Prilenia Therapeutics has signed a partnership and licence agreement with Ferrer to jointly develop and commercialise pridopidine in Europe and other chosen markets.
The partnership could potentially bring a new treatment option to individuals with Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS).
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Prilenia will receive an upfront payment of almost €80m ($91m) and could earn up to €45m ($51.1m) in near-term development, commercial and regulatory milestones.
The deal’s total value could reach €500m in upfront and milestone payments, with Prilenia also set to receive tiered double-digit royalties on net sales.
Administered orally, pridopidine acts as a sigma-1 receptor (S1R) agonist, tailored to regulate neuroprotective mechanisms that are found impaired in ALS and HD.
In the therapy’s HD development programme, it has shown benefits across various aspects of the disease, including cognition, function and motor skills, with these effects sustained for up to a two-year period.
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By GlobalDataPrilenia filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for the approval of the therapy in treating HD.
The EMA has accepted the application for review, and an opinion from the Committee for Medicinal Products for Human Use is anticipated in the second half of this year.
Discussions are ongoing with the US Food and Drug Administration regarding the next steps for the therapy’s development in HD in the US.
For ALS treatment, both companies are planning to commence a Phase III trial of the therapy, aiming to confirm outcomes from the Phase II HEALEY ALS platform trial.
Prilenia Therapeutics CEO Dr Michael Hayden stated: “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.
“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 broaden its impact through additional indications in the future.”
