Drug Delivery is a funny old business. Back in the hey day, companies such as ALZA and Penwest were all the rage. These companies enabled Big Pharma companies to develop truly valuable, patent protected line extensions. Procardia XL was a blockbuster for Pfizer based primarily on convenience.
But, progress means change. Eventually, oral controlled release slowly became a commoditized capability, to be distinguished from a commoditized technology. In fact, there are many technologies which can confer oral or even parenteral controlled/sustained release. Once the generic companies mastered the skill of developing their own oral controlled delivery systems, the drug delivery industry seemed to wither slowly. In fact, most major generic companies are better capitalized, technologically sophisticated, and have access to capabilities in low-cost regions of the world. Thus, drug delivery companies with business models based exclusively on life cycle extensions are simply no longer sustainable.
Yet while the big pharma companies remain fixed on developed New Chemical Entities, there remain a plethora of therapeutic challenges which can be solved via drug delivery approaches. We are reminded of this today by some work perfumed at Syracuse University. Here, Bader and colleagues have described an approach for long-term delivery of methotrexate and cyclosporin locally for the treatment of rheumatoid arthritis.
This is a good example of how drug delivery approaches can be combined with “old” drugs to address unmet therapeutic medical needs. Other unmet medical needs that can be addressed via drug delivery include:
Ophthalmic Delivery – Companies such as DSM Biomedical are developing polymers which can be chemically linked to drugs and delivered to the back of the eye via injection. Once in place, the drug is slowly released from the polymer, an approach which is perfect for ophthalmic diseases.
Pain – As discussed in a prior post, there are very few new chemical entities in development for the treatment of moderate chronic pain. Until new drugs are developed, sustained and delayed release formulations of the old standbys remain highly useful. I think we need to see more novel combinations of pain medications (like an opioid and a non-opioid), but with delivery profiles that maximize and synergies the safety and efficacy profile of the individual entities.
Long Acting Depot – I think we are scratching the surface with what can be done with biodegradable, drug-containing implants. Companies such as Alkermes are successfully demonstrating what can be done with depot formulation. Personally I would like to see a depot of carbidopa/levodopa developed for Parkinson’s Disease.
Oral Films – Films are no longer restricted to mouthwash-like products. Example includes that Alzheimer’s drug. The critical issues with films are that the dose must be relatively low, and the drug must be taste masked. Companies such as APR are leaders in the field of designing and developing oral film formulations.
About 10 years ago I worked on a project for a drug delivery company. They were successful in working with companies who wanted to extend the life of their branded products. However, the drug delivery client wanted to penetrate deeper into Big Pharma R&D, especially into Preclinical and Phase I. The drug delivery company’s hypothesis was that a stronger presence in early-stage clinical research would enable them to salvage compounds that were being dropped due to poor pharmacokinetics.
I interviewed a number of big pharma researchers and a few heads of R&D. At that time, the conclusion was that big pharma generally preferred to “synthesize” their way out of a pharmacokinetic problem. This would enable them to create a new, patented chemical entity. But more importantly, it would save the pharma company the need to pay development fees and a Royalty to an external drug delivery company. The desire to avoid a Royalty payment is significant, as a drug delivery company could argue that they would deserve a large Royalty if the compound is saved from termination, and the opportunity is lost completely.
I believe a lot of pharmaceutical companies are missing the boat when it comes to using drug delivery technologies to rapidly develop products. It is true that the commercial life of a reformulated drug is shorter than a new chemical entity. It is also true that a Royalty will have to be paid to the technology provider. However, using more modern marketing techniques might bring development costs down and result in an attractive ROI for the right situation.