SK’s epilepsy drug makes over ₩400 billion in 3 years

in technology transfer+milestones… continues to make a streak of new records

Sk Biopharmaceuticals makes technology exports of cenobamate to Latin America… upfront payment of $15 million

Technology export from 2019 to Europe, Canada, China, etc... ₩400 billion in upfront payment and milestones

The largest licensing deal ever made among homegrown new drugs

SK Biopharmaceuticals’s new anti-epileptic drug ‘Xcopri’ has brought in a total of ₩400 billion in upfront payments and milestone payments over the past 3 years.

 

This is the largest amount of cash secured by a new drug that was licensed out by Korean pharmaceutical companies.

 

According to the Financial Supervisory Service on the 14th, SK Biopharmaceuticals signed a licensing deal with the Brazilian pharmaceutical company Eurofarma Laboratorios SA for its anti-epileptic drug Xcopri.

 

Under the agreement, SK Biopharmaceuticals will receive an upfront payments of $15 million and up to $47 million in milestone payments which are paid when each phase of development, approval, etc.

 

is completed.

 

The company will also separately collect royalties proportional to net sales upon Xcopri’s commercialization.

 

Under the licensing agreement, Eurofarma will sell cenobamate in 17 Latin American countries including Brazil and Mexico.

 

Eurofarma, which owns expertise in the sales and marketing of central nervous system (CNS) disorder treatments owns a sales network throughout Latin America.

 

Cenobamate is a new anti-epileptic developed solely by SK Biopharmaceuticals from its initial development to US FDA approval as a treatment for partial-onset seizures in adults.

 

It simultaneously regulates 2 targets related to excitatory/inhibitory signaling that is known to cause epilepsy to reduce seizure frequency.

 

SK Biopharmaceutical received approval for cenobamate under the brand name ‘Xcopri’ from the US FDA in November 2019 and has been directly selling the drug through its US subsidiary SK Life Science ever since.

 

SK Biopharmaceutical has been entering overseas countries other than the US by licensing out cenobamate to its local partners.

 

SK Biopharmaceutical entered into a licensing agreement last February with the Swiss pharmaceutical company Arvelle Therapeutics to transfer technology on cenobamate for up to $530 million.

 

At the time, SK Biopharmaceutical received an upfront payment of $100 million with no obligation of return.

 

In October 2020, the company entered into an exclusive licensing agreement with Ono Pharmaceutical for Ono to develop and commercialize Xcopri in Japan.

 

Under the agreement, SK Biopharmaceutical received an upfront payment of ¥5 billion with no obligation of return, and will also be eligible to receive up to ¥48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as double-digit royalties on net sales generated in Japan.

 

In November last year, SK Biopharmaceutical licensed out 6 new central nervous systems (CNS) drugs including cenobamate to Ignis Therapeutics.

 

Under the deal, SK Biopharmaceutical received an upfront payment of $20 million, a milestone payment of $15 million, and royalties on net sales in the future.

 

Through the technology export, SK Biopharmaceutical acquired 150 million shares of Ignis (share amounts to 44.9% including common stock).

 

And in December last year, SK Biopharmaceutical signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada.

 

Under the deal, SK Biopharmaceutical received an upfront payment of $20 million in USD.

 

The company will also be able to receive up to $21 million in Canadian dollars based on the achievement of certain regulatory and commercial milestones in the future.

 

Paladin Labs Inc., a Canada-based operating subsidiary of Endo, will be responsible for all commercial activities related to cenobamate in the region, including its release.

 

Endo is a global healthcare company headquartered in Ireland.

 

In addition to upfront payments, the company has also received milestone payments upon cenobamate’s approval abroad.

 

SK Biopharmaceutical received $123.22 million from its European partner Angelini Pharma as milestone payments last year.

 

Angelini Pharma (formerly Arvelle Therapeutics UK) has collected additional milestone payments after receiving marketing authorization from the European Commission in March last year.

 

SK Biopharmaceutical’s cash inflow from upfront payments and further milestones from the technology transfer of cenobamate is $278.22 million and ¥5 billion.

 

Based on the recent exchange rates, the company had secured about ₩400 billion through upfront and milestone payments through technology transfer with cenobamate.

 

This is estimated to be the largest amount earned from the technology transfer of a single new drug developed in Korea.

 

In 2015, Hanmi Pharmaceutical received the largest amount as an upfront payment, €240 million (approximately ₩260 billion, to transfer the license of its 3 new diabetes drugs to Sanofi.

 

No additional milestone occurred and all rights were returned to Hanmi Pharmaceutical.

 

Yuhan Corp’s new anticancer drug ‘Leclaza (lasertinib)’ received $150 million (approximately ₩190 billion) in upfront and milestone payments.

 

Yuhan Corp has made a licensing deal with Janssen biotech in November 2018.

 

At the time, the company received an upfront payment of $50 million with no obligation of return.

 

Yuhan Corp received a milestone payment of $35 million from Janssen in April 2020 for lasertinib.

 

At the time, Janssen had paid an additional milestone to Yuhan Corp when it started a clinical trial for combination therapy using amivantamab and lasertinib.

 

Yuhan Corp had collected an additional $65 million in milestone payments when Janssen started recruiting subjects for the Phase III trial of its self-developed anticancer drug amivantamab and lasertinib combination.