Angelini Pharma, part of the privately owned Angelini Industries,
and Cureverse Inc., an early-stage research and development
company, announced today that they entered into an exclusive global
option agreement for the development and commercialization of
Cureverse’s innovative brain health asset CV-01.
Under the terms of the agreement, Angelini
Pharma will lead all the development efforts for CV-01 and,
following an initial option period, will have the right to obtain
the global exclusive development and commercialization license for
the compound, outside of the Republic of Korea, China, Hong Kong,
Macau and Taiwan. CV-01 is a novel and innovative investigational
compound that activates protective pathways regulated by the
nuclear factor erythroid 2-related factor 2 (Nrf2) and has a strong
potential to be a medication with disease-modifying properties
across a range of brain health disorders, including epilepsy.i
CV-01 is an investigational compound currently undergoing a Phase 1
clinical trial in the Republic of Korea and is being developed by
Cureverse for Alzheimer’s Disease.
Cureverse will receive an upfront payment and
will also be eligible to receive additional payments upon
pre-defined development and commercial milestones of up to approx.
US$360 million, as well as tiered royalties on post-approval net
sales.
“Our strategic collaboration with Cureverse
further strengthens Angelini Pharma’s position as an emerging
leader in brain health,” said Jacopo Andreose, Chief Executive
Officer of Angelini Pharma. “Neurological conditions such as
epilepsy are among leading causes of disease burden worldwide.ii
While significant progress has been achieved in the past 15 years,
many people living with epilepsy are still unable to reach seizure
control despite combination treatment of several anti-seizure
medications.iii Through the development of CV-01 and potentially
other compounds, we aim to provide much-needed solutions for people
living with brain health conditions across the world.”
“Our research has unveiled the remarkable
potential of CV-01 to transform the landscape of brain health, from
epilepsy to Alzheimer’s and Parkinson’s Disease,” said Sung Jin
Cho, Chief Executive Officer at Cureverse Inc. “We are truly
delighted to be partnering with Angelini Pharma on this journey.
Their deep therapeutic expertise and commitment to brain health
perfectly align with our vision. Together, we are not just
developing a treatment—we are paving the way for a future where
patients with neurological conditions have access to truly
life-changing therapies.”
About Brain HealthBrain health
as a therapeutic area includes both neurological and mental health
conditions.iv Brain health is defined by the World Health
Organization as a state of brain functioning across cognitive,
sensory, social-emotional, behavioral and motor domains, allowing a
person to realize their full potential over the course of their
life, irrespective of the presence or absence of disorders.v
Brain health represents an urgent global health
priority. An estimated 179 million Europeans are living with brain
health conditionsvi and more than 18% of all health loss around the
world is associated with brain conditions.vii Additionally, brain
health conditions are responsible for considerable individual,
economic and societal impact, including loss of independence,
reduced productivity, strained relationships, increased risk of
suicide as well as high healthcare costs.viii There is an urgent
need to raise awareness, and reduce stigma, prejudice and
discrimination, to ensure that brain health is valued, promoted and
protected for all.v
About EpilepsyEpilepsy is one
of the most widespread neurological diseases in the world,
affecting globally approximately 50 million people of all ages.ix
In Europe, up to six million people are estimated to be living with
this disease.x Epilepsy can have multiple potential causes,
including structural, metabolic, genetic and other factors, though
approximately half of cases worldwide do not have a known
cause.ix
The complications associated with epilepsy are
severe, with a risk of premature mortality up to three times higher
than the general population.ix The recurrent seizures associated
with this condition also have wide-ranging effects on a person’s
broader physical and mental health, education and employment
opportunities and other quality of life factors. ix
Treatments are available to help reduce seizures
and improve quality of life, however approximately 40% of people
living with epilepsy are still uncontrolled despite the treatment
with two anti-seizure medications.iii
About Angelini PharmaAngelini
Pharma is an international pharmaceutical company, part of the
privately owned multi-business Angelini Industries. The Company
researches, develops and commercializes health solutions with a
focus on the areas of Brain Health, including Mental Health and
Epilepsy, and Consumer Health. Founded in Italy at the beginning of
the 20th century, Angelini Pharma operates directly in 20
countries, employing more than 3,000 people. Its products are
marketed in over 70 countries through strategic alliances with
leading international pharmaceutical groups. For more information
about Angelini Pharma please visit
https://www.angelinipharma.com.
