HANOVER, Germany - As the first Biotechnica Partnering conference, piggybacked on the annual trade fair at the Hanover Fairgrounds, drew to a close, attendees gathered for the last of two panel sessions to look at the increasing popularity of drug/device combination products and the challenges of getting those to patients.
The combination product market, which include drug-eluting stents, antimicrobial catheters, photodynamic therapy and bone graft substitutes, totaled about $5.4 billion in 2005, and is expected to grow to $11.5 billion in 2010, said John Sterling, of Genetic Engineering, who chaired a panel, titled "Drug-Device Combination: Issues, Trends and Products." But despite the growing interest, biotech and medical device firms generally have been slow to ink collaboration deals.
Part of the problem has to do with biotech's lack of awareness with regard to firms in the medical device space, said Lothar Krinke, vice president of business development for Minneapolis-based Medtronic Inc. Biotech has long been accustomed to working with big pharma, and many small firms still aim for that big collaboration, like the potential $1 billion deal Lexington, Mass.-based Synta Pharmaceuticals Corp. signed last week with London-based GlaxoSmithKline plc. But those firms typically have been more reticent about working with medical device companies. Yet, Krinke argued, "biotech and medical device [firms] have more in common than biotech and big pharma." (See BioWorld Today, Oct. 11, 2007.)
Both tend to focus on targeted and controlled treatment and often place higher emphasis on innovation than the big pharmaceutical firms, which address large markets. So the challenge is "to educate biotech," he said. Undoubtedly, collaborations with medical device firms will lend themselves to different terms from the big pharma deals - maybe not the big dollars in up-front and milestone payments - that might be better for the small firms in the long run.
"I think there will be the capability for biotech to retain value" in a medical device collaboration, Krinke said.
For its part, Medtronic already has established several partnerships with drug companies, and Krinke said about a fourth of the medical device firm's revenue comes from combination products. The company has been working with Cambridge, Mass.-based Genzyme Corp. since 2004 on a joint venture to accelerate the development of cell therapies for cardiovascular disease using Medtronic's delivery devices and Genzyme's biological approaches to cardiac repair. And, in July, Medtronic expanded its 2005 deal with Alnylam Pharmaceuticals Inc., also of Cambridge, to develop drug/device combination products using RNAi for central nervous system diseases, with an initial focus on Huntington's disease. (See BioWorld Today, July 31, 2007.)
There are, however, plenty of issues to overcome before drug/device combinations become more common.
For one thing, both spaces require different sets of skills, and the small biotech companies might not have someone aboard their teams with device experience, and for another, drugs involve much higher risk and more development time than medical devices. Add to that a complicated process involving both a new drug application and a premarket approval application, and the drug/device combination market can seem a little daunting.
But as drug development moves away from "mass market" products and toward personalized medicine, combination products likely will become more critical, said Charl van Zyl, CEO of JADO Technologies, a Dresden, Germany-based firm spun out from the Max Planck Institute to develop small-molecule compounds targeting RAFT subcompartments in cellular membranes. While he said that medical devices will not completely supplant oral and topical formulations, the device market will be crucial for delivering certain drugs, especially those that have to cross the tricky blood-brain barrier.
Devices also will "play a big role in patient compliance," he said, and "in the convenience factor, as well."