When is a drug not a drug? When it is a biologically active device...or so I learned while attending Insight Information's Medical Devices conference in Toronto last week. And that subtle difference could make a huge difference as the biopharmaceutical industry tries to make its way forward.
The thought arose as I listened to Dr. Michael May, president of Rimon Therapeutics , discuss his experiences in spinning out a company from an academic project. Aside from his comments about building networks and optimizing information flow, he described the early steps in the development of Theramers, therapeutic polymers that the company has been promoting for wound healing. With one Theramer, May and his colleagues discovered that something in the polymer itself inhibited matrix metalloproteases (MMPs), which are associated with tissue weakening.
As May was quick to point out, one of the keys to the company's present and future success was getting the FDA to designate their invention a medical device rather than a drug, dramatically simplifying the hoops through which they would have to jump to get a product to market. From an investment perspective, the company proudly boasts of druglike value delivered over device timelines—an attractive offer given the recent challenges in the pharmaceutical arena.
Theramers—and chemical constructions like them—add a new layer to the rhetoric about nanotechnology and materials science, which has largely focused on the development of drug delivery vehicles and devices. In this case, to borrow from Marshall McLuhan, the medium is the message.
To draw a parallel: Where drug-eluting stents—which have had their own share of media attention in the last year or so—went the next step beyond systemic drug delivery, Theramers go one step beyond drug-eluting stents, providing therapeutic value in the absence of a distinct therapeutic molecule.
As materials science continues to develop and new applications are being added to the medical repertoire, regulatory agencies will be flooded with submissions for therapeutic products offering drug-like value—to patient and investor, alike—on device timelines. How much we can expect these timelines to change is anyone's guess.
In 2005, Kalorama Information released a series of reports about wound dressings—for surgical, burn, and ulcer indications—which saw each of these markets measured in the $2- to $10-billion range. Within these markets, biological dressings were showing double-digit growth.