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
CERA R-744 by Roche
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
PEAK ANNUAL SALES
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."