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PharmaMar Advances Lurbi Eadine Development with Japanese Licensing Talks and European Submission Plans

• PharmaMar is in advanced licensing discussions for Lurbi Eadine in Japan, with negotiations expected to conclude in 2025, indicating expansion into a key Asian market.

• The company plans to submit Lurbi Eadine's first-line therapy dossier to EMA in first half of 2024, with potential approval timeline of 7-12 months depending on accelerated review status.

• PharmaMar's partner Rua Pharma received approval in China in December 2024, with product launch expected in first half of 2025, marking significant market expansion.

PharmaMar's oncology portfolio is gaining significant momentum across global markets, with multiple strategic developments underway for its key drug candidates. The company's management provided detailed updates during their Q4 2024 earnings call, highlighting several important advances in their international expansion efforts.

Japanese Market Entry Progress

Luis Mora, Managing Director of Oncology and Virology Business Units, revealed that PharmaMar is currently engaged in advanced discussions with multiple potential partners for licensing Lurbi Eadine in Japan. "We are in advanced discussions with several companies and expect to finalize negotiations in 2025," stated Mora, emphasizing the strong interest from the Japanese market for this therapeutic option.

European Regulatory Timeline

The company has outlined a clear regulatory pathway for Lurbi Eadine's first-line indication in Europe. According to Mora, PharmaMar plans to submit the regulatory dossier to the European Medicines Agency (EMA) in the first half of 2024. The review timeline could range from 7 to 12 months, depending on whether the application qualifies for accelerated review status.

Chinese Market Expansion

A significant milestone was achieved in December 2024 when PharmaMar's partner, Rua Pharma, received regulatory approval in China. The company's Chief Financial Officer, Maria Luisa de Francia Caballero, confirmed that revenue from China in 2024 was attributed to this approval milestone. Commercial launch preparations are currently underway, with the market entry expected in the first half of 2025.

Ongoing Clinical Development

The company continues to advance its clinical development programs, including the Ecubedin basket trial, which is investigating efficacy across 56 different tumor types. Enrollment for this comprehensive study is expected to complete this year, with data anticipated in 2025. Additionally, discussions with the FDA regarding development plans are scheduled.

Strategic Partnership Updates

In the United States, PharmaMar's partner Jazz Pharmaceuticals is pursuing regulatory advancement for labinectadine. While the company remains optimistic about potential priority review status, Senior Vice President of Strategic Development Pascal Besman noted that this decision ultimately rests with the FDA.
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