Pharm-Olam is proud to have contributed to the execution and completion of Cablivi ivotal Phase III study

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Pharm-Olam, a global, midsized CRO offering full-service clinical development solutions for oncology, infectious diseases and vaccines, and rare and orphan diseases, extends its congratulations to Ablynx, a Sanofi company, for its launch of CabliviĀ® (caplacizumab) in the German market for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

Pharm-Olam is proud to have contributed to the execution and completion of its pivotal Phase III study.

aTTP is a rare, life-threatening, autoimmune-based blood clotting disorder. The European Commission has granted marketing authorization for the drug. In the U.S., the FDA will give priority review to the drug, with a decision expected in early 2019.

Pharm-Olam, a leader in orphan and rare disease research, was contracted in April 2015 to conduct the pivotal Phase III HERCULES study. The company has also been contracted to run the three-year follow-up study to characterize the long-term impact of the drug and evaluate its repeated use.

Despite the challenges of enrolling patients into an orphan disease study, Pharm-Olam completed enrollment for the HERCULES study ahead of schedule — the team managed 92 sites across 16 countries to dose 145 patients.

ā€œThis achievement reinforces our experience and expertise in orphan diseases and blood disorders,ā€ said Maria Jesus Seivane, project director at Pharm-Olam. ā€œWith more than 100 studies in this category, our team has become a well-suited partner to ensure success.ā€

ā€œHelping to bring a new treatment to patients is something we can be immensely proud of,ā€ said David L. Grange, CEO at Pharm-Olam. ā€œWe also want to congratulate Ablynx. This is not only the first therapeutic drug for the treatment of aTTP, it’s the first NanobodyĀ®-based medicine on the market.ā€

About Pharm-Olam
Pharm-Olam is Helping Create a Healthier World as a global, midsized CRO that offers flexible, innovative and highly personalized clinical solutions to pharmaceutical, biotechnology and life science companies. Our team is well-known for producing quality results with reduced risk, costs and timelines in challenging international trials. Learn more about our full-service solutions, data protection services and expertise in oncology, infectious diseases and vaccines, rare and orphan diseases, pediatrics and general medicine at pharm-olam.com.Ā 

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