Sam Chun Dang Pharmaceutical said on Thursday that it signed a $15 million licensing-out agreement to supply its biosimilar referencing Eylea (ingredient:aflibercept), SCD411, to Apotex, a Canadian pharmaceutical company. Eylea, developed by Regeneron and Bayer, treats wet age-related macular degeneration. 

The contract period runs for 10 years from the sale of the product and will be automatically renewed every two years after 10 years elapses.

Under the agreement, Sam Chun Dang Pharmaceutical will receive an upfront payment of $3 million (approximately 4 billion won) within 30 days of signing the agreement.

Also, the Korean company expects to receive up to 50 percent of the gross profit of sales on a quarterly basis if the SCD411 (prefilled syringe) PFS product is the first to be listed on the insurance or if it it is listed within three months of the first Eylea biosimilar PFS product. 

However, it will only receive 35 percent if the PFS product is listed within four to six months of the other PFS product's first approval.

Sam Chun Dang said Apotex estimates total product sales to amount to $20 million Canadian dollars  in this period. This figure represents more than 40 percent of the Canadian Eylea market.

Additionally, the milestone condition is subject to the achievement of local approval from Health Canada and sales conditions such as the registration as the first prefilled syringe (PFS) Eylea biosimilar formulation and cumulative sales of $10 million and $20 million Canadian dollars respectively.

"Apotex was impressed with our product quality and patent avoidance strategy, and we are particularly confident that our prefilled syringe product will be the first to be covered by Canadian health insurance," said a company official at Sam Chun Dang Pharmaceutical. "Payment from this agreement is conditional and based on the success of obtaining approval but all milestone payments received at each stage, including upfront payments, are non-refundable and we are not obligated to pay any penalties for termination.”

Based on the company’s phase 3 clinical trial data of Eylea biosimilar in March this year, Sam Chun Dang Pharmaceutical is accelerating negotiations to finalize agreements with overseas partners and preparations to apply for simultaneous approval of the biosimilar’s global vial and prefilled syringe formulations.