Italian decision sets up launch of Oncopeptides' Pepaxti

Swedish biotech Oncopeptides has been given reimbursement approval in Italy for its multiple myeloma therapy Pepaxti, which it sees as a key step on the growth path for the product.

The publication of the pricing and reimbursement decision for Pepaxti (melflufen) in the Gazetta Ufficiale removes the last obstacle in front of the launch of the drug in Italy, which is now scheduled to take place in the first half of this year.

That will add to its existing commercial sales in Germany, Austria, and Spain, and named-patient distribution in Greece via a partner, said a spokesperson for Oncopeptides, who added that the Italian approval is important to the company's ambition of growing sales of Pepaxti in Europe to a peak of around €150 million ($158 million) at peak.

"The Italian market is expected to become one of Oncopeptides most important European markets with a yearly incidence of about 6,000 multiple myeloma patients, of which about 1,800 are within Pepaxti's target population," said the company in a statement.

Oncopeptides is already running an early access programme in Italy, which has included 86 patients to date, which the company says emphasises the unmet need for Pepaxti in Italy.

Pepaxti was approved by the European Commission in 2022 in combination with dexamethasone for multiple myeloma patients with so-called 'triple class refractory disease' – in other words, those who don't respond to all three of the major classes of treatment for the blood cancer.

The drug is used as a rescue therapy for adults with multiple myeloma who have previously failed treatment with at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.

It provides a much-needed new treatment option for these patients, who have no defined treatment options – limited mainly to conventional chemotherapy, a salvage stem cell transplant, or repeating prior treatments – and a low survival rate.

"This is great news for Italian patients suffering from relapsing, refractory multiple myeloma, as well as a major step forward for our company's ambition to reach profitability by the end of 2026," according to Sofia Heigis, Oncopeptides' chief executive.

The company reported sales of SEK 21 million (around $2 million) in the first nine months of 2024, a decline of more than 25%, which Heigis said was a result of "a promising start in Spain […] offset by slower-than-expected growth in Germany due to a soft market and a slow-down in Greece." On a most positive note, third-quarter sales rose to SEK 8.5 million from SEK 2.8 million in the same period of 2024.

Pepaxti has been withdrawn from the market in the US, where it was sold as Pepaxto by Spectrum Pharma, after a confirmatory clinical trial was unable to convince the FDA that it should firm up the product's 2021 accelerated approval.