Update on the Type II application process

Stockholm – December 15, 2023 – Oncopeptides today announces that the European Commission has decided to formally approve the company’s application to the European Medicines Agency (EMA) for an extended indication for Pepaxti into earlier lines. The previously communicated decision by Oncopeptides to opt out of the process to extend the indication remains.

Oncopeptides has submitted an application to adjust the indication of Pepaxti to the originally approved indication, a process that is expected to be finalized in early 2024. During this time, Oncopeptides will work together with the European Commission, EMA as well as local stakeholders to ensure an efficient removal process for the extended indication.

Questions and answers for investors

What is this?

As Oncopeptides communicated on September 28, the company has decided to not extend its indication for Pepaxti into earlier lines of treatment. Despite the company not having an intention to expand the indication, the European Commission has approved the application to do so. To address this, Oncopeptides has submitted a so called type IB-variation to remove the new indication from the product information, ultimately leading to the same intended outcome. A type IB-variation does not require formal approval by the EMA. We expect the process to be finalized in early 2024.

What will you do now?

We will now work with the European Commission, EMA as well as relevant local regulators in order to ensure an efficient removal process for the extended indication.

As an added benefit, this process will also allow Oncopeptides to keep peripheral administration as a method of administration in the officially approved conditions of use a medicine.

Will this affect/temporarily halt the availability of Pepaxti in Germany?

No.

You applied for the extended indication after all, was the European Commission approving it not expected?

It was not. This is an unusual step in a process in which the company voluntarily opts out ahead of the approval by the European Commission.