• The agreement gives Angelini Pharma an option to exclusive licensing rights to develop and commercialize CV-01¹, a clinical Phase 1 investigational novel compound with broad potential to treat brain health diseases
• Cureverse receives undisclosed upfront payments and is eligible for future milestone-dependent payments and royalties, while retaining rights to commercialize CV-01 in the Republic of Korea, China, Hong Kong, Macau and Taiwan
• The collaboration builds on Angelini Pharma’s strong portfolio and deep therapeutic expertise in brain health as well as Cureverse’s early development know-how and capabilities
  

ROME, Oct. 21, 2024 (GLOBE NEWSWIRE) -- 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 Health
Brain 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 conditions^vi 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 Epilepsy
Epilepsy 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 Pharma
Angelini 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 20^th 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 Industries
Angelini 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 Antoniucci
Global Head of Brand and Media Communications, Angelini Pharma
Phone: +39 3477133926
Email: chiara.antoniucci@angelinipharma.com

Sung Jin Cho
Chief Executive Officer, Cureverse Inc.
Email: sjcho@cureverse.co.kr, sjcho@kist.re.kr

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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.