HANOVER, Germany - With nine out of 10 drugs in development falling to the wayside on the road to market, biotech and pharma could find new opportunities for those stalled programs by partnering with device firms to look at different delivery methods, panelists suggested at the Biotechnica Partnering conference here.
The two-day conference, part of the annual Biotechnica trade show at the Hanover Fair Grounds, began with a panel chaired by BioWorld's Michael Harris on drug/device combination products and the valuation of those products to drug and device companies. While the idea of mixing drugs and devices has shown success in some areas - the drug-eluting stents from Johnson & Johnson and Boston Scientific are becoming widely used, and existing products are being reformulated with devices to extend their patent protection - it's hard to get biotech and pharma to look at device options for novel compounds. Those firms tend to focus more on getting their drugs successfully through clinical testing, and looking at opportunities to include a device come much later.
But new drugs are not being discovered at a rapid rate, at least not compared to the number of existing products, said Raghu Raghavan, of Baltimore-based Therataxis LLC, so it might be prudent to look at existing drugs, including compounds that have been shelved by biotech and pharma due to inadequate efficacy, and investigate whether a new delivery method via a device would improve outcome.
The drug's initial administration might be the reason that it failed, he said, or a different delivery system via a device might enable a compound for use in an indication previously unexplored.
The challenge there, said Gerben Moolhuizen, of OctoPlus NV, of Leiden, the Netherlands, is getting drug companies to take those old programs off the shelf. There tends to be a "negative feeling about those abandoned compounds," he said.
Drug development firms already need a little prodding to consider working with their counterparts on the medical device side, especially when it comes to brand-new compounds, but they "do see the benefits for next-generation" drugs, said Simon Bennett, whose company, Oxfordshire, UK-based Glide Pharma, develops a spring-loaded delivery device to "push" pharmaceutical compounds into the skin. Glide, which changed its name from Caretek Medical Ltd. last year to reflect its ambitions of building a product pipeline, is creating its own drug/device product pipeline using generic compounds, while collaborating with partners to develop new compounds with its delivery system.
But Moolhuizen recommended looking at the drug's "delivery access right from the start," rather than waiting for drug approval before adding the device. That's what OctoPlus is doing in its ongoing collaboration with Pittsboro, N.C.-based Biolex Therapeutics Inc. The companies are in Phase II testing with Locteron, a recombinant version of human alpha-interferon produced using Biolex's LEX system and combined with OctoPlus' biodegradable PolyActive drug delivery technology for controlled release. Locteron initially is in development for chronic hepatitis C infection.
As in all of drug development, the greatest risk - and greatest reward - comes from creating innovative therapeutics, so it might take time before the drug and device companies start advancing combination products to the market on a regular basis. Reformulating generics, on the other hand, poses much less development risk, though panelists agreed that drug/device versions must provide several improvements on the original. It should be able to improve response rate and tolerability while ensuring that its administration is simple enough to increase patient compliance and convenience. And perhaps most importantly, the cost "should be at least on par with what's out already," if not less, Moolhuizen said.
As the conference wraps up today, a second panel will explore the trends of drug/device combination efforts.