Profitable lazertinib makes 5-year income for Oscotec

Yuhan splits USD 22.1 million for lazertinib clinical milestone

Lazertinib license-out deal generates USD 51 million from 2018

Product image of Leclaza

For last couple of years, Oscotec has generated 57 billion won from licensing out a new drug candidate.

 

The South Korean company earned more than five years of income by selling a profitable new drug candidate to Yuhan Corporation.

 

On Jan.

 

26, Oscotec announced Yuhan Corporation would pay out USD 22.1 million (approximately 24.8 billion won) out of the license-out milestone payment received from Janssen Biotec.

 

The expected transaction would be processed within three months from the official announcement.

 

The company explained, “The income is from the epidermal growth factor receptor (EGFR) targeted therapy candidate license-out deal signed with Yuhan Corporation in 2015.

 

40 percent out of the total milestone payment would be paid out to both Oscotec and a subsidiary company Genosco.” The payment Oscotec announced is for Janssen reaching the milestone of administering the combination of the company’s own dual anticancer treatment amivantamab and an EGFR targeted therapy lazertinib licensed in from Yuhan to initiate a Phase III trial.

 

Lazertinib is the main substance of Yuhan’s non-small cell lung cancer (NSCLC) treatment Leclaza approved as the 31st new drug developed in South Korea.

 

Oscotec and its subsidiary Genosco inked 1.5 billion won worth of a license-out deal with Yuhan in July 2015 for the EGFR targeted therapy candidate lazertinib.

 

Within 30 days of the contract signing, the upfront payment of 1 billion won was received, and 500 million won is to be paid out after Yuhan’s Phase I clinical protocol is cleared.

 

In the contract, Yuhan added a term to split the income 60 to 40 for the upfront payment and the clinical milestone payments from the global pharmaceutical company licensing out the candidate medicine.

 

Yuhan took over the development rights on lazertinib in the preclinical trial phase, and licensed out the drug in November 2018, after optimizing the substance, designing the pipeline and undergoing the preclinical and clinical trials in South Korea.

 

The deal is valued at maximum 1.26 billion dollars (approximately 1.5 trillion won) covering the initial contract payment of 50 million dollars and phase-by-phase milestone payments.

 

Yuhan has earned total of 150 million dollars for last two years from licensing out lazertinib.

 

Janssen provided 35 million dollars for achieving the milestone of initiating the global Phase I/II trial with a combination of amivantamab and lazertinib in last April.

 

Also another 6.5 million won was given to Yuhan in last November for starting a global Phase III trial on the combination therapy.

 

During the process, Oscotec also improved its income significantly.

 

Oscotec received the upfront payment of 17 million dollars from Yuhan as the Janssen’s upfront contract payment went through in 2018.

 

And as of the second milestone, additional 34 million dollars were paid out from splitting the income.

 

The lazertinib license-out deal basically generated 51 million dollars (approximately 57 billion won) in last two years for the initial contract and further development.

 

In five years from 2015 through 2019, Oscotec has made 48.9 billion won.

 

The license-out deal signed six years ago generated more than the five-year income in just two years.

 

The industry highly anticipates positive effect in Oscotec’s income structure based on lazertinib progressing smoothly.

 

Janssen is also expediting the global Phase III clinical trial on amivantamab and lazertinib combination as the company confirmed a positive outcome during the initial clinical trial.

 

In last December, the company applied for amivantamab Biologics License Application (BLA) to the U.S.

 

Food and Drug Administration’s (FDA), and it also aims to complete the New Drug Application (NDA) for lazertinib by 2023.

 

Besides Janssen’s progress, Yuhan is also independently conducting a global Phase III trial on lazertinib.