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Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.
Cenobamate – under the brand name ONTOZRY® – has been commercialized in five major European countries such as Germany, the UK, Italy, Spain, and France, accounting for about 73 percent of the total value of the continent’s epilepsy market.
Medytox applied for a license for Meditoxin (export name: Neuronox having Clostridium Botulinum Toxin type A), Medytox’s BTX product, to China’s National Medical Products Administration in February 2018.
Under the terms of agreement, SK Biopharmaceuticals has granted Eurofarma the exclusive rights to develop and commercialize Xcopri (cenobamate) in Latin America. SK Biopharmaceuticals will now be present in four continents: North America, Europe, Asia, and Latin America.
Donepezil is a current typical treatment that has been widely prescribed for the longest period for Alzheimer’s disease patients in severity ranging from mild to moderate and severe ones among FDA-approved Alzheimer's treatments.
Angelini Pharma plans to launch ONTOZRY® in the European Union and other countries in the European Economic Area. SK Biopharmaceuticals, which discovered and developed cenobamate, will collaborate with Angelini Pharma to launch ONTOZRY® in Europe.
Presentations will feature new post-hoc analyses of safety, efficacy and pharmacokinetic clinical trial data from adult patients taking cenobamate for uncontrolled partial-onset (focal) seizures.
SK Biopharmaceuticals will conduct a Phase 3 clinical study for partial-onset seizures in adults in Northeast Asia (Japan, China, and Korea). In addition, SK Biopharmaceuticals has an option for co-promotion with Ono in the Japanese market.
The Phase 3 trial is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of cenobamate as an adjunctive therapy in subjects with partial-onset seizures, with an optional open-label extension.
SK Biopharmaceuticals Co Ltd priced its initial public offering on Friday at the top of its indicative range, aiming to raise 959 billion won ($794 million) in South Korea's biggest IPO in three years.