Ferrer Enters Into a Collaboration and License Agreement With Prilenia for the Commercialization and Co-Development of Pridopidine

(BUSINESS WIRE) -- Ferrer, an international B Corp pharmaceutical company with an increasing focus on rare neurological diseases, and Prilenia Therapeutics B.V., a clinical-stage biotech company, have announced the signing of a strategic co-development and license agreement in which Ferrer obtains the rights to develop, manufacture and commercialize Pridopidine in the European Region, the Middle East and North African Region, the Southern African Region, the Central and South American Region, and the Commonwealth of Independent States Region.

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

Pridopidine is currently being reviewed by the European Medicines Agency, which has accepted the Marketing Authorisation Application submission for the treatment of HD. An opinion from the Committee for Medicinal Products for Human Use is expected in the second half of 2025.

The terms of the agreement include an upfront payment and multiple regulatory, development, commercial and sales milestone payments. Prilenia will also receive tiered double-digit royalties on net sales of Pridopidine.

“This agreement with Prilenia means we can continue making our purpose of using business to fight for social justice a reality, while focusing our pipeline development on diseases with high unmet medical need,” stated Mario Rovirosa, CEO of Ferrer. “The combination of strengths and capabilities of our two companies makes the future brighter for the patients suffering from such underserved conditions.”

“We are proud to partner with Ferrer as we advance our shared mission to bring transformative therapies to people living with neurodegenerative diseases around the world,” said Dr. Michael R. Hayden, CEO of Prilenia. “Ferrer continues to grow their already significant presence throughout Europe and key international markets with particular focus on innovative products for rare diseases. By combining our unique strengths and shared commitment to these patient communities, we believe that this partnership has the potential to accelerate the delivery of Pridopidine to the thousands of people who are waiting for a new treatment option as well as to broaden its impact through additional indications in the future.”

“Securing rights to this molecule represents a pivotal step in our research strategy in the neurodegeneration arena,” said Oscar Pérez, Chief Scientific and Business Development Officer at Ferrer. “Given the mechanism of action of Pridopidine, we are fully committed to exploring its potential use across a range of indications.”

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.

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