Pipeline - Pharmaceutical Executive

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Pipeline
Rays of Light


Pharmaceutical Executive



MORE THAN JUST A PHASE: Starting R&D Studies at "Zero" Could Save Pharma Millions
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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