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We signed a collaboration and licensing agreement with Prilenia for the commercialization and co-development of pridopidine

Ferrer corporate building with glazed and exposed brick façade, the oversized logo on top and gardens in the foreground under a blue sky.

Barcelona (Spain), April 28, 2025 – Together with Prilenia Therapeutics B.V., a biotechnology clinical development company, we announce the signing of a strategic co-development and licensing agreement through which Ferrer obtains the rights to develop, manufacture and commercialize pridopidine in Europe, the Middle East and North Africa, the Southern African region, and the Middle East and North Africa. Central and South America, and the region of the Commonwealth of Independent States.

 

Pridopidine, a potent and highly selective agonist of the sigma-1 receptor, administered orally and designed to regulate key neuroprotective mechanisms that are often impaired in people with neurodegenerative diseases, is a promising candidate molecule for the treatment of Huntington's disease, a rare inherited neurodegenerative disease, with a high unmet medical need1. Pridopidine has been studied in more than 1,700 people and long-term safety data of up to 7 years are available from previous clinical studies2. These research studies demonstrate that, at therapeutic doses, pridopidine has a safety and tolerability profile comparable to placebo2.

 

Pridopidine is currently being evaluated by the European Medicines Agency (EMA), which has accepted the submission of the marketing authorization application for the treatment of Huntington's disease. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected during the second half of 2025.

 

The terms of the agreement include a down payment and multiple payments for regulatory, development, commercial and sales milestones. Prilenia will also receive double-digit progressive royalties on net sales of pridopidine.

 

"This agreement with Prilenia allows us to continue to realize our purpose of using the business to fight for social justice, as we strengthen our pipeline in diseases with a high unmet medical need," said Mario Rovirosa, CEO of Ferrer. "The combined strengths and capabilities of our two companies make the future brighter for patients living with these underserved diseases."

 

"We are proud to partner with Ferrer as we advance our shared mission of bringing transformative therapies to people living with neurodegenerative diseases around the world," said Dr. Michael R. Hayden, CEO of Prilenia. "Ferrer continues to expand its already significant presence in Europe and key international markets, with a particular focus on innovative products for rare diseases. By combining our unique strengths and commitment to these patient communities, we believe this alliance has the potential to accelerate the arrival of pridopidine to the thousands of people waiting for a new therapeutic option, as well as expand its impact to other indications in the future."

 

"Securing the rights to this molecule represents a key step in our research strategy in the field of neurodegenerative diseases," said Oscar Pérez, Chief Scientific and Business Development Officer at Ferrer. "Due to pridopidine's mechanism of action, we are fully committed to exploring its potential use in multiple additional indications."

 

About Huntington's disease
 

Huntington's disease is a rare, hereditary, autosomal dominant and neurodegenerative disease that produces functional, motor, cognitive and behavioural symptoms. Huntington's disease is caused by a mutation in the huntingtin gene. This mutation results in a toxic form of the multifunctional huntingtin protein, which alters the functioning of neurons and ultimately causes neuronal death³⁻⁵.

 

HD affects approximately 100,000 people worldwide, and an estimated 300,000 additional people are at risk of developing it6. It is usually diagnosed between the ages of 30 and 50, although it can occur at any age, including children and young adults (known as juvenile-onset HD or JHD7). The disease progresses slowly over 15 to 20 years, during which patients gradually lose the ability to work, communicate, lead an ordinary life, and care for themselves1-5. This increasing disability often leads to total dependence on a caregiver and eventually death.

 

Currently, the only treatments available for HD focus on symptomatic relief and palliative care, without influencing the overall progression of the disease1-3.

 

About Prilenia

 

Prilenia is a privately held biopharmaceutical company driven by a strong commitment to scientific excellence and accelerating progress for people affected by Huntington's disease and amyotrophic lateral sclerosis. Our mission is simple but urgent: to develop and provide sustainable access to transformative medicines for people affected by devastating neurodegenerative diseases

 

Prilenia operates in the United States, Canada, Europe and Israel. The company is incorporated in the Netherlands and is backed by leading life sciences investors.

 

For more information, visit www.prilenia.com and connect with us on LinkedIn or X (Twitter).
 

 

References:

  1. Naia L, Ly P, Mota SI, Lopes C, Maranga C, Coelho P, Gershoni-Emek N, Ankarcrona M, Geva M, Hayden MR, Rego AC. The Sigma-1 Receptor Mediates Pridopidine Rescue of Mitochondrial Function in Huntington Disease Models. Neurotherapeutics. 2021 Apr; 18(2):1017-1038. DOI: 10.1007/S13311-021-01022-9. Epub 2021 Apr 1. PMID: 33797036; PMCID: PMC8423985.
  2. Goldberg YP, Navon-Perry L, Cruz-Herranz A, Chen K, Hecker-Barth G, Spiegel K, Cohen Y, Niethammer M, Tan AM, Schuring H, Geva M, Hayden MR. The Safety Profile of Pridopidine, a Novel Sigma-1 Receptor Agonist for the Treatment of Huntington's Disease. CNS Drugs. 2025 May; 39(5):485-498. DOI: 10.1007/S40263-025-01171-X. Epub 2025 Mar 7. PMID: 40055280; PMCID: PMC11982116.
  3. Bates, G., Dorsey, R., Gusella, J. et al. Huntington disease. Nat Rev Dis Primers 1, 15005 (2015). https://doi.org/10.1038/nrdp.2015.5
  4. Bachoud-Lévi AC, Ferreira J, Massart R, Youssov K, Rosser A, Busse M, Craufurd D, Reilmann R, De Michele G, Rae D, Squitieri F, Seppi K, Perrine C, Scherer-Gagou C, Audrey O, Verny C, Burgunder JM. International Guidelines for the Treatment of Huntington's Disease. Front Neurol. 2019 Jul 3;10:710. doi:10.3389/fneur.2019.00710.PMID: 31333565; PMCID: PMC6618900.
  5. Tabrizi, S.J., Flower, M.D., Ross, C.A. et al. Huntington disease: new insights into molecular pathogenesis and therapeutic opportunities. Nat Rev Neurol 16, 529–546 (2020). https://doi.org/10.1038/s41582-020-0389-4
  6. Medina, A., Mahjoub, Y., Shaver, L. and Pringsheim, T. (2022), Prevalence and Incidence of Huntington's Disease: An Updated Systematic Review and Meta-Analysis. Mov Disord, 37: 2327-2335. https://doi.org/10.1002/mds.29228
  7. Anil M, Mason SL, Barker RA. The clinical features and progression of late-onset versus younger-onset in an adult cohort of Huntington's disease patients. J Huntingtons Dis. 2020; 9(3):275-282. doi:10.3233/JHD-200404. PMID: 32675419; PMCID: PMC7683085.