The PharmExec 2005 Pipeline Report - Pharmaceutical Executive

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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


This oncology drug was born of a rare 50/50 partnership between a Big Pharma company and one with a single drug in clinical development. This Raf kinase inhibitor also suppresses VEGF. The anti-angiogenic compound is effective against a variety of cancers, including renal-cell carcinoma, hepatocellular carcinoma, and malignant melanoma.

"FDA is basically working on this one right now," says Georgetown's Gelmann. "It has shown interesting yet unpredictable activity in renal-cell cancer, and it will be tried, I'm sure, in other cancers as well."

Onyx and Bayer submitted an NDA earlier this year. They are also exploring the drug's efficacy in combination with chemotherapy agents, and as a solo therapy for additional tumor types.

Hematide [erythropoietin mimetic] by Affymax

TARGET INDICATION
Anemia
DEVELOPMENT
Phase II
LAUNCH DATE
Unknown

CERA R-744 by Roche

TARGET INDICATION
Anemia
DEVELOPMENT
Phase III
LAUNCH DATE
2006

Hematide is a peptide that functions like erythropoietin, the hormone that stimulates peripheral stem cells in the bone marrow to produce red blood cells. But unlike natural erythropoietin, which it does not resemble in its amino-acid sequence, Hematide is stable at room temperature and can be easily manufactured. The drug is currently in Phase II trials for treatment-induced anemia in cancer and chronic-kidney-disease patients.

The new drug will compete for market share with erythropoietin α, Amgen's $4 billion drug, distributed under a variety of brand names, including Procrit.

CERA (continuous erythropoesis receptor activator), on the other hand, is a me-too biotech, according to UBS's Molowa. "It is basically the exact same thing as erythropoietin," he says. "It's just that they potentially manufacture CERA in a way that gets them around the Amgen patents." Wood McKenzie projects CERA as a billion-dollar drug by 2009, and as a strong competitor of Procrit, primarily because of its more convenient dosing regimen. CERA is administered once every three to four weeks, about half as often as erythropoietin α.

Sutent [sunitinib malate] by Pfizer

TARGET INDICATION
Cancer (GIST)
DEVELOPMENT
Phase III
LAUNCH DATE
2006
PEAK ANNUAL SALES
$750 million

Sutent, still sometimes referred to as SU-11248, is a targeted therapy that acts on a wide variety of kinase receptors with significant anti-angiogenic properties. That is, it retards the growth of tumors by slowing the production of new blood vessels. In addition to its strong clinical data, Sutent has attracted attention as Pfizer's first significant oncology launch. Although the company did not develop the drug, Sutent will be the first cancer-drug marketing campaign Pfizer designs from the beginning.

"The current companies in the oncology space will be watching Pfizer's moves very closely," says Aitken. "They have a strong reputation for their sales and marketing prowess. Other companies will be watching how they apply that to what is generally recognized as a distinctive therapy area."


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