Manufacturing Challenge

Case Study: Revolutionizing Hepatitis C Treatment - First Ever to be Accepted by FDA 

Problem/Challenge: Millions worldwide suffer from chronic hepatitis C, lacking effective and affordable treatment options. The high cure rates achievable with a safe and effective therapy were desperately needed. An additional hurdle arose when taking over the project – technology transfer issues from the previous CRO working on Sofosbuvir. 

Solution Approach:

• Breakthrough Therapy: Dr. El-Khateeb led a team at Cambrex to transfer the technology of drug substance, i.e. Sofosbuvir and provided the directions for the team to enable the development and launch of the product. This drug product was the first anti-hepatitis C product submitted to the U.S. FDA for approval. This groundbreaking treatment promised significant improvements in cure rates and patient outcomes.

• Fast-Track Approval: Recognizing the urgency of addressing the hepatitis C, the team pursued a fast-track approach with the FDA to expedite the approval process.

• Collaborative Quality Management: Dr. El-Khateeb played a pivotal role in securing a three-way quality agreement between the client, Cambrex,  and a specialized third-party laboratory. This ensured rigorous quality control throughout the development and manufacturing process.

Outcome:

• Market Game-Changer: Sofosbuvir tablets secured FDA approval in 2013 for treating chronic hepatitis C in adults, in combination with other medications. This marked a remarkable achievement in the field of HCV treatment, offering patients a faster path to recovery. 

• Financial Success: The rapid approval and market launch secured the first milestone payment of over $9 million within a month, exceeding expectations.

• Patient Impact: Sofosbuvir tablets revolutionized the treatment of chronic hepatitis C, offering patients a highly effective and well-tolerated therapy.