Angelini Pharma Signs Exclusive Option Agreement With Sovargen To License Global Development and Commercialization Rights For Innovative Brain Health Asset

  • Angelini Pharma secures exclusive option to license global development and commercialization rights for SVG1051, a pre–clinical investigational novel compound with broad potential to treat brain health diseases, excluding the Republic of Korea, China, Hong Kong, Macau and Taiwan
  • Sovargen receives upfront payment and is eligible for future milestone–dependent payments and royalties
  • Agreement further expands Angelini Pharma’s strong portfolio and deep therapeutic expertise in brain health, following a series of strategic partnerships in the space, including in orphan and rare epilepsy

ROME, Sept. 22, 2025 (GLOBE NEWSWIRE) — Angelini Pharma, part of the privately owned Angelini Industries, and Sovargen, a South–Korean biotechnology company, announced today that they signed an exclusive global option agreement for the development and commercialization of Sovargen’s innovative brain health asset SVG105.

Under the terms of the agreement, Angelini Pharma and Sovargen will collaboratively lead the pre–clinical development efforts for SVG105 and, following an initial option period, Angelini Pharma will have the right to advance the compound into clinical development and commercialization outside of the Republic of Korea, China, Hong Kong, Macau and Taiwan. SVG105 is a potentially first–in–class anti–sense oligonucleotide technology to target mTOR (mammalian target of rapamycin) pathways. mTOR is a genetically validated target for a number of brain health disorders, including drug–resistant childhood epilepsy.i

Sovargen 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$550 million, as well as tiered royalties on post–approval net sales.

The announcement follows a number of strategic acquisitions and collaboration agreements that Angelini Pharma has entered over the course of the past two years, which have bolstered the company’s pipeline in brain health, adding to its strong portfolio in the space through sustained investment. In May 2025, Angelini Pharma and GRIN Therapeutics Inc. announced a collaboration for the development and commercialization rights outside of North America for radiprodil, an investigational drug currently being studied in multiple rare genetic epilepsies and neurodevelopmental disorders. A few days earlier, the company signed an asset purchase and assignment agreement for the development and commercialization of OmniAb’s innovative preclinical asset RO’599, a novel preclinical–stage investigational compound with broad potential to treat various brain health diseases. Last year, Angelini Pharma entered into a strategic partnership with Cureverse, a Korean spin–off of the Korean Institute of Science and Technology, which is developing small molecules with broad CNS applications. In 2023, the company partnered with JCR Pharmaceuticals, a Japanese biotech company with a breakthrough blood–brain barrier technology based on a transferrin receptor mechanism, allowing biologics to cross the barrier. Consequently, Angelini’s brain health pipeline now includes diversified and modern therapeutic modalities ranging from innovative small molecule compounds to biologics and anti–sense oligonucleotides.

“This partnership with Sovargen further solidifies Angelini Pharma’s leading role in the field of brain health, adding additional breadth to our robust portfolio and pipeline,” said Jacopo Andreose, Chief Executive Officer of Angelini Pharma. “Neurological disorders like epilepsy are major contributors to global disease challenges.ii For example, many people living with epilepsy are still unable to reach seizure control despite combination treatment of several anti–seizure medications.iii Our work on SVG105 will be motivated by the ambition to bring much–needed solutions to people living with brain health conditions across the world.”

“We are incredibly excited about the opportunity to work with Angelini Pharma to further advance SVG105,” said Cheolwon Park, Chief Executive Officer at Sovargen. “Our research so far demonstrates great potential for SVG105 to transform the treatment landscape in brain health and we are confident that Angelini Pharma’s strong therapeutic expertise will propel our research further and bring us closer to identifying new treatment options for patients in need.”

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 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

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

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 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. More information: https://www.angelinipharma.com.

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. More information: www.angeliniindustries.com.

Sovargen
Founded in 2018, Sovargen is a Korean biotech company pioneering treatments for intractable brain diseases caused by somatic mutations—genetic changes acquired during brain development or aging. These mutations underlie serious conditions like focal cortical dysplasia (FCD) type II, hemimegalencephaly, and brain tumors, yet remain largely unaddressed.

Sovargen’s proprietary antisense oligonucleotide (ASO) platform enables precise gene modulation in the brain. Its lead program, SVG105, is a first–in–disease ASO therapy in preclinical development for drug–resistant epilepsy caused by FCD type II. With a growing pipeline and a differentiated scientific approach, Sovargen is advancing next–generation CNS therapies to bring new hope to patients worldwide. More information: www.sovargen.com.

Contact                
Chiara Antoniucci
Global Head of Brand and Media Communications, Angelini Pharma
+39 3477133926
[email protected]

Rosie JH Lee
Director of Corporate PR, Sovargen
+82–70–5222–2771
[email protected]

1 SVG105 is an investigational compound, not approved for use by regulatory authorities.

i Data on file (Sovargen).
ii Institute for Health Metrics and Evaluation (IHME). 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: July 2025.
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 WHO. 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 IHME. Understanding brain health around the world. Available at: https://brainhealthatlas.org/ Last accessed: July 2025.
viii WHO. 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.


GLOBENEWSWIRE (Distribution ID 1001129265)

Extrovis AG and Dr. Reddy’s announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.

                                      

Extrovis AG
Bahnhof Park 4
6340, Baar, Switzerland
Media Relations Contact
Madhu Marur
[email protected]

                                        

Press Release

Extrovis AG and Dr. Reddy’s announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.

Baar, Switzerland; August 14, 2025

Extrovis AG, a global pharmaceutical company focused on research–driven innovation, and Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy's”), today announced the launch of Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac® (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration (USFDA).

Manufactured in Texas at one of Extrovis’ facilities, Dr. Reddy’s Fluorouracil Cream, 0.5%, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.

“This product generic launch marks a key milestone in our commitment to increasing patient access and long–term value creation for the U.S. healthcare system. Our partnership with Dr. Reddy’s helps ensure that patients and healthcare providers in the United States have continued access to a high–quality and cost–effective product,” said Hans R. Kamma Co–CEO and Chief Strategy Officer of Extrovis AG.

“Dr. Reddy’s brings deep expertise in commercialization and distribution within the U.S. market,” added Raghavendra Rao PV, Chief Financial Officer of Extrovis AG. “This collaboration is aligned with our mission to strengthen pharmaceutical supply chains and serve public health needs responsibly.”

The partnership reinforces Extrovis’ strategy to extend the reach of its therapeutics while advancing long–term affordability and sustainability in healthcare.

Dr. Reddy’s Fluorouracil Cream, 0.5%, is supplied in a 30–gram tube for topical use only. Please click here to see the full prescribing information.

                                                                                     

Carac® is a trademark of Extrovis AG

……………………………………………………………………………………..……………………………………………………………………………………………………………………

About Dr. Reddy’s
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About Extrovis AG
Extrovis AG is a Switzerland–based global biopharmaceutical company committed to developing and commercializing high–quality therapies for unmet and under–addressed medical needs. With R&D and manufacturing operations in the USA, Italy, Hungary, and India, Extrovis delivers innovative, differentiated products across key therapeutic areas. Backed by strong R&D capabilities, regulatory expertise, and a robust global quality framework, the company advances its mission to improve patient outcomes and expand access to essential health care products worldwide. For more information, log on to: http://www.extrovis.com

………………………………………………………………………………………………………………………………………………………

Disclaimer: This press release may include statements of future expectations and other forward–looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward–looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward–looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID–19). The company assumes no obligation to update any information contained herein.

 

Attachment


GLOBENEWSWIRE (Distribution ID 1001123392)