Dutch biotech Prilenia Therapeutics has entered a licensing pact with Spanish pharmaceutical company Ferrer to push the biotech's sole asset through clinical development and beyond in Europe.
Under the terms of the deal, Prilenia and Ferrer will jointly develop and potentially commercialize neurodegenerative disease candidate pridopidine in Europe and other undisclosed select markets, the companies said in an April 28 release. Prilenia will retain full rights to the oral sigma-1 receptor agonist in North America, Japan and the Asia-Pacific region.
Ferrer is paying Prilenia 80 million euros upfront, with up to 45 million euros available in near-term development, regulatory and commercial milestones. In total, Prilenia can garner as much as 500 million euros (around $568 million) in upfront and milestone payments, according to the release, plus royalties on net sales.
The focus of the partnership will be Huntington's disease and amyotrophic lateral sclerosis (ALS), with the partners planning to launch a phase 3 ALS trial in early 2026, a Ferrer spokesperson told Fierce Biotech in an email.
Pridopidine previously failed to improve ALS disease severity in a phase 2 test, but the company said at the time that “positive trends” warranted further studies of the drug candidate. A post hoc analysis of the data found that some patients who were rapidly declining in speech, handwriting and other daily functions had “substantially less decline” when given pridopidine compared to those who received placebo, Prilenia said.
In addition to Huntington's and ALS, Ferrer has first rights to develop pridopidine in other potential indications, the company's spokesperson said.
Prilenia has already submitted a marketing authorization application to the European Medicines Agency (EMA) for the use of pridopidine in Huntington’s disease, according to the release, and the biotech is in discussions with the FDA about next steps for Huntington's in the U.S. A decision from the EMA's Committee for Medicinal Products for Human Use is expected in the second half of 2025, the Ferrer spokesperson said.
“Ferrer continues to grow their already significant presence throughout Europe and key international markets with particular focus on innovative products for rare diseases,” Prilenia CEO Michael Hayden, Ph.D., said in the release. “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 broaden its impact through additional indications in the future.”
In addition to Huntington’s and ALS, Prilenia is also testing pridopidine in vanishing white matter disease, an inherited genetic disorder, and exploring the asset’s potential in other neurodegenerative diseases, according to the biotech’s website.
Ferrer’s R&D work focuses on neurological and pulmonary diseases, and the Spanish pharma has bought into ALS assets in the past. In March 2024, the firm pledged more than $121.7 million in upfront and potential milestone payments for the ex-U.S. rights to Verge Genomics’ ALS candidate, which is currently in a phase 1b proof-of-concept trial.