PITTSBURGH, March 27,
2024 /PRNewswire/ -- At a meeting with the
investment community today, Viatris Inc. (NASDAQ: VTRS), a
global healthcare company, will outline how it is continuing to
evolve its R&D strategy to deliver on its goal of building a
more durable, higher-margin portfolio of patented innovation on the
foundation of its strong base business. The focus of the event will
be a discussion of its collaboration with Idorsia, Phase 3 assets
selatogrel and cenerimod and key elements of the Company's
pipeline.
Viatris CEO Scott A.
Smith said: "Our confidence in our ability to continue
to drive future growth and unlock shareholder value comes from our
strong base business, well-established global infrastructure, and
significant financial flexibility all of which give us the
opportunity to continue to evolve our pipeline with the addition of
potential blockbuster assets like selatogrel and cenerimod. The
addition of high-science programs that deliver novel, meaningful
patient impact and address significant unmet patient need will also
give us the opportunity to accelerate long-term growth."
Event highlights will include:
- Overview of global collaboration with Idorsia. The
collaboration with Idorsia is a great example of Viatris' strategy
in action—adding two late-stage potential blockbuster assets,
selatogrel and cenerimod—and connecting Idorsia's highly productive
drug development team and innovation engine with Viatris' existing
infrastructure and experience. The Company will review key elements
of the collaboration including how Viatris can make a difference in
the delivery of these assets.
- The Company's history of development success. Viatris'
confidence is rooted in the strength of its base business, its deep
in-house development capabilities, the diversity of its pipeline
and its proven track record of scientific success, including a
remarkable list of firsts that have enabled the Company to address
some of the world's most enduring health challenges. The Company
will review key highlights from its high-margin organic pipeline,
which it expects will deliver $450
million to $550 million in
revenue in 2024.
- Overview of selatogrel. Selatogrel, a potentially
life-saving medicine, aims to become the first and only
self-administered treatment for Acute Myocardial Infarction (AMI),
or heart attack, by filling the medical gap between the onset of
symptoms and hospitalization when early intervention is critical.
The Company will review the pharmacological profile of selatogrel
and the currently enrolling Selatogrel Outcome Study in suspected
Acute Myocardial Infarction (SOS-AMI) global Phase 3 multi-center
trial. This cardiovascular outcomes-based trial has received
Special Protocol Assessment (SPA) agreement from the U.S. Food and
Drug Administration (FDA) and selatogrel has received Fast-Track
designation from the FDA.
- Overview of cenerimod. Cenerimod's novel mechanism of
action has the potential to be a differentiated therapy for the
treatment of Systemic Lupus Erythematosus (SLE), a chronic and
progressive autoimmune disease in constant need of new treatment
options that are safe and tolerable. The Company will review key
learnings from the comprehensive Phase 2 program that has already
been conducted and will review Oral S1P1 Receptor ModUlation in SLE
(OPUS), the two ongoing Phase 3 multicenter, randomized,
double-blind, placebo-controlled, parallel-group studies designed
to evaluate cenerimod's efficacy, safety and tolerability in adult
patients with moderate-to-severe SLE in addition to standard
background therapy. Cenerimod has also received Fast-Track
designation from the FDA.
2024 R&D Event Presenters
The event will feature
presentations from the following Viatris executives:
- Scott A. Smith, Chief
Executive Officer
- Rajiv Malik,
President
- Philippe Martin, Chief
R&D Officer
- Doretta Mistras, Chief
Financial Officer
Expert thought leaders presenting at the event are:
- Dr. Deepak L. Bhatt, MD,
MPH, MBA, FACC, FAHA, FESC, MSCAI, a top expert in cardiovascular
medicine and interventional cardiology, is the Director of Mount
Sinai Fuster Heart Hospital. 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
(NYU) 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.
Webcast Details
Interested parties will be able
to access a live webcast of the event at investor.viatris.com. An
archived version also 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.
Viatris 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. Selatogrel has received
Fast-Track designation from 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 cenerimod
Cenerimod is a highly-selective S1P1
receptor modulator given as an oral once-daily tablet. Cenerimod
potentially offers a novel approach for the treatment of SLE, a
disease with a significant impact on patients and limited treatment
options.
In December 2022, the Oral S1P1
receptor ModUlation in SLE (OPUS) program was initiated, 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
received Fast-Track designation from 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).
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 how it is
continuing to evolve its R&D strategy to deliver on its goal of
building a more durable, higher margin portfolio of patented
innovation on the foundation of its strong base business; its
collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod
and key elements of the Company's pipeline; our confidence in our
ability to continue to drive future growth and unlock shareholder
value comes from our strong base business, well-established global
infrastructure, and significant financial flexibility all of which
give us the opportunity to continue to evolve our pipeline with the
addition of potential blockbuster assets like selatogrel and
cenerimod; the addition of high-science programs that deliver
novel, meaningful patient impact and address significant unmet
patient need will also give us the opportunity to accelerate
long-term growth; the collaboration with Idorsia is a great example
of Viatris' strategy in action—adding two late-stage potential
blockbuster assets, selatogrel and cenerimod—and connecting
Idorsia's highly productive drug development team and innovation
engine with Viatris' existing infrastructure and experience; the
Company's high-margin organic pipeline, which it expects will
deliver $450 million to $550 million in revenue in 2024; information
about selatogrel and cenerimod, information about clinical trials
and studies; that 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;
selatogrel has received fast-track designation from the FDA; the
investigation of cenerimod for the treatment of SLE has received
fast-track designation from the FDA. 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: 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 outcome of clinical trials and studies; the scope,
timing and outcome of any ongoing legal proceedings, and the impact
of any such proceedings; 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; 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 press release other
than as required by law.
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