Prilenia Therapeutics B.V. and Ferrer have announced a major collaboration and license agreement valued at up to €500 million for the commercialization and further development of pridopidine in Europe and other select markets. The deal focuses on advancing treatment options for patients with neurodegenerative conditions, particularly Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS).
Under the terms of the agreement, Prilenia will receive an upfront payment of approximately €80 million, with potential for an additional €45 million in near-term development, regulatory, and commercial milestones. The partnership also includes tiered double-digit royalties on net sales for Prilenia, which will retain full rights to pridopidine in other major markets including North America, Japan, and Asia Pacific.
The Therapeutic Candidate
Pridopidine is a potent and highly selective, orally administered sigma-1 receptor (S1R) agonist designed to regulate key neuroprotective mechanisms that are often impaired in neurodegenerative diseases. The drug has been studied in more than 1,700 people with long-term safety data of up to 7 years available from previous clinical studies. According to the companies, at therapeutic doses, pridopidine has demonstrated a safety and tolerability profile comparable to placebo.
The European Medicines Agency (EMA) has accepted the Marketing Authorisation Application for pridopidine in the treatment of Huntington's disease, with an opinion from the Committee for Medicinal Products for Human Use expected in the second half of 2025.
Strategic Collaboration
The partnership grants Ferrer the rights to develop, manufacture, and commercialize pridopidine across the European Region, Middle East and North African Region, Southern African Region, Central and South American Region, and the Commonwealth of Independent States Region.
Dr. Michael R. Hayden, CEO of Prilenia, emphasized the strategic importance of the partnership: "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. Ferrer continues to grow their already significant presence throughout Europe and key international markets with particular focus on innovative products for rare diseases."
Both companies have agreed to jointly develop and fund the expansion of pridopidine in the territory for additional indications beyond Huntington's disease, potentially broadening the drug's impact on other neurodegenerative conditions.
Addressing Unmet Medical Needs
Huntington's disease is a rare inherited neurodegenerative disorder with significant unmet medical needs. The progressive nature of the disease, which causes the breakdown of nerve cells in the brain, leads to movement disorders, cognitive decline, and psychiatric symptoms.
Mario Rovirosa, CEO of Ferrer, highlighted the alignment of the partnership with the company's mission: "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. The combination of strengths and capabilities of our two companies makes the future brighter for the patients suffering from such underserved conditions."
Ferrer, an international B Corp pharmaceutical company, has been increasing its focus on rare neurological diseases, making this partnership a strategic fit for both organizations committed to addressing the needs of patients with limited treatment options.
Future Development Plans
Beyond the immediate focus on Huntington's disease, the collaboration aims to explore pridopidine's potential in treating amyotrophic lateral sclerosis and possibly other neurodegenerative conditions. The companies believe that by combining their respective strengths and shared commitment to these patient communities, they can accelerate the delivery of pridopidine to thousands of people awaiting new treatment options.
The partnership represents a significant step forward in the development of novel therapies for neurodegenerative diseases and underscores the growing importance of collaborative approaches in addressing complex medical challenges with high unmet needs.
