Oncopeptides opts to abandon Type II variation process for Pepaxti to optimize patient and shareholder value
Stockholm – September 28, 2023 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces its decision to opt to abandon the application process to allow Pepaxti access to earlier lines of treatment for patients with relapsed, refractory multiple myeloma (RRMM), a so-called type II variation. The decision follows an updated, comprehensive analysis of the current landscape for treatment of multiple myeloma and is made to optimize value for both patients and shareholders. The decision does not impact the company´s financial projections or the estimated market potential of Pepaxti negatively.
In its analysis, Oncopeptides has concluded that the highest value for both patients and shareholders lies in the current indication, due to a high unmet medical need, a fair price reflecting the innovation of Pepaxti and fewer alternative treatments.
The company assesses that this decision does not negatively affect the previously communicated market potential for Pepaxti in Europe (i.e. >1.5 billion SEK), or when the company can expect to be cash flow positive (i.e. before end of 2026).
“While we have strong scientific support and are pleased with the clinical benefit/risk profile, confirmed by the recent positive opinion from the CHMP, our assessment is that we would serve patients best if the drug remained within its current indication where the unmet medical need remains high and the number of patients is increasing,” says Sofia Heigis, CEO of Oncopeptides. “The European treatment landscape already holds a broad range of viable options with a mix of both generic and innovative drugs. To move forward with an extension into earlier lines of treatment before fulfilling the higher unmet need in later lines could mean a new European price level for Pepaxti that does not reflect our innovation and ultimately risk the availability of Pepaxti for all patients and also erode shareholder value. We are convinced that focusing on later lines of treatment in a growing market is in the best interest of both patients and our shareholders.”
For more information, please see the Q&A for investors below as well as a video interview where Sofia Heigis further describes the decision.
What is this?
Oncopeptides has opted to abandon the application process to extend the approval for Pepaxti into earlier lines of treatment to focus on its current indication, as the company believes that is where the highest unmet need and optimal value for patients and the company´s shareholders lie.
What has led to this decision?
On September 14 Oncopeptides received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) to allow the extension of Pepaxti into earlier lines of treatment and also peripheral administration, meaning delivery of treatment through peripheral veins.
Ahead of the decision, the company initiated an updated analysis of the rapidly evolving multiple myeloma landscape and the market potential for Pepaxti in different scenarios.
Have you abandoned the process voluntarily or upon EMA’s request?
The decision was solely made by Oncopeptides.
What implications will this have for patients with multiple myeloma?
The potential patient population is larger in earlier lines of therapy. This does not mean, however, that more patients would automatically benefit from Pepaxti being extended into earlier lines of therapy. Our assessment is that the highest value patient of Pepaxti is in later lines of therapy where there is a higher unmet need. While the decision to not extend the indication into earlier lines of treatment means that Oncopeptides will not be able to market the drug to these target groups, doctors are still able to prescribe Pepaxti to any patient they believe would benefit from the drug.
The type II variation submission was based on the OCEAN study, wasn’t the data strong enough?
Yes. On September 14, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), recommended to approve Oncopeptides’ application to allow access to earlier lines of treatment, based on a scientific evaluation of the OCEAN study data.
What impact has the competition in earlier treatment lines had on your decision?
It was an important factor among others as part of a broader analysis of the current multiple myeloma treatment landscape.
What impact will this have on the price in Germany and Europe?
Oncopeptides on September 26 announced it has successfully agreed on a fair reimbursed price that reflects the innovation of Pepaxti in Germany. It´s hard to speculate on what price Pepaxti would have received had it been extended into earlier lines of treatment, but there is a substantial risk that it would have been significantly lower following the renewed price negotiation that would have been triggered.
You have previously stated that the market potential in Europe is partly built on the approval of the type II variation. What impact will this have on the annual market potential?
We have previously communicated (for example in this press release) that a type II variation approval is a part of the market potential for Pepaxti, along with successful price negotiations. Based on an updated analysis of the rapidly changing multiple myeloma landscape, we now believe that the type II variation approval is no longer a necessary factor (the second, a price that reflects the innovation of Pepaxti was recently fulfilled) as we now assess that the highest market potential lies in later lines of treatment where there is a high unmet need and where the price better reflects the innovation of Pepaxti. Therefore, our assessed total market potential remains at the same level as previously communicated, although with a different foundation.
How come you submitted the type II variation application to EMA in the first place?
The submission was made based on an assessment made at the time of the application, when the treatment and payer landscape for multiple myeloma looked different.