Teva gave Celltrion ₩200 billion in copyright deposit

Teva, In the SEC submission report, the payment details for the October 2016 payment were released.

Herzuma, Truxima, subject to monopolistic supply to the US and Canada, paid $ 160 million.

허쥬마(왼쪽)와 트룩시마 제품사진

Celltrion group surpassed the exclusive rights of the two biosimilars in North America, and it was found that it generated a technology fee of nearly ₩200 billion.

 

In a report submitted to the Securities and Exchange Commission (SEC) on the 7th (local time), multinational pharmaceutical company Teva revealed the history of a biosimilar copyright agreement signed with Celltrion Healthcare in the past.

 

According to the report, the company confirmed that in October 2016, it paid out $160 million to Celltrion Healthcare under the condition of exclusive supply of 'Truxima' and 'Herzuma' in the United States and Canada.

 

At the time, both products were subject to a condition of being refundable for $60 million of the down payment because they were prior to obtaining official approval.

 

At present, both 'Truxima' and 'Herzuma' have been approved by the FDA and Health Canada, and their condition has expired when they start selling products.

 

This is the first time that Celltrion Healthcare has revealed the amount of license revenue received from handing over biosimilars' exclusive overseas distribution rights.

 

Celltrion Healthcare was an unlisted company when it signed an agreement with Teva, and did not disclose details of the contract.

 

In the business report submitted to the Financial Supervisory Service by Celltrion Healthcare, only the timing of the contract (October 4, 2016) and distribution countries (USA, Canada, Puerto Rico) were mentioned for the 'Truxima' and 'Herzuma' supply contract' with Teva.

 

The main thing to note in this contract is the size of the down payment.

 

The $160 million secured by Celltrion Healthcare is the third largest among technology transfer contracts signed by domestic pharmaceutical bio companies.

 

In 2015, three types of diabetic new drugs, which Hanmi exported to Sanofi, received the largest contract amount of €204 million.

 

Hanmi's long-lasting obesity diabetes treatment drug ($105 million) was handed over to Janssen for the second largest down payment.

 

SK Biopharmaceuticals signed a technology transfer contract with Able Therapeutics of Switzerland in February last year for a new drug candidate for encephalopathy, 'Cenobamate'.

 

'Truxima' is a biosimilar product of 'Mabthera' (Rituximab), a flagship product of multinational pharmaceutical company Roche.

 

Mabthera is prescribed for autoimmune diseases such as rheumatoid arthritis, including blood cancer.

 

In the U.S.

 

alone, it is forming a market of about ₩5 trillion (based on 2018 IQVIA).

 

Celltrion Healthcare and Teva were approved for FDA sales of Truxima in November 2018, and launched in the U.S.

 

market starting in November 2019.

 

In February this year, the product was launched in Canada.

 

'Herzuma' is a biosimilar product of Roche's anti-cancer drug 'Herceptin' (Trastuzumab), which is prescribed for breast cancer, stomach cancer, etc.

 

Herzuma was approved by the FDA in December 2018, and began selling in the US in March this year.

 

In Canada, it was released in January this year.

 

Under the agreement, Teva and Celltrion Healthcare share revenue from product sales in the United States and Canada.

 

An official of Celltrion Healthcare said, "The $ 160 million that Teva released was a pre-paid deposit when it signed a biosimilar license transfer agreement in October 2016.

 

There was a provision that Teva would refund $ 60 million if it did not get FDA approval." "There is no obligation to return when we start selling locally." "Other details cannot be mentioned at a public expense," he said.