The PharmExec 2005 Pipeline Report - Pharmaceutical Executive


The PharmExec 2005 Pipeline Report
Dry? Not quite. Instead of 1990s-style blockbusters, pharma's new molecules are niche drugs, cancer treatments and—at last—innovative mechanisms for troublesome targets.

Pharmaceutical Executive

One of next year's few potential blockbusters, Exubera, an inhalable form of insulin, promises a therapeutic advance based exclusively on a new delivery system. Instead of injecting insulin when their blood sugar spikes, patients suffering from type-1 or type-2 diabetes inhale insulin powder deep into the lungs, where it is absorbed directly into the bloodstream.

Clinical data suggest that the inhaled drug takes effect about as fast as injected insulin, perhaps faster if the preparation time for IV or subcutaneous injections is taken into account. But the real advantages are convenience and comfort for patients who dislike injections and who will have a faster-acting alternative than orally administered insulin.

"It may allow patients to more appropriately manage their disease," says Ryan.

"Exubera will be very interesting in terms of a breakthrough product in short-acting inhaled insulin," says IMS' Murray Aitkin. "This means patient compliance and persistence improves."

However, Ryan warns that the new system's anticipated high price tag may be a deterrent for some patients or payers: "It will be interesting to see whether the market views the new system as a significant enough advance," she says.

Pfizer licensed the system for the inhaler and the formulation of the powdered insulin from Nektar Therapeutics, and Sanofi-Aventis will supply the insulin to Nektar for processing. Novo Nordisk and Eli Lilly also have inhaled insulin products in their pipelines, which are projected to launch in 2009 and 2010, respectively.

Lucentis [ranibizumab] by Genentech

Age-related macular degeneration
$600 million

Hotly anticipated by clinicians, patients, and Genentech shareholders, this antibody is a fragment of the larger Avastin (bevacizumab) antibody that inhibits vascular endothelial growth factor (VEGF). The anti-angiogenic properties are similar, but the smaller molecule penetrates deeper into the eye to stem leaks in vessels that deliver blood to the retina, and stop new blood-vessel growth behind the eye.

"This is the first product that's been proven in large clinical trials to improve eyesight for the average patient with the wet form of AMD," says Molowa.

The currently marketed products, Visudyne (verteporfin) and Macugen (pegaptanib), have been shown to reduce the progression of the disease, but not to actually reverse the blindness caused by AMD.

Provenge APC 8015 by Dendreon/Kirin

Prostate cancer
Phase III

Dendreon created a prostate cancer vaccine based on fusing common cellular components that generally occur in a successful immune response onto a dendritic cell, which usually presents an antigen. In this case, the dendritic cell carries PSA, a prostate-specific antigen, an enzyme that co-occurs with prostate cancer, and an agent that stimulates the growth of white blood cell colonies that fight the disease.

So far, the immunomodulator proved most effective for patients with a Gleason score of 7 (on a scale of 2 to 10, where 10 represents the highest likelihood that a tumor would spread). FDA has agreed that a final, ongoing Phase III study with approximately 275 patients with Gleason scores of 7—in other words, potentially the sickest patients—will provide a BLA. Kirin Brewery has licensed the vaccine.

"The preliminary data are interesting and encouraging," says Edward Gelmann, MD, an oncologist and professor of medicine at Georgetown. "But there's a huge amount of work still to be done in understanding how drugs like this are to be used in combination. The medical community, not pharma, takes up the task of mixing and matching them."

Sorafenib BAY 439006 by Onyx/Bayer

Phase III


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