About Angelini
IndustriesAngelini Industries is a multinational
industrial group founded in Ancona in 1919 by Francesco Angelini.
Today, Angelini Industries represents a solid and diversified
industrial reality that employs approximately 5,800 employees and
operates in 21 countries around the world with revenues of over 2
billion euros, generated in the health, industrial technology, and
consumer goods sectors. A targeted investment strategy for growth;
constant commitment to research and development; deep knowledge of
markets and business sectors, make Angelini Industries one of the
Italian companies of excellence in the sectors in which it
operates. To learn more visit www.angeliniindustries.com.
About Cureverse Inc.Founded in
2021, Cureverse has rapidly become a key innovator in the Korean
biotech landscape, with a bold vision to revolutionize brain health
on a global scale. Specializing in cutting-edge small-molecule
therapies, Cureverse focuses on tackling central nervous system
(CNS) disorders like Alzheimer’s disease (AD), aiming to bring hope
to millions worldwide. While many AD drugs have made it to market,
a true breakthrough has yet to be realized—until now. At the heart
of our innovation is CV-01, a 'First-in-Class' therapy that
uniquely targets the Keap1/Nrf2 pathway, activating Nrf2 through
precise modulation. This approach offers unprecedented selectivity,
effectively controlling neuroinflammation with precision unmatched
by existing treatments. Alongside CV-01, Cureverse is actively
advancing CV-02, a biased S1P1 agonist that is now IND-ready, as
well as several promising follow-up non-clinical programs. With
recent IND approvals and strong clinical progress, Cureverse is
well-positioned to transform the way we treat neurological
conditions and improve patients' lives across the globe.
Media
Contact Chiara
AntoniucciGlobal Head of Brand and Media Communications, Angelini
PharmaPhone: +39 3477133926Email:
chiara.antoniucci@angelinipharma.com
Sung Jin ChoChief Executive Officer, Cureverse Inc.Email:
sjcho@cureverse.co.kr, sjcho@kist.re.kr
________________________________
1 CV-01 is an investigational compound, not approved for use by
regulatory authorities
i Data on file from Cureverse.ii Institute for Health Metrics
and Evaluation. Global burden of conditions affecting the nervous
system. Available at:
https://www.healthdata.org/research-analysis/library/global-burden-conditions-affecting-nervous-system
Last accessed: October 2024.iii Chen Z, Brodie MJ, Liew D, Kwan P.
Treatment Outcomes in Patients With Newly Diagnosed Epilepsy
Treated With Established and New Antiepileptic Drugs: A 30-Year
Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279-286.iv
Winkler AS, et al. Lancet Glob Health. 2024;12(5):e735-e736.v World
Health Organization. Optimizing brain health across the life
course: WHO position paper. Geneva: World Health Organization;
2022.vi Nutt D, et al. Eurohealth (Int) 2017;23:21–5.vii Institute
for Health Metrics and Evaluation. Understanding brain health
around the world. Available at: https://brainhealthatlas.org/ Last
accessed: October 2024.viii World Health Organization. World mental
health report: transforming mental health for all. Geneva: World
Health Organization; 2022.ix WHO. “Epilepsy Key Facts.” N.p., 9
Feb. 2023. Web. 24 Aug. 2023.x Behr et al. Epidemiology of
epilepsy. Revue Neurologique 2016 Jan; 172(1):27-36. doi:
10.1016/j.neurol.2015.11.003.