Abliva AB | MedPath

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

3 months ago

• 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.

Pharming Group to Acquire Abliva in $66.1 Million Deal, Bolstering Mitochondrial Disease Pipeline

5 months ago

• Pharming Group N.V. has announced a public cash offer to acquire Abliva AB for approximately US$66.1 million, strengthening its pipeline. • Abliva's lead product, KL1333, is in a pivotal clinical trial for primary mitochondrial disease (PMD) driven by mitochondrial DNA mutations. • KL1333 has shown positive clinical effects and has received Fast Track and Orphan Drug designations, targeting over 30,000 patients. • The acquisition, funded by Pharming's existing cash, aims for a U.S. launch of KL1333 in 2028, pending regulatory approvals.