UCB, maker of several epilepsy drugs, is expanding its portfolio in the field with an acquisition.
For up to $1.9 billion, UCB has agreed to buy Zogenix. In what UCB CEO Jean-Christophe Tellier described as a strong “strategic fit,” the deal gives the Belgian pharma Fintepla, a drug with blockbuster potential for treating rare types of epilepsy.
The deal comes as UCB’s own epilepsy drug Vimpat, currently one of the only two products in the company’s offerings with blockbuster sales, is expected to lose U.S. market exclusivity in March. As an FDA-approved therapy, Fintepla can immediately contribute to UCB’s top line once the deal closes, which is expected in the second quarter of 2022.
UCB hopes to leverage its existing expertise and global reach to accelerate the drug's rollout, Charl van Zyl, UCB’s executive vice president of neurology & head of Europe and international markets, said in a statement.
The Belgian pharma already markets four epilepsy treatments: Keppra, Vimpat, Briviact and Nayzilam. Together, those drugs have treated more than 3 million patients worldwide, UCB says. The four meds booked €1.4 billion sales in the first half of 2021, with over half from Vimpat.
Meanwhile, through a 2020 acquisition of Engage Therapeutics for $125 million upfront, UCB gained an inhaled version of alprazolam, which is now in phase 3 testing for acute treatment of epileptic seizure.
RELATED: Chasing GW's Epidiolex, Zogenix finally wins FDA nod for rare childhood epilepsy drug Fintepla
As for Fintepla, the drug was approved by the FDA in 2020 to treat seizures associated with Dravet syndrome, a rare type of epilepsy. Zogenix has an application under FDA priority review for seizures caused by Lennox-Gastaut syndrome (LGS), another rare and severe form of epilepsy that begins early in life. The U.S. biotech is also targeting the drug for a genetic epilepsy called CDKL5 deficiency disorder in a phase 3 trial. All told, Zogenix thinks Fintepla could reach $1 billion in peak sales.
Fenfluramine, the active ingredient in Fintepla, was previously offered as part of an anti-obesity regimen known as Fen-Phen. That therapy was later pulled off the market because of the side effects of pulmonary hypertension and heart valve disease. Thanks to that earlier safety signal, Fintepla is now managed through an FDA-designated monitoring program.
The cardiovascular disease problem only manifests when fenfluramine is given at a high dose that’s not used in Fintepla’s clinical programs, Iris Loew-Friedrich, UCB’s chief medical officer, said during a conference call Wednesday. Neither the drug’s clinical trials nor the postmarketing surveillance program has spotted any of the heart problems, she added.
RELATED: 'Forced into a virtual world': UCB gets out of the driver's seat
Zogenix’s stock has been under pressure as COVID-19 slows the ramp of Fintepla. The rare disease drug brought in $21.4 million in sales in the third quarter, with 133 new patient starts during the quarter.
UCB is buying Zogenix shares for $26 apiece in cash, which represents a 72% premium to the company’s shares based on a 30-day average. The $1.9 billion deal also includes a $2-per-share payment in the form of a contingent value right that’s conditioned upon EU approval of Fintepla as an orphan medicine for LGS before the end of 2023.
Despite UCB’s existing presence in epilepsy, the company doesn’t expect any antitrust resistance from regulators, van Zyl told investors during Wednesday’s call. The rare epilepsy subtypes that Fintepla is targeting don’t overlap with any UCB drugs, he noted.