MORE THAN JUST A PHASE: Starting R&D Studies at "Zero" Could Save Pharma Millions
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While nearly 30 companies have DPP-IV products in their pipelines, two have emerged as leaders of the pack: Merck's Januvia
(sitagliptin), approved in October, and Novartis' Galvus (vildaglitin). Two weeks before Galvus' expected approval date, Novartis got word from FDA that the agency needs three more months to review
dosing and indication data. Despite this hiccup, industry watchers expect Januvia and Galvus eventually to go head-to-head,
racking up $2-to-$3 billion in annual sales each. "It's a very fair game," says Decision Resources senior pharmaceutical analyst
Donny Wong. "The efficacy and side effects are about the same."
Some trial results, though, suggest that Galvus may ultimately have an edge in efficacy. When used with other drugs, both
DPP-IV inhibitors produce similar drops in HbA1c (blood glucose)—close to three percent in patients with the highest baseline
HbA1c. But in one study, Galvus was as effective as TZDs—without their edema, heart-failure, and weight-gain complications.
Januvia so far has proved equally gentle, but industry watchers are touting Galvus' profile as superior overall.
Other companies with DPP-IV products in their pipelines: Bristol-Myers Squibb (saxagliptin, in Phase III), GlaxoSmithKline
(Redona, Phase III), and Sanofi-Aventis (SSR-162369, Phase I). Ferring Pharmaceuticals and Johnson & Johnson are also designing
a DPP-IV blocker, but with a twist—it's being tested for both diabetes and obesity. –JEANNETTE PARK
ONE-SHOT WONDER: Vaccines for HIV Spark Hope—and Ethical Debates
MRKAd5
Merck
TARGET INDICATION HIV vaccine
DEVELOPMENT Phase II
VCR-HIVADVO14-00-VP & VCR-HIVDNAO16-00-VP
NIH Vaccine Research Center
TARGET INDICATION HIV vaccine
DEVELOPMENT Phase II
With global HIV infections set to double to 80 million by 2010, the hunt for a vaccine is an urgent priority. But developing
and testing candidates poses so many scientific, ethical, and economic challenges that pharma has been understandably cool
to the concept.
As a result, the pipeline is a classic good news–bad news scenario. On the one hand, there are more molecules in play than
ever—and more money, thanks to Bill and Melinda Gates' $300 million bankroll. On the other, the 30-plus contenders "are almost
all based on the same approach," says Wayne Koff, vice president of R&D at the International AIDS Vaccine Initiative (IAVI).
"They elicit an immune response that may blunt HIV replication. What they won't do is prevent infection."
That's not your father's vaccine. But an inexpensive one-shot method of slowing disease in large numbers of people worldwide
is as good as it's likely to get for the next decade. After Sanofi-Aventis and VaxGen's 16,000-person ALVA/AIDSVAX trial went
bust last year, the traditional vaccine model—stimulating antibodies to neutralize a virus before it invades cells—got kicked
to the curb.
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