Eylea biosimilar by SCD applies for Phase 3 global IND

Planning to apply for IND in the U.S. Q1, result would be out within 90 days

Global trial in each region including the U.S. would start from Q2 at earliest

To receive USD 3 million as milestone payment from Japan

Samchundang Pharm (SCD) plans to have Phase 3 global clinical trial protocol approved for Eylea’s biosimilar ‘SCD411’ within the first quarter of the year.

 

The protocol approval would be reviewed for 90 days at longest, and green light the company to start the Phase 3 trial by the coming second quarter.

 

The multiregional study is planned to be conducted in the U.S., Europe and Japan with a set number of participants.

 

When the trial in Japan starts, SCD would receive USD 3 million (about 3.4 billion won) as a milestone payment stated on the substance license-out deal.

 

According to pharmaceutical industry on Jan.

 

23, SCD is submitting an Investigational New Drug (IND) application to the U.S.

 

Food and Drug Administration (FDA) in the first quarter to obtain approval on a Phase 3 global clinical trial testing a biosimilar product of anti-vascular endothelial growth factor (VEGF) medication Eylea (aflibercept).

 

When FDA clears the Phase 3 IND application, clinical trial in each region would be carried out with respective set number of participants.

 

The approval would be reviewed within 90 days.

 

SCD official stated, “Clinical trials in respective regions are ready to start immediately when the IND application is passed.

 

The protocol review takes 90 days at most, but it could be a month at earliest.

 

We are compiling a flawless application.

 

The target schedule is to submit the IND application within the first quarter.” Initiating the study in Japan after the IND application approval would grant SCD three million dollars.

 

In last March, SCD has signed a deal on SCD411 with Japan-based SENJU Pharmaceutical for 50 billion won.

 

The deal gives exclusive sales rights of the drug in Japan.

 

The Japanese company has paid upfront payment of 2.5 billion won, and agreed to pay out 47.5 billion won for achieving each clinical milestone.

 

The Korean company has received total of 11.5 billion won from the upfront payment (2.5 billion won) and CRO deal related to global clinical trials (nine billion won).

 

Preparation for IND approval has already been completed.

 

In last August, SCD announced the company had a successful pre-IND meeting with the U.S.

 

FDA as a preparation process prior to IND application submission.

 

The company explained, at the meeting, the U.S.

 

health authority generally reviewed the SCD 411’s quality equivalence test outcome and clinical protocol and confirmed the candidate medicine would not have an issue proceeding with IND application.

 

Moreover, the company elaborated about the U.S.

 

FDA recommending execution of Phase 3 trial straight without Phase 1, as recommended by European Medicine Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

 

Basically, the company can simultaneously process the marketing approval in the U.S., Europe and Japan and other major global markets with the Phase 3 global clinical trial.

 

The VEGF treatment has relatively high marketability due to rarity of the treatment option.

 

At the moment, the only options available are Bayer’s Elyea (aflibercept) and Novartis’ Lucentis (ranibizumab).

 

The market volume is expected to grow from seven trillion won in 2017 to 13 trillion won by 2026.