Catalyst Pharmaceuticals, Inc. (Catalyst) recently reported that Santhera Pharmaceuticals (Santhera) has obtained U.S. Food and Drug Administration approval for AGAMREE® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy (DMD) in patients aged two years and older.
AGAMREE offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need. In July 2023, Catalyst secured the exclusive North American license and commercial rights for AGAMREE from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset.
As part of that transaction, Santhera will promptly transfer the approved New Drug Application for AGAMREE to Catalyst. AGAMREE leverages Catalyst’s FIRDAPSE franchise expertise and optimizes existing capabilities with minimal expansion. The new drug has the potential to deliver meaningful near and long-term value, adding to continued growth momentum.
Anovo was selected to work with Catalyst as the exclusive distributor and specialty pharmacy for AGAMREE®. Anovo’s unique business is purpose-built exclusively for niche products designed to treat or impact rare diseases.
As an all-in-one, exclusive partner, Anovo is driven to deliver meaningful results for our partners and positive experiences for their patients. Coordinated by one management team, the company’s integrated service model delivers customized program management, 3PL, specialty pharmacy, and patient care services.
Anovo was founded at a time when many specialty pharmacies were consolidating – merging with and creating larger entities, while also creating a void in thoughtful support for rare disease medications.
Several veterans of the rare disease specialty pharmacy space combined efforts to find a better approach – founding Anovo and developing its dedicated, exclusive, unique, single-source model.
Takeaway: Anovo’s model provides end-to-end support for drug manufacturers, patients and healthcare providers. Anovo helps all parties succeed, by taking all the complexities of managing rare disease medications and the related support onto the company and orchestrating them seamlessly.
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