Case Study

From IV To Oral: Leveraging Softgel To Extend Vinorelbine's Lifecycle & Improve Patient Convenience

Source: Catalent
GettyImages-1032667996-Softgels

Pierre Fabre partnered with Catalent to develop the first oral vinorelbine softgel capsule, transforming a traditionally intravenous chemotherapy agent into a patient-friendly oral therapy for approved oncology indications. This innovative formulation enabled reliable oral delivery, achieving consistent systemic exposure and gaining approval across multiple European markets. Catalent played a key role throughout the program, supporting formulation development, clinical-phase production, and commercial manufacturing.

Beyond its immediate clinical benefits, the oral softgel also served as a strategic tool for life cycle management. Launched in 2001, the oral formulation offered a differentiated follow-on to the original intravenous product, helping sustain brand value and market share even after the introduction of intravenous generics in 2007. This example underscores how innovative oral formulations can enhance patient convenience, maintain therapeutic consistency, and provide long-term commercial advantages.

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