[tt] Combining drugs and devices

[Hughes, James J.]

http://www.medicaldevicedaily.com/content/?cntid=225

Medical devices and how they can 'save' drugs

By JENNIFER BOGGS
Medical Device Daily Staff Writer

The MDD Perspectives column usually looks at new device-related
ventures. Changing that up a bit, we underline the emerging ability of
devices to bring a "new venture" emphasis to the device drug sector.

HANOVER, Germany - With nine out of 10 drugs in development falling to
the wayside on the road to market, biotech and pharma can find new
opportunities for those stalled programs by partnering with device firms
to look at different pathways and methods for delivery. That was a key
take-away from panelists discussing new drug/device possibilities at the
Biotechnica Partnering conference last week.

Part of the annual Biotechnica trade show at the Hanover Fair Grounds,
the conference began with a panel on combination products and the
valuation of those products to drug and device companies. The idea of
combining drugs and devices is increasingly opportunistic - most
obviously in drug-eluting stent technologies from Johnson & Johnson (New
Brunswick, New Jersey) and Boston Scientific (Natick, Massachusetts) -
and existing products are being reformulated with devices to extend
their patent life.

But there are significant difficulties in bringing together the
different skill sets of biomedical engineers and biomedical chemists.
And pharmas tend to focus more on getting their drugs successfully
through clinical testing, the opportunities for combinations with device
applications appearing far downstream.

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
Therataxis (Baltimore), emphasizing the need to look at existing drugs,
including compounds that have been shelved. The emphasis, he said,
should be on investigating whether a new device delivery method might
improve outcomes. 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 to be used in a previously unexplored
indication.

The challenge, said Gerben Moolhuizen, of OctoPlus (Leiden, the
Netherlands), is getting drug companies to take those old programs off
the shelf. 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. Bennett's company, Glide Pharma (Oxford, UK), develops a
spring-loaded, needle-free drug delivery device. A cartridge is placed
into the device and spring-loading is used to "push" a pharmaceutical
compound beneath the skin where it dissolves over a controlled period.
Glide, which changed its name from Caretek Medical 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
Biolex Therapeutics (Pittsboro, North Carolina) in the Research Triangle
area. 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 is initially 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, the panelists said, and they 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.