Insight Pharma Reports has published the latest of our technology and market assessment reports: Advanced Drug Delivery Technologies: Enabling Drug Reformulations and Administration Routes. A detailed description of its contents can be found here.
As I have stated several times on this blog (last time, here), the classical concept of pharmaceutical innovation – as measured by drug approvals based on new chemical entities – is broken. According to the Centre for Medicines Research International, the average for the combined success rate at Phase III and submission has fallen to ~50% in recent years. The “biotech revolution” has not happened in the way it had been foretold since the late1980s, when you could read forecasts in industry publications such as SCRIP stating that more than half of all pharma sales would come from biologicals in 2000.
The simple take-home message is that we need to make better use of what we already have. One option is drug repurposing, for which I have founded a steadily growing discussion group on Linked In (which you can join here). The second one is developing new formulations for known drugs. Of course these approaches are intimately connected: intelligent new formulation technologies, especially those driven by nanotechnology and medical devices, can enable repurposing of known drugs in ways that would not have been possible otherwise.
Our newest report discusses how drug delivery can overcome the blood brain barrier and how drugs can be effectively delivered to tumors while minimizing systemic exposure to cytotoxic drugs. Then the report turns to non-injection delivery modalities for peptides, proteins, and antibodies, and to the role that alternative formulations will play in the emerging field of follow-on biologicals (“biogenerics”). We then explore the role of alternative delivery in drug lifecycle management. It is shown that development of a follow-up new chemical entity is already an economically unattractive proposition, as opposed to reformulation or repurposing. Case studies demonstrate how cleverly applied technologies can reinvigorate drugs that have lost patent protection or have not fully exploited their potential.
The report concludes with as showcase of dozens of reformulation companies and their development pipelines, and with an outlook to what we call the “Preprogrammed Rise of Alternative Drug Delivery”—an unavoidable development driven by the fact that lifecycle management and recouping of value from existing resources will continue to rule the pharmaceutical industry’s business throughout the 2010s.