Patent expirations on blockbuster products and a lack of candidates coming through the pipeline to replace lost revenues are pressuring biopharma companies to make more of existing assets. Novel drug delivery technologies can help by extending the life-cycle of a drug facing generic competition.
“The need for new drug delivery technologies is greater than ever”Shams Rustom, senior director, product development and manufacturing, at Labopharm said in a presentation at Interphex 2012.
In their efforts to extract maximum value from each drug in their portfolio biopharma companies are looking to drug delivery technologies that improve the asset, for example by increasing convenience.
Similarly, manufacturers of generics are looking to gain an edge over innovator products through the use of novel drug delivery devices. The generics sector has become crowded, Rustom said, and a novel drug delivery device or other improvement can differentiate a product from the competition.
Without a drug delivery technology edge generics manufacturers are left competing on marketing or pricing, areas in which big companies can often use their scale to outmuscle smaller players. By using a novel delivery device generics manufacturers can gain a “huge” advantage, Rustom said.
The drug delivery battlefield could also extend to biosimilars if the US Food and Drug Administration (FDA) resists calls to overturn device flexibility in its current draft guidance. Since publication of the draft guidance innovator biopharma companies have criticised the FDA’s flexibility on device choice.
Stopping dose dumping
An area manufacturers of small molecule generics can improve existing products is release profiles. Some controlled release products suffer from deliberate or unintentional dose dumping – when the active is delivered all at once – and new technologies and formulations can cut this risk.
Dose dumping can happen when a controlled released product interacts with alcohol and, Rustom said, is a “really major issue for the FDA”. Labopharm is developing technologies that prevent dose dumping and is seeking a partner to move its oxycodone product into Phase III, Rustom said.