BELGIUM – Belgian-based UCB has agreed to buy Zogenix Inc, a U.S. maker of drugs to treat seizures and rare diseases, for US$1.9 billion, expanding its portfolio to treat epilepsy.

Investors will receive cash for each Zogenix share they own, as well as a potential US$2 per share payment if Zogenix’s Fintepla drug is approved by the FDA for Lennox-Gastaut syndrome by the end of 2023.

Both companies’ boards of directors unanimously approved the transaction, which will increase UCB’s focus on drugs for specific and rare types of epilepsy.

Fintepla is approved in the United States and Europe for the treatment of seizures associated with Dravet syndrome in patients two years of age and older, and it is being evaluated in Japan for this indication.

Fenfluramine, the active ingredient in Fintepla, was previously available as part of the Fen-Phen anti-obesity regimen.

That therapy was later withdrawn from the market due to the risk of pulmonary hypertension and heart valve disease. Fintepla is now managed through an FDA-designated monitoring program as a result of that earlier safety signal.

The cardiovascular disease issue appears only when fenfluramine is administered at a high dose, which is not used in Fintepla’s clinical programs, according to Iris Loew-Friedrich, UCB’s chief medical officer.

She went on to say that neither the drug’s clinical trials nor the post marketing surveillance program had detected any of the heart problems.

The agreement comes as UCB’s own epilepsy drug Vimpat, currently one of the company’s only two blockbuster products, is set to lose market exclusivity in the United States in March.

Fintepla, as an FDA-approved therapy, can immediately contribute to UCB’s bottom line once the transaction is completed, which is expected in the second quarter of 2022.

Fintepla is also being pursued by Zogenix for the treatment of seizures associated with other rare epilepsies, such as Lennox-Gastaut syndrome, for which filings have been submitted in the United States and Europe, and CDKL5 deficiency disorder.

UCB hopes to accelerate the drug’s rollout by leveraging its existing expertise and global reach, according to Charl van Zyl, UCB’s executive vice president of neurology and head of Europe and international markets.

The Belgian pharmaceutical company already sells four epilepsy medications: Keppra, Vimpat, Briviact, and Nayzilam. According to UCB, these drugs have treated more than 3 million patients worldwide.

The four medications generated €1.4 billion (US$1.59 billion) in sales in the first half of 2021, with Vimpat accounting for more than half of that total, as Fiercepharma reports.

Meanwhile, through a US$125 million upfront acquisition of Engage Therapeutics in 2020, UCB gained an inhaled version of alprazolam, which is now in phase 3 testing for the acute treatment of epileptic seizures.

Meanwhile, UCB stated that the acquisition, which is expected to be completed by the end of the second quarter, will immediately contribute to revenue growth and be earnings accretive in 2023.

Jazz Pharmaceuticals acquired the anti-seizure treatment Epidiolex (cannabidiol) last year as part of its US$7.2-billion acquisition of GW Pharmaceuticals.

The cannabinoid-based medication is specifically approved for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.

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