SK Biopharm Entering Middle East with 'Cenobamate'... "Successful Entry into Most Global Markets"

Contract worth 30.8 billion KRW with Hikma
Priority negotiation rights for key product technology export and
Commercialization rights agreement for Cenobamate

SK Biopharm's epilepsy drug 'Cenobamate' is expanding into the Middle East and North Africa region, known as 'MENA.' By securing a contract worth a total of 30 billion KRW, the company has succeeded in entering most global markets, including the United States, Europe, Asia, South America, and now the MENA region.

SK Biopharm's epilepsy treatment 'Cenobamate'
[Photo by SK Biopharm]

On the 18th, SK Biopharm announced that it signed a strategic partnership agreement granting Hikma the exclusive right of first negotiation for technology export of 17 products in the MENA region, along with a technology export contract for Cenobamate. The contract target is 'Hikma MENA FZE,' a local subsidiary responsible for overall sales in the MENA region operated by the global pharmaceutical company Hikma, which operates across the United States, Europe, and the Middle East and Africa. Hikma, one of the leading pharmaceutical companies in the region, is recognized for its strong market dominance and extensive sales network within the MENA region. The epilepsy market in the MENA region is estimated to be worth 442 million USD (approximately 592 billion KRW).

The strategic partnership agreement involves an advance payment of 20 million USD (approximately 26.8 billion KRW) and grants Hikma the exclusive right of first negotiation for technology export of key products, including Cenobamate, across 17 countries in the MENA region. The contract period is set for 20 years from the launch date of the first product under this agreement.

Included in this is a technology export contract transferring the commercialization rights of Cenobamate in 16 MENA countries to Hikma. The contract includes a signing fee of 3 million USD (approximately 4 billion KRW), and royalties proportional to net sales after launch will also be received. However, royalties will not be paid for the first three years from the initial launch year. The contract period is set for 15 years from the first sales occurrence. Palestine, which was included among the 17 countries, was excluded from the 16 commercialization countries due to difficulties in commercialization at this time. The company explained, "We will consider additional expansion in the future based on changes in the regional situation."

Through this, SK Biopharm is expected to receive a total of 23 million USD (approximately 30.8 billion KRW) from Hikma soon. However, since the advance payment will be deducted from the contract fees for technology export contracts executed during the contract period, any remaining balance will be refunded if the strategic partnership agreement ends. Conversely, technology export contracts signed after the advance payment is exhausted will be received as additional cash. The company plans to use the new funds, along with Cenobamate’s cash-generating power, to activate future research and development and inorganic investments.

Lee Dong-hoon, President of SK Biopharm
[Photo by SK Biopharm]

Since receiving approval as a new drug from the U.S. Food and Drug Administration (FDA) in November 2019, Cenobamate has been accelerating its entry into the U.S. market under the product name 'Xcopri.' In the second quarter, it recorded sales of 63.4 billion KRW in the U.S., a 57.5% increase compared to the same period last year. Total prescriptions (TRx) also doubled compared to the same period after the launch of competing new drugs, rapidly expanding its market.

In markets outside the U.S., Cenobamate has been launched under the product name 'Ontozry' in 18 European countries, including Germany, the United Kingdom, Italy, Spain, and France. Clinical trials are underway in three Asian countries?Korea, China, and Japan?with a target launch in 2025.

SK Biopharm aims for Xcopri to achieve 30,000 monthly TRx by next year and to break even on an annual basis, expecting this to improve the overall company performance. If these goals proceed smoothly, the company forecasts a quarterly profit turnaround in the fourth quarter and an annual profit turnaround next year.

Cenobamate will be sold in 16 MENA countries, including Saudi Arabia, the United Arab Emirates, and Egypt, through Hikma. The epilepsy market in the MENA region is valued at 442 million USD. The MENA market has significant growth potential due to continuous population growth and increased average life expectancy, experiencing explosive growth.

Lee Dong-hoon, CEO of SK Biopharm, said, “By establishing a strategic partnership with Hikma, we have laid the groundwork to strengthen long-term market dominance in the MENA region. We are pleased to provide innovative treatments to epilepsy patients in the MENA region based on the solid value of Cenobamate.”

This content was produced with the assistance of AI translation services.