Life cycle management of branded products
Our ‘life cycle management’ development services are focused on maximizing the value of your drug during its product life cycle. Typically, we are asked by pharmaceutical and biotech companies to develop new product formulations of branded drugs to anticipate on patent expiries, generic competition and profit erosions. Besides hands-on formulation and CMC development work, we also provide specialized analytical, regulatory, intellectual property and competitive intelligence solutions in order to proactively plan your molecule’s path to success from the start.
Case Study – Evolution towards fixed dose combination therapy
Artemisinin based monotherapy, a therapy using one active compound, has been extensively used in Asia and Africa in the ongoing battle against Malaria. A short treatment course of 5 days is sufficient to cure a patient but reoccurrence in this case is fairly common. In order to avoid risk of drug resistance, the WHO recommended to develop Fixed dose combination therapies whereby Artemisinin compounds are combined with other drugs with different modes of action.
Based on a thorough literature overview, we postulated that a combination of artesunate with pyrimethamine (a dihydrofolate reductase inhibitor) and sulfamethoxypyrazine (a dihydropteroate synthase inhibitor) all combined in one tablet could form an ideal combination.
The combination product is safe for children and pregnant women, the elimination half-lifes of the drugs overlap nicely to keep up the synergy of the different mode of actions and the resulting tablets are stable under tropical storage conditions.
We subsequently filed a patent, developed the product in house and the client performed several clinical trials in Africa to show the effectiveness and safety of the novel FDC product with very good results and the product was registered all across Sub-Saharan Africa.
For many years, the product has now been available in the private market in Africa, generating steady sales.