Swedish biotech Oncopeptides has achieved a significant milestone with the Italian regulatory authorities granting reimbursement approval for Pepaxti, their innovative therapy for multiple myeloma. The decision, published in the Gazetta Ufficiale, clears the final hurdle for the drug's commercialization in Italy, scheduled for the first half of 2024.
Strategic Market Expansion
The Italian launch will expand Pepaxti's commercial presence beyond its existing markets of Germany, Austria, and Spain, where the drug is already available, along with named-patient distribution in Greece. Italy represents a crucial market in Oncopeptides' European commercial strategy, with the company targeting peak sales of €150 million ($158 million) across the region.
Italy's multiple myeloma landscape presents a substantial opportunity, with approximately 6,000 new cases diagnosed annually. Of these, around 1,800 patients fall within Pepaxti's target population, making it potentially one of Oncopeptides' most significant European markets.
Clinical Need and Treatment Profile
Pepaxti, approved by the European Commission in 2022, is administered in combination with dexamethasone for a specific patient population - those with triple-class refractory multiple myeloma. These patients have previously failed treatment with three major therapeutic classes: proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.
The drug's importance is underscored by the limited options available to these patients, who typically face poor survival rates and are restricted to conventional chemotherapy, salvage stem cell transplants, or retreatment with previously failed therapies. The ongoing early access program in Italy, which has already included 86 patients, demonstrates the significant unmet need for this treatment option.
Commercial Performance and Future Outlook
Sofia Heigis, Oncopeptides' chief executive, views the Italian reimbursement decision as crucial for both patient care and the company's financial objectives, stating, "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."
Recent financial results show mixed performance, with sales reaching SEK 21 million (approximately $2 million) in the first nine months of 2024, representing a 25% decline. However, third-quarter results showed improvement, with sales increasing to SEK 8.5 million from SEK 2.8 million in the previous year. The company attributes slower growth in Germany to market softness and a slowdown in Greece, while noting promising initial results in Spain.
Regulatory Context
While Pepaxti advances in European markets, it's worth noting that the drug, marketed as Pepaxto in the United States, was withdrawn from that market following challenges in confirming its clinical benefits in a post-approval study required by the FDA.
