Zogenix, a pharmaceutical company focused on the treatment of pain-related and central nervous system disorders, acquired Brabant Pharma for $20 million in cash and $15 million in stock. The acquisition includes worldwide development and commercialization rights to Brabafen™, low-dose fenfluramine, for the treatment of Dravet syndrome, a rare form of intractable epilepsy that begins in infancy.
In addition to the acquisition cost and 11,995,202 shares of Zogenix stock to be registered, the terms of the agreement include $50 million in potential regulatory milestone payments and up to $45 million in royalty payments on Brabafen sales.
Brabafen recently received orphan drug designation in Europe and the U.S. According to Brabant, the latest results from an ongoing, long-term clinical study in 15 Dravet syndrome patients treated with Brabafen show that 93% of patients were either seizure-free or had greatly reduced seizure frequency, during an average treatment period of greater than 12 years. More than two-thirds (67%) of patients were seizure free for at least a year after the latest assessment with an average seizure free period of 5.5 years. The majority (87%) of patients had a greater than 75% reduction in seizure frequency.
Expenses related to the Phase III programs for Brabafen are estimated at $10 million, with an additional $5 million in post-approval clinical expenses. Zogenix said it ended the third quarter of 2014 with approximately $50 million in cash plus an additional $8.5 million remaining in escrow from the sale of Sumavel DosePro earlier this year.
“Since securing an exclusive license from the Universities of Antwerp and Leuven in Belgium for the key clinical studies conducted by collaborators Berten Ceulemans, M.D., Ph.D., and Lieven Lagae, M.D., Ph.D., Brabant has made remarkable progress in defining the overall development program and regulatory filing strategy through formal meetings with the U.S. Food and Drug Administration and the European Medicines Agency,” said Stephen Farr, Ph.D., president of Zogenix. “Based upon agency feedback, we plan to initiate two Phase 3 studies (of 40–60 Dravet syndrome patients per study) in the second quarter of next year in the U.S. and Europe, with top line results potentially available in the first half of 2016.”