Given Green Light to Sell Cenobamate in Europe
SK Group is stepping up its efforts to tap into the European biopharmaceutical market. SK Biopharmaceuticals has been given the green light to sell its new drug Cenobamate in Europe. The group has also completed the acquisition of French contract manufacturing organization (CMO) company Yposkesi.
SK Biopharmaceuticals said it has obtained approval for the sale of Cenobamate from the European Commission (EC). Cenobamate is the first new drug developed by a Korean biopharmaceutical company to enter both the U.S. and European markets.
SK Biopharmaceuticals was previously allowed to sell Cenobamate by the United States Food and Drug Administration (FDA) in November 2019. The company began to sell the drug in the U.S. under the name of Xcopri through SK Life Sciences in May 2020.
However, in Europe, commercialization is carried out through Angelini Pharma, a partner company, due to unique market situations. Angelini Pharma is one of the top three pharmaceutical companies in Italy, and has a specialized product line for troubles in the central nervous system such as pain, depression, and schizophrenia.
With the sale permit from the EC, SK Biopharmaceuticals will receive US$110 million in milestones from Angelini Pharma. It will also receive an additional US$13.22 million in milestones following the sale of a stake in its former partner Arvelle Therapeutics.
When Arvelle Therapeutics was acquired by Angelini Pharma in January, SK Biopharmaceuticals transferred its 12 percent stake in Arvelle Therapeutics to Angelini Pharma. SK Biopharmaceuticals already received US$32 million. Of the remaining US$23 million, US$13.22 million will be received this time.
Cenobamate will be sold under the name of Ontozri in the European market starting in the third quarter of 2021. The product will be launched sequentially in major countries such as Germany, France, Italy, Spain, and Britain, Iceland and Norway.
Another SK subsidiary, SK Pharmteco, has acquired French gene-cell therapy CMO company Yposkesi. It acquired a 70 percent stake in the French drugmaker including its management right. Yposkesi has a platform for producing vectors, the core of gene and cell therapy R&D activities.
Until now, SK Pharmteco advanced into the CMO field through aggressive mergers and acquisitions. In 2017, it acquired BMS’s Irish production facilities. In 2019, it bought 100 percent of AMPAC, a U.S. CMO company.