Expected to be released under the product name’On2uri’
Expectation of Milestone Revenue When Acquiring Marketing License
SK Biopharm(149,000 +2.76%)Announced on the 1st that Senobamate has been recommended for marketing approval from the Drug User Advisory Committee (CHMP) under the European Medicines Agency (EMA).
Final approval by the European Commission (EC) takes place approximately 67 days from the date of the CHMP recommendation. Considering this, it is expected that Senobamate will be able to obtain a marketing license within the second quarter of this year. Europe is the world’s second largest epilepsy treatment market. It is estimated that there are about 6 million patients, according to the World Health Organization (WHO).
Senobamate is an epilepsy treatment (U.S. name Excofree) developed by SK Biopharm and approved by the U.S. Food and Drug Administration (FDA) in November 2019. In Europe, it will be released under the product name’ONTOZRYTM’ through its partner Angelini Pharma. Angelini Pharma plans to target major European countries through 15 local subsidiaries and distribution networks in 70 countries.
When Senobamate obtains a European license, SK Biopharm will receive up to $430 million (about 480 billion won) of step-by-step technology fees (milestone) from Angelini Pharma. Current technology usage fees (royalties) according to sales are separately received When signing a contract with Abel Therapeutics in 2019, Senobamate’s technology export contract was expanded from 32 countries to 41 as of December last year. As a result, revenue is expected to increase.
SK Biopharm signed a technology transfer contract with Abel, a Swiss pharmaceutical company, in 2019 to commercialize Cenovamate in Europe. When Abel was acquired by Angelini Pharma, an Italian pharmaceutical company, the commercialization rights of Senobamate were also transferred.
SK Biopharm CEO Jo Jung-woo said, “We will work closely with our partners to successfully launch innovative new drugs.”
“Senovamate’s recommendation to approve the sale of CHMP is a monumental thing for Angelini Pharma,” said Pierluigi Antonelli, president of Angelini Pharma. I will be a runner.”
Reporter Minsoo Han [email protected]
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