Brivaracetam

Adalvo is proud to announce the first-to-market launch of generic Brivaracetam film-coated tablets in Croatia, in partnership with one of Europe’s leading generic pharmaceutical companies. This milestone marks the first generic launch of Brivaracetam anywhere in Europe, enabled by Adalvo’s dossier and delivered at a pivotal moment for the market. While additional generic entrants are expected in the coming weeks, this first-to-market launch reflects the strength of the partnership and the quality and precision of Adalvo’s development programme. Brivaracetam is indicated as an adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults, adolescents, and children from two years of age with epilepsy. The product is a bioequivalent generic of the reference brand Briviact, developed by UCB Pharma. Adalvo’s Brivaracetam dossier was submitted via the Decentralised Procedure (DCP) on Day-1 following expiry of the data exclusivity period, demonstrating the company’s commitment to first-to-market execution and its ability to move with speed and precision as exclusivity windows open. Anil Okay, CEO of Adalvo, commented: “Reaching patients first is never an accident—it is the product of discipline, speed, and the right partnerships. Working with a partner who understands the value of moving decisively, we have achieved something meaningful for patients in Croatia living with epilepsy. Our European marketing authorisations have been granted, and upon expiry of the relevant patents we will roll out the product across Europe.” This launch further demonstrates Adalvo’s broader CNS portfolio strategy and its ability to convert regulatory milestones into commercial outcomes for partners. Adalvo continues to expand its neurological offerings, providing differentiated, high-quality generics across key therapeutic areas.

Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine thats being tested as a potential therapy for a few seizure disorders as well as Alzheimers disease.UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.The therapy, codenamed NRTX1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the mesial temporal lobe part of the brain.Such an asset would diversify UCBs arsenal of seizure treatments, which are all small molecule drugs. That list includes Vimpat, Keppra, Briviact and Fintepla with the last being the most recent to secure U.S. approval, for seizures associated with a rare, severe type of childhood epilepsy that often causes long-term disabilities. In 2025, UCB recorded close to 1.2 billion euros, or roughly $1.3 billion, in net sales from just Briviact and Fintepla.In a statement, the company said this acquisition marks a strategic expansion into regenerative medicine and advanced therapies, while showcasing a commitment to inorganic growth and to epilepsy solutions that go beyond symptomatic management.We believe this therapy has the potential to provide durable targeted repair of the nervous system following a single dose and could represent a major step forward for people living with mesial temporal lobe epilepsy, CEO Jean-Christophe Tellier said in the statement.Though often expensive to make and challenging to administer, cell therapies have proven to be powerful tools for fighting certain cancers. A growing body of evidence also indicates these treatments can be helpful combating diseases tied to the immune and nervous systems, which in turn has piqued investor interest. Back in 2024, for instance, Neurona raised $120 million to support its research, through a funding round co-led by Viking Global Investors and Cormorant Asset Management.More recently, Aspen Neuroscience, a biotech developing a cell therapy for Parkinsons disease, closed a $115 million Series C round. And just last month, Oryon Cell Therapies, another startup making a cellular medicine for Parkinson's, emerged from stealth with $42 million in funding.Early this year, analysts at the investment bank Stifel met with two prominent doctors in the epilepsy space, who said around one-third of patients with focal onset seizures a broad category that encompasses mesial temporal lobe epilepsy remain treatment-refractory despite a significant increase in the number of FDA-approved anti-seizure medications over the past 20 years.The statistic underscores a significant unmet need among this population, the analysts wrote.Additionally, the doctors described how community neurologists often prefer to prescribe drugs that are easy to use, like Vimpat or Keppra. They viewed azetukalner, a closely watched, ion-channel-opening medicine from Xenon Pharmaceuticals, as having many of the same attributes that made Vimpat or Keppra commercial successes. Xenon, notably, has become a top takeover target to some on Wall Street.A cell therapy like NRTX1001 may therefore face a bit of an uphill battle. But UCB sees an opportunity. Among other potentially advantageous characteristics, like being a durable, one-off treatment, the therapy is administered to the brain through a minimally invasive surgical procedure.UCB confirmed the deal wont impact the companys 2026 revenue guidance, which is expected to grow in a high single-digit to low double-digit percentage range at constant exchange rates. Underlying profitability, meanwhile, is now expected to grow in a high single-digit to mid-teens percentage range at constant exchange rates. '