Appendix: selected adaptive development projects

Category

Product

Objectives

Progress to date

Expansion of clinical use of existing medicines into new indications and populations

Femara

Extend label to treatment of epithelial ovarian cancer

Phase III clinical trial started recruitment in January 2021.

Entresto

Conduct a Phase IV clinical trial to assess the efficacy and safety of Entresto in people with heart failure due to chronic Chagas cardiomyopathy

The study is still recruiting in Argentina, Brazil, Colombia and Mexico, due to the COVID-19 situation.

Hydroxyurea

Develop pediatric formulation for treatment of sickle cell disease

The drug was approved in Ghana in September and
the launch is expected in February 2022; a dossier was submitted for registration in Uganda, Tanzania, and Kenya in July.

Development of new formulations for greater incremental benefit to vulnerable patients

Coartem

Develop pediatric formulation for infants <5 kg body weight

Enrollment for the first cohort is complete and the trial started in 2021 in collaboration with the PAMAfrica consortium, funded by the European & Developing Countries Clinical Trials Partnership.

Conducting research that enables us to better pursue adaptive development of new medicines

Tamoxifen

Conduct a study to understand how Africa-specific CYP2D6 polymorphism – a key enzyme to metabolize a large number of clinically important drugs – potentially affects how the drug metabolizes in the body

Enrollment is complete and the study is on track. The final study report is planned for release in Q1 2022.