainties and matters beyond the
control of management, including general economic conditions,
inflation and exchange rates; failure to execute stock repurchases
consistent with current expectations; stock price volatility; and
the other risks described in Viatris' filings with the Securities
and Exchange Commission (SEC). Viatris routinely uses its website
as a means of disclosing material information to the public in a
broad, non-exclusionary manner for purposes of the SEC's Regulation
Fair Disclosure (Reg FD). Viatris undertakes no obligation to
update these statements for revisions or changes after the date of
this release other than as required by law.
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SOURCE Viatris Inc.