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 final two panel sessions to look at the increasing popularity of drug/device combination products and the various challenges faced in getting these to patients.
The combination product market, which includes drug-eluting stents, antimicrobial catheters, photodynamic therapy and bone graft substitutes, totaled about $5.4 billion in 2005 — and the DES device sector exceeded all of that amount in 2006.
The combination market 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 in this area, biotech and medical device firms generally have not made much haste 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, VP of business development for Medtronic (Minneapolis) Biotech has long been accustomed to working with big pharma, and many small firms still aim for that big collaboration, such as the potential $1 billion-deal inked earlier this week between Synta Pharmaceuticals (Lexington, Massachusetts) and GlaxoSmithKline (London). But those firms typically have been more reticent about working with medical device companies.
Yet, Krinke argued that biotech and medical device firms “have more in common than biotech and big pharma.”
Both tend to focus on targeted and controlled treatment and often place higher emphasis on innovation than the big pharma 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 one-fourth of the medical device firm’s revenue comes from combination products.
The company has been working with Genzyme (Cambridge, Massachusetts) 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 (Cambridge), to develop drug/device combination products using RNAi for central nervous system diseases, with an initial focus on Huntington’s disease.
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 with device experience. Device firms may not understand the protocols used by pharmas. Additionally, drugs involve much higher risks and more development time than medical devices.
Add to that a complicated process involving both a new drug application and a premarket 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 (Dresden, Germany), a firm spun out from the Max Planck Institute (Bonn, Germany) to develop small-molecule compounds targeting RAFT sub-compartments 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,” van Zyl said, and “in the convenience factor, as well.”