Hospital antibiotics remain an attractive niche for specialty and biotech companies, which can remain profitable by charging
high prices and keeping small sales forces. IMS reports, for example, that with $250 million in sales from January through
November 2007, Cubicin was the fifth-highest-grossing antibiotic in the United States. But small companies can't gain the
global reach and supply chain savvy to distribute drugs outside developed or—at best—emerging nations.
"I've talked to all the companies with antibiotics in Phase III, and none of them plan to introduce those second-line antibiotics
into Africa," says University of Massachusett's Margaret Riley.
That being said, there's at least one forecast that can be made with confidence: As therapies become more advanced and expensive,
the developing world is likely to fall further behind. "The costs for some of the very sophisticated antibiotics that work
against multidrug-resistant infections are problematic," says Rib-X's Froshauer. "The armamentarium available to hospitals
in developing countries is very different."
Small companies also don't have the ability to establish support projects, like Lilly's technology-transfer program to teach
local and generic companies how to manufacture MDR-TB therapies, or even GSK's Alexander Project, a decade-long global AMR-surveillance
study. And if their drugs are not marketed in the developing world, these companies will be less likely to pursue counterfeiters—as
Pfizer has done.
"It's difficult to get therapies to the developing world," says Eisenstein of Cubist Pharmaceuticals. "Larger companies, like
Lilly, have a policy and process to get antibiotics to catastrophes. But [Cubist] just became profitable a year ago—we don't
have that kind of international machinery."
However, at least early-stage biotechs are trying new approaches to combat AMR. "It's important that there are a lot of irons
in the fire, that a lot of people are trying to reach the destination," says Novartis' Thomas Evans. "That's important because
we don't yet know the right road."
Some new promising approaches include peptide deformylase inhibitors and novel inhibitors of fatty acid biosynthesis, which
are entering clinical development. Still, by any measure, investment in research is weak—GSK estimates that a fourfold increase
is needed to generate a new antibiotic by 2012.
"If we block the ability of the microbe in one way, it will naturally select for ways around the therapy that we use," says
Thomas Parr, Targanta's chief scientific officer. "So it is a race—but not one that we're likely to win outright. It's going
to be a chronic struggle for all of us."
Greasing the Wheels of R&D
So when it comes to creating new antibiotics, what is the way forward? It's likely to include a variety of approaches.
On the legislative front, the passage of the FDA Revitalization Act offered a small victory. The bill includes a provision
geared toward incentivizing neglected-disease R&D by offering a priority-review voucher. This voucher will be given to companies
that develop drugs for neglected diseases, which they can use to "jump the queue" for FDA review of another product. Biotechs,
if they wish, might sell the voucher to gain cash. "The voucher can get a product to market more than a year ahead of schedule,"
says Jeffrey Moe, adjunct associate professor and senior director of business development for Duke University's Fuqua School
of Business. Moe proposed the voucher idea and said it can help companies secure the highly coveted first-in-market position.
These products can also qualify for orphan status.